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<?xml version="1.0" encoding="utf-8"?><feed xmlns="http://www.w3.org/2005/Atom" ><generator uri="https://jekyllrb.com/" version="3.10.0">Jekyll</generator><link href="https://transfemscience.org/feed-posts.xml" rel="self" type="application/atom+xml" /><link href="https://transfemscience.org/" rel="alternate" type="text/html" /><updated>2025-08-26T19:03:55-07:00</updated><id>https://transfemscience.org/feed-posts.xml</id><title type="html">Transfeminine Science</title><subtitle>Transfeminine Science is a site for information on hormone therapy for transfeminine people.</subtitle><author><name>Transfeminine Science</name></author></feed>
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<?xml version="1.0" encoding="utf-8"?><feed xmlns="http://www.w3.org/2005/Atom" ><generator uri="https://jekyllrb.com/" version="3.10.0">Jekyll</generator><link href="https://transfemscience.org/feed.xml" rel="self" type="application/atom+xml" /><link href="https://transfemscience.org/" rel="alternate" type="text/html" /><updated>2025-08-26T19:03:55-07:00</updated><id>https://transfemscience.org/feed.xml</id><title type="html">Transfeminine Science | Articles</title><subtitle>Transfeminine Science is a site for information on hormone therapy for transfeminine people.</subtitle><author><name>Transfeminine Science</name></author><entry><title type="html">Puberty Blockers: A Review of GnRH Analogues in Transgender Youth</title><link href="https://transfemscience.org/articles/puberty-blockers/" rel="alternate" type="text/html" title="Puberty Blockers: A Review of GnRH Analogues in Transgender Youth" /><published>2022-01-30T15:04:00-08:00</published><updated>2022-01-31T00:00:00-08:00</updated><id>https://transfemscience.org/articles/puberty-blockers</id><content type="html" xml:base="https://transfemscience.org/articles/puberty-blockers/"><![CDATA[<h1 id="puberty-blockers-a-review-of-gnrh-analogues-in-transgender-youth">Puberty Blockers: A Review of GnRH Analogues in Transgender Youth</h1>
<?xml version="1.0" encoding="utf-8"?><feed xmlns="http://www.w3.org/2005/Atom" ><generator uri="https://jekyllrb.com/" version="3.10.0">Jekyll</generator><link href="https://transfemscience.org/feed.xml" rel="self" type="application/atom+xml" /><link href="https://transfemscience.org/" rel="alternate" type="text/html" /><updated>2025-09-11T15:19:01-07:00</updated><id>https://transfemscience.org/feed.xml</id><title type="html">Transfeminine Science | Articles</title><subtitle>Transfeminine Science is a site for information on hormone therapy for transfeminine people.</subtitle><author><name>Transfeminine Science</name></author><entry><title type="html">A Review of Pharmaceutical Interventions for Scalp Hair Loss and Implications for Transfeminine People</title><link href="https://transfemscience.org/articles/hair-loss/" rel="alternate" type="text/html" title="A Review of Pharmaceutical Interventions for Scalp Hair Loss and Implications for Transfeminine People" /><published>2025-09-08T18:00:00-07:00</published><updated>2025-09-09T00:00:00-07:00</updated><id>https://transfemscience.org/articles/hair-loss</id><content type="html" xml:base="https://transfemscience.org/articles/hair-loss/"><![CDATA[<h1 id="a-review-of-pharmaceutical-interventions-for-scalp-hair-loss-and-implications-for-transfeminine-people">A Review of Pharmaceutical Interventions for Scalp Hair Loss and Implications for Transfeminine People</h1>
<!-- Supports up to four authors per article currently (author, author2, author3, author4) -->
<p>By
<!-- First author --><a href="/about/#sam">Sam</a><!-- Second author --><!-- Third author --><!-- Fourth author --> | First published September 8, 2025
| Last modified September 9, 2025</p>
<h2 id="abstract--tldr">Abstract / TL;DR</h2>
<p>Androgenetic alopecia is a common condition affecting a significant proportion of transfeminine people at onset of hormonal transition. Although several studies have assessed the influence of gender-affirming hormone therapy on scalp hair, there are no robust data to guide optimal dosing regimens. In the wider population, 5α-reductase inhibitors and other treatments, such as minoxidil, have been found to act dose-dependently and additively or synergistically with each other to halt and partially reverse hair loss caused by androgens. Some transfeminine people prefer to add these treatments to their regimens to try to regrow more hair or as prophylaxis against further hair loss. Dutasteride is a superior 5α-reductase inhibitor to finasteride in terms of efficacy and has similar adverse effects. For transfeminine people who wish to use minoxidil, the route of administration should be considered and determined on an individual basis. Other agents, such as spironolactone, may also provide benefit. Research into new therapies which could one day result in new pharmaceutical options for transfeminine people is currently ongoing in the general population.</p>
<h2 id="introduction">Introduction</h2>
<p>Scalp hair loss, particularly <a href="https://en.wikipedia.org/wiki/Pattern_hair_loss">androgenetic alopecia</a> (AGA), is a condition that affects millions of people worldwide and that carries significant psychosocial implications. Hair is a major component of human identity and is often integral to gender expression. As such, hair loss can be particularly distressing for transfeminine people (<a href="https://doi.org/10.1016/j.det.2019.10.010">Marks &amp; Senna, 2020</a>; <a href="https://doi.org/10.1016/j.jaad.2023.01.037">Gao et al., 2023a</a>; <a href="https://doi.org/10.1093/ced/llad203">Tang et al., 2023</a>). Over the last decade, there has been a surge in interest in pharmaceutical treatments for treating AGA among both the scientific community and the general population. However, considerably less attention has been devoted to treating AGA in transfeminine people, specifically.</p>
<p>A few studies have evaluated the effects of feminising hormone therapy on scalp hair. A multicentre prospective study found a slight but statistically significant reduction in average <a href="https://en.wikipedia.org/wiki/Hamilton%E2%80%93Norwood_scale">Norwood–Hamilton score</a> after 12 months in transfeminine people treated with estradiol and cyproterone acetate (<a href="https://doi.org/10.1007/s40618-022-01944-x">Cocchetti et al., 2023</a>). In another study, duration of estradiol use with or without <a href="https://en.wikipedia.org/wiki/Spironolactone">spironolactone</a> was associated with a −0.07 cm (95% CI: [−0.10, −0.04]) reduction in lateral forehead length per year in the first few years of treatment (<a href="https://doi.org/10.1016/j.bjps.2024.07.044">Nguyen et al., 2025</a>). Finally, a prospective study demonstrated statistically significant increases in follicular density and total hair count at both the midfrontal and vertex (crown) scalp after 24 weeks in transfeminine people on an unspecified regimen (<a href="https://doi.org/10.1016/j.jaad.2025.01.087">Tang et al., 2025a</a>). This was accompanied by a reduction in average hair shaft diameter, driven by increases in intermediate and vellus hair density, but with no significant change in terminal hair density. Individual case studies and series showing improvement have also been reported in the literature (<a href="https://scholar.google.com/scholar?cluster=103653152682932548">Dewhurst &amp; Underhill, 1979</a>; <a href="https://doi.org/10.1016/j.jaad.2011.10.017">Adenuga, Summers, &amp; Bergfel, 2012</a>; <a href="https://doi.org/10.1089/trgh.2016.0022">Stevenson, Wixon, &amp; Safer, 2016</a>). Overall, it appears that AGA progression is usually halted and partially reversed due to reduced or suppressed testosterone levels. However, there is a lack of data to inform long-term outcomes. Reversal of AGA may be incomplete in many transfeminine people, particularly in advanced stages, due to irreversible follicular miniaturisation.</p>
<p>The most common therapies for AGA in cisgender people include <a href="https://en.wikipedia.org/wiki/5%CE%B1-Reductase_inhibitor">5α-reductase inhibitors</a> (5-ARIs) and <a href="https://en.wikipedia.org/wiki/Minoxidil">minoxidil</a> (<a href="https://doi.org/10.1016/j.jaad.2021.08.067">Gao et al., 2023b</a>; <a href="https://doi.org/10.1007/s40265-023-01880-x">Devjani et al., 2023</a>). Minoxidil use in transfeminine people has been examined by a small study (<a href="https://doi.org/10.1016/j.jaad.2025.06.029">Zaminski et al., 2025</a>). A study also found that concomitant use of <a href="https://en.wikipedia.org/wiki/Finasteride">finasteride</a>, <a href="https://en.wikipedia.org/wiki/Dutasteride">dutasteride</a>, and/or minoxidil was associated with a lower hairline compared to treatment with estradiol alone or estradiol and spironolactone alone (<a href="https://doi.org/10.1016/j.bjps.2024.07.044">Nguyen et al., 2025</a>). However, limitations of these studies include risk of bias due to study design, possible confounding due to secondary factors, and in the case of the former study, lack of a control group. As such, there is a paucity of reliable data to show if these treatments, especially 5-ARIs, provide additional benefit over gender-affirming hormone therapy alone (<a href="https://doi.org/10.1210/er.2018-00011">T’Sjoen et al., 2019</a>; <a href="https://doi.org/10.1080/17446651.2020.1825075">Prince &amp; Safer, 2020</a>; <a href="https://doi.org/10.1111/andr.12881">Irwig, 2021</a>; <a href="https://doi.org/10.1080/26895269.2022.2100644">Coleman et al., 2022</a>; <a href="https://doi.org/10.1016/j.jaad.2021.08.067">Gao et al., 2023b</a>). Despite this, a considerable subset of transfeminine people opt to use 5α-reductase inhibitors and minoxidil (<a href="https://doi.org/10.1089/trgh.2017.0035">Leinung, Feustel, &amp; Joseph, 2018</a>; <a href="https://doi.org/10.1016/j.bjps.2024.07.044">Nguyen et al., 2025</a>).</p>
<p>The purpose of this literature review is to critically summarise various pharmaceutical interventions that have been shown to have an acceptable safety profile in the general population and that may therefore be used as adjunct therapy to treat and as prophylaxis against hair loss in transfeminine people if desired. Non-pharmaceutical interventions, such as <a href="https://en.wikipedia.org/wiki/Collagen_induction_therapy">microneedling</a> and <a href="https://en.wikipedia.org/wiki/Hair_transplantation">hair transplantation</a>, are outside the scope of this article. Specifically, this review focuses predominantly on 5-ARIs and minoxidil but also discusses androgen receptor antagonists, in addition to some further therapies that may be available in the future.</p>
<h2 id="etiology-of-androgenetic-scalp-hair-loss">Etiology of Androgenetic Scalp Hair Loss</h2>
<p>Androgenetic alopecia, commonly referred to as male-pattern or female-pattern hair loss, is a polygenic condition characterised by progressive miniaturisation of scalp hair follicles in a pattern-specific distribution (<a href="https://doi.org/10.1007/978-3-030-76111-0_11">Anastassakis, 2022</a>; <a href="https://doi.org/10.1007/978-3-031-64083-4_9">Ovcharenko, Khobzei, &amp; Lortkipanidze, 2025</a>). The pathophysiology of male-pattern hair loss is fundamentally androgen-dependent. Specifically, <a href="https://en.wikipedia.org/wiki/Dihydrotestosterone">dihydrotestosterone</a> (DHT) binds to the androgen receptors in susceptible hair follicles, in turn initiating a cascade of transcriptional changes that alter the follicular growth cycle. This includes shortening of the <a href="https://en.wikipedia.org/wiki/Human_hair_growth#Anagen_phase">anagen</a> (growth) phase, prolongation of the <a href="https://en.wikipedia.org/wiki/Human_hair_growth#Telogen_phase">telogen</a> (resting) phase, and eventually, follicular miniaturisation (<a href="https://doi.org/10.1002/der2.58">Dhurat &amp; Daruwalla, 2021</a>). Notably, while androgens are necessary for the development of AGA, they are not sufficient on their own; individuals with high circulating androgens may not develop AGA if their follicles lack the required sensitivity level (<a href="https://doi.org/10.4103/ejdv.ejdv_46_19">Khaled et al. 2020</a>).</p>
<p>The genetic architecture of AGA is complex and involves multiple loci, although the AR gene on the X chromosome is generally thought to be a significant contributor (<a href="https://doi.org/10.4103/ijd.ijd_729_23">Sadasivam et al., 2024</a>). Polymorphisms in the AR gene, particularly those affecting receptor sensitivity, have been associated with increased risk of AGA. Additionally, epigenetic factors, including methylation patterns and histone modifications, may also play a role in regulating gene expression relevant to hair follicle cycling. Large <a href="https://en.wikipedia.org/wiki/Genome-wide_association_study">genome-wide association studies</a> (GWAS) have identified other loci which modulate follicular response to androgens in the scalp (<a href="https://doi.org/10.1038/s41467-017-01490-8">Pirastu et al., 2017</a>; <a href="https://doi.org/10.1038/s41431-022-01201-y">Chen et al., 2022</a>; <a href="https://doi.org/10.1016/j.xhgg.2025.100428">Janivara et al., 2025</a>).</p>
<p>Not all scalp follicles are equally sensitive to androgens. Susceptibility is region-specific and genetically determined, with the vertex and frontal scalp being most affected (<a href="https://doi.org/10.1111/j.1365-2133.2003.05565.x">Severi et al., 2003</a>; <a href="https://doi.org/10.1016/j.jdin.2024.07.003">Fujimaki et al., 2024</a>). The expression of <a href="https://en.wikipedia.org/wiki/5%CE%B1-Reductase">5α-reductase</a>, the enzyme responsible for converting testosterone to DHT, is elevated in these regions, which serves to further amplify local androgenic signalling (<a href="https://doi.org/10.1002/der2.58">Dhurat &amp; Daruwalla, 2021</a>). While androgens promote hair growth in areas such as the beard and chest, they paradoxically cause scalp hair loss in genetically predisposed individuals (<a href="https://doi.org/10.1007/978-3-030-76111-0_11">Anastassakis, 2022</a>; <a href="https://doi.org/10.1007/978-3-031-64083-4_9">Ovcharenko, Khobzei, &amp; Lortkipanidze, 2025</a>). Miniaturised scalp hair follicles in AGA undergo a progressive transformation. There may be a critical window for intervention in which current therapeutic strategies may reverse or significantly slow progression. Ultimately, the follicles eventually enter a state of dormancy or senescence, rendering them unable to produce cosmetically significant hair. However, the follicles themselves do appear to remain <em>in situ</em>.</p>
<p>Although pattern hair loss is often divided into “male-“ or “female-“ pattern hair loss in the literature, the presentation is often similar. Studies of men with pattern hair loss have consistently shown the role of DHT (<a href="https://doi.org/10.1210/jcem.86.12.8078">Vierhapper et al., 2001</a>; <a href="https://doi.org/10.1111/j.1365-2133.2005.07072.x">Ryu et al., 2006</a>; <a href="https://doi.org/10.1016/j.jaad.2006.05.007">Olsen et al., 2006</a>). There are three isoforms of 5α-reductase: type I, II, and III, all of which are thought to contribute to AGA. However, the mechanism of type III 5α-reductase is less well understood. It is notable that men with <a href="https://en.wikipedia.org/wiki/5%CE%B1-Reductase_2_deficiency">5α-reductase type II deficiency</a> do not experience AGA (<a href="https://doi.org/10.1016/S0303-7207(02)00368-4">Imperato-McGinley &amp; Zhu, 2002</a>). Consequently, reducing intracellular DHT concentrations can prevent AGA. However, the involvement of DHT in female AGA is less clear. A study of women with pattern hair loss found that mean average concentrations of testosterone and DHT were higher than in controls without AGA, but still within the female range (<a href="https://doi.org/10.1016/S0026-0495(03)00060-X">Vierhapper et al., 2003</a>). Hence, female concentrations of testosterone and DHT appear to be associated with pattern hair loss in a certain subset of women. A case of a woman with <a href="https://en.wikipedia.org/wiki/Complete_androgen_insensitivity_syndrome">complete androgen insensitivity syndrome</a> (CAIS) with female pattern hair loss has been reported in the literature (<a href="https://doi.org/10.1111/j.1365-2133.2010.09661.x">Cousen &amp; Messenger, 2010</a>).</p>
<h2 id="5α-reductase-inhibitors">5α-Reductase Inhibitors</h2>
<p>5α-Reductase inhibitors are a class of medications developed to treat conditions caused by the effects of DHT, such as benign prostatic hyperplasia and androgenetic alopecia. As implied by their name, these medications function by inhibiting 5α-reductase enzyme activity. Whilst not curative, 5-ARIs appear to halt or substantially slow hair loss in cisgender men. Globally, the two most widely used 5-ARIs include finasteride and dutasteride.</p>
<h3 id="efficacy-of-finasteride-compared-to-dutasteride-in-aga">Efficacy of Finasteride Compared to Dutasteride in AGA</h3>
<p>In the United States, finasteride prescriptions have increased exponentially in recent years, largely driven by its use in the treatment of hair loss (<a href="https://www.americanhairloss.org/booming-demand-us-sees-200-surge-in-finasteride-prescriptions-over-7-years/">AHLA, 2024</a>). Dutasteride prescriptions are far fewer, estimated in the hundreds of thousands, but also growing due to increased use for AGA. This difference is largely due to finasteride being widely licensed for this indication throughout the world, whilst dutasteride remains off-label in most countries (<a href="https://doi.org/10.1152/physrev.00005.2024">Altendorf et al., 2025</a>). However, dutasteride is licensed for use in the treatment of AGA in South Korea, Japan and Mexico. Increasing interest is driving further adoption and research into its use.</p>
<p>Despite its use for AGA being mostly off-label, dutasteride is now widely regarded as a more efficacious and hence superior 5-ARI than finasteride. Numerous studies have established that dutasteride results in greater suppression of serum DHT concentrations (i.e., about 70% with finasteride vs 90–95% with dutasteride) (<a href="https://doi.org/10.1210/jc.2003-030330">Clark et al., 2004</a>; <a href="https://doi.org/10.1016/j.jaad.2006.05.007">Olsen et al., 2006</a>; <a href="https://doi.org/10.1210/jc.2006-2203">Amory et al., 2007</a>; <a href="https://doi.org/10.1016/j.talanta.2014.07.087">Upreti et al., 2015</a>). Another study directly comparing scalp tissue concentrations found that dutasteride reduced DHT substantially more than finasteride (mean reduction of about 65% with finasteride versus 90% with dutasteride, though with wide interindividual variation). (<a href="https://doi.org/10.1016/j.cca.2023.117456">Hobo et al., 2023</a>). These differences have been primarily attributed to its broader inhibition of the 5α-reductase enzyme. More specifically, finasteride is a selective inhibitor of type II and III 5α-reductase, whereas dutasteride indiscriminately acts on all three isoforms (<a href="https://doi.org/10.1016/S0009-9236(98)90054-6">Gisleskog et al., 1998</a>; <a href="https://doi.org/10.2165/00003495-200868040-00008">Keam &amp; Scott, 2008</a>; <a href="https://doi.org/10.1515/HMBCI.2010.035">Yamana, Labrie, &amp; Luu-The, 2010</a>). Dutasteride has also been theorised to accumulate inside certain tissues, further enhancing its therapeutic effect.</p>
<p>In accordance with the above, two large network meta-analysis studies found that oral dutasteride is superior to oral and topical finasteride in the treatment of male AGA in terms of both total hair density and terminal hair density (<a href="https://doi.org/10.1111/jocd.16362">Gupta et al., 2024a</a>; <a href="https://doi.org/10.1111/jocd.70320">Gupta et al., 2025a</a>). These studies also found the effects of finasteride and dutasteride to be dose-dependent. On average, there was no difference between treatment groups using oral and topical finasteride. A systematic review found that dutasteride was superior to finasteride in some studies in terms of hair thickness (<a href="https://doi.org/10.4081/dr.2024.9909">Almudimeegh et al., 2024</a>). However, in contrast to the above findings in the case of male AGA, a network meta-analysis of studies investigating different interventions for female AGA found that clinical trials assessing the effectiveness of dutasteride do not yet exist (<a href="https://doi.org/10.1111/jocd.15910">Gupta et al., 2024b</a>). Notably, oral finasteride given at a dose of 1 mg/day was not found to be effective in treating female AGA, yet oral finasteride used at a dose of 5 mg/day outperformed all other single-agent interventions. Because of the dose-dependent effects of 5-ARIs, it could well be that dutasteride might be more efficacious than finasteride in the treatment of female AGA, as in male AGA. Hopefully, future clinical trials will shed light on this.</p>
<h3 id="adverse-effects-of-5α-reductase-inhibitors">Adverse Effects of 5α-Reductase Inhibitors</h3>
<p>5-ARIs are associated with certain adverse effects in a subset of individuals. These include, but are not limited to decreased libido, erectile dysfunction, reduced ejaculate volume and, possibly, fatigue and depression (<a href="https://pubmed.ncbi.nlm.nih.gov/32790610/">Gupta, Vujcic, &amp; Gupta, 2020</a>; <a href="https://doi.org/10.5021/ad.22.027">Choi et al., 2022</a>; <a href="https://doi.org/10.1371/journal.pone.0309849">Zhong et al., 2025</a>; <a href="https://doi.org/10.1038/s41443-025-01025-6">Cilio et al., 2025</a>). In the case of transfeminine hormone therapy, some of these effects may actually be desirable.</p>
<p>Currently, there are no large cohort studies or randomised controlled trials that have investigated the incidence of certain adverse effects of hormone therapy with 5-ARIs in transfeminine people. Studies of the general cisgender population may provide some limited insight. A meta-analysis of clinical trials found that the odds of hypoactive sexual desire and erectile dysfunction were each approximately 1.5-fold greater, in male users of 5-ARIs versus placebo (<a href="https://doi.org/10.1111/andr.12353">Corona et al., 2017</a>). No difference was found between finasteride and dutasteride in their effects on sexual desire. This is in accordance with findings from more recent publications (<a href="https://doi.org/10.2147/CIA.S192435">Zhou et al., 2019</a>; <a href="https://doi.org/10.1016/j.jaad.2019.03.043">Zahkem et al., 2019</a>; <a href="https://doi.org/10.52504/001c.88531">Estill et al., 2023</a>; <a href="https://doi.org/10.1111/ijd.17887">Neubauer, Ong, &amp; Lipner, 2025</a>). It is possible that 5-ARIs could produce further reduction in sexual function combined with other hormone therapy medications in transfeminine people, but there are no data to confirm or refute this.</p>
<p>Some studies have found that 5-ARIs are associated with slightly increased circulating testosterone levels (<a href="https://doi.org/10.1210/jc.2006-2203">Amory et al., 2007</a>; <a href="https://doi.org/10.1016/j.jsbmb.2013.02.015">Stanczyk, Azen, &amp; Pike, 2013</a>; <a href="https://doi.org/10.1111/iju.13470">Maeda et al., 2018</a>). However, a 2019 meta-analysis of studies of cisgender men concluded that finasteride and dutasteride use did not unequivocally result in statistically significant increases in serum testosterone levels (<a href="https://doi.org/10.1016/j.sxmr.2018.06.002">Traish et al., 2019</a>). The relevance of marginally raised testosterone in individuals receiving gender-affirming hormone therapy is unclear because exogenous estrogen and antiandrogen therapy typically suppresses endogenous testosterone production to concentrations far below the male range. Nevertheless, a retrospective analysis of transfeminine people using oral estradiol and spironolactone did find that finasteride use appeared to have a moderately deleterious effect on testosterone suppression (<a href="https://doi.org/10.1089/trgh.2017.0035">Leinung, Feustel, &amp; Joseph, 2018</a>). Studies have generally found that spironolactone does not, by itself, actually lower testosterone concentrations in transfeminine people (<a href="https://doi.org/10.1111/cen.14329">Angus et al., 2021</a>). As such, these findings might not be applicable to other antigonadotrophic antiandrogens such as GnRH agonists and progestogens including cyproterone acetate. The influence of 5-ARIs on testosterone concentrations in transfeminine people would be an interesting point for more studies to explore in the future.</p>
<p>The possible effect of 5-ARIs on cognitive function, mood, depression, and suicide risk is controversial. Androgen deprivation therapy, in general, results in an increased risk of psychiatric complications (<a href="https://doi.org/10.1016/j.euf.2019.11.010">Izard &amp; Siemens, 2020</a>; <a href="https://doi.org/10.1016/j.euf.2020.05.014">Siebert, Lapping-Carr, &amp; Morgans, 2020</a>). These effects have been attributed to the depletion of circulating testosterone available for conversion into estrogens and hence can be mitigated with the use of concomitant estradiol administration (<a href="https://doi.org/10.1210/jendso/bvae107">Coelingh Bennink et al., 2024</a>). However, in some studies, 5-ARIs have been associated with increased rates of depression despite testosterone levels remaining well within the male range. Several large pharmacovigilance studies have found signals for reduced cognitive function, depression, and suicidality in users of finasteride and dutasteride (<a href="https://doi.org/10.1001/jamadermatol.2020.3385">Nguyen et al., 2021</a>; <a href="https://doi.org/10.1080/14740338.2023.2294926">Cho et al., 2024</a>; <a href="https://doi.org/10.1371/journal.pone.0309849">Zhong et al., 2025</a>; <a href="https://doi.org/10.1111/jocd.70102">Gupta et al., 2025b</a>; <a href="https://doi.org/10.1007/s00228-025-03851-5">Lee at al., 2025</a>). In some of these studies, the signals have been quite strong. These data have prompted some countries to mandate warnings about possible long-term side effects on product labels. The psychiatric effects of 5-ARIs have been hypothesised to be a consequence of this class of drugs also inhibiting the synthesis of <a href="https://en.wikipedia.org/wiki/Neurosteroid">neuroactive steroids</a> such as <a href="https://en.wikipedia.org/wiki/Allopregnanolone">allopregnanolone</a>. These neurosteroids may have antidepressant and anxiolytic effects. In contrast to the findings of pharmacovigilance studies, a 2024 meta-analysis incorporating prospective study data from around 2 million users of 5-ARIs did not find associations for depression (aHR: 1.30, 95% CI: 0.85–2.00) or suicide (aHR 1.30, 95% CI: 0.65–2.61) (<a href="https://doi.org/10.1016/j.euf.2024.04.009">Uleri et al., 2024</a>). Subgroup analyses for finasteride and dutasteride yielded similar findings. It should be noted that despite the extremely large sample size, the confidence intervals in the pooled risk estimates were still wide and hence could not rule out marginal risk increases. Overall, these findings may be both concerning and reassuring at the same time. Whilst the involvement of 5-ARIs in mood and depression still remains unclear, the preponderance of evidence strongly suggests that any excess risk is likely to be small.</p>
<h3 id="post-finasteride-syndrome">Post-Finasteride Syndrome</h3>
<p><a href="https://en.wikipedia.org/wiki/Finasteride#Post-finasteride_syndrome">“Post-finasteride syndrome”</a> (PFS) is an even more controversial and poorly understood condition characterised by persistent sexual, neurological, and psychological symptoms that arise during or after the use of finasteride or dutasteride (<a href="https://doi.org/10.1038/s41443-025-01025-6">Cilio et al., 2025</a>; <a href="https://doi.org/10.1038/s41443-023-00759-5">Leliefeld, Debruyne, &amp; Reisman, 2025</a>). PFS has gained increasing attention since it was popularised in the literature in 2012 following a subset of 5-ARI users reporting enduring adverse effects after discontinuation (<a href="https://doi.org/10.1111/j.1743-6109.2012.02846.x">Irwig, 2012</a>).</p>
<p>Various case reports and studies have been published reporting associations between 5-ARIs and PFS symptoms (<a href="https://doi.org/10.1111/j.1743-6109.2010.02157.x">Traish et al., 2011</a>; <a href="https://doi.org/10.1111/j.1743-6109.2011.02255.x">Irwig &amp; Kolukula, 2011</a>; <a href="https://doi.org/10.1111/j.1743-6109.2012.02846.x">Irwig, 2012</a>; <a href="https://doi.org/10.1002/smrj.19">Irwig, 2014</a>; <a href="https://doi.org/10.1016/j.jsbmb.2014.03.012">Caruso et al, 2015</a>; <a href="https://doi.org/10.1002/phar.1612">Ali, Heran, &amp; Etminan, 2015</a>; <a href="https://doi.org/10.1002/phar.1837">Guo et al., 2016</a>; <a href="https://doi.org/10.7717/peerj.3020">Kiguradze et al., 2017</a>; <a href="https://doi.org/10.1016/j.abd.2020.02.001">Pereira &amp; Coelho, 2020</a>). Notably, one apparently well-designed study reported altered levels of neuroactive steroids in cerebrospinal fluid and plasma after discontinuation of finasteride in men who reported suffering from PFS symptoms (<a href="https://doi.org/10.1016/j.jsbmb.2014.03.012">Caruso et al, 2015</a>). A retrospective analysis also found that rates of erectile dysfunction were higher in men with cumulatively greater exposure to finasteride and dutasteride (<a href="https://doi.org/10.7717/peerj.3020">Kiguradze et al., 2017</a>). However, overall these data have been of low-quality, at high risk of bias, may have been confounded by secondary variables, and universally suffer from the lack of a placebo control group to establish causation (<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC5023004/">Hirshburg et al., 2016</a>; <a href="https://doi.org/10.1159/000497362">Trüeb et al., 2019</a>; <a href="https://doi.org/10.4103/ijt.ijt_122_21">Trüeb et al., 2024</a>). As such, by themselves they are of limited usefulness. More recently, a pharmacovigilance study identified the existence of a signal for “post-finasteride syndrome” with finasteride in the FAERS database (<a href="https://doi.org/10.1371/journal.pone.0309849">Zhong et al., 2025</a>).</p>
<p>A substantial <a href="https://en.wikipedia.org/wiki/Nocebo">nocebo</a> effect appears to exist in users of 5-ARIs pertaining to PFS-like symptoms (<a href="https://doi.org/10.1080/13685538.2018.1548589">Maksym, Kajdy, &amp; Rabijewski, 2019</a>). A study found that men who were made aware of sexual adverse effects before being treated were much more likely to report them during follow-up (43.6%), compared to men who were not (14.3%) (<a href="https://doi.org/10.1111/j.1743-6109.2007.00563.x">Mondaini et al., 2007</a>). These data show that the power of suggestion is likely to influence the experience of many individuals using 5-ARIs. A more comprehensive pharmacovigilance study of the FAERS database performed analyses stratified by time period and 5-ARI medication (<a href="https://doi.org/10.1111/jocd.70102">Gupta et al., 2025b</a>). The study conducted disproportionality analyses for five adverse events related to suicide between 2006 and 2011, 2013 and 2018, and 2019 and 2023. No signals were detected for oral finasteride between 2006 and 2011, but signals emerged in later periods, with increased reporting odds for suicidal ideation between 2013 and 2018 and between 2019 and 2023. Despite oral dutasteride being more efficacious in its action as a 5-ARI, dutasteride showed no significant signals across any time period. The authors concluded that these findings were suggestive of increased awareness of PFS being the cause of heightened reporting of psychiatric adverse events to FAERS, rather than reflecting a true pharmacological effect (<a href="https://doi.org/10.1111/jocd.70102">Gupta et al., 2025b</a>).</p>
<p>Taken together, all these findings provide limited evidence for the existence of PFS in a small subset of individuals. However, the evidence for persistent long-term adverse effects stemming from finasteride and dutasteride use is tenuous at best.</p>
<h2 id="minoxidil">Minoxidil</h2>
<p>Minoxidil is a medication with antihypertensive and vasodilator effects which was originally developed as an oral formulation for high blood pressure. However, it was found to have the unexpected side effect of promoting hair growth, which led to its reformulation as a topical solution and adoption for AGA. Oral minoxidil is also now increasingly being used at lower doses to treat hair loss.</p>
<h3 id="mechanism-of-action-of-minoxidil-in-hair-loss">Mechanism of Action of Minoxidil in Hair Loss</h3>
<p>The exact means by which minoxidil is involved in promoting hair growth is not fully understood (<a href="https://doi.org/10.1159/000531890">Gupta et al., 2023</a>; <a href="https://doi.org/10.18773/austprescr.2025.020">Iyengar &amp; Li, 2025</a>). It is believed that minoxidil functions by improving blood flow to hair follicles, which in turn increases circulation and which may help revitalise shrunken follicles, extend the growth phase of the hair cycle, and encourage thicker, longer hair strands (<a href="https://doi.org/10.2340/actadv.v104.24213">Zeltzer et al., 2024</a>; <a href="https://doi.org/10.1016/j.bioadv.2025.214423">Tan et al., 2025</a>). A sulphotransferase enzyme converts minoxidil into its active metabolite, <a href="https://en.wikipedia.org/wiki/Minoxidil_sulfate">minoxidil sulfate</a>. Differences in sulphotransferase enzyme expression between individuals appear to augment the efficacy of minoxidil (<a href="https://doi.org/10.1111/dth.12686">Goren &amp; Naccarato, 2018</a>). Clinical effects on hair growth typically begin after 2 to 4 months of consistent use, with maximal results seen around 6 to 12 months. Clinical response with minoxidil therapy appears to be highly variable. In randomised controlled trials, minoxidil monotherapy has been effective in increasing total hair density, as well as terminal hair density in both male and female AGA compared to controls (<a href="https://doi.org/10.1001/jamadermatol.2021.5743">Gupta et al., 2022a</a>; <a href="https://doi.org/10.1111/jocd.16362">Gupta et al., 2024a</a>; <a href="https://doi.org/10.1111/jocd.15910">Gupta et al., 2024b</a>; <a href="https://doi.org/10.1111/jocd.70320">Gupta et al., 2025a</a>). In these studies, the efficacy of minoxidil has also been shown to be strongly dose-dependent.</p>
<p>Minoxidil has also been found to act synergistically with 5-ARIs and certain other therapies in the treatment of AGA. Studies have shown that users of both minoxidil and a 5-ARI experience greater improvements in hair density and thickness compared to those using monotherapy (<a href="https://pubmed.ncbi.nlm.nih.gov/23193746/">Tanglertsampan, 2012</a>; <a href="https://doi.org/10.1111/dth.12246">Hu et al., 2015</a>; <a href="https://doi.org/10.1111/jdv.15171">Suchonwanit et al., 2018</a>; <a href="https://doi.org/10.1007/s40257-018-0387-0">Suchonwanit, Iamsumang, &amp; Rojhirunsakool, 2019</a>; <a href="https://doi.org/10.1111/jocd.15953">Rossi &amp; Caro, 2024</a>; <a href="https://doi.org/10.36849/JDD.7826">Asad, Naseer, &amp; Ghafoor, 2024</a>). In some cases, the combination of minoxidil with a 5-ARI has also been associated with faster onset of visible results and improved patient satisfaction.</p>
<p>Minoxidil has been evaluated for its therapeutic effects on hair loss in some small studies of transfeminine and transmasculine people (<a href="https://doi.org/10.1016/j.jaad.2025.06.029">Zaminski et al., 2025</a>; <a href="https://airdrive.eventsair.com/eventsairaueprod/production-ashm-public/f659aa59dcd74b1f8ea5437e033b2055">Tang et al., 2025b</a>). These studies have reported positive results, in line with data from the wider population.</p>
<h3 id="comparison-of-different-minoxidil-routes-of-administration">Comparison of Different Minoxidil Routes of Administration</h3>
<p>The most widely used formulations of minoxidil include oral minoxidil and topical minoxidil. The main difference is that oral minoxidil is absorbed extensively into systemic circulation, whereas topical minoxidil is designed to act locally at the site of application, at which it stimulates hair follicles directly, hence resulting in limited systemic exposure.</p>
<p>Oral minoxidil is metabolised rapidly into minoxidil sulfate in the gastrointestinal tract (<a href="https://www.ncbi.nlm.nih.gov/books/NBK482378/">Patel, Nessel &amp; Kumar, 2023</a>). Peak plasma concentrations are typically reached within 1 hour. Oral minoxidil has been used at a range of 0.25–7.5 mg/day for AGA in clinical trials. The oral route has an average bioavailability of nearly 100%, whereas the local absorption of topical minoxidil into the scalp is around 1.4%. However, there remains substantial interindividual variation for each. As such, clinical doses of topical minoxidil are much higher (typically a 2 or 5% concentration) in order to compensate. Food does not appear to influence the bioavailability of oral minoxidil (<a href="https://doi.org/10.1159/000531890">Gupta et al., 2023</a>).</p>
<p>The efficacy of oral and topical minoxidil has been investigated extensively in clinical studies. Higher doses of oral minoxidil have been associated with more favourable outcomes for AGA in terms of hair diameter, total hair density, and terminal hair density, but also with increasing adverse effects (<a href="https://doi.org/10.1159/000525137">Gupta et al., 2022b</a>). Generally, lower doses have been used in women as compared to men. Oral minoxidil has been investigated at doses of up to 7.5 mg/day in clinical trials in this indication (<a href="https://doi.org/10.1016/j.abd.2023.08.016">Sanabria et al., 2024a</a>). Large meta-analyses have found that studies are mixed on whether oral or topical minoxidil, on average, results in better, worse, or equal efficacy (<a href="https://doi.org/10.1001/jamadermatol.2021.5743">Gupta et al., 2022a</a>; <a href="https://doi.org/10.1111/jocd.16362">Gupta et al., 2024a</a>; <a href="https://doi.org/10.1111/jocd.15910">Gupta et al., 2024b</a>; <a href="https://doi.org/10.1093/skinhd/vzaf009">Fazal et al., 2025</a>; <a href="https://doi.org/10.1111/jocd.70320">Gupta et al., 2025a</a>). However, the dose-dependent effects of oral minoxidil have similarly been found to occur with topical minoxidil (<a href="https://doi.org/10.1111/ced.15338">Singh et al., 2022</a>). A possibility is that oral and topical minoxidil may not have always been used at clinically equivalent doses.</p>
<p>The inconsistent differences in efficacy shown between oral and topical minoxidil in clinical studies may be driven by interindividual variation in response due to sulphotransferase enzyme expression, particularly in the scalp (<a href="https://www.ncbi.nlm.nih.gov/books/NBK482378/">Patel, Nessel &amp; Kumar, 2023</a>). There is growing evidence that in some individuals oral minoxidil may be more efficacious than topical minoxidil and vice versa (<a href="https://doi.org/10.1111/dth.12164">Goren et al., 2015</a>; <a href="https://doi.org/10.1016/j.jid.2017.02.867">Goren et al., 2016</a>; <a href="https://doi.org/10.1111/jocd.15910">Gupta et al., 2024b</a>; <a href="https://doi.org/10.1111/jocd.70320">Gupta et al., 2025a</a>). These data suggest that a subset of individuals who may not respond to one route of administration could see benefit by changing to the other.</p>
<p>Sublingual minoxidil has also been investigated for treating AGA (<a href="https://doi.org/10.1111/jdv.16616">Sinclair et al., 2020</a>; <a href="https://doi.org/10.1111/jdv.17623">Bokhari, Jones, &amp; Sinclair, 2021</a>; <a href="https://doi.org/10.1093/ced/llaf012">Sinclair et al., 2025</a>). Another route of administration which is being considered is injectable minoxidil (<a href="https://doi.org/10.1007/s00403-025-04068-3">Needle et al., 2025</a>). However, these routes have received comparatively much less attention and so limited data are available to inform their usage. A randomised controlled trial comparing oral and sublingual minoxidil at a daily dosage of 5 mg found similar efficacy at 24 weeks follow-up, suggesting that sublingual minoxidil may be a useful alternative to oral minoxidil (<a href="https://doi.org/10.1111/jdv.20508">Sanabria et al., 2024b</a>). Whilst these initial data are promising, further and larger scale studies are likely to be needed before sublingual minoxidil could see the same level of adoption as oral and topical administration.</p>
<h3 id="safety-and-tolerability-of-oral-and-topical-minoxidil">Safety and Tolerability of Oral and Topical Minoxidil</h3>
<p>Minoxidil has generally been shown to be well tolerated in clinical trials. Nevertheless, usage is associated with various adverse effects in some individuals (<a href="https://doi.org/10.1159/000525137">Gupta et al., 2022b</a>; <a href="https://doi.org/10.1159/000531890">Gupta et al., 2023</a>; <a href="https://doi.org/10.18773/austprescr.2025.020">Iyengar &amp; Li, 2025</a>). The adverse effects of minoxidil have been shown to be dependent on the route of administration, as well as being positively dose-dependent.</p>
<p>A retrospective study of users of oral minoxidil investigated the frequency of adverse effects in both men and women receiving a median dose of 1.63 mg/day (<a href="https://doi.org/10.1016/j.jaad.2021.02.054">Vañó-Galván et al., 2021</a>). The following were found to occur: <a href="https://en.wikipedia.org/wiki/Hypertrichosis">hypertrichosis</a> (excessive facial/body hair) in 15.1%, lightheadedness in 1.7%, fluid retention in 1.3%, tachycardia in 0.9%, headache in 0.4%, periorbital edema (temporary swelling around the eyes) in 0.3%, and insomnia in 0.2%. The total frequency of adverse effects was 20.4%, which prompted discontinuation in 1.2% of users, overall. Another study reported an overall hypertrichosis incidence of 24%, with the highest rates being found in the sideburns (81%), temples (73%), arms (63%), and upper lip (51%) (<a href="https://doi.org/10.1016/j.jaad.2020.08.124">Jimenez-Cauhe et al., 2021</a>). By contrast, topical minoxidil is associated with much lower overall rates of hypertrichosis. Most studies have reported incidence rates of between 0 and 5% (<a href="https://doi.org/10.1016/j.jaad.2003.06.014">Lucky et al., 2004</a>; <a href="http://jddonline.com/articles/dermatology/S1545961616P0883X">Blume-Peytavi et al., 2016</a>; <a href="https://doi.org/10.1016/j.jaad.2019.08.060">Ramos et al., 2020</a>; <a href="https://doi.org/10.1001/jamadermatol.2024.0284">Penha et al., 2024</a>; <a href="https://doi.org/10.1016/j.pdpdt.2024.103966">Yang et al., 2024</a>). These findings are consistent with a meta-analysis that reported point estimates of incidence rates for hypertrichosis of 10%, 15%, and 33% for oral minoxidil at 0.25 mg/day, 0.5 mg/day, and 1.25 mg/day, respectively, and 0% and 2% for topical minoxidil at a 2% and 5% concentration, respectively (<a href="https://doi.org/10.1016/j.jdrv.2025.02.013">Wiechert et al., 2025</a>). Despite this, the discontinuation rate across all studies was 0.49%. There also seemed to be no statistically significant difference between the rate of discontinuation for oral and topical formulations, suggesting that hypertrichosis appears to be very well tolerated.</p>
<p>A concern associated with the use of oral minoxidil is its potential impact on cardiovascular health (<a href="https://doi.org/10.5070/D32946186">Ibraheim et al., 2023</a>). Since tachycardia can increase myocardial workload and lead to symptoms such as palpitations or chest discomfort, oral minoxidil should be approached cautiously, especially by individuals with underlying cardiovascular issues. Fortunately, the overall risk of severe cardiovascular complications from low-dose oral minoxidil seems to be very low in the general population (<a href="https://doi.org/10.1016/j.jaad.2020.06.1009">Randolph &amp; Tosti, 2021</a>; <a href="https://doi.org/10.1016/j.jaad.2021.02.054">Vañó-Galván et al., 2021</a>). Meanwhile, skin reactions appear to be relatively common in users of topical minoxidil. This often manifests as scalp eczema and itching, although rates of incidence vary by study (<a href="https://doi.org/10.1016/j.jaad.2003.06.014">Lucky et al., 2004</a>; <a href="https://doi.org/10.2174/187221312800166859">Rossi et al., 2012</a>; <a href="https://doi.org/10.1001/jamadermatol.2024.0284">Penha et al., 2024</a>). The culprit behind this irritating effect appears not to be minoxidil itself, but rather the ingredients in certain formulations such as propylene glycol (<a href="https://doi.org/10.2147/DDDT.S214907">Suchonwanit, Thammarucha, &amp; Leerunyakul, 2019</a>). These solvents help deliver minoxidil into the scalp, but are known to cause skin irritation in susceptible individuals. It also appears that, for most people, long-term topical minoxidil therapy may be precluded by non-compliance (<a href="https://doi.org/10.1080/09546630701383727">Ali Mapar &amp; Omidian, 2007</a>; <a href="https://doi.org/10.1007/s13555-023-00919-x">Shadi, 2023</a>).</p>
<p>The increase in overall body hair growth (i.e., hypertrichosis) is arguably the most consequential side effects for transfeminine people found to occur with minoxidil. As noted above, hypertrichosis is much more common with oral minoxidil than with topical minoxidil. This is a result of the differences in pharmacology between these routes and the extensive systemic absorption that occurs in the case of the former (<a href="https://doi.org/10.1016/j.jdrv.2024.08.002">Desai et al., 2024</a>; <a href="https://doi.org/10.1016/j.jdrv.2025.02.013">Wiechert et al., 2025</a>). In transmasculine people, an increase in body hair growth and diameter could be beneficial. However, these effects are usually not desired by transfeminine people. Consequently, some transfeminine people may prefer to use topical minoxidil over oral minoxidil, despite possible benefits to effectiveness from the latter in some individuals.</p>
<h2 id="steroidal-and-non-steroidal-antiandrogens">Steroidal and Non-Steroidal Antiandrogens</h2>
<p>Antiandrogens such as spironolactone and cyproterone acetate are widely employed to reduce or suppress testosterone levels in transfeminine people. Some clinics have also used the non-steroidal antiandrogen <a href="https://en.wikipedia.org/wiki/Bicalutamide">bicalutamide</a>. However, these medications have all also been investigated in the treatment of pattern hair loss in cisgender women. After gonadectomy, antiandrogen treatment is often discontinued. Nevertheless, it appears some transfeminine people continue antiandrogen treatment, particularly spironolactone, in order to suppress the effects of non-gonadal androgen production.</p>
<h3 id="spironolactone">Spironolactone</h3>
<p>Spironolactone has been studied at oral doses of 25 to 200 mg/day for the treatment of pattern hair loss in women (<a href="https://doi.org/10.2147/CCID.S398950">Wang et al., 2023</a>; <a href="https://doi.org/10.1080/14764172.2024.2362126">Rosenthal et al., 2024</a>). Oral spironolactone has been found to be effective in halting and, in some cases, reversing female AGA (<a href="https://doi.org/10.1111/j.1365-2133.2005.06218.x">Sinclair, Wewerinke &amp; Jolley, 2005</a>; <a href="https://doi.org/10.1016/j.jaad.2020.03.087">Burns et al., 2020</a>). Often, it has been paired with other interventions such as minoxidil. A randomised controlled trial found that oral spironolactone at a dose of 80 to 100 mg/day had similar efficacy to minoxidil when used as a single agent therapy (<a href="https://doi.org/10.3389/fmed.2022.905140">Liang et al., 2022</a>). Spironolactone has also been studied topically (<a href="https://doi.org/10.1111/dth.14678">Abdel‐Raouf et al., 2020</a>; <a href="https://doi.org/10.1111/jocd.15328">Ammar et al., 2022</a>). In the highest quality studies, spironolactone has been found to act additively with minoxidil in improving hair density and hair diameter.</p>
<p>Overall, spironolactone appears to be well tolerated for treating AGA, as well as other androgen sensitive conditions in women (<a href="https://doi.org/10.1001/jamadermatol.2020.5468">Barbieri et al., 2021</a>; <a href="https://doi.org/10.2147/CCID.S398950">Wang et al., 2023</a>; <a href="https://doi.org/10.1016/j.jaad.2025.02.056">Martin et al., 2025</a>). Likewise, it may also be useful for some transfeminine people as an adjunct therapy, especially when paired with minoxidil. However, spironolactone has been scarcely studied for male AGA. It could well be the case that other more established therapies, such as dutasteride, would be better for transfeminine people with more extensive hair loss.</p>
<h3 id="flutamide-and-bicalutamide">Flutamide and Bicalutamide</h3>
<p>Flutamide is a potent non-steroidal antiandrogen and antagonist of the androgen receptor which has predominantly been used to treat prostate cancer. Some clinicians have also employed the use of flutamide in treating female AGA, with positive findings (<a href="https://doi.org/10.1016/S0015-0282(02)04551-X">Carmina &amp; Lobo, 2003</a>; <a href="https://doi.org/10.1111/j.1440-0960.2010.00735.x">Yazdabadi &amp; Sinclair, 2011</a>; <a href="https://doi.org/10.1345/aph.1P600">Paradisi et al., 2011</a>; <a href="https://doi.org/10.1111/jocd.14788">Faghihi et al., 2022</a>). In a randomised controlled trial, 500 mg/day flutamide was found to be superior to 100 mg/day spironolactone in treating scalp hair loss (<a href="https://doi.org/10.1016/S0015-0282(16)56518-2">Cusan et al., 1994</a>). However, this may have been at least partially down to the cyclic use of spironolactone, which meant that women randomised to spironolactone were not actually receiving it for the duration of the entire month. In spite of the above findings, flutamide is associated with a high risk of elevated liver enzymes, which can progress to life-threatening organ failure in a very small but clinically significant subset of cases (<a href="https://doi.org/10.1093/jjco/hyd106">Ozono et al., 2000</a>; <a href="https://doi.org/10.1345/aph.1P600">Paradisi et al., 2011</a>; <a href="https://pubmed.ncbi.nlm.nih.gov/28379593/">Giorgetti et al., 2017</a>). This appears to have precluded its widespread adoption for female AGA.</p>
<p>Bicalutamide is another non-steroidal antiandrogen which has been considered for female AGA (<a href="https://doi.org/10.1016/j.jdrv.2025.03.005">Perez, Nguyen, &amp; Senna, 2025</a>). Generally, bicalutamide is believed to have a lower risk of liver toxicity than flutamide, making it a much more promising candidate for large-scale adoption in otherwise healthy people (<a href="https://doi.org/10.1016/S0090-4295(96)80012-4">Kolvenbag &amp; Blackledge, 1996</a>; <a href="https://doi.org/10.1007/s40265-023-01880-x">Devjani et al., 2023</a>). A number of retrospective studies have reported encouraging data with 10 to 50 mg/day oral bicalutamide, both in terms of safety and efficacy (<a href="https://doi.org/10.1016/j.jaad.2020.03.034">Ismali et al., 2020</a>; <a href="https://doi.org/10.1016/j.jaad.2020.04.054">Fernandez-Nieto et al., 2020</a>; <a href="https://doi.org/10.1016/j.jaad.2025.01.056">Yoong et al., 2025</a>). Interestingly, a study also found that bicalutamide was associated with improvements in hypertrichosis induced by oral minoxidil (<a href="https://doi.org/10.1016/j.jaad.2021.10.048">Moussa et al., 2022</a>). Only one randomised controlled trial has been conducted with bicalutamide, in which minoxidil plus 25 mg/day oral bicalutamide was compared to minoxidil plus placebo (<a href="https://doi.org/10.1016/j.jdin.2024.12.002">da Silva Libório et al., 2025</a>). In this study, there was no additional benefit of bicalutamide on total hair density. This finding is surprising in light of the seemingly additive effects that occur with minoxidil and spironolactone. It is possible that differences in methodology could be responsible for this discrepancy. Another study, although also retrospective, found that 50 mg/day oral bicalutamide was associated with moderately greater improvement in scalp hair loss than was 100 mg/day oral spironolactone (<a href="https://doi.org/10.1111/ajd.14306">Jha et al., 2024</a>).</p>
<p>Concerns about safety have also historically precluded widespread adoption of bicalutamide in transgender medicine. However, increasing numbers of studies are adding to our knowledge of bicalutamide in transfeminine people (<a href="https://doi.org/10.1080/26895269.2023.2294321">Fuqua, Shi, &amp; Eugster, 2024</a>; <a href="https://doi.org/10.1177/20420188241305022">Angus et al., 2024</a>).</p>
<h2 id="other-medications-and-future-developments">Other Medications and Future Developments</h2>
<p>Despite several decades of research, only two medications have been approved for male AGA by the FDA in the United States. These are minoxidil and finasteride. Even though the use of these agents is increasingly common in men, they remain only partially effective in reversing androgenic hair loss.</p>
<h3 id="topical-androgen-receptor-antagonists">Topical Androgen Receptor Antagonists</h3>
<p>Two novel topical androgen receptor antagonists of possible interest are <a href="https://en.wikipedia.org/wiki/Clascoterone">clascoterone</a> and <a href="https://en.wikipedia.org/wiki/Pyrilutamide">pyrilutamide</a> (<a href="https://doi.org/10.1007/s40257-022-00730-y">Saceda-Corralo et al., 2023</a>; <a href="https://doi.org/10.1007/s40265-023-01880-x">Devjani et al., 2023</a>). Unlike oral non-steroidal antiandrogens such as flutamide and bicalutamide, these medications are applied topically so that there is minimal systemic absorption. Clascoterone has shown some limited success in phase 3 clinical trials for treating acne in men and women and has been approved by the FDA for this indication (<a href="https://doi.org/10.1001/jamadermatol.2020.0465">Hebert et al., 2020</a>). It is hoped that clascoterone could also be effective in treating AGA. An exploratory study found that clascosterone was superior to topical cyproterone acetate and alfatradiol in improving hair shaft diameter and hair follicle density and had comparable efficacy to minoxidil (<a href="https://doi.org/10.1016/j.jaad.2019.06.087">Cartwright et al., 2019</a>). Phase 3 clinical trials of clascosterone in AGA are currently underway. Pyrilutamide had shown favourable results in phase 2 clinical trials for both male and female AGA, however it failed to outperform placebo in phase 3 clinical trials (<a href="https://www1.hkexnews.hk/listedco/listconews/sehk/2024/0328/2024032802816.pdf">Kintor Pharmaceuticals, 2024</a>). Studies are now underway using a higher dose of pyrilutamide over a longer duration of follow-up in the hope that this will show improved results.</p>
<p>Despite the above, these findings are rather disappointing. Notably, clascoterone only marginally outperformed placebo in clinical trials for acne (reduction in symptoms by about 8 to 18% more than placebo) (<a href="https://doi.org/10.1001/jamadermatol.2020.0465">Hebert et al., 2020</a>). A systematic review and network meta-analysis found that oral spironolactone was substantially more effective for treating acne than topical clascoterone (<a href="https://doi.org/10.1371/journal.pone.0298155">Basendwh et al., 2024</a>). Clascoterone and pyrilutamide may someday provide another option for treating AGA in transfeminine people. However, since their mechanism of action is not dissimilar to well-established therapies such as 5-ARIs, it seems that this class of medications is unlikely to ever be revolutionary.</p>
<h3 id="prostaglandin-analogues">Prostaglandin Analogues</h3>
<p><a href="https://en.wikipedia.org/wiki/Prostaglandin_analogue">Prostaglandin analogues</a> could have some utility in treating AGA. These include <a href="https://en.wikipedia.org/wiki/Latanoprost">latanoprost</a> and <a href="https://en.wikipedia.org/wiki/Bimatoprost">bimatoprost</a>. Prostaglandin analogues have mostly been used to treat glaucoma by lowering intraocular pressure but are also believed to prolong the anagen phase and hence cause hair growth in certain susceptible tissues (<a href="https://doi.org/10.1517/13543784.2013.784743">Valente Duarte de Sousa &amp; Tosti, 2013</a>).</p>
<p>Latanoprost has mostly been studied for <a href="https://en.wikipedia.org/wiki/Alopecia_areata">alopecia areata</a> within the context of hair loss. However, one small randomised controlled trial found that topical latanoprost outperformed placebo after 24 weeks in increasing hair density in young men with mild AGA (<a href="https://doi.org/10.1016/j.jaad.2011.05.026">Blume-Peytavi et al., 2012</a>). Bimatoprost has also been evaluated in various clinical trials. In four separate phase 2 clinical trials, bimatoprost mildly to moderately outperformed placebo (<a href="https://doi.org/10.1007/978-3-030-76111-0_11">Anastassakis, 2022</a>). However, compared to minoxidil, findings were inconsistent. Bimatoprost had similar efficacy in some measures in some studies, but inferior efficacy in others. Overall, prostaglandin analogues appear to have received little subsequent attention. These data are relatively underwhelming by themselves compared to the large amount of literature pertaining to more established AGA therapies.</p>
<h3 id="mitochondrial-pyruvate-carrier-inhibition">Mitochondrial Pyruvate Carrier Inhibition</h3>
<p>In perhaps one of the more interesting developments in recent years, researchers have identified a topically delivered molecule, called PP-405, that appears to be capable of reactivating dormant follicles by modulating <a href="https://en.wikipedia.org/wiki/Mitochondrial_pyruvate_carrier">mitochondrial pyruvate carrier</a> (MPC) activity (<a href="https://nymag.com/intelligencer/article/pp405-baldness-cure-hair-loss-treatment-follicles-science-tressless.html">Brown, 2025</a>). Unlike current therapies that focus on hormone suppression and increased blood flow, PP-405 is a regenerative, stem-cell-focused approach to treating hair loss. The molecule is currently being investigated for male and female AGA.</p>
<p>Recently, a phase 2a clinical trial that randomised 78 men and women to either PP-405 or placebo concluded with positive safety findings (<a href="https://www.dermatologytimes.com/view/pelage-s-pp405-demonstrates-efficacy-in-phase-2a-trial-for-androgenetic-alopecia">Meara, 2025</a>). However, preliminary results from 4 weeks of treatment at 8 weeks follow-up also showed a rapid and statistically significant clinical response versus placebo. This was despite the study not actually being conducted to show efficacy. The researchers found that 31% of the men with advanced AGA who were treated with the active medication showed a 20% or greater increase in total hair density, compared to 0% of patients in the placebo group. This is particularly notable because current interventions for AGA, such as minoxidil, typically take at least several months of follow-up to show a statistically significant difference from placebo. Most strikingly, PP-405 apparently induced new terminal hair growth from follicles where no hair was previously present.</p>
<p>As of September 2025, PP-405 is in phase 2b clinical trials and is expected to enter phase 3 clinical trials early next year if subsequent clinical findings are promising. With all this said, it should be noted that these are merely early results. More rigorous studies are necessary to determine if PP-405 can be an effective intervention against AGA.</p>
<h2 id="summary-and-conclusions">Summary and Conclusions</h2>
<p>AGA is a common and distressing condition that has particular relevance for transfeminine people, given the role of hair in gender identity and expression. While feminising hormone therapy appears to at least partially reverse AGA, many individuals appear to experience incomplete regrowth. Limited data suggest that adjunct use of 5-ARIs and/or minoxidil, particularly in the first few years of hormonal transition, may have positive effects but more studies are necessary to confirm this.</p>
<p>The most established treatments for AGA in the wider population are 5-ARIs, including finasteride and dutasteride, and minoxidil. The role of 5-ARIs in women remain less clear. Nevertheless, dutasteride achieves superior outcomes in male AGA to finasteride, whilst having similar safety and tolerability. Hence, wherever possible, it seems reasonable to use the former should the use of a 5α-reductase inhibitor be desired. Minoxidil, whether oral or topical, provides dose-dependent improvements in total and terminal hair density in male and female AGA and acts synergistically with 5-ARIs. However, oral minoxidil is associated with higher rates of hypertrichosis, which may be undesirable for many transfeminine individuals.</p>
<p>Other agents, such as spironolactone and bicalutamide, could also offer additional benefit by antagonising the androgen receptor. Spironolactone is already widely used in transfeminine hormone therapy and shows synergy with minoxidil in studies of female AGA. Bicalutamide is of emerging interest given its relatively favourable safety profile. Novel therapies of benefit to transfeminine people may also become available in the future.</p>
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</ul>]]></content><author><name>{&quot;first_name&quot;=&gt;&quot;Sam&quot;, &quot;last_name&quot;=&gt;&quot;S.&quot;, &quot;author-link&quot;=&gt;&quot;/about/#sam&quot;, &quot;articles-link&quot;=&gt;&quot;/articles-by-author/sam/&quot;}</name></author><category term="github" /><category term="workspace" /><summary type="html"><![CDATA[A Review of Pharmaceutical Interventions for Scalp Hair Loss and Implications for Transfeminine People By Sam | First published September 8, 2025 | Last modified September 9, 2025]]></summary></entry><entry><title type="html">Puberty Blockers: A Review of GnRH Analogues in Transgender Youth</title><link href="https://transfemscience.org/articles/puberty-blockers/" rel="alternate" type="text/html" title="Puberty Blockers: A Review of GnRH Analogues in Transgender Youth" /><published>2022-01-30T15:04:00-08:00</published><updated>2022-01-31T00:00:00-08:00</updated><id>https://transfemscience.org/articles/puberty-blockers</id><content type="html" xml:base="https://transfemscience.org/articles/puberty-blockers/"><![CDATA[<h1 id="puberty-blockers-a-review-of-gnrh-analogues-in-transgender-youth">Puberty Blockers: A Review of GnRH Analogues in Transgender Youth</h1>
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@ -4829,258 +5136,4 @@ Figure 5. Meta-analysis of estradiol concentration-time data from cisgender wome
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</ul>]]></content><author><name>{&quot;first_name&quot;=&gt;&quot;Aly&quot;, &quot;last_name&quot;=&gt;&quot;W.&quot;, &quot;author-link&quot;=&gt;&quot;/about/#aly&quot;, &quot;articles-link&quot;=&gt;&quot;/articles-by-author/aly/&quot;}</name></author><category term="github" /><category term="workspace" /><summary type="html"><![CDATA[Supplement: The Interactions of Sex Hormones with Sex Hormone-Binding Globulin and Relevance for Transfeminine Hormone Therapy By Aly | First published July 8, 2020 | Last modified March 14, 2023]]></summary></entry><entry><title type="html">Bicalutamide and its Adoption by the Medical Community for Use in Transfeminine Hormone Therapy</title><link href="https://transfemscience.org/articles/bica-adoption/" rel="alternate" type="text/html" title="Bicalutamide and its Adoption by the Medical Community for Use in Transfeminine Hormone Therapy" /><published>2020-07-01T18:39:00-07:00</published><updated>2025-08-23T00:00:00-07:00</updated><id>https://transfemscience.org/articles/bica-adoption</id><content type="html" xml:base="https://transfemscience.org/articles/bica-adoption/"><![CDATA[<h1 id="bicalutamide-and-its-adoption-by-the-medical-community-for-use-in-transfeminine-hormone-therapy">Bicalutamide and its Adoption by the Medical Community for Use in Transfeminine Hormone Therapy</h1>
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<p>By
<!-- First author --><a href="/about/#aly">Aly</a><!-- Second author --><!-- Third author --><!-- Fourth author --> | First published July 1, 2020
| Last modified August 23, 2025</p>
<h2 id="abstract--tldr">Abstract / TL;DR</h2>
<p>Bicalutamide is an antiandrogen which was introduced for the treatment of prostate cancer many years ago. Cost precluded its widespread use for other indications for many years. However, its cost has since come down and bicalutamide is now seeing significant adoption for use in transfeminine hormone therapy as well as for treatment of androgen-dependent conditions in other populations like cisgender women. Bicalutamide has risks of certain rare adverse effects like liver toxicity which have generated concerns about its safety and have limited its use in transfeminine people. However, while still significant, these risks are low with appropriate monitoring and clinical management. Prominent researchers in transgender medicine have recently shown openness to bicalutamide for potential use in transfeminine people and have written positively about it. Bicalutamide could eventually come to be regarded as acceptably safe for use in transfeminine hormone therapy, similarly to other antiandrogens with rare risks like spironolactone and cyproterone acetate. However, more studies and characterization of bicalutamide in transfeminine people will likely be needed before it could see wider adoption in transgender medicine.</p>
<h2 id="history-of-bicalutamide-for-transfeminine-people">History of Bicalutamide for Transfeminine People</h2>
<p><a href="https://en.wikipedia.org/wiki/Bicalutamide">Bicalutamide</a> (Casodex) is a <a href="https://en.wikipedia.org/wiki/Nonsteroidal_antiandrogen">nonsteroidal antiandrogen</a> and <a href="https://en.wikipedia.org/wiki/Binding_selectivity">selective</a> <a href="https://en.wikipedia.org/wiki/Receptor_antagonist">antagonist</a> of the <a href="https://en.wikipedia.org/wiki/Androgen_receptor">androgen receptor</a> which was originally introduced for the treatment of <a href="https://en.wikipedia.org/wiki/Prostate_cancer">prostate cancer</a> in cisgender men in 1995. Prostate cancer is an <a href="https://en.wikipedia.org/wiki/Androgen-dependent_condition">androgen-dependent disease</a>, so antiandrogens are effective in treating it. Bicalutamide has major advantages over other antiandrogens such as <a href="https://en.wikipedia.org/wiki/Spironolactone">spironolactone</a> (Aldactone) and <a href="https://en.wikipedia.org/wiki/Cyproterone_acetate">cyproterone acetate</a> (Androcur) in terms of <a href="https://en.wikipedia.org/wiki/Antiandrogen">antiandrogenic</a> <a href="https://en.wikipedia.org/wiki/Potency_(pharmacology)">potency</a>, <a href="https://en.wikipedia.org/wiki/Clinical_effectiveness">clinical effectiveness</a>, <a href="https://en.wikipedia.org/wiki/Binding_selectivity">pharmacological selectivity</a>, and <a href="https://en.wikipedia.org/wiki/Tolerability">tolerability</a>. It also has improved potency, <a href="https://en.wikipedia.org/wiki/Pharmacokinetics">pharmacokinetic</a> properties, and tolerability, as well as far better <a href="https://en.wikipedia.org/wiki/Drug_safety">safety</a>, compared to the older nonsteroidal antiandrogens <a href="https://en.wikipedia.org/wiki/Flutamide">flutamide</a> (Eulexin) and <a href="https://en.wikipedia.org/wiki/Nilutamide">nilutamide</a> (Anandron, Nilandron). However, use of bicalutamide as an antiandrogen in transfeminine hormone therapy is very recent. The employment of bicalutamide for transfeminine people was largely precluded for many years by the fact that bicalutamide had pharmaceutical patent protection and was very expensive. However, this changed with the availability of generic versions of bicalutamide starting in 2007 to 2009. In addition, newer and more effective antiandrogens like <a href="https://en.wikipedia.org/wiki/Abiraterone_acetate">abiraterone acetate</a> (Zytiga) in 2011 and <a href="https://en.wikipedia.org/wiki/Enzalutamide">enzalutamide</a> (Xtandi) in 2012 were introduced and superseded bicalutamide as the <a href="https://en.wikipedia.org/wiki/Standard_of_care#Medical_standard_of_care">standard-of-care</a> antiandrogen for the treatment of prostate cancer. These developments have greatly reduced the cost of bicalutamide and it has gradually become much more affordable in the last decade.</p>
<p>Before 2015, there were only a few mentions in the literature of bicalutamide for transfeminine people and a handful of anecdotal reports online of transfeminine people using it. The earliest clear mention of bicalutamide in the literature in the context of transfeminine hormone therapy was by <a href="https://en.wikipedia.org/wiki/Louis_Gooren">Louis Gooren</a> in 2011 (<a href="http://doi.org/10.1056/NEJMcp1008161">Gooren, 2011</a>). Gooren is a major longtime researcher in the field of transgender medicine and is one of the coauthors of the <a href="https://en.wikipedia.org/wiki/Endocrine_Society">Endocrine Society</a>’s transgender hormone therapy guidelines (<a href="https://doi.org/10.1210/jc.2009-0345">Hembree et al., 2009</a>; <a href="https://doi.org/10.1210/jc.2017-01658">Hembree et al., 2017</a>). He and his colleagues at the <a href="https://en.wikipedia.org/wiki/Center_of_Expertise_on_Gender_Dysphoria">Center of Expertise on Gender Dysphoria</a> of the <a href="https://en.wikipedia.org/wiki/VU_University_Medical_Center">Vrije Universiteit Medical Center</a> (VUMC) in Amsterdam, Netherlands had conducted studies on <a href="https://en.wikipedia.org/wiki/Nilutamide">nilutamide</a> (Anandron, Nilandron) as an antiandrogen for transfeminine people in the late 1980s and early 1990s (<a href="https://kinseyinstitute.org/pdf/HBIGDA_S10_1987OCR.pdf#page=55">de Voogt et al., 1987a</a>; <a href="https://doi.org/10.1002/pros.2990110403">de Voogt et al., 1987b</a>; <a href="https://doi.org/10.1210/jcem-64-4-763">Gooren et al., 1987</a>; <a href="https://kinseyinstitute.org/pdf/HBIGDA_S10_1987OCR.pdf#page=35">Johannes et al., 1987</a>; <a href="https://doi.org/10.1016/0022-4731(88)90024-6">Rao et al., 1988</a>; <a href="https://doi.org/10.1111/j.1365-2230.1989.tb02585.x">Asscheman, Gooren, &amp; Peereboom-Wynia, 1989</a>; <a href="https://doi.org/10.1007/BF01543196">van Kemenade et al., 1989</a>; <a href="https://en.wikipedia.org/wiki/Nilutamide#Transgender_hormone_therapy">Wiki</a>). However, they seem to have abandoned it—probably due to its high incidence of lung toxicity and other <a href="https://en.wikipedia.org/wiki/Off-target_activity">off-target</a> side effects. Nonetheless, Gooren began including nonsteroidal antiandrogens like flutamide and nilutamide in his publications as potential treatment options for transfeminine hormone therapy starting in the 1990s (<a href="https://doi.org/10.1300/J056v05n04_03">Asscheman &amp; Gooren, 1992</a>; <a href="http://web.archive.org/web/20070430161048/http://www.symposion.com/ijt/ijt990301.htm">Gooren, 1999</a>). Subsequently, flutamide was included in transgender health guidelines and other publications, though not necessarily favorably (e.g., <a href="https://books.google.com/books?id=IlPX6E5glDEC&amp;pg=PA66">Israel &amp; Tarver, 1997</a>; <a href="https://doi.org/10.1046/j.1365-2265.2003.01821.x">Levy, Crown, &amp; Reid, 2003</a>; <a href="https://doi.org/10.1300/J485v09n03_06">Dahl et al., 2006a</a>; <a href="https://www.cpath.ca/wp-content/uploads/2009/12/guidelines-endocrine.pdf">Dahl et al., 2006b</a>; <a href="https://doi.org/10.1210/jc.2009-0345">Hembree et al., 2009</a>; <a href="https://doi.org/10.1016/j.endoen.2012.07.004">Moreno-Pérez et al., 2012</a>). As a researcher interested in nonsteroidal antiandrogens for transfeminine people, bicalutamide—with its far better safety profile than flutamide and nilutamide—may have been appealing to Gooren. However, Gooren and his colleagues didn’t conduct clinical studies on bicalutamide for transfeminine people and never went beyond brief mention of it for such uses in their publications. Nor did any other academics.</p>
<p>Besides transfeminine people and men with prostate cancer, bicalutamide has been studied for use in the treatment of androgen-dependent conditions in other populations. For example, it has been used in the treatment of <a href="https://en.wikipedia.org/wiki/Hirsutism">hirsutism</a> (excessive facial/body hair growth) in cisgender women with and without <a href="https://en.wikipedia.org/wiki/Polycystic_ovary_syndrome">polycystic ovary syndrome</a> (PCOS) (<a href="https://doi.org/10.1093/humrep/14.Suppl_3.366-a">Müderris, Bayram, &amp; Güven, 1999</a>; <a href="https://doi.org/10.1080/gye.16.1.63.66">Müderris et al., 2002</a>; <a href="https://doi.org/10.1159/000081973">Bahceci et al., 2004</a>; <a href="https://www.turkiyeklinikleri.com/article/en-hirsutizm-tedavisinde-flutamid-ve-bikalutamid-kullanimi-55753.html">Müderris &amp; Öner, 2009</a>; <a href="https://web.archive.org/web/20221108144934/https://endo.confex.com/endo/2016endo/webprogram/Paper26631.html">Moretti et al., 2016</a>; <a href="https://doi.org/10.1210/jc.2017-01186">Moretti et al., 2018</a>; <a href="https://en.wikipedia.org/wiki/Medical_uses_of_bicalutamide#Medical_uses_of_bicalutamide#Skin_and_hair_conditions">Wiki</a>). Bicalutamide has also been studied in combination with <a href="https://en.wikipedia.org/wiki/Anastrozole">anastrozole</a> (Arimidex), an <a href="https://en.wikipedia.org/wiki/Aromatase_inhibitor">aromatase inhibitor</a>, for the treatment of <a href="https://en.wikipedia.org/wiki/Familial_male-limited_precocious_puberty">gonadotropin-independent precocious puberty</a> in cisgender boys (<a href="https://doi.org/10.1016/j.jpeds.2006.04.027">Kreher et al., 2006</a>; <a href="https://doi.org/10.1159/000239668">Lewis et al., 2009</a>; <a href="https://doi.org/10.1515/JPEM.2009.22.12.1163">Mitre &amp; Lteif, 2009</a>; <a href="https://doi.org/10.1159/000239668">Stenger et al., 2009</a>; <a href="https://doi.org/10.1542/peds.2010-0596">Lenz et al., 2010</a>; <a href="https://doi.org/10.1515/jpem.2010.161">Reiter et al., 2010</a>; <a href="https://doi.org/10.1507/endocrj.ej11-0214">Tessaris et al., 2012</a>; <a href="https://doi.org/10.4274/jcrpe.2067">Özcabı et al., 2015</a>; <a href="https://doi.org/10.1007/s42000-018-0029-1">Kor, 2018</a>; <a href="https://doi.org/10.1515/jpem-2018-0419">Arya &amp; Davies, 2019</a>; <a href="https://doi.org/10.4158/ACCR-2018-0246">Nabhan &amp; Eugster, 2019</a>; <a href="https://doi.org/10.1097/DBP.0000000000000865">Finkle et al., 2020</a>; <a href="https://doi.org/10.4274/jcrpe.galenos.2020.2020.0067">Gurnurkar, DiLillo, &amp; Carakushansky, 2021</a>; <a href="https://en.wikipedia.org/wiki/Medical_uses_of_bicalutamide#Male_early_puberty">Wiki</a>). This is a rare form of <a href="https://en.wikipedia.org/wiki/Precocious_puberty">precocious puberty</a> in which <a href="https://en.wikipedia.org/wiki/Gonadotropin-releasing_hormone_modulator">gonadotropin-releasing hormone modulators</a> are not effective. A <a href="https://en.wikipedia.org/wiki/Phases_of_clinical_research#Phase_II">phase 2</a> clinical trial was completed and a <a href="https://en.wikipedia.org/wiki/New_Drug_Application">New Drug Application</a> (NDA) was submitted in the United States for treatment of the condition with bicalutamide and anastrozole, but the application was not approved due to inadequate evidence of effectiveness on the primary efficacy endpoint of limiting height (<a href="https://web.archive.org/web/20190730023433/https://www.fda.gov/media/75809/download">AstraZeneca, 2008</a>). However, bicalutamide is still used <a href="https://en.wikipedia.org/wiki/Off-label_use">off-label</a> for this indication, and information on bicalutamide for this use is provided in the the Casodex <a href="https://en.wikipedia.org/wiki/Food_and_Drug_Administration">Food and Drug Administration</a> (FDA) label (<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020498s028lbl.pdf">FDA, 2017</a>).</p>
<p>Although there was little discussion or use of bicalutamide in transfeminine people prior to 2015, this started to change in mid-2015. At that time, the <a href="https://en.wikipedia.org/wiki/Bicalutamide">Wikipedia content for bicalutamide</a> was greatly expanded, which made information about bicalutamide more accessible. In addition, certain transfeminine people, noting its advantages over existing options and its excellent potential for use in transfeminine hormone therapy, began advocating for use of bicalutamide in transfeminine people in online circles. A number of open-minded clinicians started adopting bicalutamide in transfeminine people around this time and thereafter as well. The first clinical study of bicalutamide in transfeminine people, which began in 2013, was published as an abstract in 2017 and as a full paper in 2019 (<a href="https://files.transfemscience.org/pdfs/Neyman,%20Fuqua,%20&amp;%20Eugster%20(2017)%20-%20Bicalutamide%20as%20an%20Androgen%20Blocker%20with%20Secondary%20Effect%20of%20Promoting%20Feminization%20in%20Male%20to%20Female%20(MTF)%20Transgender%20Adolescents.pdf#page=4">Neyman, Fuqua, &amp; Eugster, 2017</a>; <a href="https://doi.org/10.1016/j.jadohealth.2018.10.296">Neyman, Fuqua, &amp; Eugster, 2019</a>). It was a small retrospective chart review of bicalutamide alone as a second-line <a href="https://en.wikipedia.org/wiki/Puberty_blocker">puberty blocker</a> in adolescent transgender girls for whom <a href="https://en.wikipedia.org/wiki/Gonadotropin-releasing_hormone_analogue">gonadotropin-releasing hormone analogues</a> were denied by insurance. As of present, it remains the only published clinical data on bicalutamide in transfeminine people. It’s not exactly great data by any means, but it’s a study at least. The researchers who conducted the study had previously published on bicalutamide as a puberty blocker in boys with gonadotropin-independent precocious puberty (e.g., <a href="https://doi.org/10.1542/peds.2010-0596">Lenz et al., 2010</a>; <a href="https://doi.org/10.1007/978-1-4419-1795-9_71">Haddad &amp; Eugster, 2012</a>). While limited in its findings, <a href="https://doi.org/10.1016/j.jadohealth.2018.10.296">Neyman, Fuqua, and Eugster (2019)</a> helped to generate significant interest among clinicians and researchers in bicalutamide for use in transfeminine hormone therapy.</p>
<p>In any case, due to the recent nature of bicalutamide as an option for use in transfeminine hormone therapy, as well as the lack of studies and characterization of bicalutamide in transfeminine people and concerns about its safety (see <a href="#concerns-about-bicalutamide-limiting-its-use">next section</a>), bicalutamide isn’t widely used in transfeminine people at this time. In fact, transgender hormone therapy guidelines largely don’t even mention it still. At present, the use of bicalutamide in transfeminine people is mostly limited to a number of more flexible clinicians and to people in the transgender <a href="https://en.wikipedia.org/wiki/Self-medication">do-it-yourself</a> (DIY) hormone therapy community.</p>
<h2 id="concerns-about-bicalutamide-limiting-its-use">Concerns About Bicalutamide Limiting its Use</h2>
<p>The transgender medical community has been reluctant to endorse the use of bicalutamide in transfeminine people to date. This is because of the lack of clinical studies and characterization of bicalutamide in transfeminine people, most importantly in terms of safety. There have been concerns about rare instances of <a href="https://en.wikipedia.org/wiki/Liver_failure">liver failure</a> that have occurred with bicalutamide in men with prostate cancer (<a href="https://en.wikipedia.org/wiki/Side_effects_of_bicalutamide#Liver_toxicity">Wiki</a>). The reported cases of liver toxicity with bicalutamide have generally been sudden-onset and severe. Rare liver toxicity is an acceptable risk in men with prostate cancer because the <a href="https://en.wikipedia.org/wiki/Risk%E2%80%93benefit_ratio">risk–benefit ratio</a> of bicalutamide therapy is very favorable, with the benefit of treating prostate cancer vastly outweighing the harm of the very rare instances of liver problems. But transfeminine people are typically young and healthy, and bicalutamide isn’t treating a terminal illness when it’s used in us. If a transfeminine person develops liver failure and dies because of bicalutamide, that’s unnecessary harm and a life needlessly lost. Accordingly, the <a href="https://en.wikipedia.org/wiki/University_of_California,_San_Francisco">University of California San Francisco</a> (UCSF) transgender care guidelines warn against use of bicalutamide in transfeminine people currently due to potential liver risks (<a href="https://transcare.ucsf.edu/guidelines">Deutsch, 2016</a>). Aside from risks, there is also a lack of data to guide appropriate dosing of bicalutamide in transfeminine people at this time. A typical bicalutamide dosage of 50 mg/day is being used and recommended, but this has been arbitrarily chosen with little basis to support it.</p>
<p>To date, there are 10 published case reports of serious <a href="https://en.wikipedia.org/wiki/Hepatotoxicity">liver toxicity</a> in association with bicalutamide (<a href="https://en.wikipedia.org/wiki/Template:Published_case_reports_of_bicalutamide-associated_liver_injury">Table</a>). All of these cases were in men with prostate cancer and all occurred within 6 months of initiation of bicalutamide therapy, with two of the cases resulting in death. While this is not a lot of cases and may seem reassuring, it must be noted that quantity of published case reports tends to vastly underestimate the true incidence of rare adverse reactions. As an example, there are around 50 published case reports of meningioma with cyproterone acetate (<a href="https://en.wikipedia.org/wiki/Template:Published_case_reports_of_cyproterone_acetate-associated_meningioma">Table</a>), but a recent large study by the French government found that there were more than 500 <em>operated</em> instances of meningioma in association with high-dose cyproterone acetate over an 8-year period in France alone (<a href="/articles/cpa-meningioma/">Aly, 2020</a>). Accordingly, as of writing there are 40 reports of liver failure, including 25 consequent deaths, in association with bicalutamide in the U.S. FDA’s international <a href="https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard">MedWatch/FAERS database</a>. (As well as 240 cases of <a href="https://en.wikipedia.org/wiki/Interstitial_lung_disease">interstitial lung disease</a> associated with bicalutamide notably—relative to only 14 published case reports; <a href="https://en.wikipedia.org/wiki/Template:Published_case_reports_of_bicalutamide-associated_lung_toxicity">Table</a>.) Even with this database however, fewer than 10% of serious adverse reactions are estimated to be reported (<a href="https://doi.org/10.1002/0470853093.ch17">Graham, Ahmad, &amp; Piazza-Hepp, 2002</a>). Hence, the true numbers may be much greater. These instances are merely co-occurrences, and causality in terms of bicalutamide and liver toxicity has not been established. But they are concerning nonetheless. There is additionally an unpublished case anecdote of death in a young transfeminine person associated with bicalutamide that’s been making its rounds through the transgender medical community. Per certain very credible people in the field of transgender medicine (e.g., <a href="https://web.archive.org/web/20230321104049/https://callen-lorde.org/providers/asa-radix/">Asa Radix</a> and <a href="http://web.archive.org/web/20221208035109/https://callen-lorde.org/providers/zil-goldstein/">Zil Goldstein</a>), she is said to have been a 20-year-old transgender girl in Texas taking bicalutamide with rapid-onset liver failure and no warning signs. This case has given clinicians and researchers who are aware of it reservations about the use of bicalutamide in hormone therapy for transfeminine people. Another case of liver failure and death in a transgender person over 60 years of age who was treated with bicalutamide has also been informally reported (<a href="https://queerdoc.com/how-do-you-know-which-t-blocker-to-take-what-is-going-on-with-bica/">QueerDoc</a>).</p>
<p>In any case, the reported cases of serious liver toxicity with bicalutamide in transgender people have not been published nor properly confirmed. In addition, the absolute incidence of liver toxicity with bicalutamide is likely to be very low. For instance, the incidence of abnormal <a href="https://en.wikipedia.org/wiki/Liver_function_tests">liver function tests</a> (i.e., <a href="https://en.wikipedia.org/wiki/Elevated_transaminases">elevated liver enzymes</a> on <a href="https://en.wikipedia.org/wiki/Blood_test">blood work</a>) was only 3.4% with high-dose (150 mg/day) bicalutamide monotherapy relative to 1.9% for placebo (a 1.5% difference attributable to bicalutamide) at 3.0 years of follow-up in the <a href="https://en.wikipedia.org/wiki/Early_Prostate_Cancer_(clinical_programme)">Early Prostate Cancer</a> (EPC) clinical programme, a series of three <a href="https://en.wikipedia.org/wiki/Phases_of_clinical_research#Phase_III">phase 3</a> <a href="https://en.wikipedia.org/wiki/Randomized_controlled_trial">randomized controlled trials</a> consisting of over 8,000 patients in which bicalutamide was evaluated for treatment of early prostate cancer (<a href="https://doi.org/10.1046/j.1464-410X.2003.04026.x">Anderson, 2003</a>; <a href="https://doi.org/10.1097/01.ju.0000139719.99825.54">Iversen et al., 2004</a>; <a href="https://en.wikipedia.org/wiki/Side_effects_of_bicalutamide#Liver_toxicity">Wiki</a>; <a href="https://en.wikipedia.org/wiki/Early_Prostate_Cancer_(clinical_programme)">Wiki</a>). Moreover, there were no cases of serious liver toxicity or liver failure with bicalutamide in the initial clinical development programme of bicalutamide for advanced prostate cancer, in which almost 4,000 men were treated with bicalutamide (<a href="https://doi.org/10.1159/000473847">Blackledge, 1996</a>; <a href="https://doi.org/10.1016/S0090-4295(96)80012-4">Kolvenbag &amp; Blackledge, 1996</a>; <a href="https://doi.org/10.1634/theoncologist.2-1-18">McLeod, 1997</a>; <a href="https://doi.org/10.1046/j.1464-410X.2003.04026.x">Anderson, 2003</a>; <a href="https://doi.org/10.1097/01.ju.0000139719.99825.54">Iversen et al., 2004</a>; <a href="https://en.wikipedia.org/wiki/Side_effects_of_bicalutamide#Liver_toxicity">Wiki</a>). However, it should be noted that this was with careful monitoring of liver function in patients and with prompt discontinuation of bicalutamide upon detection of clinically concerning hepatic abnormalities. About 0.5 to 1.5% of men taking 50 to 150 mg/day bicalutamide in the major clinical programmes of bicalutamide for prostate cancer developed liver changes sufficiently marked that they required discontinuation (<a href="https://doi.org/10.1159/000473847">Blackledge, 1996</a>; <a href="https://doi.org/10.1016/S0022-5347(05)64652-6">See et al., 2002</a>; <a href="https://en.wikipedia.org/wiki/Side_effects_of_bicalutamide#Liver_toxicity">Wiki</a>). Hence, regular liver monitoring is essential with bicalutamide to ensure that the possibility of severe liver toxicity is avoided.</p>
<p>Bicalutamide has a much lower risk of liver toxicity than its analogue flutamide (<a href="https://doi.org/10.1016/S0090-4295(96)80012-4">Kolvenbag &amp; Blackledge, 1996</a>; <a href="https://doi.org/10.1016/s0090-4295(97)00279-3">Schellhammer et al., 1997</a>; <a href="https://doi.org/10.1159/000081585">Thole et al., 2004</a>; <a href="https://doi.org/10.1002/pds.1168">Manso et al., 2006</a>; <a href="https://en.wikipedia.org/wiki/Template:Side_effects_of_combined_androgen_blockade_with_nonsteroidal_antiandrogens">Table</a>). However, it retains a small risk of liver toxicity of its own—one with the potential for serious consequences. Hence, caution is warranted with its use, and careful liver monitoring is a necessity for anyone taking it.</p>
<h2 id="recent-developments-and-the-future">Recent Developments and the Future</h2>
<p>Bicalutamide is currently being adopted and characterized for use in the treatment androgen-dependent skin and hair conditions in cisgender women. For instance, a rigorous Italian phase 3 randomized controlled trial of bicalutamide for hirsutism was recently published (<a href="https://doi.org/10.1210/jc.2017-01186">Moretti et al., 2018</a>). Retrospective chart reviews of bicalutamide for scalp hair loss in cisgender women have also been published recently (<a href="https://doi.org/10.1111/dth.13096">Fernandez-Nieto et al., 2019</a>; <a href="https://doi.org/10.1016/j.jaad.2020.03.034">Ismail et al., 2020</a>; <a href="https://doi.org/10.1016/j.jaad.2020.04.054">Fernandez-Nieto et al., 2020</a>; <a href="https://doi.org/10.1016/j.jaad.2021.10.048">Moussa et al., 2021</a>). The hair loss studies have observed low though significant rates of liver changes with bicalutamide.</p>
<p>Certain transgender medical researchers are showing interest in bicalutamide as well. Perhaps most notably, Wylie Hembree—the lead author of the Endocrine Society’s 2009 and 2017 transgender hormone therapy guidelines (<a href="https://doi.org/10.1210/jc.2009-0345">Hembree et al., 2009</a>; <a href="https://doi.org/10.1210/jc.2017-01658">Hembree et al., 2017</a>)—wrote positively about bicalutamide for transfeminine people in a recent review (<a href="https://doi.org/10.1007/978-3-030-05683-4_8">Fishman, Paliou, Poretsky, &amp; Hembree, 2019</a>). He and his colleagues cited the recent phase 3 trial of bicalutamide for hirsutism in cisgender women and the study of bicalutamide as a puberty blocker in transgender girls in support of potential use of bicalutamide for transfeminine people. <a href="https://nl.wikipedia.org/wiki/Guy_T'Sjoen">Guy T’Sjoen</a>—another major researcher in transgender medicine and co-author of the Endocrine Society guidelines (<a href="https://doi.org/10.1210/jc.2017-01658">Hembree et al., 2017</a>; <a href="https://doi.org/10.1016/S2213-8587(20)30192-3">Mitchell, 2020</a>)—seemed to show openness to bicalutamide with his colleagues in a recent review as well (<a href="https://doi.org/10.1177%2F2042018819871166">Iwamoto et al., 2019</a>). Researchers outside of the United States in particular may be more open to bicalutamide, owing to accumulating health concerns with cyproterone acetate—the most commonly used antiandrogen outside of the United States (<a href="/articles/cpa-meningioma/">Aly, 2020</a>). John Randolph, a researcher at the University of Michigan, has also written positively about bicalutamide (<a href="http://doi.org/10.1097/GRF.0000000000000396">Randolph, 2018</a>), though he may have since changed his mind on it (<a href="http://www.med.umich.edu/1libr/ComprehensiveGenderServicesProgram/MMapproachFemGenderAffirmingHormones.pdf">Michigan Medicine, 2020</a>). On the other hand, other authors have not been as welcoming of bicalutamide for transfeminine people (e.g., <a href="https://doi.org/10.1016/j.ecl.2019.02.001">Hamidi &amp; Davidge-Pitts, 2019</a>; <a href="https://doi.org/10.3390/jcm9061609">Cocchetti et al., 2020</a>).</p>
<p>The small risks of bicalutamide with appropriate monitoring may prove to be acceptable to the transgender medical community. This would perhaps be analogous to the rare incidences of serious adverse effects with say spironolactone (e.g., hyperkalemia) or cyproterone acetate (e.g., benign brain tumors, blood clots, breast cancer, liver toxicity). It’s possible that bicalutamide may not ultimately be recommended as a first-line therapy due to its risks. However, it could still be allowed as a second-line option when other antiandrogens are less feasible or not possible due to being for instance inadequately effective, poorly tolerated, <a href="https://en.wikipedia.org/wiki/Contraindication">contraindicated</a>, or unavailable. The transgender medical community isn’t there at this time though. More developments—namely studies and characterization of bicalutamide in actual transfeminine people—are likely to be needed before bicalutamide could become more accepted for use in transfeminine people or recommended in transgender hormone therapy guidelines.</p>
<h2 id="updates">Updates</h2>
<h3 id="update-1-thompson-et-al-2021-fenway-health-guidelines">Update 1: Thompson et al. (2021) [Fenway Health Guidelines]</h3>
<p>In March 2021, the <a href="https://en.wikipedia.org/wiki/Fenway_Health">Fenway Health</a> transgender health clinical practice guidelines were updated from the last version (October 2015) to the following latest edition (<a href="/articles/transfem-hormone-guidelines/">Aly, 2020</a>):</p>
<ul>
<li>Thompson, J., Hopwood, R. A., deNormand, S., &amp; Cavanaugh, T. (2021). <em>Medical Care of Trans and Gender Diverse Adults.</em> Boston: Fenway Health. [<a href="https://www.lgbtqiahealtheducation.org/publication/medical-care-of-trans-and-gender-diverse-adults-2021/">URL</a>] [<a href="https://www.lgbtqiahealtheducation.org/wp-content/uploads/2021/07/Medical-Care-of-Trans-and-Gender-Diverse-Adults-Spring-2021.pdf">PDF</a>]</li>
</ul>
<p>This update is notable as these guidelines included bicalutamide as an antiandrogen option for transfeminine people. While they did not recommend bicalutamide as a first-line agent due to its limited characterization in transfeminine people and its known small risk of liver toxicity, they were cautiously permissive of its use in transfeminine hormone therapy:</p>
<blockquote>
<p>Bicalutamide can be used for [gender-affirming hormone therapy], but there are very few studies examining its use and the relative risk/benefit for this purpose. Because of reported cases of fulminant hepatitis, consensus is that its use in gender affirming hormonal regimen should be carefully considered, used only after alternative options have been trialed or offered, and an in-depth discussion of these potential risks have been had.</p>
</blockquote>
<p>These are the first transgender care guidelines to allow the use of bicalutamide, and only the second guidelines to include bicalutamide. Previously, only the UCSF guidelines mentioned bicalutamide, but they were not permissive of its use in transfeminine people.</p>
<h3 id="update-2-tomson-et-al-2021-sahcs-guidelines">Update 2: Tomson et al. (2021) [SAHCS Guidelines]</h3>
<p>In September 2021, the <a href="https://sahivsoc.org/">Southern African HIV Clinicians Society</a> (SAHCS) published clinical guidelines for transgender care for the first time:</p>
<ul>
<li>Tomson, A., McLachlan, C., Wattrus, C., Adams, K., Addinall, R., Bothma, R., Jankelowitz, L., Kotze, E., Luvuno, Z., Madlala, N., Matyila, S., Padavatan, A., Pillay, M., Rakumakoe, M. D., Tomson-Myburgh, M., Venter, W., &amp; de Vries, E. (2021). Southern African HIV Clinicians’ Society gender-affirming healthcare guideline for South Africa. <em>Southern African Journal of HIV Medicine</em>, <em>22</em>(1), a1299. [DOI:<a href="https://doi.org/10.4102/sajhivmed.v22i1.1299">10.4102/sajhivmed.v22i1.1299</a>] [<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8517808/pdf/HIVMED-22-1299.pdf">PDF</a>]</li>
</ul>
<p>Surprisingly, these guidelines not only included bicalutamide but recommended it as the preferred antiandrogen over spironolactone and cyproterone acetate. The reason stated for this was “less risk of neurosteroid depletion (does not cross blood-brain-barrier readily).” However, this supposed effect isn’t a known concern with antiandrogens besides <a href="https://en.wikipedia.org/wiki/5%CE%B1-Reductase_inhibitor">5α-reductase inhibitors</a>, and bicalutamide actually does appear to be centrally permeable in humans (<a href="https://en.wikipedia.org/wiki/Pharmacology_of_bicalutamide#Distribution">Wiki</a>). Also surprisingly, no mention of liver toxicity or liver enzyme monitoring with bicalutamide was made in these guidelines. Considering these apparent oversights and others, these guidelines’s recommendations should probably be interpreted with caution.</p>
<h3 id="update-3-coleman-et-al-2022-wpath-soc8-guidelines">Update 3: Coleman et al. (2022) [WPATH SOC8 Guidelines]</h3>
<p>In September 2022, the <a href="https://en.wikipedia.org/wiki/World_Professional_Association_for_Transgender_Health">World Professional Association for Transgender Health</a> (WPATH) <a href="https://en.wikipedia.org/wiki/Standards_of_Care_for_the_Health_of_Transgender_and_Gender_Diverse_People">Standards of Care for the Health of Transgender and Gender Diverse People</a> Version 8 (SOC8) were published (<a href="https://doi.org/10.1080/26895269.2022.2100644">Coleman et al., 2022</a>). The WPATH SOC8 are among the most important if not the most important transgender care guidelines that exist and that are consulted by health care professionals. These guidelines briefly discussed bicalutamide including in the following two instances:</p>
<blockquote>
<p>Bicalutamide is an antiandrogen that has been used in the treatment of prostate cancer. It competitively binds to the androgen receptor to block the binding of androgens. Data on the use of bicalutamide in trans feminine populations is very sparse and safety data is lacking. One small study looked at the use of bicalutamide 50 mg daily as a puberty blocker in 23 trans feminine adolescents who could not obtain treatment with a GnRH analogue (Neyman et al., 2019). All adolescents experienced breast development which is also commonly seen in men with prostate cancer who are treated with bicalutamide. Although rare, fulminant hepatotoxicity resulting in death has been described with bicalutamide (O’Bryant et al., 2008). Given that bicalutamide has not been adequately studied in trans feminine populations, we do not recommend its routine use.</p>
</blockquote>
<blockquote>
<p>When selecting a medication, we advise using those which have been studied in multiple transgender populations (i.e., estrogen, cyproterone acetate, GnRH agonists) rather than medications with little to no peer-reviewed scientific studies (i.e., bicalutamide, rectal progesterone, etc.) (Angus et al., 2021; Butler et al., 2017; Efstathiou et al., 2019; Tosun et al., 2019).</p>
</blockquote>
<p>As can be seen, the WPATH SOC8 did not recommend the routine use of bicalutamide in transfeminine people owing to the lack of studies of it in this population and its potential risks. As touched on in the present article, it is likely that more studies of bicalutamide in transfeminine people will be needed before bicalutamide could become endorsed by major transgender care guidelines.</p>
<h3 id="update-4-jamie-reed-2023-bicalutamide-liver-toxicity-case">Update 4: Jamie Reed 2023 Bicalutamide Liver Toxicity Case</h3>
<p>In February 2023, Jamie Reed, a former case manager at the <a href="https://physicians.wustl.edu/specialties/lgbtq-health/washington-university-transgender-center/">The Washington University Transgender Center</a> at <a href="https://en.wikipedia.org/wiki/St._Louis_Children%27s_Hospital">St. Louis Children’s Hospital</a> in St. Louis, Missouri, published the op-ed <a href="https://www.thefp.com/p/i-thought-i-was-saving-trans-kids">“I Thought I Was Saving Trans Kids. Now I’m Blowing the Whistle.”</a> in a conservative online news outlet called <em><a href="https://en.wikipedia.org/wiki/The_Free_Press_(media_company)">The Free Press</a></em>. In this article, Reed expressed that she had become disillusioned with the medical care of transgender youth and layed out her grievances. In addition however, she briefly described an additional case of liver toxicity with bicalutamide in a transfeminine person that had allegedly occurred at her center. This individual was said to be 15 years of age and was given bicalutamide as a puberty blocker by <a href="https://profiles.wustl.edu/en/persons/christopher-lewis">Dr. Christopher Lewis</a>, one of the co-founders of the center. She was said to have subsequently developed liver toxicity and was taken off of bicalutamide. In an electronic message to the center, her mother said that they were “lucky her family was not the type to sue”. This instance, and Reed’s op-ed in general, were subsequently widely reported on in conservative news media, for instance on Fox News and in the <em>Daily Mail</em> (<a href="https://www.google.com/search?q=%22jamie+reed%22+bicalutamide+transgender+OR+trans+OR+gender-affirming&amp;tbs=cdr%3A1%2Ccd_min%3A2%2F9%2F2023%2Ccd_max%3A2%2F28%2F2023">Google</a>). In addition to her op-ed, Reed provided a sworn affidavit to the office of Republican Missouri attorney general <a href="https://en.wikipedia.org/wiki/Andrew_Bailey_(politician)">Andrew Bailey</a>, who proceeded to launch an investigation of the clinic (<a href="https://web.archive.org/web/20230828192422/https://ago.mo.gov/home/news/2023/02/09/missouri-attorney-general-andrew-bailey-confirms-launch-of-multi-agency-investigation-into-st.-louis-transgender-center-for-harming-hundreds-of-children">Missouri Government, 2023a</a>). The following further information was released in the affidavit:</p>
<blockquote>
<p>One doctor at the Center, Dr. Chris Lewis, is giving patients a drug called Bicalutamide. The drug has a legitimate use for treating pancreatic cancer [<em>sic</em>], but it has a side effect of causing breasts to grow, and it can poison the liver. There are no clinical studies for using this drug for gender transitions, and there are no established standards of care for using this drug.</p>
<p>Because of these risks and the lack of scientific studies, other centers that do gender transitions will not use Bicalutamide. The adult center affiliated with Washington University will not use this medication for this reason. But the Center treating children does.</p>
<p>I know of at least one patient at the Center who was advised by the renal department to stop taking Bicalutamide because the child was experiencing liver damage. The child’s parent reported this to the Center through the patient’s online self-reporting medical chart (MyChart). The parent said they were not the type to sue, but “this could be a huge PR problem for you.”</p>
</blockquote>
<p>While unpublished and unverified like the earlier reports of liver toxicity with bicalutamide in transfeminine people, this case represents yet another report, and is notably by far the best-documented one. No other clinical details on the case were provided, and it is unclear whether it involved serious liver toxicity, merely asymptomatic liver function test abnormalities, or a clinical situation somewhere in-between these extremes. In any case, it does seem clear that this instance is not likely to have a positive influence on the further adoption of bicalutamide in transfeminine hormone therapy.</p>
<p>Subsequent to the investigation of the clinic being launched, in April 2023, Missouri greatly restricted gender-affirming care for transgender youth and adults, with some of the most severe limits that have been enacted in the United States (<a href="https://apnews.com/article/transgender-gender-affirming-care-restrictions-missouri-4def2189dac9979a00d298efb3baf12a">Associated Press, 2023a</a>; <a href="https://ago.mo.gov/home/news/2023/04/13/missouri-attorney-general-andrew-bailey-promulgates-emergency-regulation-targeting-gender-transition-procedures-for-minors">Missouri Government, 2023b</a>). Bicalutamide and the liver toxicity instance were not further described with these developments. The new state law restricting gender-affirming care took effect August 28, 2023, and Washington University announced that it would stop prescribing puberty blockers and hormone therapy to transgender youth shortly thereafter (<a href="https://apnews.com/article/transgender-care-minors-missouri-b65a81c842c6add70529acec231858cd">Associated Press, 2023b</a>).</p>
<p>A <em>New York Times</em> article with additional information on the case was also subsequently published (<a href="https://www.nytimes.com/2023/08/23/health/transgender-youth-st-louis-jamie-reed.html">Ghorayshi, 2023</a> [<a href="https://archive.is/oqLqD">Excerpts</a>]). It was noted that the adolescent had been on bicalutamide for 1 year and definitely experienced hepatotoxicity. However, she also had a complicated medical history, including being immunocompromised, having recently had COVID-19, and having taken another drug known to be associated with hepatotoxicity. As such, the hepatotoxicity cannot be definitively attributed to bicalutamide, but it simultaneously cannot be ruled out that bicalutamide was involved or causative.</p>
<h4 id="subsequent-burgener-et-al-2023-2024-findings">Subsequent Burgener et al. (2023, 2024) Findings</h4>
<p>Following the preceding case, Lewis and colleagues went on to publish a conference abstract and preprint of a study of bicalutamide in transfeminine youth and young adults in which they stated that it does not increase liver enzymes in this population (<a href="https://karger.com/hrp/article-pdf/96/Suppl.%203/1/4008437/000531602.pdf#page=377">Burgener et al., 2023</a>; <a href="https://www.medrxiv.org/content/10.1101/2024.02.21.24302999v1">Burgener et al., 2024</a>). However, a closer look at their data show that bicalutamide <em>did</em> statistically significantly elevate certain liver parameters relative to other antiandrogens, namely rates of elevated <a href="https://en.wikipedia.org/wiki/Aspartate_transaminase">aspartate aminotransferase</a> (AST) (upper limit of normal 10.7% vs. 1.5%, <em>P</em> = 0.02) (<a href="https://www.medrxiv.org/content/10.1101/2024.02.21.24302999v1">Burgener et al., 2024</a>). Likewise, rates of elevated <a href="https://en.wikipedia.org/wiki/Alanine_transaminase">alanine aminotransferase</a> (ALT) appeared to trend in the direction of being increased, though this was not statistically significant (upper limit of normal 16.7% vs. 11.6%, <em>P</em> = 0.37) (<a href="https://www.medrxiv.org/content/10.1101/2024.02.21.24302999v1">Burgener et al., 2024</a>). In any case, rates of clinically significant elevations in liver enzymes with bicalutamide, defined as greater than three times the upper limit of normal, were not significantly increased in the study.</p>
<p>On the basis of the relevant research in men with prostate cancer (<a href="https://en.wikipedia.org/wiki/Side_effects_of_bicalutamide#Liver_toxicity">Wiki</a>), Lewis and colleagues’ study, with a bicalutamide-group sample size of only 84 transfeminine individuals, was clearly greatly <a href="https://en.wikipedia.org/wiki/Power_of_a_test">underpowered</a> for evaluating liver function changes. Per the <a href="https://en.wikipedia.org/wiki/Early_Prostate_Cancer_(clinical_programme)">Early Prostate Cancer trial</a> of high-dose bicalutamide monotherapy in men with prostate cancer, elevated liver enzymes appear to occur with bicalutamide at a rate of only about 1.5% more than placebo, or roughly an additional 1 in every 66 people (<a href="https://en.wikipedia.org/wiki/Side_effects_of_bicalutamide#Liver_toxicity">Wiki</a>). Based on <a href="https://clincalc.com/stats/samplesize.aspx">power analysis</a>, this would require a far larger sample size to have adequate statistical power and actually have a chance of achieving statistical significance.</p>
<p>As such, it seems to the present author premature to conclude that bicalutamide does not elevate liver enzymes in transfeminine people.</p>
<p>Lewis and colleagues didn’t mention in their study paper the transfeminine adolescent liver toxicity case reported by Jamie Reed that was said to have occurred at their clinic nor have they published a case report about this instance. Instead, only the following is stated:</p>
<blockquote>
<p>One case report published in 2024 described a transgender female adolescent prescribed bicalutamide 50 mg daily who presented to a hospital with liver toxicity that resolved after stopping bicalutamide (Wilde et al., 2024). This appears to be the first documented case of bicalutamide-induced hepatoxicity in a transgender female.</p>
</blockquote>
<p>While this case was, coincidentally, also a 17-year-old transfeminine adolescent (<a href="https://doi.org/10.1016/j.jadohealth.2023.08.024">Wilde et al., 2024</a>), this instance, per the medical histories and reporting authors/institutions, appears to be distinct from Dr. Lewis’s that was reported by Jamie Reed.</p>
<p>However, Lewis and colleagues did note the following in their paper, which plausibly might have been the Jamie Reed case:</p>
<blockquote>
<p>There was one individual in whom bicalutamide was stopped after the follow-up period designated for the study. This individual developed ALT and AST &gt;2x ULN after an episode of COVID and had a thorough hepatology evaluation. As ALT and AST were never &gt; 3x ULN, it was not recommended that bicalutamide be stopped; however, ultimately a clinical decision was made to stop the medication and ALT and AST normalized.</p>
</blockquote>
<p>Another concern with Lewis and colleagues’ paper pertains to the following statements:</p>
<blockquote>
<p>Whereas bicalutamide doses for prostate cancer reach 150 mg daily, doses used in the care of AMAB transfeminine individuals are much lower (25-50 mg daily).</p>
</blockquote>
<blockquote>
<p>Bicalutamide doses used in prostate cancer are up to 150 mg daily. Due to these concerns of liver toxicity, bicalutamide has not been routinely used as an anti-androgen in AMAB transfeminine individuals, despite the much lower doses needed in this population (∼25-50 mg daily).</p>
</blockquote>
<p>In actuality, bicalutamide is most widely used in prostate cancer, in the form of combined androgen blockade with surgical or medical castration, at a dosage of 50 mg/day, whereas the 150 mg/day dosage is used less commonly, in the form of monotherapy (<a href="https://en.wikipedia.org/wiki/Bicalutamide">Wiki</a>). Moreover, only the 50 mg/day dosage is used in the United States, where monotherapy is not approved. Among the published case reports of hepatotoxicity with bicalutamide in men with prostate cancer, half have been at a dose of 50 mg/day and the other half have been at a dose of 80 to 150 mg/day (<a href="https://en.wikipedia.org/wiki/Template:Published_case_reports_of_bicalutamide-associated_liver_injury">Wiki</a>). The two instances of death due to hepatotoxicity with bicalutamide were both at 50 mg/day. There is currently no evidence that the hepatotoxicity of bicalutamide is dose-dependent across its clinically used dosage range (<a href="https://en.wikipedia.org/wiki/Side_effects_of_bicalutamide#Liver_toxicity">Wiki</a>), although employment of the lowest effective dose in transfeminine people nonetheless seems prudent just in case. Hence, in contrast to Lewis and colleague’s claims, a bicalutamide dosage of 50 mg/day is not less than that generally used in prostate cancer, and clearly retains substantial hepatotoxic potential.</p>
<h3 id="update-5-new-bicalutamide-publications-in-2022-through-2025">Update 5: New Bicalutamide Publications in 2022 Through 2025</h3>
<ul>
<li>Angus, L., Nolan, B., Zajac, J., &amp; Cheung, A. (November 2022). Use of bicalutamide as an androgen receptor antagonist in transgender women. <em>ESA/SRB/APEG/NZSE ASM 2022, November 13-16, Christchurch, Abstracts and Programme</em>, 127–127 (abstract no. 280). [<a href="https://esa-srb-apeg-nzse-2022.p.asnevents.com.au/days/2022-11-14/abstract/85266">URL</a>] [<a href="https://files.transfemscience.org/pdfs/Angus%20et%20al.%20(2022)%20-%20Use%20of%20bicalutamide%20as%20an%20androgen%20receptor%20antagonist%20in%20transgender%20women%20(ESA-SRB-APEG-NZSE%20ASM%202022,%20abstract%20no.%20280).pdf">PDF</a>] [<a href="https://www.endocrinesociety.org.au/esa-srb-apeg-nzse-2022-program_abstracts.pdf#page=127">Full Abstract Book</a>]</li>
<li>Angus, L. M., Nolan, B. J., Zajac, J. D., &amp; Cheung, A. S. (November 2023). Bicalutamide as an anti-androgen in trans people: a cross-sectional study. <em>AusPATH 2023 Symposium</em>. [<a href="https://ashm.eventsair.com/QuickEventWebsitePortal/auspath-conference-2023/aus24/Agenda/AgendaItemDetail?id=0c7c2d1d-21c4-4b21-920f-99446f96a548">URL</a>] [<a href="https://az659834.vo.msecnd.net/eventsairaueprod/production-ashm-public/071ac7b75cbe4d35a6fa168110ea3070">PDF</a>] [<a href="https://files.transfemscience.org/pdfs/misc/Angus%20et%20al.%20AUSPATH%202023%20Bicalutamide%20Study%20Slides.pdf">Slides</a>] [<a href="https://www.transresearch.org.au/post/2023_auspath">Trans Health Research Blog Post</a>]</li>
<li>Bambilla, A., Beal, C., &amp; Vigil, P. (2023). Improving Access to Bicalutamide in Gender Affirming Medical Care. [Unpubished/pending publication] [<a href="https://www.queercme.com/blog/bicalutamide-prescribing-in-gender-affirming-care">QueerCME Blog Post</a>]</li>
<li>Burgener, K., DeBosch, B., Lewis, C., Wallendorf, M., &amp; Herrick, C. (May 2023). Assessment of Liver Function and Toxicity in Transgender Female Adolescents Prescribed Bicalutamide. <em>Hormone Research in Paediatrics</em>, <em>96</em>(Suppl 3 [<em>Abstracts of the 2023 Pediatric Endocrine Society (PES) Annual Meeting’ to Hormone Research in Paediatrics</em>]), 377–378 (abstract no. 6232). [DOI:<a href="https://doi.org/10.1159/000531602">10.1159/000531602</a>] [<a href="https://files.transfemscience.org/pdfs/Burgener%20et%20al.%20(2023)%20-%20Assessment%20of%20Liver%20Function%20and%20Toxicity%20in%20Transgender%20Female%20Adolescents%20Prescribed%20Bicalutamide%20(PES%202023,%20abstract%20ID%206232).pdf">PDF</a>]</li>
<li>Gómez-Aguilar, F., Martínez-Sánchez, L., Arias-Constantí, V., Muñoz-Santanach, D., &amp; Sarquella-Brugada, G. (2023). QT prolongation and Torsade de Pointes in a 13-year-old transgender adolescent in treatment with bicalutamide and tacrolimus. <em>Clinical Toxicology</em>, <em>61</em>(Suppl 1 [<em>43rd International Congress of the European Association of Poisons Centres and Clinical Toxicologists (EAPCCT), 23–26 May 2023, Palma de Mallorca, Spain</em>]), 81–82 (abstract no. 170). [DOI:<a href="https://doi.org/10.1080/15563650.2023.2192024">10.1080/15563650.2023.2192024</a>] [<a href="https://www.eapcct.org/publicfile.php?folder=congress&amp;file=Abstracts_Mallorca23.pdf#page=81">PDF</a>] [<a href="https://doi.org/10.1007/s40278-023-45800-4">Reactions Weekly</a>]</li>
<li>Karakılıç Özturan, E., Öztürk, A. P., Baş, F., Erdoğdu, A. B., Kaptan, S., Kardelen Al, A. D., Poyrazoğlu, Ş., Yıldız, M., Direk, N., Yüksel, Ş., &amp; Darendeliler, F. (2023). Endocrinological Approach to Adolescents with Gender Dysphoria: Experience of a Pediatric Endocrinology Department in a Tertiary Center in Turkey. <em>Journal of Clinical Research in Pediatric Endocrinology</em>, <em>15</em>(3), 276–284. [DOI:<a href="https://doi.org/10.4274/jcrpe.galenos.2023.2023-1-13">10.4274/jcrpe.galenos.2023.2023-1-13</a>]</li>
<li>Vierregger, K., Tetzlaff, M., Zimmerman, B., Dunn, N., Finney, N., Lewis, K., Slomoff, R., &amp; Strutner, S. (May 2023). Bicalutamide Use as Antiandrogen in Trans Feminine Adults - A Safety Profile. <em>National Transgender Health Summit (NTHS) 2023 Symposium</em>. [<a href="https://web.archive.org/web/20240321010915/https://d1keuthy5s86c8.cloudfront.net/static/ems/upload/files/nyhs_202305_agenda_pdf_lbjyz.pdf">Event Agenda PDF</a>] [<a href="https://whova.com/embedded/session/D7SYg0LqOnCqwqXqLsWNIdaSkH1LCYZ1IG6HZi0Pc-U%3D/3000743/">Symposium Session</a>] [<a href="https://prevention.ucsf.edu/transhealth/education/nths">Symposium Abstracts/Program Book</a>]</li>
<li>Vierregger, K., Tetzlaf, M., Zimmerman, B., Dunn, N., Finney, N., Lewis, K., Slomoff, R., &amp; Strutner, S. (November 2023). Bicalutamide Use as Antiandrogen in Trans Feminine Adults - A Safety Profile. <em>USPATH Scientific Symposium, November 1-5, 2023, The Westin Westminster, Westminster, Colorado, Abstract Submissions</em>, 96–96 (abstract no. SAT-B2-T4). [<a href="https://www.wpath.org/media/cms/Upcoming%20Conferences/2023/Schedules/Final%20USPATH%202023%20Scientific%20Symposium%20Main%20Program%20-%20Full%20Schedule.pdf">Symposium Schedule</a>] [<a href="https://files.transfemscience.org/pdfs/Vierregger%20et%20al.%20(2023)%20-%20Bicalutamide%20Use%20as%20Antiandrogen%20in%20Trans%20Feminine%20Adults%20-%20A%20Safety%20Profile%20(USPATH%202023,%20abstract%20no.%20SAT-B2-T4).pdf">PDF</a>] [<a href="https://files.transfemscience.org/pdfs/wpath-symposia-materials/USPATH%202023%20Symposium%20Abstracts.pdf#page=96">Full Abstract Book</a>]</li>
<li>Warus, J., Rincon, M. G., Salvetti, B., &amp; Olson-Kennedy, J. (November 2023). Safety of Bicalutamide as Anti-Androgenic Therapy in Gender Affirming Care for Adolescents and Young Adults: A Retrospective Chart Review. <em>USPATH Scientific Symposium, November 1-5, 2023, The Westin Westminster, Westminster, Colorado, Abstract Submissions</em>, 124–124 (abstract no. SUN-B1-T5). [<a href="https://www.wpath.org/media/cms/Upcoming%20Conferences/2023/Schedules/Final%20USPATH%202023%20Scientific%20Symposium%20Main%20Program%20-%20Full%20Schedule.pdf">Symposium Schedule</a>] [<a href="https://files.transfemscience.org/pdfs/Warus%20et%20al.%20(2023)%20-%20Safety%20of%20Bicalutamide%20as%20Anti-Androgenic%20Therapy%20in%20Gender%20Affirming%20Care%20for%20Adolescents%20and%20Young%20Adults_%20A%20Retrospective%20Chart%20Review%20(USPATH%202023,%20abstract%20no.%20SUN-B1-T5).pdf">PDF</a>] [<a href="https://files.transfemscience.org/pdfs/wpath-symposia-materials/USPATH%202023%20Symposium%20Abstracts.pdf#page=124">Full Abstract Book</a>]</li>
<li>Wilde, B., Diamond, J. B., Laborda, T. J., Frank, L., O’Gorman, M. A., &amp; Kocolas, I. (2023). Bicalutamide-Induced Hepatotoxicity in a Transgender Male-to-Female Adolescent. <em>Journal of Adolescent Health</em>, <em>74</em>(1), 202–204. [DOI:<a href="https://doi.org/10.1016/j.jadohealth.2023.08.024">10.1016/j.jadohealth.2023.08.024</a>]</li>
<li>Burgener, K., DeBosch, B., Wang, J., Lewis, C., &amp; Herrick, C. (2025). Bicalutamide does not raise transaminases clinically significantly compared to alternative anti-androgen regimens among transfeminine adolescents and young adults: a retrospective cohort study. <em>International Journal of Transgender Health</em>, 1–10. [DOI:<a href="https://doi.org/10.1080/26895269.2025.2452184">10.1080/26895269.2025.2452184</a>]</li>
<li>Fuqua, J. S., Shi, E., &amp; Eugster, E. A. (2024). A retrospective review of the use of bicalutamide in transfeminine youth; a single center experience. <em>International Journal of Transgender Health</em>, advance online publication. [DOI:<a href="https://doi.org/10.1080/26895269.2023.2294321">10.1080/26895269.2023.2294321</a>]</li>
<li>Shumer, D., &amp; Roberts, S. A. (2024). Placing a Report of Bicalutamide-Induced Hepatotoxicity in the Context of Current Standards of Care for Transgender Adolescents. <em>Journal of Adolescent Health</em>, <em>74</em>(1), 5–6. [DOI:<a href="https://doi.org/10.1016/j.jadohealth.2023.10.010">10.1016/j.jadohealth.2023.10.010</a>]</li>
<li>Angus, L. M., Hong, Q. V., Cheung, A. S., &amp; Nolan, B. J. (2024). Effect of bicalutamide on serum total testosterone concentration in transgender adults: a case series. <em>Therapeutic Advances in Endocrinology and Metabolism</em>, <em>15</em>. [DOI:<a href="https://doi.org/10.1177/20420188241305022">10.1177/20420188241305022</a>]</li>
</ul>
<h3 id="update-6-original-bicalutamide-liver-and-lung-toxicity-analysis-by-sam">Update 6: Original Bicalutamide Liver and Lung Toxicity Analysis by Sam</h3>
<p>A few years ago back in 2021, Transfeminine Science author <a href="/about/#sam">Sam</a> conducted an original analysis of the incidence of liver and lung toxicity with bicalutamide in the published clinical trial literature. This project was never finished or made publicly available. However, with bicalutamide being increasingly studied and adopted for use in transfeminine people, it seems quite valuable and relevant today. As such, we have opted to now publish Sam’s analysis in this section.</p>
<p>Sam’s analysis can be found in the provided document <a href="https://files.transfemscience.org/pdfs/docs/Supplementary%20Material_%20Liver%20and%20Lung%20Toxicity%20with%20Bicalutamide%20in%20Clinical%20Trials.pdf">here</a>. In terms of methodology, she searched <a href="https://pubmed.ncbi.nlm.nih.gov/">PubMed</a> for all clinical trials of bicalutamide, collated all of the relevant results into a table, and then calculated the incidences of serious liver toxicity and lung toxicity from those data. In clinical trials, adverse events are rated in terms of grades of severity, with a Grade 3 adverse event defined as “severe”, Grade 4 as “life-threatening”, and Grade 5 as “death” (<a href="https://en.wikipedia.org/wiki/Common_Terminology_Criteria_for_Adverse_Events">Wiki</a>).</p>
<p>Of 229 results, 33 trials were found to be relevant and were included. Most of the trials were in men with prostate cancer, but a few were in women with cancer and boys with precocious puberty. Sam found that of a total of 7,703 evaluable participants, there were 2 instances of serious liver toxicity and 2 instances of serious lung toxicity with bicalutamide. This resulted in the same incidence rate of 0.026% (95% CI: 0.003% to 0.094%) or approximately 1 in 3,846 individuals for both liver toxicity and lung toxicity. Combining these toxicities resulted in a total incidence of serious liver <em>or</em> serious lung toxicity with bicalutamide of 0.052% (95% CI: 0.014% to 0.133%) or approximately 1 in 1,923 individuals. All of the observed toxicity events were rated as Grade 3 or 4. It should be noted that clinical trials of bicalutamide typically employ careful laboratory monitoring and assessment of clinical adverse events as well as prompt medication discontinuation upon unfavorable laboratory changes.</p>
<p>While the <a href="https://en.wikipedia.org/wiki/Confidence_interval">confidence intervals</a> (CIs) in Sam’s analysis were wide and hence the estimates are very rough, they provide an idea of the potential real-world risk of serious toxicity with bicalutamide in transfeminine people based on high-quality clinical data. Notably, they do not suffer from the problem of <a href="https://en.wikipedia.org/wiki/Under-reporting">under-reporting</a> of adverse events that occurs with published <a href="https://en.wikipedia.org/wiki/Case_report">case reports</a>, <a href="https://en.wikipedia.org/wiki/Pharmacovigilance">pharmacovigilance databases</a>, and certain types of <a href="https://en.wikipedia.org/wiki/Observational_study">observational studies</a>. However, limitations of Sam’s analysis include (1) toxicity incidence rates for non-bicalutamide-treated controls not being assessed and (2) most of the patients having cancer and being of older age, and hence the generalizability of the findings to healthy transfeminine people not being fully clear. In any case, I was surprised by how high the incidence rates were when I first saw her analysis, and I suspect that others may be as well.</p>
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</ul>]]></content><author><name>{&quot;first_name&quot;=&gt;&quot;Aly&quot;, &quot;last_name&quot;=&gt;&quot;W.&quot;, &quot;author-link&quot;=&gt;&quot;/about/#aly&quot;, &quot;articles-link&quot;=&gt;&quot;/articles-by-author/aly/&quot;}</name></author><category term="github" /><category term="workspace" /><summary type="html"><![CDATA[Bicalutamide and its Adoption by the Medical Community for Use in Transfeminine Hormone Therapy By Aly | First published July 1, 2020 | Last modified August 23, 2025]]></summary></entry></feed>
</ul>]]></content><author><name>{&quot;first_name&quot;=&gt;&quot;Aly&quot;, &quot;last_name&quot;=&gt;&quot;W.&quot;, &quot;author-link&quot;=&gt;&quot;/about/#aly&quot;, &quot;articles-link&quot;=&gt;&quot;/articles-by-author/aly/&quot;}</name></author><category term="github" /><category term="workspace" /><summary type="html"><![CDATA[Supplement: The Interactions of Sex Hormones with Sex Hormone-Binding Globulin and Relevance for Transfeminine Hormone Therapy By Aly | First published July 8, 2020 | Last modified March 14, 2023]]></summary></entry></feed>