{"id":361336,"date":"2026-09-18T17:29:18","date_gmt":"2026-09-18T22:29:18","guid":{"rendered":"https:\/\/www.etrafficlane.com\/60dollarmiracle\/fda-examines-use-of-testosterone-prescriptions-for-menopause"},"modified":"2026-09-18T17:29:22","modified_gmt":"2026-09-18T22:29:22","slug":"fda-examines-use-of-testosterone-prescriptions-for-menopause","status":"publish","type":"post","link":"https:\/\/www.etrafficlane.com\/60dollarmiracle\/fda-examines-use-of-testosterone-prescriptions-for-menopause","title":{"rendered":"FDA examines use of testosterone prescriptions for menopause"},"content":{"rendered":"<p><br \/>\n<\/p>\n<div data-testid=\"prism-article-body\">\n<p class=\"EkqkG IGXmU nlgHS yuUao MvWXB TjIXL aGjvy ebVHC \">Testosterone therapy is increasingly being used by menopausal women but specialists at a Food and Drug Administration (FDA) public<!-- -->\u00a0<a class=\"zZygg UbGlr iFzkS qdXbA WCDhQ DbOXS tqUtK GpWVU iJYzE \" data-testid=\"prism-linkbase\" href=\"https:\/\/abcnews.com\/Health\/fda-examines-testosterone-prescriptions-menopause\/Testosterone%20therapy%20is%20increasingly%20being%20used%20by%20menopausal%20women%20but%20specialists%20at%20a%20Food%20and%20Drug%20Administration%20(FDA)%20public%20workshop%20cautioned%20on%20Thursday%20that%20key%20questions%20about%20its%20long-term%20safety%20remain%20unanswered.%20%20%20%20%20Studies%20show%20that%20while%20adult%20males%20generally%20have%2015%20times%20more%20total%20testosterone%20than%20females,%20testosterone%20is%20the%20most%20abundant%20sex%20hormone%20in%20premenopausal%20women,%20produced%20at%20about%20three%20times%20the%20rate%20of%20estrogen.%20%20%20%20%20With%20age,%20women\u2019s%20testosterone%20levels%20gradually%20decline,%20and%20low%20levels%20have%20been%20linked%20to%20loss%20of%20bone%20density%20and%20muscle%20mass,%20along%20with%20declines%20in%20cognition,%20mood,%20sexual%20function%20and%20energy.%20%20%20%20Because%20there%20is%20no%20FDA-approved%20testosterone%20formulation%20for%20women%20in%20the%20United%20States,%20clinicians%20who%20prescribe%20the%20hormone%20may%20do%20so%20off-label%20and%20use%20smaller%20doses%20of%20testosterone%20products%20designed%20for%20men.%20%20%20%20%20\u201cThere%20are%20no%20FDA%20approved%20uses%20for%20testosterone%20therapy%20for%20menopausal%20women,\u201d%20Dr.%20Christina%20Chang,%20division%20director%20of%20the%20division%20of%20urology,%20obstetrics,%20and%20gynecology%20in%20the%20FDA\u2019s%20Center%20for%20Drug%20Evaluation%20and%20Research%20said%20at%20the%20FDA%20workshop%20Thursday.%20She%20noted%20that%20the%20agency%20is%20aware%20of%20increasing%20off-label%20use%20of%20testosterone%20among%20women%20experiencing%20menopause.%20%20%20%20%20Currently,%20evidence%20supporting%20testosterone%20therapy%20in%20women%20is%20largely%20focused%20on%20hypoactive%20sexual%20desire%20disorder,%20a%20condition%20characterized%20by%20persistently%20low%20sexual%20desire%20that%20causes%20distress.%20%20%20%20Specialists%20in%20the%20FDA%20workshop%20Thursday%20said%20women%20are%20seeking%20testosterone%20for%20a%20much%20broader%20range%20of%20concerns%20including%20energy%20and%20mood.%20Based%20on%20current%20guidelines,%20testosterone%20therapy%20is%20not%20considered%20a%20treatment%20for%20these%20symptoms.%20%20%20%20Measuring%20testosterone%20in%20women%20also%20presents%20challenges%20because%20concentrations%20are%20much%20lower%20than%20in%20men.%20As%20such,%20there%20is%20no%20blood-test%20threshold%20that%20can%20diagnose%20whether%20a%20woman%20has%20a%20testosterone%20deficiency.%20%20%20%20Unlike%20estrogen,%20testosterone%20levels%20do%20not%20suddenly%20fall%20when%20women%20reach%20menopause.%20\u201cThere%20is%20a%20gradual%20decline%20in%20testosterone%20levels%20across%20the%20premenopausal%20levels,\u201d%20Dr.%20Margaret%20Wierman,%20professor%20of%20medicine%20at%20the%20University%20of%20Colorado%20School%20of%20Medicine,%20told%20ABC%20News.%20%20%20%20%20The%20growing%20interest%20in%20testosterone%20comes%20amid%20an%20increase%20in%20hormone%20replacement%20therapy%20(HRT)%20among%20menopausal%20women,%20which%20typically%20uses%20estrogen%20with%20or%20without%20progesterone%20to%20replace%20declining%20hormones%20during%20menopause.%20%20%20%20%20HRT%20prescriptions%20among%20women%20ages%2050%20to%2065%20rose%2072%25%20from%202021%20to%202025,%20according%20to%20data%20from%20Epic%20Research.%20It%20comes%20after%20the%20FDA%20removed%20its%20strong%20safety%20warning%20from%20HRT%20products%20for%20menopause%20earlier%20this%20year%20followed%20by%20the%20removal%20of%20the%20warning%20on%20testosterone%20products.%20%20%20%20%20\u201cMenopause%20is%20inevitable,%20women%20should%20not%20have%20to%20suffer%20through%20it,\u201d%20Chang%20said.%20%22To%20best%20serve%20the%20American%20women%20we%20need%20high-quality%20data%20and%20we%20are%20looking%20forward%20to%20working%20with%20all%20the%20manufacturers%20to%20be%20able%20to%20get%20that%20data.\u201d\" dir=\"ltr\">workshop<\/a>\u00a0<!-- -->cautioned on Thursday that key questions about its long-term safety remain unanswered.<!-- -->\u00a0<\/p>\n<p class=\"EkqkG IGXmU nlgHS yuUao lqtkC TjIXL aGjvy \">Studies show that while adult males generally have<!-- -->\u00a0<a class=\"zZygg UbGlr iFzkS qdXbA WCDhQ DbOXS tqUtK GpWVU iJYzE \" data-testid=\"prism-linkbase\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/26510959\/\" dir=\"ltr\">15<!-- -->\u00a0<!-- -->times<\/a>\u00a0<!-- -->more total testosterone than females,<!-- -->\u00a0<!-- -->testosterone is the most<!-- -->\u00a0<a class=\"zZygg UbGlr iFzkS qdXbA WCDhQ DbOXS tqUtK GpWVU iJYzE \" data-testid=\"prism-linkbase\" href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC7098532\/\" dir=\"ltr\">abundant<\/a>\u00a0<!-- -->sex hormone in premenopausal women, produced<!-- -->\u00a0<!-- -->at about three times the rate of estrogen.<\/p>\n<p class=\"EkqkG IGXmU nlgHS yuUao lqtkC TjIXL aGjvy \">With age, women&#8217;s testosterone levels gradually decline, and low levels have been linked to loss of bone density and muscle mass, along with declines in cognition, mood, sexual function and energy.<\/p>\n<p class=\"EkqkG IGXmU nlgHS yuUao lqtkC TjIXL aGjvy \">Because there is no FDA-approved testosterone formulation for women in the U.S., clinicians who prescribe the hormone may do so off-label and use smaller doses of testosterone products designed for men.<!-- -->\u00a0<\/p>\n<p class=\"EkqkG IGXmU nlgHS yuUao lqtkC TjIXL aGjvy \">&#8220;There are no FDA-approved uses for testosterone therapy for menopausal women,&#8221; Dr. Christina Chang, division director of the division of urology, obstetrics and gynecology in the FDA&#8217;s Center<!-- -->\u00a0<!-- -->for Drug Evaluation and Research said at the FDA workshop Thursday. She noted that the agency is aware of increasing off-label use of testosterone among women experiencing menopause.<!-- -->\u00a0<\/p>\n<div class=\"oLzSq QrHMO fnRUo pvsTF EhJPu vPlOC zNYgW OsTsW RMeqy daRVX ISNQ sKyCY eRftA acPPc MENS nFwaT MCnQE mEeeY SmBjI xegrY rPLsU iulOd NIuqO zzscu lzDCc aHUBM IEgzD OjMNy eQqcx SVqKB GQmdz jaoD VWDdR ONJdw vrZxD OnRTz gbbfF roDbV GPGwb oMlSS gfNzt oJhud eXZcf zhVlX \">\n<div>\n<div class=\"InlineImage GpQCA lZur asrEW \" data-testid=\"prism-inline-image\">\n<figure class=\"kzIjN GNmeK pYrtp dSqFO \" data-testid=\"prism-figure\">\n<div class=\"GpQCA lZur gIjeL \" data-testid=\"prism-ratio-frame\">\n<div class=\"FvQLF iLTd NqeUA UzzHi iWsMV \"><img decoding=\"async\" title=\"Christina Chang\" alt=\"Christina Chang\" class=\"hsDdd NDJZt sJeUN IJwXl vBqtr KrDt itslR SjwtZ hakZw HlUVI \" data-testid=\"prism-image\" draggable=\"false\" loading=\"lazy\" src=\"https:\/\/s.abcnews.com\/images\/Politics\/fda-1-gty-er-221229_1672352712249_hpMain.jpg\"\/><\/div>\n<\/div><figcaption>\n<div class=\"nMMea bNYiy Mjgpa dGwha DDmxa jgKNG RGHCC aBIU PriDW aiQHS lZur \" data-testid=\"prism-caption\">\n<p><span class=\"hsDdd OOSI GpQCA lZur VlFaz \" data-testid=\"prism-truncate\"><span><span class=\"gtOSm FbbUW tUtYa vOCwz EQwFq yCufu eEak Qmvg nyTIa SRXVc vzLa jgBfc WXDas CiUCW kqbG zrdEG txGfn ygKVe BbezD UOtxr CVfpq xijV soGRS XgdC sEIlf daWqJ \">In this July 20, 2020, file photo, a sign for the Food And Drug Administration is seen outside of the headquarters, in White Oak, Md.<\/span><\/span><\/span><\/p>\n<p><span class=\"gtOSm FbbUW tUtYa vOCwz EQwFq yCufu eEak Qmvg nyTIa SRXVc vzLa jgBfc WXDas CiUCW kqbG zrdEG txGfn ygKVe BbezD UOtxr CVfpq xijV soGRS XgdC sEIlf daWqJ YNujN JGtjI aZFDu rkKLh \">Sarah Silbiger\/Getty Images, FILE<\/span><\/p>\n<\/div>\n<\/figcaption><\/figure>\n<\/div>\n<\/div>\n<\/div>\n<p class=\"EkqkG IGXmU nlgHS yuUao lqtkC TjIXL aGjvy \">Currently,<!-- -->\u00a0<a class=\"zZygg UbGlr iFzkS qdXbA WCDhQ DbOXS tqUtK GpWVU iJYzE \" data-testid=\"prism-linkbase\" href=\"https:\/\/journals.lww.com\/greenjournal\/abstract\/10.1097\/aog.0000000000006015~testosterone-for-the-treatment-of-hypoactive-sexual-desire?redirectionsource=fulltextview\" dir=\"ltr\">evidence<\/a>\u00a0<!-- -->supporting testosterone therapy in women is largely focused on hypoactive sexual desire disorder, a condition characterized by persistently low sexual desire that causes distress.<\/p>\n<p class=\"EkqkG IGXmU nlgHS yuUao lqtkC TjIXL aGjvy \">Specialists<!-- -->\u00a0<!-- -->in the FDA workshop on Thursday said women are seeking testosterone for a much broader range of concerns including energy and mood. Based on current<!-- -->\u00a0<a class=\"zZygg UbGlr iFzkS qdXbA WCDhQ DbOXS tqUtK GpWVU iJYzE \" data-testid=\"prism-linkbase\" href=\"https:\/\/www.fda.gov\/drugs\/postmarket-drug-safety-information-patients-and-providers\/testosterone-information\" dir=\"ltr\">guidelines<\/a>, testosterone therapy is not considered a treatment for these symptoms.<\/p>\n<p class=\"EkqkG IGXmU nlgHS yuUao lqtkC TjIXL aGjvy \">Measuring testosterone in women also presents challenges because concentrations are much lower than in men. As such, there is no blood-test threshold that can diagnose<!-- -->\u00a0<!-- -->whether a woman has a testosterone<!-- -->\u00a0<a class=\"zZygg UbGlr iFzkS qdXbA WCDhQ DbOXS tqUtK GpWVU iJYzE \" data-testid=\"prism-linkbase\" href=\"https:\/\/nam04.safelinks.protection.outlook.com\/?url=https%3A%2F%2Fhealth.clevelandclinic.org%2Ftestosterone-in-women&amp;data=05%7C02%7CMary.Kekatos%40abc.com%7C9a51ea3f5c534f4b0d4308df15b243c2%7C56b731a8a2ac4c32bf6b616810e913c6%7C1%7C0%7C639253527553368909%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=PlCkWIwOjKXiH9dxq2%2FAOTq1EFiVWvDjMWeaaadOFrg%3D&amp;reserved=0\" dir=\"ltr\">deficiency<\/a>.<\/p>\n<p class=\"EkqkG IGXmU nlgHS yuUao lqtkC TjIXL aGjvy \">Unlike estrogen, testosterone levels do not suddenly fall when women reach menopause.<\/p>\n<p class=\"EkqkG IGXmU nlgHS yuUao lqtkC TjIXL aGjvy \">&#8220;There is a gradual decline in testosterone levels across the premenopausal levels,&#8221; Dr. Margaret Wierman, professor of medicine at the University of Colorado School of Medicine, told ABC News.<!-- -->\u00a0<\/p>\n<p class=\"EkqkG IGXmU nlgHS yuUao lqtkC TjIXL aGjvy \">The growing interest in testosterone comes amid an increase in<!-- -->\u00a0<a class=\"zZygg UbGlr iFzkS qdXbA WCDhQ DbOXS tqUtK GpWVU iJYzE \" data-testid=\"prism-linkbase\" href=\"https:\/\/www.fda.gov\/consumers\/womens-health-topics\/menopause#hormonetherapy\" dir=\"ltr\">hormone replacement therapy<\/a>\u00a0<!-- -->(HRT) among menopausal women, which typically uses estrogen with or without progesterone to replace<!-- -->\u00a0<!-- -->declining hormones during menopause.<\/p>\n<p class=\"EkqkG IGXmU nlgHS yuUao lqtkC TjIXL aGjvy \">HRT prescriptions among women ages 50 to 65<!-- -->\u00a0<a class=\"zZygg UbGlr iFzkS qdXbA WCDhQ DbOXS tqUtK GpWVU iJYzE \" data-testid=\"prism-linkbase\" href=\"https:\/\/www.epicresearch.org\/articles\/hormone-replacement-therapy-prescriptions-for-women-up-72-since-2021\/\" dir=\"ltr\">rose<\/a>\u00a0<!-- -->72% from 2021 to 2025, according<!-- -->\u00a0<!-- -->to data from Epic Research. It comes after the FDA removed its &#8220;black box&#8221; warning label from HRT products for menopause earlier this year followed by the removal of the warning on testosterone products.<!-- -->\u00a0<\/p>\n<p class=\"EkqkG IGXmU nlgHS yuUao lqtkC eTIW sUzSN \">&#8220;Menopause is inevitable, women should not have to suffer through it,&#8221; Chang said. &#8220;To best serve the American women we need high-quality data and we are looking forward to working with all the manufacturers to be able to get that data.&#8221;<!-- -->\u00a0<\/p>\n<\/div>\n<p><br \/>\n<br \/><a href=\"https:\/\/abcnews.com\/Health\/fda-examines-testosterone-prescriptions-menopause\/story?id=136570571\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Testosterone therapy is increasingly being used by menopausal women but specialists at a Food and Drug Administration (FDA) public\u00a0workshop\u00a0cautioned on Thursday that key questions about [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":361339,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[35431,36975,6691,1387,36974,36973,36972,269,36976,9431,173],"class_list":["post-361336","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-christina-chang","tag-division-director-of-the-division","tag-dysfunction","tag-fda","tag-hormone-replacement-therapy","tag-hrt","tag-margaret-wierman","tag-maryland","tag-professor-of-medication","tag-testosterone","tag-united-states"],"_links":{"self":[{"href":"https:\/\/www.etrafficlane.com\/60dollarmiracle\/wp-json\/wp\/v2\/posts\/361336","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.etrafficlane.com\/60dollarmiracle\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.etrafficlane.com\/60dollarmiracle\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.etrafficlane.com\/60dollarmiracle\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.etrafficlane.com\/60dollarmiracle\/wp-json\/wp\/v2\/comments?post=361336"}],"version-history":[{"count":2,"href":"https:\/\/www.etrafficlane.com\/60dollarmiracle\/wp-json\/wp\/v2\/posts\/361336\/revisions"}],"predecessor-version":[{"id":361338,"href":"https:\/\/www.etrafficlane.com\/60dollarmiracle\/wp-json\/wp\/v2\/posts\/361336\/revisions\/361338"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.etrafficlane.com\/60dollarmiracle\/wp-json\/wp\/v2\/media\/361339"}],"wp:attachment":[{"href":"https:\/\/www.etrafficlane.com\/60dollarmiracle\/wp-json\/wp\/v2\/media?parent=361336"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.etrafficlane.com\/60dollarmiracle\/wp-json\/wp\/v2\/categories?post=361336"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.etrafficlane.com\/60dollarmiracle\/wp-json\/wp\/v2\/tags?post=361336"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}