Testosterone for Menopausal Women: What the FDA Meeting Said, What It Did Not, and What It Means for You
Medically reviewed by Dr. Mia Chorney, DNP, FNP-BC, MSCP — Cofounder & Chief Medical Officer, Amsara Health
The short answer: Testosterone for menopausal women was the subject of the U.S. Food and Drug Administration’s first public workshop on the topic, held September 17, 2026. The agency did not approve a product, change a label, or issue new prescribing guidance. It confirmed that no FDA-approved testosterone product exists for women, stated that current evidence supports testosterone only for postmenopausal women with hypoactive sexual desire disorder (HSDD), named the research gaps that must close before any approval, and opened a public comment period that runs through October 19, 2026.
What happened at the FDA’s testosterone meeting?
The FDA Office of Women’s Health and the Center for Drug Evaluation and Research (CDER) co-hosted the public workshop, “Testosterone Use in Menopausal Women,” on Thursday, September 17, 2026, from 9:00 a.m. to 4:30 p.m. Eastern at the agency’s White Oak campus in Silver Spring, Maryland, with a live stream for the public. The FDA’s stated purpose was to “examine the current scientific evidence and critical knowledge gaps related to testosterone use in menopausal women to help inform future research and potential drug development.”
The agenda moved through three sessions. The morning covered the biology of testosterone across a woman’s life (Dr. Margaret Wierman, University of Colorado) and the difficulty of measuring it accurately (Dr. James Simon, George Washington University). A second session reviewed clinical guidelines (Dr. Rajita Patil, UCLA Comprehensive Menopause Program), benefit-risk and dosing (Dr. Pelin Batur, Cleveland Clinic), a clinician’s view (Dr. Rachel Rubin, Georgetown), and a patient’s experience. The afternoon belonged to FDA reviewers, who walked through what the agency requires to approve a drug: efficacy standards, safety, how to measure outcomes that matter to patients, and what role blood testosterone concentrations should play in developing a product for women.
Two officials set the tone at the top of the day. Admiral Brian Christine, Assistant Secretary for Health at HHS, and Dr. Dorothy Fink of the National Institutes of Health delivered the keynote. Dr. Christina Chang, who directs CDER’s Division of Urology, Obstetrics, and Gynecology, opened and closed the regulatory discussion on testosterone for menopausal women.
Why now? Testosterone prescriptions for women have surged
The meeting did not come out of nowhere. Interest in testosterone for menopausal women has climbed sharply. According to healthcare analytics firm Truveta, testosterone prescriptions for women rose 146% between January 2023 and July 2026, as reported by Reuters two days before the workshop. That is a near-tripling in three and a half years, driven almost entirely by off-label use, since no product is approved for women.
It follows a broader shift in menopause care. In November 2025 the FDA removed the boxed warnings from menopausal hormone therapy, a reversal of language that had discouraged treatment since the 2002 Women’s Health Initiative. ABC News reported that hormone therapy prescriptions among women ages 50 to 65 increased 72% from 2021 to 2025, and Truveta data cited by eMarketer show estrogen-based hormone therapy use roughly doubled since 2023. We cover that history in detail in Is HRT Safe?.
Testosterone had already been on the FDA’s desk for men. In February 2025 the agency issued class-wide labeling changes for testosterone products after the TRAVERSE trial found no increase in major cardiovascular events, removing that language from the boxed warning while adding a blood pressure warning. In December 2025 an FDA expert panel on testosterone replacement therapy for men urged easier access, and in April 2026 the agency published a Federal Register notice inviting manufacturers to seek a new indication for low libido in men with idiopathic hypogonadism. September’s workshop was the first time the agency gave women the same public hearing.
What did the FDA actually say about testosterone for menopausal women?
The agency was direct about the current state of affairs. “There are no FDA approved uses for testosterone therapy for menopausal women,” Dr. Chang told the meeting, per ABC News. She added: “Menopause is inevitable, women should not have to suffer through it. To best serve American women we need high-quality data.”
The FDA identified three gaps that stand between today’s practice and an approved product. First, the role of testosterone in sexual function, cognition, mood, and musculoskeletal health is not established beyond one indication. Second, measuring and interpreting testosterone levels in women remains a technical problem. Third, there are no long-term safety data, particularly on cardiovascular and breast cancer risk.
On the question many women are asking, why a product approved in Australia or the United Kingdom cannot simply be approved here, FDA reviewer Dr. Anandi Kotak was clear, according to Reuters: “The regulatory standard for approval in the United States is the same for every drug.” Admiral Christine, by contrast, voiced the frustration in the room when he described the gap between what is available to women abroad and at home: “Something’s wrong with that.”
What the FDA did not do matters as much. It did not approve a product, propose a label, endorse compounded testosterone, or set a target blood level for women. Its concrete next step is an invitation: the agency wants manufacturers to bring high-quality trial data, and it is collecting public comments in docket FDA-2026-N-5479 until 11:59 p.m. Eastern on October 19, 2026.
What the evidence supports today: low desire in postmenopausal women
Testosterone for menopausal women is not an evidence-free zone. In 2019, eleven medical societies, including the Endocrine Society and The Menopause Society, endorsed the Global Consensus Position Statement on the Use of Testosterone Therapy for Women. It supports one use: hypoactive sexual desire disorder (HSDD) in postmenopausal women, meaning a loss of sexual desire that causes personal distress and is not explained by another condition, relationship factor, or medication.
The consensus rests on a systematic review and meta-analysis in The Lancet Diabetes & Endocrinology that pooled 36 randomized controlled trials with 8,480 participants. In postmenopausal women, testosterone improved sexual desire, arousal, orgasm, and pleasure, reduced sexual distress, and increased the number of satisfying sexual events by a mean of 0.85 per month compared with placebo. That is a modest, real, and well-replicated effect.
The condition is common. Data from the PRESIDE study, cited in The Pharmaceutical Journal, put HSDD at 12.3% of women ages 45 to 64, higher than in younger (8.9%) or older (7.4%) women. Dr. Patil’s presentation at the workshop reached the same conclusion as the consensus: the evidence supports testosterone for postmenopausal women with HSDD, and the data are insufficient for mood, cognition, or general well-being.
What the evidence does not (yet) support
Much of the social media enthusiasm for testosterone for menopausal women concerns energy, muscle, mood, focus, and bone. Dr. Stephanie Faubion, medical director of The Menopause Society and director of Mayo Clinic’s Center for Women’s Health, told Reuters: “We do not have any evidence in women that it will improve muscle mass or bone density or mood or well-being or really any other metric.” She added, “What testosterone is being touted for in the lay public and on social media is not really what we have data for.”
The meta-analysis agrees, with a caveat worth stating plainly: it found no effect of testosterone on body composition, musculoskeletal variables, or cognitive measures, but the number of women contributing data on those outcomes was small. Absence of evidence is not the same as evidence of absence. That is precisely the gap the FDA wants trials to fill.
Safety is the other half of the picture. In the pooled trials, testosterone was associated with a significantly greater likelihood of acne (risk ratio 1.46) and increased hair growth (risk ratio 1.69), with no serious adverse events recorded in the trials to date. Oral testosterone raised LDL cholesterol and lowered HDL; transdermal testosterone did not, which is why guidelines favor gels and creams over pills. Reported effects at higher doses include scalp hair loss and voice deepening, and the long-term questions about heart and breast health remain open.
Why testing matters, and why most testosterone labs mislead women
One of the most practical points of the day came from Dr. Simon: the immunoassays most laboratories run for testosterone were designed for men and are unreliable at the low concentrations typical of women. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is the reference method. If a woman has been told her testosterone is “low” or “normal” on a standard panel, that number may not mean much.
The global consensus adds a second principle: no blood level diagnoses HSDD, and testosterone is prescribed for symptoms, not for a number. Where levels do matter is in monitoring, keeping a treated woman’s testosterone within the range seen in healthy premenopausal women to avoid overtreatment. At Amsara, our testing and diagnostics are chosen with that in mind, and functional genomics can add context on how an individual metabolizes hormones. A lab value is the beginning of a conversation, not the end of one.
The access problem: divided gels, compounding, and pharmacy denials
Because there is no approved product, American clinicians improvise. Most prescribe a male testosterone gel such as AbbVie’s AndroGel, Testim, or Vogelxo and instruct women to use roughly one-tenth of the male dose, or they turn to compounded creams. Testosterone products formulated and approved for women exist in the United Kingdom, Australia, New Zealand, and South Africa, but not in the United States.
That workaround is getting harder. Reuters reported that Amazon Pharmacy no longer dispenses some testosterone prescriptions that require women to customize doses, and that at one Massachusetts sexual-wellness practice more than one-third of 80 patients had trouble filling prescriptions. Most insurers do not cover testosterone for women. The cost gap is stark: about $100 for a three-month supply of compounded testosterone versus roughly $30 for a ten-month supply of a discounted commercial gel, according to the same report.
There is movement. More than 30 trials of testosterone in women are underway or planned on ClinicalTrials.gov. Marius Pharmaceuticals plans a trial in female sexual dysfunction later in 2026, and Aviva Bio is developing a next-generation product intended to address breast cancer risk. An approved, appropriately dosed product for women is the outcome the FDA said it wants to see. The workshop was the agency signaling to industry that the door is open, provided the data are rigorous.
What testosterone for menopausal women means for you in midlife
If you have lost sexual desire, it bothers you, and you are postmenopausal, a conversation about testosterone is evidence-based and endorsed by the major menopause societies. It should happen after estrogen and, where needed, vaginal estrogen are optimized, since low desire often improves when hot flashes, sleep, and painful intercourse are treated first. Our guide to perimenopause and menopause symptoms explains how these pieces fit together.
If your main concerns are fatigue, brain fog, low mood, or loss of muscle, testosterone is not the first place to look. Sleep, thyroid function, iron, insulin resistance, estradiol and progesterone dosing, and mental health all have stronger evidence and should be assessed first. In our practice we regularly meet women who were prescribed hormone therapy without a full evaluation, and getting the fundamentals right frequently resolves the symptoms that sent them looking for testosterone.
Questions worth asking any clinician who offers you testosterone: What symptom are we treating, and how will we know it is working? Which product and dose, and is it transdermal? How will you monitor my levels, and with which assay? What are the side effects I should watch for, and when will we reassess? A clinician who answers those clearly is practicing the way the consensus statement recommends. This is how our providers approach women’s hormone health at Amsara, including concierge menopause care in Arizona and telehealth in Texas, Florida, and Nevada.
A note for men
The regulatory story for men is further along. The February 2025 label change acknowledged the TRAVERSE cardiovascular findings, the December 2025 expert panel pushed for broader access, and the April 2026 notice invited applications for a libido indication. Testosterone remains approved only for men with low testosterone and an associated medical condition, and the same principles apply: treat a diagnosed problem, use accurate testing, and monitor. Learn how we approach men’s hormone and metabolic health.
How to make your voice heard
The FDA is accepting public comments on testosterone for menopausal women through October 19, 2026, at 11:59 p.m. Eastern. Anyone can submit at regulations.gov under docket FDA-2026-N-5479. The most useful comments describe specific experiences with symptoms, access, testing, cost, and side effects, and ask for the research that would answer the open questions rather than for blanket approval or prohibition.
Frequently asked questions
Did the FDA approve testosterone for women at the September 2026 meeting?
No. The September 17, 2026 event was a public scientific workshop, not an approval meeting. The FDA did not approve a product, change any label, or issue new prescribing guidance. It reviewed the evidence, identified research gaps, and opened a public comment period through October 19, 2026.
Is testosterone FDA-approved for menopause?
No. As of September 2026 there is no FDA-approved testosterone for menopausal women, or for women of any age, for any indication. Testosterone products are approved only for men with low testosterone associated with a medical condition. Women in the United States who use testosterone do so off-label, typically with a small dose of a male gel or a compounded cream.
What does the evidence support testosterone for in women?
One indication: hypoactive sexual desire disorder (HSDD) in postmenopausal women. A 2019 meta-analysis of 36 randomized trials with 8,480 participants found improvements in desire, arousal, orgasm, and sexual distress, and a global consensus endorsed by eleven medical societies supports use for HSDD only.
Does testosterone help women with energy, mood, brain fog, or muscle?
Current evidence does not show a benefit for these outcomes. Trials measuring mood, cognition, bone, and body composition were small and found no effect, and The Menopause Society states there is no evidence in women for muscle mass, bone density, mood, or well-being. These are the gaps the FDA wants new trials to address.
Is testosterone safe for women?
In the randomized trials to date, transdermal testosterone at physiologic doses caused more acne and hair growth but no serious adverse events. Oral testosterone worsened cholesterol and is not recommended. Long-term data on cardiovascular and breast cancer risk do not yet exist, which is why the FDA has called for more research.
Why are testosterone prescriptions for women rising?
Healthcare analytics firm Truveta reports testosterone prescriptions for women rose 146% from January 2023 to July 2026. The increase follows the FDA’s November 2025 removal of boxed warnings from menopausal hormone therapy and growing public discussion of midlife women’s health.
Does insurance cover testosterone for women?
Usually not, because there is no approved product for women. Compounded testosterone typically costs about $100 for a three-month supply out of pocket. Some pharmacies have also stopped filling prescriptions that require women to divide a male dose.
Can Amsara Health help me decide whether testosterone is right for me?
Yes. Amsara Health provides integrative telehealth for women and men in Arizona, Texas, Florida, and Nevada. Our providers evaluate the full hormonal, metabolic, and lifestyle picture, use accurate testing, and prescribe testosterone only when it is appropriate for a diagnosed indication, with monitoring. You can begin with a free 15-minute discovery call.
Sources
- FDA, Public Meeting: Testosterone Use in Menopausal Women (Sept 17, 2026)
- FDA, Workshop agenda and speakers (PDF)
- Regulations.gov, Docket FDA-2026-N-5479
- Reuters, US regulators urge more research on testosterone therapy for women (Sept 17, 2026)
- Reuters, Testosterone scripts for women rise, along with denials and delays (Sept 15, 2026)
- ABC News, FDA examines use of testosterone prescriptions for menopause (Sept 18, 2026)
- FDA, Class-wide labeling changes for testosterone products (Feb 28, 2025)
- FDA, Expert Panel on Testosterone Replacement Therapy for Men (Dec 10, 2025)
- Federal Register, Potential New Indication for Testosterone Replacement Therapy (Apr 20, 2026)
- FDA/HHS, Removal of boxed warnings on menopausal hormone therapy (Nov 2025)
- eMarketer, Hormone therapy prescriptions climb after safety label change (Truveta data)
- Endocrine Society, Global Consensus Position Statement on the Use of Testosterone Therapy for Women (2019)
- Islam RM et al., The Lancet Diabetes & Endocrinology (2019): Safety and efficacy of testosterone for women, meta-analysis of 36 RCTs
- The Pharmaceutical Journal, Testosterone in menopause: a review of the evidence and prescribing practice (HSDD prevalence, PRESIDE)
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