FDA Examines Testosterone Use in Menopausal Women

What Happened

On September 17, 2026, the FDA’s Office of Women’s Health and Center for Drug Evaluation and Research held a hybrid public workshop on testosterone use in menopausal women. It followed a Federal Register notice published on August 18 that opened a public docket (FDA-2026-N-5479) for comments on the risks and benefits of testosterone use in this group.

The workshop brought together FDA officials, researchers, clinicians and patients to review what is known and what is not. Topics included:

• How testosterone functions in women throughout life
• Changes in testosterone during the menopausal transition
• How testosterone levels should be measured and interpreted
• Potential uses in menopausal women, including sexual function, cognition, mood and musculoskeletal health
• Long-term safety, including cardiovascular and breast health
• How future clinical trials could evaluate testosterone therapies for women

According to the FDA Law Blog, the workshop traces back in part to the FDA’s December 2025 meeting on testosterone therapy in men, and to women asking for equal attention.

Why It Matters

Women make testosterone throughout life, and levels generally decline with age. Yet unlike estrogen products, no testosterone product has an FDA-approved indication for women. A law firm analysis of the workshop reported that off-label prescribing of testosterone to women near or past menopause has tripled over the past five years, even though fewer than 0.36% of menopausal women are prescribed it.

The absence of an approved product creates real problems. Clinicians described variability between formulations and discomfort prescribing something that isn’t approved, and medical societies generally discourage compounded products. This is not the first attempt: in 2004, an FDA advisory committee considered a testosterone patch for low sexual desire in surgically menopausal women, and more than two decades later there is still no approved product for women. The FDA Law Blog also reported that more than 80% of the comments submitted to the docket in the period following the meeting came from women.

What This Means for Women in Perimenopause and Menopause

Nothing changes at the pharmacy today. The workshop was not an approval, and it does not mean testosterone has been proven for every use. You can still discuss testosterone with a qualified clinician. Off-label prescribing is legal and common in medicine, but the decision should be made with a clinician who is experienced in dosing for women and in monitoring.

If low libido, brain fog or low energy is what brought you here, track what you’re experiencing with our symptom trackers and browse our symptoms by category page. Some of these symptoms have other, treatable causes that are worth checking first. Our article on sexual health during menopause covers changes in desire and intimacy, and if dryness or painful sex is part of the picture, see managing vaginal dryness in menopause.

Access and Availability

There is no FDA-approved testosterone product indicated for women. When testosterone is prescribed, it is off-label, typically using an FDA-approved product made for men at a lower, female-appropriate dose, or a compounded product. Medical societies generally discourage compounding, and quality and dosing can vary. Whether a women-specific product ever reaches the market depends on drug companies running the trials the FDA says are needed, and no timeline has been announced. Other countries have moved ahead: in August 2025 the UK approved a testosterone cream for postmenopausal women with low sexual desire (see our story on the UK approval of a testosterone cream for women), while the U.S. has no equivalent FDA-approved product. To find a clinician who focuses on midlife hormone care, see our menopause specialist directory.

Benefits and Risks

The strongest clinical evidence for testosterone in women relates to sexual function in appropriately selected postmenopausal women. Researchers are also studying mood, cognition, muscle and physical function, but the FDA meeting does not establish these uses as proven treatments.

Safety is the other half of the question. The FDA concluded that available data are inadequate to assess cardiovascular risks of long-term testosterone use in women, and breast cancer risk is also an area needing more data. Measurement is another challenge: the “normal” testosterone range in women is poorly defined, and results can vary by lab method and by whether free or total testosterone is measured. For details on benefits, testing and side effects, read our complete guide to testosterone for menopause. For more on how testosterone works in the body, see the role of testosterone in women during menopause.

Next Steps: What to Watch For

Update (November 3, 2026): The public comment period closed on October 19, 2026. The FDA says the information from the workshop and public comments will help inform future research and potential drug development. FDA officials described the meeting as a “call to action” for drug developers, and one law firm analysis described the workshop as signaling a possible regulatory pathway for a women’s testosterone product. That is interpretation, not an FDA announcement.

Watch for a summary of the docket, announcements from companies about clinical trials and any FDA guidance on trial design. This is also one piece of a busy fall for menopause policy. See our coverage of the women’s health executive order and the FDA’s estradiol patch labeling update.

What This Means for Your Midlife Health

Testosterone is a normal part of women’s biology, and the questions now being asked are more specific: which women may benefit, which symptoms it can actually improve, at what dose and with what long-term safety. Those are worth answering with good research. In the meantime, the best next step is an informed conversation with your clinician. For what major medical groups now recommend for symptoms like hot flashes, see our stories on the ACP hormone therapy guideline and the ACOG guideline update. We’ll keep following this story so you’ll know when the FDA or drug developers make their next move.

Frequently Asked Questions

Is testosterone FDA-approved for women?

No. There is currently no testosterone product approved by the FDA for use in women in the United States.

Can my doctor prescribe testosterone for menopause?

Clinicians may prescribe FDA-approved testosterone products off-label, using doses appropriate for women. Off-label prescribing is legal, but the decision should be made with a qualified healthcare professional.

What did the FDA decide at the testosterone workshop?

Nothing was decided. The September 17 workshop was designed to examine the evidence and research gaps and to help inform future research and potential drug development. It was not an approval decision.

Is testosterone safe for women long term?

That is still unknown. The FDA concluded that available data are inadequate to assess cardiovascular risks of long-term use in women, and more data are needed on breast health.

Can I still submit a comment to the FDA?

No. The public docket closed on October 19, 2026.

This article is for informational purposes only and is not medical advice. Please consult a qualified healthcare provider about your symptoms and treatment options.

References

1. U.S. Food and Drug Administration. (2026). Testosterone Use in Menopausal Women.
2. Federal Register. (2026). Testosterone Use in Menopausal Women; Public Workshop; Request for Comments.
3. Holland & Knight. (2026). FDA Workshop Signals Potential Approval Pathway for Testosterone Therapy in Menopausal Women.
4. FDA Law Blog. (2026). T Time: Women Were First to Put Testosterone Back on FDA’s Agenda. Now It’s Industry’s Turn.