The U.S. Food and Drug Administration (FDA) held a public meeting on September 17 to examine the use of testosterone in menopausal women, an area that has generated growing interest among women, clinicians and researchers.
The meeting brought together FDA officials, researchers and menopause experts to review what is currently known about testosterone in women and where important questions remain unanswered.
Why the FDA Is Looking at Testosterone
Testosterone is a hormone produced by women as well as men, and levels generally decline with age. Testosterone has been used off-label in some menopausal women for years, particularly for persistent low sexual desire.
But there is currently no testosterone product specifically FDA-approved for use in menopausal women in the United States.
The FDA said the purpose of the meeting was to examine the scientific evidence and critical knowledge gaps related to testosterone use in menopausal women and to help inform future research and potential drug development.
What Did the FDA Discuss?
The meeting covered several areas of testosterone research, including:
- How testosterone functions in women throughout life
- Changes in testosterone during the menopausal transition
- How testosterone levels should be measured and interpreted
- Potential uses for testosterone in menopausal women
- 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
The FDA's meeting notice specifically identified challenges in measuring testosterone levels and the lack of long-term safety data as areas requiring additional study.
Does This Mean Testosterone Is Being Approved for Menopause?
No. The September meeting was not an FDA approval decision.
The FDA is examining the existing evidence and the research needed to evaluate testosterone products for menopausal women. There is still no FDA-approved testosterone product specifically indicated for women in the United States.
That does not mean women cannot currently be prescribed testosterone. Clinicians may prescribe FDA-approved testosterone products off-label, using doses appropriate for women. Off-label prescribing is legal and commonly used in medicine, although the specific treatment decision should be made with a qualified healthcare professional.
Why This Matters
For women who have been prescribed testosterone, or who have questions about whether it could have a role in their menopause care, the FDA meeting is significant because it puts women's testosterone use directly into a federal research and drug-development discussion.
The FDA's focus also reflects an important distinction: there is evidence supporting some uses of testosterone in women, while other potential benefits remain areas of investigation.
For example, the strongest clinical evidence currently relates to sexual function in appropriately selected postmenopausal women. Researchers are also studying whether testosterone could have a role in other aspects of women's health, including mood, cognition, muscle and physical function.
The FDA meeting does not establish those additional uses as proven treatments. Instead, it highlights the need for better research to determine where testosterone may be helpful, for whom, at what dose and with what long-term safety profile.
What Happens Next?
The FDA opened a public docket for comments about the risks and benefits of testosterone use in menopausal women. Comments were accepted through October 19, 2026. The agency said the information from the workshop and public comments will help inform future research and potential drug development.
For now, testosterone remains an area of active research rather than a newly approved menopause treatment. But the FDA's decision to bring researchers, clinicians and regulators together specifically to examine testosterone in menopausal women marks an important step in understanding what we know, what we don't know and what needs to be studied next.
What This Means for Women
If you've been wondering about testosterone during menopause, you're not alone. The conversation is changing, but the science is still evolving.
Testosterone is a normal part of women's biology. The questions now being asked are more specific: Which women may benefit from testosterone therapy? Which symptoms can it actually improve? What doses are appropriate? And what do we need to know about long-term safety?
Those are questions worth answering with good research.
Learn More
Want to understand testosterone in more detail? Read our complete guide to testosterone for menopause, including what testosterone does in women, potential benefits, testing, treatment options, side effects and the latest research.
References
- U.S. Food and Drug Administration. (2026). Testosterone Use in Menopausal Women.
- Federal Register. (2026). Testosterone Use in Menopausal Women; Public Workshop; Request for Comments.