Testosterone for Menopausal Women Gains FDA Attention but Not Approval

Written by Ted Samson · October 6, 2026

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Testosterone therapy is once again making headlines, but this time, women are demanding access. On Sept. 17, the U.S. Food and Drug Administration (FDA) held a workshop exploring the use of testosterone in menopause to treat hypoactive sexual desire disorder (HSDD) as well as other uses.

Currently, no testosterone medications are FDA-approved for use for women, but doctors frequently prescribe medications tested for men in lower doses for off-label use.

The workshop solicited comments from endocrinologists, urologists, and gynecologists from the U.S. and abroad. Testosterone is commonly prescribed for women with HSDD and other menopausal symptoms in Australia, New Zealand, the United Kingdom, and South Africa.

Testosterone Treatment Applications

Testosterone is primarily used to address sexual dysfunction, like low libido and difficulty achieving orgasm. Andrea Martin, DNP, a menopause certified provider and founder of Glow Health, explained that testosterone may have other uses as well.

“Low libido is a big complaint, but also fatigue, lack of motivation, and concern with maintaining muscle mass during the menopause transition,” Martin told ThisIsMenopause. “Some patients also try it to help with sleep if they’ve tried everything else.”

Although many women try testosterone for nonsexual issues, The Menopause Society only endorses its use for HSDD due to lack of clinical evidence that it helps with other issues.

Barriers to Testosterone Approval

While substantial clinical research exists on testosterone use for men, there is much less research on women, especially over a long period of time. Currently, most research stops at 24 months, making long-term side effects difficult to anticipate.

The FDA meeting surfaced a few concerns with prescribing testosterone off-label, including:

Testosterone level testing — Testing for female testosterone levels is more difficult because the current tests are not sensitive enough to accurately assess levels.
Lack of research on long-term impact — There is currently insufficient data on the long-term effects on cardiovascular disease and breast cancer.
Side effect reporting — There is no effective way to report side effects for compounded and off-label uses.
Access barriers — Since testosterone is a controlled substance, it’s more difficult to prescribe and obtain. Currently, any controlled substance can only be prescribed by practitioners who have a physical location in each state, effectively eliminating telehealth.

FDA Expressed Interest in Ways Forward

Despite these barriers, the agency expressed willingness to work directly with drug sponsors to develop a female-appropriate testosterone product and called for research on dosing for women.

They also indicated they would be open to using clinical research from international sources, which could potentially speed up an approval process.

After the workshop, the FDA requested public comments until Oct. 19, 2026. There are currently more than 2,000 comments, with many from healthcare providers in favor of approval and individuals seeking an affordable, accessible option.

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