FDA Reviews Testosterone Therapy for Women in First Workshop

On September 17, 2026, the Food and Drug Administration held its first full-day public workshop on testosterone therapy for women. Run jointly by the FDA's Office of Women's Health and its Center for Drug Evaluation and Research, the session brought clinicians, researchers, patients, and industry representatives together at the agency's White Oak campus in Silver Spring, Maryland, with a virtual option for everyone else. The stated goal was to examine the current scientific evidence on testosterone use in menopausal women and map out where the evidence runs out, so future research and potential drug development have something to build on.

The reason the workshop drew attention is the size of the gap it was trying to name. Right now, no testosterone product is approved by the FDA for women in the United States. Every prescription of testosterone therapy for women is off-label. There is no product formulated for women, no agreed dosing guide, and usually no insurance coverage. Women still seek the treatment. Interest has grown as more women look for help with low sexual desire, fatigue, and a reduced quality of life during menopause, and physicians have been left to handle the mismatch between what patients want and what the research supports.

What doctors are doing without a rulebook

Dr. Kudzai Dombo, a board-certified obstetrician-gynecologist, Menopause Society-certified practitioner, and prescribing physician at Alloy Health, sees this dynamic daily in her Los Angeles practice. Once patients get settled on standard estrogen and progesterone regimens, she told Fox News Digital, the immediate next question is whether they need testosterone too.

Answering that question honestly is difficult, because the evidence only stretches so far. Current evidence-based guidelines support testosterone therapy for women for exactly one indication: hypoactive sexual desire disorder, or persistently low sexual desire. The clinical evidence for the other benefits patients ask about, like energy, mood, bone health, or sleep, remains limited, even though many patients are eager to try it for those reasons. And talking about low desire with a partner is its own challenge; this guide to healthy sexual communication is a reasonable starting point. A recent study on lumateperone, for example, showed sexual function gains for depression patients, a reminder that research into sexual health keeps moving even when the treatments themselves lag behind.

Without an approved testosterone therapy for women, doctors work around the gap. The two usual options are custom compounding pharmacies or micro-dosing FDA-approved male gel packets, which patients have to measure out carefully at home. Dombo described a patient in her private practice who measured out one-tenth of a male gel packet daily using a syringe. After three months of consistency, follow-up bloodwork showed no change in hormone levels, and the patient experienced no symptom relief. "It's all experimentation," Dombo said. "We don't have a set guideline for how to be able to do this for women. We have to rely on the art of medicine."

The price of improvising

The lack of standardized options creates administrative and financial problems that land directly on patients. Because the therapy is off-label, insurance routinely denies coverage, forcing clinicians and patients to improvise. Dombo ran into that wall herself. When she was prescribed testosterone, her insurance denied coverage, and her physician recommended a compounded cream to avoid the administrative burden. She had already tried compounded cream and wanted the gel instead, so she used a discount coupon and paid out of pocket. She found that a 10-month supply of male gel packets cost less than a single month of compounded cream. "It's just an example, I think, of how we have to adapt to a system that has not supported patients when it comes to access to testosterone therapy," she said.

The FDA workshop took up these problems alongside the scientific ones. According to the agency's announcement, the critical knowledge gaps include the role of testosterone therapy in sexual function, cognition, mood, and musculoskeletal health, the difficulty of measuring and interpreting testosterone levels in women, and the absence of long-term safety data, especially regarding cardiovascular and breast cancer risks. None of that gets resolved in a single meeting. But the workshop is not the end of the process: the FDA also opened a public docket for comments on the risks and benefits of testosterone use in menopausal women, open for 60 days, with comments due by 11:59 p.m. Eastern Time on October 19, 2026.

For Dombo, the meeting itself was a sign that pressure from patients and clinicians is finally registering. "We're not going to stop knocking on the door, because there are several of us who believe that women deserve to be able to have access to just what they need," she said. "Sexual health is part of your entire health." That framing lands differently in a medical system where one in three women say doctors dismissed their symptoms. Testosterone therapy for women is not a proven fix for everything social media claims it fixes, and the FDA was careful to say the workshop was about gathering evidence, not announcing an approval. For now, the most concrete thing to come out of the day is the open docket: until October 19, anyone can tell the FDA what the risks and benefits look like from where they sit.