FDA workshop flags unanswered safety questions as testosterone use rises among menopausal women

Testosterone prescriptions for menopausal women are rising fast — but the science needed to approve them in the United States does not yet exist. The FDA recently convened a public workshop at its White Oak Campus in Silver Spring, Maryland, to confront that gap directly, gathering researchers, clinicians, industry representatives, and patients to examine what is known, what is not, and what it would take to bring an approved product to market.

There are no FDA-approved uses for testosterone therapy for menopausal women.— Dr. Christina Chang, Division Director, Division of Urology, Obstetrics and Gynecology, FDA Center for Drug Evaluation and Research

Chang noted at the workshop that the agency is aware of increasing off-label use of testosterone among women experiencing menopause. Because no testosterone formulation has been approved for women in the U.S., clinicians who prescribe it do so off-label, typically using smaller doses of products designed for men.

The workshop, organized jointly by the FDA's Office of Women's Health and its Center for Drug Evaluation and Research, was designed to examine current scientific evidence and identify critical knowledge gaps — with the explicit goal of informing future research and potential drug development. A public comment docket opened alongside the event and will remain open for 60 days, with comments due no later than October 19, 2026.

The case for testosterone in menopausal women starts with basic biology. Studies show testosterone is the most abundant sex hormone in premenopausal women, produced at roughly three times the rate of estrogen, according to ABC News. Adult males generally have 15 times more total testosterone than females, but women's levels decline gradually with age — and low levels have been linked to loss of bone density and muscle mass, along with declines in cognition, mood, sexual function, and energy.

There is a gradual decline in testosterone levels across the premenopausal levels.— Dr. Margaret Wierman, Professor of Medicine, University of Colorado School of Medicine

Unlike estrogen, testosterone does not drop sharply at menopause — the decline is slower and harder to detect. That creates a diagnostic problem: there is no blood-test threshold that can confirm a testosterone deficiency in women, because concentrations are so much lower than in men that existing tests struggle to measure them accurately.

The strongest existing evidence for testosterone therapy in women centers on hypoactive sexual desire disorder (HSDD) — a condition defined by persistently low sexual desire that causes the patient distress. Specialists at the workshop noted, however, that women are seeking testosterone for a much broader range of concerns, including energy and mood. Current guidelines do not support testosterone as a treatment for those symptoms.

The FDA's own workshop announcement identified the most pressing knowledge gaps: the role of testosterone in sexual function, cognition, mood, and musculoskeletal health; the challenges of measuring and interpreting testosterone levels in women; and — most critically — the absence of long-term safety data, particularly regarding cardiovascular and breast cancer risks. Speakers noted limited data beyond short-term physiologic doses, with particular gaps beyond 24 months of use, according to the multi-source summary.

Testosterone for postmenopausal women has already been approved in other countries, a contrast that underscores how far the U.S. regulatory process lags behind clinical practice.

The workshop comes amid a broader surge in hormone therapy. HRT prescriptions among women ages 50 to 65 rose 72% from 2021 to 2025, according to data from Epic Research cited by ABC News. Earlier this year, the FDA removed its "black box" warning label from HRT products for menopause, followed by removal of the warning on testosterone products.

Menopause is inevitable, women should not have to suffer through it. To best serve the American women we need high-quality data and we are looking forward to working with all the manufacturers to be able to get that data.— Dr. Christina Chang, Division Director, Division of Urology, Obstetrics and Gynecology, FDA Center for Drug Evaluation and Research

The workshop has already drawn significant public attention: as of its publication in the Federal Register on August 18, 2026, the docket had received 1,833 comments at Regulations.gov. The FDA's next steps — whether that means encouraging manufacturers to pursue formal approval, commissioning new research, or updating clinical guidance — will depend in part on what that comment process and the workshop's scientific presentations produce.

Why it matters — Millions of menopausal women are already using testosterone without an approved product or long-term safety data — the FDA's next steps could determine whether that changes, and how quickly.

Reported by federalregister.gov, fda.gov, abcnews.com