FDA Public Workshop: Testosterone Use in Menopausal Women
Today, the FDA’s Office of Women’s Health (OWH) and the Center for Drug Evaluation and Research (CDER) are announcing a public workshop titled: Testosterone Use in Menopausal Women to be held on September 17, 2026, from 9:00 a.m. to 4:30 p.m. ET.
Menopause is marked by a significant decline in ovarian hormones, including testosterone. Despite growing off-label use of testosterone therapy in menopausal women, critical knowledge gaps remain. These gaps include the role of testosterone therapy in sexual function, cognition, mood, and musculoskeletal health; challenges in measuring and interpreting testosterone levels; and the absence of long-term safety data, especially regarding cardiovascular and breast cancer risks.
The purpose of the workshop is to examine the current scientific evidence and critical knowledge gaps related to testosterone use in menopausal women to help inform future research and potential drug development in this area.
The workshop will be held in a hybrid format accessible both in-person at the FDA White Oak Campus (Great Room) and virtually. Registration is required to attend in either format.
In addition to workshop, the FDA is also opening a docket to allow for submission of broad, public comments on the risks and benefits related to testosterone use in menopausal women. The docket will be open for public comments for 60 days. To be assured of consideration, comments must be received no later than 11:59 p.m. Eastern Time (ET) on October 19, 2026. Visit Regulations.gov for complete details on submission requirements for comments.
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