Testosterone Use in Menopausal Women; Public Workshop; Request for Comments

The Food and Drug Administration's (FDA) Office of Women's Health and the Center for Drug Evaluation and Research are announcing a public workshop titled "Testosterone Use in Menopausal Women." The purpose of the public 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 of testosterone products for menopausal women. Researchers, educators, industry, clinicians, patients, and consumers may benefit from attending this scientific workshop. Presentations will examine the physiological roles of testosterone throughout a woman's life, including age-related decline, the menopausal transition, challenges associated with measuring and interpreting testosterone blood levels, and how these levels correlate with clinical symptoms and conditions. Speakers will review current and potential clinical uses of testosterone in menopausal women and examine the strengths and limitations of available data supporting those uses. Speakers will discuss regulatory considerations, including the development of robust efficacy and safety data, to support a marketing application for testosterone in menopausal women for the treatment of various clinical conditions, and study design considerations for evaluating long-term safety outcomes in women.

Abstract as published in the Federal Register.