FDA Workshop Explores Testosterone Use in Menopausal Women

The FDA has recently focused on reviewing scientific evidence and regulatory considerations surrounding testosterone therapy for menopausal women, with a public workshop held in September 2026.

The workshop, organized by the Office of Women’s Health and the Center for Drug Evaluation and Research, aimed to address current research and identify outstanding questions about the long-term safety of testosterone use in this population, particularly regarding cardiovascular and breast cancer risks.

According to the Federal Register notice (Docket No. FDA-2026-N-5479), the agency invited public input on the benefits and risks associated with testosterone therapy for menopausal women. The workshop included sessions on safety issues and the development of products specifically for female indications, including the importance of testosterone concentration in such products.

Research presented at the workshop included findings from recent clinical and observational studies. One observational study published in 2023 by Lopez et al. reported that cisgender women using testosterone replacement therapy experienced higher rates of cardiovascular disease, coronary artery disease, and stroke, while no increased risk was observed in transgender individuals.

What the numbers show

• The Lopez et al. study found a 24% increased risk of cardiovascular disease, 26% increased risk of coronary artery disease, and 29% increased risk of stroke among cisgender women using testosterone therapy.
• The TRAVERSE trial enrolled 5,246 men aged 45–80 and followed them for a mean of 33 months.
• In the TRAVERSE trial, major adverse cardiac events occurred in 7.0% of the testosterone group and 7.3% of the placebo group.

The TRAVERSE trial, published in June 2023, was designed to address FDA-mandated concerns about the cardiovascular safety of testosterone therapy in men. This randomized, double-blind, placebo-controlled study found that testosterone therapy was noninferior to placebo for major adverse cardiac events, although higher rates of pulmonary embolism, arrhythmias, and acute kidney injury were noted in the testosterone group.

Most randomized clinical trials examining testosterone use in women have been limited in duration, generally lasting no more than 24 months. These studies often excluded women with high cardiometabolic risk and frequently involved concurrent estrogen therapy, which restricts the ability to generalize their findings to broader populations.

The FDA workshop materials highlighted the ongoing need for more comprehensive data on the long-term safety and effectiveness of testosterone therapy for menopausal women. Sessions addressed both the scientific evidence available and the regulatory challenges in developing products intended for female patients.

The agency’s efforts, including the public workshop and call for comments, reflect an ongoing process to evaluate the risks and benefits of testosterone therapy in menopausal women. The FDA continues to review emerging research and stakeholder input as it considers potential regulatory actions in this area.

* This article is based on publicly available information at the time of writing.