The FDA is in the midst (September 17, 2026) of hosting a hybrid public meeting to discuss testosterone use in menopausal women, featuring multiple expert speakers in the menopause field paired with the federal agency’s Office of Women’s Health (OWH) and Center for Drug Evaluation and Research (CDER) in a public workshop setting.^1,2

The FDA acknowledged the “critical knowledge gaps” that remain despite the growing use of off-label use of testosterone therapy among menopausal women, including the role on sexual function, cognition, mood, and musculoskeletal health, according to a press release from the FDA.¹

“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 FDA noted.

Currently, there is no FDA approved testosterone therapy approved by the FDA indicated specifically for women, a large part of the reasoning for the public meeting.

Multiple speakers have already taken the podium thus far in the meeting, which is being livestreamed via the FDA’s YouTube channel, including²:

• Lakshmi Kannan, PhD, senior advisor, FDA OWH, Office of the Commissioner
• Kaveeta Vasisht, MD, PharmD, FDA associate commissioner for Women’s Health, FDA OWH, Office of the Commissioner
• Christina Chang, MD, MPH, Division director, Urology, Obstetrics, and Gynecology, Office of New Drugs, CDER, FDA
• Admiral Brian Christine, MD, assistant secretary for Health, Head of the United States Public Health Service Commissioned Corps, HHS
• Dorothy Fink, MD, Deputy Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health
• Margaret E. Wierman, MD, professor of Medicine, Integrative Physiology and OBGYN, University of Colorado School of Medicine
• James A. Simon, MD, CCD, clinical professor, Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology, The George Washington University School of Medicine
• Rajita Patil, MD, MSCP, FACOG, associate clinical professor, Department of Obstetrics and Gynecology, Director of the Comprehensive Menopause Program, UCLA
• Pelin Batur, MD, FACP, MSCP, center director, Women’s Comprehensive Health and Research Center, Cleveland Clinic; professor of Obstetrics and Gynecology & Reproductive Biology, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University
• Rachel Rubin, MD, urologist, sexual medicine specialist, assistant clinical professor, Department of Urology, Georgetown University School of Medicine

In opening remarks, James A. Simon, MD, CCD, explained that over the better part of 2 decades, researchers, including himself, have gathered a better understanding of the field through randomized trials, systemic reviews, and decades of clinical experience.

“Yet, despite this progress, there remains no FDA approved product in the [United States],” Simon said at the meeting. “What makes this meeting today especially noteworthy, especially for me, is the extraordinary engagement of patients, clinicians, and advocates. Their comments represent unmet needs, including the absence of female-specific products, reliance on off-label and compounded therapies, cost concerns, and the need for additional research. Most importantly, this meeting reminds us of the real impact these symptoms have on women’s lives and their relationships.”

Pelin Batur, MD, FACP, MSCP, later approached the podium to discuss real-world dosing and the implications for risk-benefit conversations with patients, noting no conflicts of interest or financial disclosures.

Batur provided an example of what could be considered a typical patient presentation, a 55-year-old woman with distressing low sexual desire who has failed behavioral interventions and knows about risks and benefits of treatment. Batur pointed to logistical hurdles clinicians face related to lack of FDA-approved prescriptions, compounding prescriptions, as well as legal issues because of the nature of a controlled substance.

RELATED: Pelin Batur, MD, on navigating sexual health concerns and HSDD throughout the life continuum

For male products, In the [United States], we have at least 12 brand names and 6 delivery routes, so that’s what we need to use,” Batur said. “Most of the time, we’re using the 1% gel because it’s the easiest to work with,” though she explained to the agency and viewers the difficulties associated with correct dosing.

Additionally, “the one thing to know about the male formulation, they have absorption enhancers or boosters, which does change how well it’s being absorbed,” she added.

After initial opening remarks and data presentations from the speakers listed above, the experts convened a panel to answer submitted questions across varying topics related to menopause.

The livestream, scheduled to run until 4:30 PM on September 17, 2026. The livestream can be accessed here.

Reviewing the evidence about testosterone in women

In a newly-launched Special Report series on Contemporary OB/GYN, Bruce Dorr, MD, FACOG, URPS, FMCP-M, discusses testosterone therapy in women with Maria Uloko, MD.

In the discussion, Uloko draws a sharp line between the one population the data supports and the much wider group of women asking about it.

Dorr frames the episode's central question: Once social media noise, clinical anecdote, and personal bias are stripped away, what does the highest-quality evidence actually establish about testosterone therapy in women, and just as importantly, what does it not establish?

Click here to find out and listen to the full discussion.

References:

1. FDA public meeting: Testosterone use in menopausal women. September 17, 2026. Accessed September 17, 2026. https://www.fda.gov/consumers/womens-health-events/fda-public-meeting-testosterone-use-menopausal-women-09172026
2. Testosterone use in menopausal women. FDA. Streamed September 17, 2026. Accessed September 17, 2026. https://www.youtube.com/live/mJQz5WBBNs8