FDA to weigh testosterone therapy for menopausal women amid safety questions

The FDA is convening a public hearing this week to examine whether testosterone should become an approved treatment for menopausal women—a question that has drawn hundreds of written submissions from patients describing restored desire, sharper energy, and a sense of reclaimed vitality. No female-specific testosterone product has ever received FDA approval in the United States, despite decades of doctors prescribing testosterone off-label to women experiencing low sexual desire, a condition clinicians call hypoactive sexual desire disorder, or HSDD. When physicians do prescribe testosterone to female patients, they typically reach for products designed and dosed for men—splitting pills from formulations like Testim or AndroGel, or ordering custom-compounded versions from specialty pharmacies. The practical awkwardness of this workaround points to a larger gap: the absence of standardized dosing, clear labeling, or insurance coverage pathways tailored to women.

The hearing represents a potential turning point in how American medicine approaches testosterone and menopause. Four times in the past, the FDA has reviewed testosterone for female use and declined to approve it, citing insufficient long-term safety data and unresolved questions about cardiovascular and breast cancer risk. Yet the landscape has shifted. Last year, the agency removed a boxed warning about elevated cardiovascular risk from male testosterone products after reviewing post-marketing studies, though warnings about blood pressure elevation remain. Meanwhile, other countries have moved ahead: Australia, South Africa, New Zealand, and the United Kingdom have all licensed or approved testosterone products specifically for women. The FDA's call for public comment drew a flood of responses, many from women testifying to tangible improvements in sexual function and overall well-being while taking testosterone.

But medical experts caution that the evidence supporting testosterone's benefits is far narrower than popular enthusiasm suggests. Dr. Stephanie Faubion, who directs the Mayo Clinic's Center for Women's Health, emphasizes that the scientific case is strongest only for HSDD—low sexual desire—and weak or absent for the broader claims circulating on social media: that testosterone sharpens cognition, strengthens bones, builds muscle, or lifts mood. "We do not have any evidence in women that it will improve muscle mass or bone density or mood or well-being or really any other metric," Faubion said. Social media has amplified these broader claims, but the research simply does not support them. Dr. Karen Adams, who directs Stanford Medicine's menopause program, notes that testosterone has been evaluated repeatedly by the FDA and rejected each time because the long-term safety picture remains murky.

The safety questions are not trivial. Testosterone can convert to estrogen in the body, raising concern for women with a history of breast cancer, where the hormone might fuel recurrence. Physicians also report that excessive testosterone exposure can cause acne and unwanted hair growth, and in less common cases, voice deepening and permanent hair loss. For women without these contraindications, testosterone is generally considered safe when prescribed and monitored by a clinician—the evidence base for this is solid in men with clinically low hormone levels, and preliminary data suggest similar safety profiles in women. Yet the long-term picture remains incomplete. Dr. Diana Tordoff, an instructor in obstetrics and gynecology at Stanford, points out that an FDA-approved female testosterone product could offer standardized dosing, clear safety-monitoring protocols, and potentially unlock insurance coverage that currently eludes off-label prescribing.

Stanford is currently running a pilot study, called MIX-T, examining how low-dose testosterone affects vaginal health and the vaginal microbiome in postmenopausal women, with results expected within two years. That research may help clarify what testosterone can and cannot do for women in midlife. For now, the FDA hearing will weigh the testimony of hundreds of women who say testosterone has changed their lives against the measured skepticism of researchers who say the evidence base is still too thin to support broad approval. The agency's decision will shape not only whether American women gain access to a standardized, approved treatment, but also what kind of evidence the medical system demands before calling a therapy safe and effective.