FDA examines testosterone therapy as use by menopausal women rises
US health regulators will review scientific evidence regarding testosterone use among menopausal women on Thursday, evaluating its benefits, risks, dosage options, role in female health, and perspectives from both patients and doctors.
The public meeting, which the US Food and Drug Administration said could help guide future medical research and drug development, comes as an increasing number of women turn to testosterone to manage menopause symptoms.
There is no FDA-approved female testosterone treatment, despite years of off-label use to manage low sexual desire, known as hypoactive sexual desire disorder, or HSDD.
Last year, the FDA removed a boxed warning about elevated cardiovascular risk from male testosterone products following post-marketing study reviews, though products still carry warnings regarding increased blood pressure.
Physicians prescribing testosterone to women typically rely on lower doses of products cleared for men, often dividing therapies such as Keenova Therapeutics' Testim and AbbVie's AndroGel, or using custom compounded formulations.
The lack of female-specific options presents practical challenges for clinicians, said Dr. Diana Tordoff, an instructor in obstetrics and gynecology at Stanford, noting that an approved drug could offer standardized dosing, labeling, safety-monitoring guidance, and potentially improve insurance coverage.
Nevertheless, key questions remain unresolved, according to medical experts. More long-term safety data are needed, said Dr. Stephanie Faubion, director of Mayo Clinic's Center for Women's Health.
Australia, South Africa, New Zealand, and the United Kingdom have licensed or approved testosterone products specifically for female patients.
The FDA's request for public input ahead of the hearing drew hundreds of submissions, with many women describing enhanced libido, energy levels, and quality of life while on testosterone.
Interest in testosterone among menopausal women has expanded alongside social media claims that it enhances energy, cognition, bone health, and muscle mass, though specialists stress that evidence remains strongest for HSDD.
"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.
Dr. Karen Adams, director of Stanford Medicine's Program in Menopause and Healthy Aging, stated testosterone has been reviewed four times by the FDA for female use but was never approved due to insufficient long-term safety data and cardiovascular and breast cancer risks.
Non-testosterone alternatives such as Sprout Pharmaceuticals' Addyi and Cosette Pharmaceuticals' Vyleesi have received FDA clearance for specific patients with HSDD.
Testosterone is generally discouraged for women with breast cancer histories, as the hormone can convert into estrogen in the body and potentially spur certain cancers. Excessive testosterone exposure can lead to acne and increased hair growth, physicians noted, while less common effects like voice deepening and hair loss can be permanent.
Studies indicate that testosterone therapy is broadly regarded as safe for men with clinically diagnosed low hormone levels when prescribed and monitored by a doctor.
Tordoff and Adams are directing Stanford's MIX-T pilot study examining how low-dose testosterone affects vaginal health and the vaginal microbiome in postmenopausal women, with results expected in the next two years.
