FDA to weigh testosterone evidence as more menopausal women seek treatment

US health regulators will examine the scientific evidence on testosterone use in menopausal women at a public meeting on Thursday, covering its benefits, risks, dosing and place in female health, along with views from doctors and patients.

The Food and Drug Administration has said the session could help shape future research and drug development. It comes as a growing number of women turn to testosterone to manage menopause symptoms.

No testosterone therapy is approved for women in the United States, even though the hormone has long been prescribed off-label for low sexual desire, a condition known as hypoactive sexual desire disorder, or HSDD.

Dosing gaps

Doctors who prescribe testosterone to women generally use low doses of products cleared for men, often splitting gels such as AbbVie's AndroGel and Keenova Therapeutics' Testim, or turning to compounded formulations.

Dr. Diana Tordoff, an instructor in obstetrics and gynecology at Stanford, said the absence of a female-specific product creates practical difficulties for clinicians. An approved option could offer standardized dosing, labeling and safety-monitoring guidance, and might improve insurance coverage, she said.

Last year, the FDA removed a boxed warning about increased cardiovascular risk from testosterone products for men after reviewing post-marketing studies. Those products still carry warnings about raised blood pressure.

Evidence and safety questions

Interest among menopausal women has grown alongside social media claims that testosterone can improve energy, muscle mass, bone health and cognition. Specialists say the strongest evidence is 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," said Dr. Stephanie Faubion, director of Mayo Clinic's Center for Women's Health.

Faubion said more long-term safety data are needed. Dr. Karen Adams, director of Stanford Medicine's Program in Menopause and Healthy Aging, said the FDA has reviewed testosterone four times for use in women but has never approved it, citing a lack of long-term safety data and concerns about cardiovascular and breast cancer risks.

The agency has approved non-testosterone options for certain HSDD patients, including Sprout Pharmaceuticals' Addyi and Cosette Pharmaceuticals' Vyleesi.

Testosterone is generally not recommended for women with a history of breast cancer because the body can convert it into estrogen, which can drive some cancers. Physicians say excessive exposure can cause acne and increased hair growth, while rarer effects such as voice deepening and hair loss may be irreversible.

Studies indicate that testosterone therapy is generally considered safe for men with medically diagnosed low hormone levels when prescribed and monitored by a doctor.

Several countries, including the United Kingdom, Australia, New Zealand and South Africa, have approved or licensed testosterone products specifically for women.

The FDA's call for public comments before the meeting drew hundreds of submissions, many from women who described better libido, energy and quality of life while using testosterone.

Tordoff and Adams are leading Stanford's MIX-T pilot study, which is examining how low-dose testosterone affects vaginal health and the vaginal microbiome in postmenopausal women. Results are expected within two years.