US regulators to examine testosterone therapy as use by menopausal women rises

The public meeting, which the US Food and Drug Administration said could help guide future research and drug development, comes as a growing number of women are turning to testosterone to manage menopause symptoms.

There is no FDA-approved testosterone therapy for women, despite years of off-label use to treat low sexual desire, known as hypoactive sexual desire disorder, or HSDD.

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

Physicians who prescribe testosterone to women typically rely on low doses of products approved for men, often dividing existing products such as AbbVie's ABBV.N AndroGel and Keenova Therapeutics' Testim, or on compounded formulations.

The lack of a female-specific product creates practical challenges for clinicians, said Dr. Diana Tordoff, an instructor in obstetrics and gynecology at Stanford, noting that an approved product could provide standardized dosing, labeling and safety-monitoring guidance and potentially improve insurance coverage.

Still, some experts say key questions remain unresolved. More long-term safety data are needed, said Dr. Stephanie Faubion, director of Mayo Clinic's Center for Women's Health.

The United Kingdom, Australia, New Zealand and South Africa have approved or licensed testosterone products specifically for women.

The FDA's request for public comments ahead of the meeting attracted hundreds of submissions, many from women describing improved libido, energy and quality of life while using testosterone.

EVIDENCE AND SAFETY GAPS

Interest in testosterone among menopausal women has grown alongside claims on social media that it can improve energy, muscle mass, bone health and cognition, though specialists say the evidence is 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, said testosterone has been reviewed by the FDA four times for use in women but has never been approved because of a lack of long-term safety data and concerns about cardiovascular and breast cancer risks.

The FDA has approved non-testosterone options like Sprout Pharmaceuticals' Addyi and Cosette Pharmaceuticals' Vyleesi for certain patients with HSDD.

Testosterone is generally not recommended for women with a history of breast cancer because it can be converted to estrogen in the body that can drive some cancers.

Excessive testosterone exposure can cause acne and increased hair growth, physicians said, while rarer effects such as voice deepening and hair loss may be irreversible.

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

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

(Reporting by Siddhi Mahatole and Padmanabhan Ananthan in Bengaluru; Editing by Mrinalika Roy and Bill Berkrot)