US Regulators Review Testosterone Therapy

Introduction to Testosterone Therapy

The US Food and Drug Administration (FDA) is set to review the scientific evidence on testosterone use in menopausal women, including its benefits, risks, dosing, and role in female health. This public meeting aims to guide future research and drug development as a growing number of women turn to testosterone to manage menopause symptoms.

Despite years of off-label use to treat low sexual desire, known as hypoactive sexual desire disorder (HSDD), there is no FDA-approved testosterone therapy for women. Physicians typically rely on low doses of products approved for men, often dividing existing products or using compounded formulations.

Background and History of Testosterone Therapy

Testosterone therapy has been used for decades to treat various health conditions, including low testosterone levels in men. However, its use in women is relatively new and has been met with controversy and debate. The FDA has previously reviewed testosterone therapy for women, but it has never been approved due to a lack of long-term safety data and concerns about cardiovascular and breast cancer risks.

Challenges and Concerns with Testosterone Therapy

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

However, some experts say key questions remain unresolved. More long-term safety data are needed, said 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.

Benefits and Risks of Testosterone Therapy

Interest in testosterone among menopausal women has grown alongside claims on social media that it can improve energy, muscle mass, bone health, and cognition. However, 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.

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

Current Research and FDA Approval

The FDA has approved non-testosterone options like Sprout Pharmaceuticals' Addyi and Cosette Pharmaceuticals' Vyleesi for certain patients with HSDD. Testosterone therapy is generally considered safe for men with medically diagnosed low levels of the hormone when prescribed and monitored by a doctor.

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 due to a lack of long-term safety data and concerns about cardiovascular and breast cancer risks.

Ongoing Studies and Future Directions

Diana Tordoff and Karen 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.

• The study aims to provide insights into the effects of testosterone on vaginal health and the vaginal microbiome.
• The results will help guide future research and drug development for testosterone therapy in menopausal women.
• The study is a significant step towards understanding the benefits and risks of testosterone therapy 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. As the FDA reviews the scientific evidence, it is essential to consider the perspectives of doctors, patients, and experts in the field to ensure that any future approvals or guidelines are based on the best available evidence.

Implications for Women in India and Other Countries

The FDA's review of testosterone therapy has implications for women not only in the US but also in other countries, including India. Many Indian women are turning to testosterone to manage menopause symptoms, despite the lack of FDA-approved products. The FDA's decision could influence the development of testosterone products for women in India and other countries.

Expert Perspectives and Future Research

Experts in the field emphasize the need for more research on testosterone therapy in women. "We need to understand the long-term effects of testosterone on women's health, including its impact on cardiovascular health, breast cancer risk, and bone density," said Faubion. The FDA's review of testosterone therapy is an important step towards addressing these questions and providing women with safe and effective treatment options.

In conclusion, the FDA's review of testosterone therapy for menopausal women is a significant development in the field of women's health. As the FDA considers the scientific evidence, it is essential to prioritize the needs and perspectives of women, ensuring that any future approvals or guidelines are based on the best available evidence and prioritize women's health and well-being.