The U.S. Food and Drug Administration (FDA) is preparing to examine scientific evidence on the use of testosterone therapy in menopausal women. This review will assess the potential benefits, risks, appropriate dosages, and the role of testosterone in female health, as well as the experiences of both patients and doctors. The upcoming public meeting could influence future medical research and drug development. Increasing numbers of women are using testosterone to manage symptoms of menopause, despite the absence of an FDA-approved treatment specifically for women. For years, testosterone has been used off-label to address hypoactive sexual desire disorder (HSDD), a condition characterized by a low sexual desire.
Currently, female patients often receive testosterone in lower doses from products originally approved for men, such as Testim and AndroGel. These are sometimes split or used in custom compounded formulations. However, this approach presents challenges for doctors, who lack standardized dosing guidelines or specific labeling for women. Dr. Diana Tordoff, an instructor in obstetrics and gynecology at Stanford, notes that an FDA-approved drug could provide clearer safety information and potentially improve insurance coverage for the treatment.
Despite growing interest, key questions about testosterone use in women remain unresolved. Dr. Stephanie Faubion, director of Mayo Clinic's Center for Women's Health, emphasizes the need for more long-term safety data. Several countries, including Australia, South Africa, New Zealand, and the United Kingdom, have already approved testosterone products for female use. The FDA's request for public input before the hearing received hundreds of responses, with many women reporting improved libido, energy, and overall quality of life while using testosterone.
Interest in testosterone has grown alongside social media claims that it can improve energy, cognition, bone health, and muscle mass. However, experts say the strongest evidence for its use is in treating HSDD. Dr. Karen Adams, director of Stanford Medicine's Program in Menopause and Healthy Aging, noted that the FDA has reviewed testosterone for female use four times but never approved it due to concerns about long-term safety, including potential cardiovascular risks and breast cancer. Non-testosterone alternatives, such as Addyi and Vyleesi, have been approved by the FDA for specific patients with HSDD.
Testosterone is generally not recommended for women with a history of breast cancer, as it can convert into estrogen in the body and potentially contribute to cancer growth. Other side effects may include acne and increased hair growth, while less common effects, such as voice deepening or hair loss, can be permanent. Studies have shown that testosterone therapy is considered safe for men with clinically diagnosed low hormone levels when used under a doctor's supervision. Dr. Tordoff and Dr. Adams are leading a Stanford study called MIX-T, which is examining the effects of low-dose testosterone on vaginal health and the vaginal microbiome in postmenopausal women. Results are expected in the next two years.
FDA Reviews Testosterone Therapy for Menopausal Women Amid Rising Use
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