U.S. regulators to examine testosterone therapy as use by menopausal women rises

The U.S. Food and Drug Administration will convene a public meeting to evaluate the scientific evidence surrounding testosterone use in menopausal women. The review will encompass the potential benefits, risks, dosing guidelines, and the hormone's role in women's health. This development comes as an increasing number of women are turning to testosterone to manage menopause symptoms, despite the absence of an FDA-approved testosterone therapy specifically for women.

There are no long-term safety data or standardized dosing recommendations for female-specific products, making it challenging for physicians to prescribe testosterone safely. While some studies suggest improved libido, energy, and quality of life in women using testosterone, experts caution that conclusive evidence is lacking for other potential benefits such as muscle mass, bone density, mood, and cognition.

The FDA's request for public comments has garnered hundreds of submissions from women who report positive effects from testosterone use. However, concerns remain about potential side effects like acne, increased hair growth, and the conversion of testosterone to estrogen, which can drive breast cancer in women with a history of the disease.

The FDA has approved non-testosterone treatments for certain patients with hypoactive sexual desire disorder (HSDD), but testosterone is generally not recommended for women with breast cancer. Stanford Medicine is currently leading a pilot study to examine the impact of low-dose testosterone on vaginal health and the vaginal microbiome in postmenopausal women, with results expected within the next two years.