The U.S. Food and Drug Administration (FDA) will review scientific evidence related to the use of testosterone in menopausal women on Thursday. This meeting will focus on evaluating the benefits, risks, dosing options, the role of testosterone in women's health, and the perspectives of patients and physicians.
Increased Use of Testosterone
This public meeting comes as an increasing number of women turn to testosterone to manage menopausal symptoms. However, there is no approved treatment for testosterone in women, although it has been informally used for years to manage low sexual desire, known as Hypoactive Sexual Desire Disorder (HSDD).
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Challenges in Prescribing Testosterone
Doctors typically prescribe testosterone to women using low doses of products approved for men and may utilize combination therapies such as Testim (Keenova Therapeutics product) and AndroGel (AbbVie product). Dr. Diana Tordoff, an obstetrics and gynecology instructor at Stanford University, noted that the lack of specific options for women creates practical challenges for physicians, and an approved drug could provide standardized dosing, labeling, and safety guidance.
Need for Long-term Safety Data
Medical experts emphasize that key questions remain unanswered. Dr. Stephanie Fabion, director of the Women's Health Center at the Mayo Clinic, stated that more long-term safety data is needed. Countries such as Australia, South Africa, New Zealand, and the United Kingdom have established and approved specific testosterone products for female patients.
The FDA's request for public comments ahead of this meeting received hundreds of submissions, with many women noting improvements in sexual desire, energy levels, and quality of life while using testosterone. However, experts stressed that the existing evidence is stronger regarding HSDD, and there is still no evidence of improved muscle mass or bone health in women.
Some alternatives to testosterone, such as Addyi (Sprout Pharmaceuticals product) and Vyleesi (Cosette Pharmaceuticals product), have been approved for specific patients with HSDD. Testosterone is generally contraindicated for women with a history of breast cancer, as this hormone can convert to estrogen and may stimulate certain cancers.
Studies indicate that testosterone therapy is generally considered safe for men diagnosed with low hormone levels. Dr. Tordoff and Dr. Adams, director of the menopause and aging program at Stanford University, are leading the MIX-T study, which examines the effects of low-dose testosterone on vaginal health and the vaginal microbiome in postmenopausal women.
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Source: independent.co.uk
