U.S. health regulators will review the scientific evidence on testosterone use in menopausal women on Thursday, including its benefits, risks, dosing and role in female health, as well as perspectives from doctors and patients.
The public meeting, which the U.S. 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. The FDA has approved non-testosterone options like Sprout Pharmaceuticals’ Addyi and Cosette Pharmaceuticals’ Vyleesi for certain patients with HSDD.
Because of a lack of long-term safety data and concerns about cardiovascular and breast cancer risks, 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.
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. The lack of a female-specific product creates practical challenges for clinicians, said Diana Tordoff, an instructor in obstetrics and gynecology at Stanford, noting that an approved product could provide standardised dosing, labeling and safety-monitoring guidance and potentially improve insurance coverage.
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. Because it can be converted to estrogen in the body that can drive some cancers, testosterone is generally not recommended for women with a history of breast cancer.
