US Studies Testosterone Use for Menopausal Women

US health regulators are reviewing testosterone use for menopausal women, with experts split over whether a female-specific product is needed and whether the hormone is safe and effective for broader use.

At a public meeting on Thursday, the US Food and Drug Administration heard from government officials, clinicians and researchers about testosterone levels in women, possible uses for menopause symptoms and long-term safety concerns.

There is no FDA-approved testosterone therapy for women in the United States, despite years of off-label use for low sexual desire, also known as hypoactive sexual desire disorder, or HSDD.

Officials at the meeting said women should have access to testosterone products formulated specifically for them. Others said the available evidence supports use only for postmenopausal women with HSDD and does not justify wider claims about mood, cognition, or general well-being.

Experts also raised concerns about safety, including cardiovascular and breast cancer risks, while noting that oral testosterone is not recommended because of its impact on cholesterol. Possible side effects include acne, increased hair growth, voice deepening, and hair loss.

The FDA has reviewed testosterone for women several times before but has never approved it because of limited long-term safety data. The agency’s public comment period on the issue remains open until October 19.