US Regulators Review Testosterone Therapy for Menopausal Women
US health regulators are reviewing the potential use of testosterone therapy for women experiencing menopause, with experts discussing its possible benefits, risks and appropriate medical applications.
The US Food and Drug Administration (FDA) recently held a public meeting involving government officials, doctors and researchers. The discussion focused on testosterone levels in women, its potential role in treating certain menopause-related concerns and questions about its long-term safety.
No FDA-Approved Testosterone Product for Women
There is currently no testosterone treatment specifically approved by the FDA for women in the United States.
Despite this, testosterone has been prescribed off-label in some cases, particularly for women experiencing hypoactive sexual desire disorder (HSDD), a condition involving persistently low sexual desire that causes personal distress.
During the meeting, some experts supported the development of testosterone products specifically designed for women. Others said current scientific evidence supports its use mainly for postmenopausal women with HSDD and does not provide enough evidence for broader claims involving mood, memory, cognition or overall well-being.
Experts Discuss Potential Health Risks
Safety was another major topic during the FDA discussion.
Experts raised questions about the possible long-term effects of testosterone therapy, including potential cardiovascular and breast health risks. Oral testosterone was also discussed cautiously because of its potential effects on cholesterol levels.
Possible side effects associated with testosterone use can include acne, increased facial or body hair, hair loss and changes in the voice.
Doctors and researchers stressed the importance of using appropriate doses and carefully selecting patients if testosterone therapy is prescribed.
FDA Has Reviewed the Issue Before
The FDA has considered testosterone therapy for women on several previous occasions but has not approved a dedicated treatment, with limited long-term safety data remaining one of the concerns.
The latest review could provide further information about whether a female-specific testosterone product should be developed and which medical conditions could potentially benefit from treatment.
The FDA’s public comment period on the issue is scheduled to remain open until October 19. Further regulatory decisions will depend on the evidence and feedback considered by the agency.
