Overview
- The FDA held a public workshop on Sept. 17 where agency officials and outside specialists warned that key questions about long-term safety, proper dosing and clear indications for testosterone in menopausal women remain unanswered.
- No testosterone product is approved for women in the U.S., so clinicians commonly prescribe off-label male gels in micro-doses or use compounded creams, practices that produce wide dosing variability and frequent insurance denials.
- Clinical guidelines and available trials support testosterone mainly for hypoactive sexual desire disorder (HSDD); evidence that it helps energy, mood, bone health or cognition is limited or inconclusive.
- Federal focus on menopause care intensified after meetings in Washington, including an HHS session with manufacturers on Sept. 15 and a Senate Special Committee on Aging hearing, where patients and clinicians urged research and better training.
- Scientists and advocates say measurement challenges — very low female testosterone levels and no agreed blood threshold for deficiency — make standardized female formulations and rigorous trials essential before routine approval and coverage changes can proceed.