Overview
- The FDA held a public workshop on Thursday that urged manufacturers to run rigorous trials and offered to review foreign data case by case to support possible female-specific approvals.
- No testosterone product is approved for women in the United States, so doctors commonly divide low-dose male gels or prescribe compounded formulations that lack standard labeling and dosing guidance.
- Experts say the clearest evidence of benefit is for hypoactive sexual desire disorder (HSDD), and there is insufficient high-quality data to support claims about mood, bone health, muscle or cognition.
- Regulators and clinicians remain concerned about long-term risks, especially possible cardiovascular and breast cancer effects, and note visible harms such as acne, increased hair growth, and rare irreversible virilizing changes.
- The FDA is taking public input through Oct. 19 and pointed to ongoing trials like Stanford’s MIX-T, with results expected in about two years, a step that could shape access, labeling, and insurance coverage for patients.