FDA examines testosterone use for menopausal women

The Food and Drug Administration (FDA) recently held a public workshop to examine the increasing off-label use of testosterone therapy among menopausal women. While testosterone levels naturally decline with age, leading to potential issues with bone density, muscle mass, and mood, there are currently no FDA-approved testosterone formulations specifically for women in the United States.

Clinicians often prescribe testosterone designed for men or use formulations from compounding pharmacies to address symptoms. While some women seek the hormone to combat fatigue and cognitive changes, current medical guidelines do not recommend testosterone for these purposes. The strongest scientific evidence for its use remains limited to treating hypoactive sexual desire disorder (HSDD), a condition involving persistently low sexual desire that causes significant distress.

Specialists at the workshop noted that key questions regarding the long-term safety and efficacy of testosterone for broader menopausal symptoms remain unanswered. Additionally, measuring testosterone levels in women presents clinical challenges due to much lower concentrations compared to men.