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FDA examines use of testosterone prescriptions for menopause

FDA examines use of testosterone prescriptions for menopause

Summary

The FDA held a public workshop to discuss the increasing use of testosterone therapy by menopausal women. There are currently no FDA-approved testosterone treatments for women, and experts say more research is needed to understand the long-term safety and effectiveness of this therapy.

Key Facts

  • Testosterone therapy is being used more by menopausal women, often prescribed off-label using men's testosterone products.
  • Women have much lower testosterone levels than men, and these levels decline gradually with age.
  • Low testosterone in women is linked to bone loss, muscle loss, lower mood, reduced sexual desire, and less energy.
  • Testosterone therapy is only approved for treating a sexual desire disorder in women, not for other symptoms like mood or energy.
  • It is hard to measure testosterone deficiency in women because no clear blood test thresholds exist.
  • Hormone replacement therapy (HRT) using estrogen, with or without progesterone, is more common and has increased 72% from 2021 to 2025.
  • Earlier in 2026, the FDA removed strong warning labels from HRT and testosterone products.
  • The FDA wants more high-quality research to better understand testosterone therapy’s risks and benefits for menopausal women.
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