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FDA examines use of testosterone prescriptions for menopause

ABC News - Breaking News, Latest News and Videos • September 18, 2026 • health

Key Points:

Testosterone therapy is increasingly used by menopausal women, but the FDA cautions that long-term safety data remain insufficient and no testosterone formulations are currently approved for women in the U.S.
Women's testosterone levels decline gradually with age and are linked to symptoms like reduced bone density, muscle mass, cognition, mood, sexual function, and energy, prompting some to seek testosterone therapy off-label.
Current evidence supports testosterone therapy mainly for hypoactive sexual desire disorder, while use for broader symptoms such as energy and mood is not supported by existing guidelines.
Measuring testosterone levels in women is challenging due to low concentrations and lack of diagnostic thresholds, and unlike estrogen, testosterone does not sharply drop at menopause but declines gradually.
Interest in testosterone therapy coincides with a 72% rise in hormone replacement therapy prescriptions for menopausal women from 2021 to 2025, following the FDA's removal of black box warnings on HRT and testosterone products.

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