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FDA holds first workshop on testosterone use in menopausal women
In September 2026, the FDA held its first public workshop regarding the use of testosterone in menopausal women to discuss safety, efficacy, and the need for standardized treatments. While testosterone is not currently FDA-approved for women, off-label prescriptions for women nearly tripled between 2016 and 2025.
FDA workshop experts noted that the strongest evidence for testosterone use in women pertains to treating hypoactive sexual desire disorder (HSDD). Other potential benefits, such as improvements in mood, memory, and muscle mass, require further study.
An analysis conducted by the longevity platform Hone Health involving 1,220 women in perimenopause or menopause found that those taking testosterone reported improvements across 18 different symptoms. The most significant reported gains occurred in sexual health, energy, stamina, and physical attributes like muscle mass.
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- [● 3 SOURCES] Off-label testosterone prescriptions for women nearly tripled between 2016 and 2025. www.hcnews.com · keyt.com · krdo.com
- [● 3 SOURCES] Testosterone is not currently FDA-approved for use in women. www.hcnews.com · keyt.com · krdo.com
- [● 3 SOURCES] FDA experts agree the strongest evidence for testosterone in women is for treating hypoactive sexual desire disorder (HSDD). www.hcnews.com · keyt.com · krdo.com
- [● 3 SOURCES] An analysis of 1,220 women reported improvements across 18 menopause symptoms when taking testosterone. www.hcnews.com · keyt.com · krdo.com
- [● 3 SOURCES] The most significant improvements reported were in sexual desire, energy, strength, and stamina. www.hcnews.com · keyt.com · krdo.com