# FDA review of testosterone use in menopausal women

> Live situation record from CLSTR: https://clstr.news/situations/fda-review-of-testosterone-use-in-menopausal-women
> Updated: 2026-10-01T15:30:04.000Z. Sources: 8. Developments: 2.

The U.S. Food and Drug Administration (FDA) held a public workshop in September 2026 to address the rising off-label use of testosterone therapy among menopausal women. While there are currently no FDA-approved testosterone formulations specifically for women in the United States, off-label prescriptions nearly tripled between 2016 and 2025.

Medical experts at the workshop noted that while the strongest scientific evidence supports testosterone use for treating hypoactive sexual desire disorder (HSDD), its efficacy for broader symptoms—such as mood, memory, muscle mass, and fatigue—remains unproven and requires further study. Clinicians currently often rely on formulations designed for men or compounding pharmacies to treat these symptoms.

Data from the longevity platform Hone Health, involving 1,220 women, indicated that users reported improvements across 18 different symptoms, with the most significant gains reported in sexual health, energy, stamina, and muscle mass. However, specialists emphasized that long-term safety and the clinical challenges of measuring lower testosterone concentrations in women remain key concerns.

## Claims

- FDA experts agree the strongest evidence for testosterone in women is for treating hypoactive sexual desire disorder (HSDD). (corroborated by 3 sources)
- An analysis of 1,220 women reported improvements across 18 menopause symptoms when taking testosterone. (corroborated by 3 sources)
- The most significant improvements reported were in sexual desire, energy, strength, and stamina. (corroborated by 3 sources)
- Off-label testosterone prescriptions for women nearly tripled between 2016 and 2025. (corroborated by 3 sources)
- Testosterone is not currently FDA-approved for use in women. (corroborated by 3 sources)

## Timeline

### 2026-10-01: FDA holds first workshop on testosterone use in menopausal women

The FDA held its first workshop on testosterone use in menopausal women. While not FDA-approved for women, an analysis of 1,220 patients showed improvements in sexual desire, energy, and muscle mass.

5 sources. https://clstr.news/cluster/fda-holds-first-workshop-on-testosterone-use-in-menopausal-women

### 2026-09-18: FDA examines testosterone use for menopausal women

The FDA held a workshop to discuss the rising off-label use of testosterone for menopausal women, noting a lack of approved formulations and uncertainty regarding long-term safety for non-HSDD symptoms.

3 sources. https://clstr.news/cluster/fda-examines-testosterone-use-for-menopausal-women

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Cite as: FDA review of testosterone use in menopausal women. CLSTR, https://clstr.news/situations/fda-review-of-testosterone-use-in-menopausal-women