FDA convenes workshop as women seek off-label testosterone for menopause symptoms
The FDA held a public workshop to review evidence and safety gaps in testosterone therapy for menopausal women, a treatment many are using despite lacking an approved product.
A public FDA workshop examined one outlet evidence, safety concerns, and research deficiencies surrounding testosterone use in menopausal women, a therapy that has grown in popularity despite no FDA-approved product for females. Doctors like Dr. Kudzai Dombo report relying on off-label prescriptions, using either custom compounding or micro-dosed male gel, which often results in insurance denials and out-of-pocket costs.
Patients frequently seek the hormone for low sexual desire, fatigue, and quality-of-life improvements, although guidelines only endorse it for hypoactive sexual desire disorder. Clinical attempts to dose male formulations have produced mixed results, with some patients seeing no hormonal change after weeks of use. The workshop represents a step toward addressing these gaps, driven by patient and clinician advocacy for safer, standardized access to testosterone therapy.
Why it matters
Women’s access to safe, effective menopause treatments hinges on clearer regulations and approved testosterone options.
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