US regulators to examine testosterone therapy as use by menopausal women rises

The US Food and Drug Administration (FDA) is set to review the scientific evidence on testosterone use in menopausal women, including its benefits, risks, dosing, and role in female health. The public meeting, which could guide future research and drug development, comes as a growing number of women turn to testosterone to manage menopause symptoms.

Despite years of off-label use for low sexual desire, known as hypoactive sexual desire disorder (HSDD), there is no FDA-approved testosterone therapy for women. The lack of a female-specific product creates practical challenges for clinicians, who often rely on low doses of products approved for men or compounded formulations.

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