Testosterone use surges without approval

Menopausal women increasingly take testosterone, but there is no FDA-approved testosterone formulation for women in the U.S. Doctors prescribe smaller doses of male-targeted products off-label.

“There are no FDA-approved uses for testosterone therapy for menopausal women.”

Testosterone naturally declines with age

Testosterone is the most abundant sex hormone in premenopausal women, produced at three times the rate of estrogen. As women age, testosterone gradually declines, linked to bone loss, muscle weakness, and mood changes.

“There is a gradual decline in testosterone levels across the premenopausal levels.”

Safety questions remain unanswered

FDA specialists warned at a public workshop that key questions about testosterone therapy's long-term safety in menopausal women are still unresolved. Current evidence focuses mainly on sexual desire disorder.

Testing testosterone in women is difficult

Testosterone concentrations in women are much lower than in men, making measurement challenging. There is no blood-test threshold to diagnose testosterone deficiency in women.

HRT prescriptions surge after FDA action

Hormone replacement therapy prescriptions among women ages 50 to 65 rose 72 percent from 2021 to 2025. This followed the FDA removing black box warnings from both HRT and testosterone products.

FDA calls for better research

The FDA says menopause should not cause suffering and is working with manufacturers to gather high-quality data on testosterone therapy. The agency aims to establish evidence-based guidelines for safe use.

“Menopause is inevitable, women should not have to suffer through it.”