FDA Scrutinizes Testosterone Use in Menopausal Women

At a recent FDA public workshop, experts sounded a cautionary note about the surge in testosterone prescriptions for women navigating menopause. While the hormone has long been a staple for men, its off‑label use in women is still a gray area, and regulators say many key safety questions remain unanswered.

It might surprise some that testosterone is actually the most abundant sex hormone in pre‑menopausal women—produced at roughly three times the rate of estrogen. Men, by contrast, carry about fifteen times more total testosterone than women. As women age, their testosterone levels slowly decline, a change that’s been linked to weaker bones, loss of muscle mass, mood swings, reduced energy, and even cognitive shifts.

Because the United States has no FDA‑approved testosterone formulation for women, doctors who prescribe it do so off‑label, usually using lower doses of products intended for men. "There are no FDA‑approved uses for testosterone therapy for menopausal women," explained Dr. Christina Chang, division director for urology, obstetrics and gynecology at the FDA’s Center for Drug Evaluation and Research. She added that the agency is aware of the growing trend, especially among women looking for relief beyond the classic hormone replacement therapy (HRT) regimen.

Current research largely ties testosterone therapy in women to treating hypoactive sexual desire disorder (HSDD)—a condition marked by persistently low sexual desire that causes distress. Yet many women are seeking the hormone for broader reasons: better energy, improved mood, or even sharper cognition. Existing guidelines, however, do not endorse testosterone for those symptoms.

Measuring testosterone in women is tricky business. The hormone circulates at much lower concentrations than in men, making it hard to establish a clear blood‑test threshold for deficiency. Unlike estrogen, which often drops sharply at menopause, testosterone tapers off gradually, further complicating diagnosis.

The interest in testosterone is part of a larger uptick in hormone replacement therapy. Data from Epic Research show HRT prescriptions for women aged 50‑65 jumped 72 % between 2021 and 2025. That rise followed the FDA’s decision earlier this year to remove the “black box” warning from both HRT and testosterone products, signaling a more permissive stance but also underscoring the need for robust safety data.

"Menopause is inevitable, and women shouldn’t have to suffer through it," Dr. Chang emphasized. "To best serve American women we need high‑quality data, and we look forward to working with manufacturers to gather it."