FDA examines use of testosterone prescriptions for menopause

Testosterone therapy is increasingly being used by menopausal women but specialists at a Food and Drug Administration (FDA) public workshop cautioned on Thursday that key questions about its long-term safety remain unanswered. 

Studies show that while adult males generally have 15 times more total testosterone than females, testosterone is the most abundant sex hormone in premenopausal women, produced at about three times the rate of estrogen.

With age, women's testosterone levels gradually decline, and low levels have been linked to loss of bone density and muscle mass, along with declines in cognition, mood, sexual function and energy.

Because there is no FDA-approved testosterone formulation for women in the U.S., clinicians who prescribe the hormone may do so off-label and use smaller doses of testosterone products designed for men. 

"There are no FDA-approved uses for testosterone therapy for menopausal women," Dr. Christina Chang, division director of the division of urology, obstetrics and gynecology in the FDA's Center for Drug Evaluation and Research said at the FDA workshop Thursday. She noted that the agency is aware of increasing off-label use of testosterone among women experiencing menopause. 

Currently, evidence supporting testosterone therapy in women is largely focused on hypoactive sexual desire disorder, a condition characterized by persistently low sexual desire that causes distress.

Specialists in the FDA workshop on Thursday said women are seeking testosterone for a much broader range of concerns including energy and mood. Based on current guidelines, testosterone therapy is not considered a treatment for these symptoms.

Measuring testosterone in women also presents challenges because concentrations are much lower than in men. As such, there is no blood-test threshold that can diagnose whether a woman has a testosterone deficiency.

Unlike estrogen, testosterone levels do not suddenly fall when women reach menopause.

"There is a gradual decline in testosterone levels across the premenopausal levels," Dr. Margaret Wierman, professor of medicine at the University of Colorado School of Medicine, told ABC News. 

The growing interest in testosterone comes amid an increase in hormone replacement therapy (HRT) among menopausal women, which typically uses estrogen with or without progesterone to replace declining hormones during menopause.

HRT prescriptions among women ages 50 to 65 rose 72% from 2021 to 2025, according to data from Epic Research. It comes after the FDA removed its "black box" warning label from HRT products for menopause earlier this year followed by the removal of the warning on testosterone products. 

"Menopause is inevitable, women should not have to suffer through it," Chang said. "To best serve the American women we need high-quality data and we are looking forward to working with all the manufacturers to be able to get that data."