FDA Takes a Closer Look at Testosterone Prescriptions for Menopausal Women

At a public workshop on Thursday, officials from the Food and Drug Administration raised a collective eyebrow over the growing trend of women in menopause turning to testosterone therapy. While the hormone is best known for its role in men, it’s actually the most abundant sex hormone in pre‑menopausal women – produced at roughly three times the rate of estrogen.

As women age, testosterone levels drift downward, a shift that some researchers link to lower bone density, loss of muscle mass, and even changes in mood, cognition, and sexual desire. Yet, in the United States there is no FDA‑approved testosterone product for women. That means doctors who prescribe it are doing so off‑label, often taking a men’s formulation and dialing the dose way down.

“There are no FDA‑approved uses for testosterone therapy for menopausal women,” explained Dr. Christina Chang, division director of the FDA’s Center for Drug Evaluation and Research. She added that the agency is aware of the uptick in off‑label prescriptions, but stressed that key safety questions remain unanswered.

Most of the scientific evidence to date focuses on one narrow indication: hypoactive sexual desire disorder, a condition where persistently low libido causes distress. Yet many women are seeking testosterone for a wider menu of complaints – fatigue, mood swings, and a general sense of low energy. Current clinical guidelines, however, do not recognize testosterone as a treatment for those symptoms.

Measuring testosterone in women is tricky business. Women’s circulating levels are a fraction of men’s, and there isn’t a universally accepted blood‑test cutoff to declare a “deficiency.” Unlike estrogen, which plummets sharply at menopause, testosterone wanes gradually, making the diagnostic line even blurrier.

The surge in interest comes on the heels of a broader resurgence in hormone replacement therapy (HRT). Data from Epic Research show that prescriptions for HRT among 50‑ to 65‑year‑olds jumped 72 % between 2021 and 2025. Earlier this year the FDA removed the dreaded black‑box warning from many HRT products – and from testosterone products as well – which some observers say has helped fuel the current enthusiasm.

Dr. Margaret Wierman, a professor of medicine at the University of Colorado, reminded us that testosterone doesn’t suddenly disappear at menopause; it tapers off over years. “The decline is gradual, and we still lack solid benchmarks to tell when, or if, supplementation is truly needed,” she told ABC News.

Chang summed up the agency’s stance with a simple sentiment: “Menopause is inevitable; women shouldn’t have to suffer through it.” She added that the FDA is eager to partner with manufacturers to generate high‑quality data that can guide safe use, but until that happens, the hormone remains an experimental option for women seeking relief.