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Prescriptions for testosterone to treat menopause-related complaints have risen sharply, even though regulators have not approved the hormone for that use and experts say strong evidence is lacking. The trend has sparked debate among clinicians about safety, dosing and what the science actually shows.
A rapid rise in off-label use
A U.S. study published in 2026 found more than 90,000 off-label testosterone prescriptions written for women in 2025, mostly for people aged 45 to 64 with menopause-related diagnoses. That represented a 58.7% increase from 2024.
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Off-label means the Food and Drug Administration has not approved testosterone as a treatment for menopause, perimenopause or postmenopause. Despite this, many clinicians in the U.S. are prescribing testosterone preparations originally formulated and dosed for men.
What the evidence does — and doesn’t — show
Endocrinologists warn that menopause is not characterized by a sudden loss of testosterone. According to Susan Davis, head of the Women’s Health Research Program at Monash University, testosterone in people assigned female at birth typically declines gradually from about age 20 to 60 and then shows a slight rebound after 60 — a pattern that does not match the abrupt hormonal changes of menopause.
Placebo-controlled trials have not demonstrated that testosterone reliably improves common menopause complaints such as cognitive fog, fatigue, mood, bone density or muscle strength, researchers say. As Davis — who has led clinical trials in this area — put it: telling women that tiredness, low mood or brain fog are plainly signs of “androgen deficiency” is misleading.
The FDA convened a public workshop on Sept. 17 to evaluate available data on testosterone for menopause and concluded that more rigorous evidence is needed before the hormone can be recommended broadly.
Sex drive is the clearest, but modest, benefit
There is some support for testosterone as a treatment for hypoactive sexual desire disorder (HSDD) in postmenopausal women. A review of 36 randomized trials covering 8,480 participants found that testosterone patches were associated with, on average, about 0.85 additional satisfying sexual events per month compared with placebo — a small but measurable effect.
Clinicians caution that anecdotal reports of dramatic sexual “awakenings” after starting testosterone have not been confirmed by the controlled studies. Dr. Nanette Santoro of the University of Colorado described the effect observed in trials as limited and warned that marketing and patient stories can inflate expectations.
Testosterone is not FDA-approved for HSDD in menopause. A separate drug, flibanserin, is approved for HSDD in pre- and postmenopausal women under age 65.
The placebo effect and ongoing trials
The placebo effect complicates interpretation of many studies: investigators report that roughly 30% to 40% of participants in placebo groups experience improved sexual desire or satisfaction, masking or narrowing apparent treatment differences.
Large trials are underway to provide clearer answers. The U.K. National Institute for Health and Care Research is running the ESTEEM trial, a randomized study testing whether a low‑dose testosterone cream applied to the lower abdomen and thighs can improve a range of menopause-linked symptoms, including sleep, memory, anxiety, migraines, body mass and overall well-being. Results are currently expected by 2028.
Safety, dosing and regulatory gaps
Only four countries — Australia, South Africa, New Zealand and the United Kingdom — have approved testosterone creams specifically formulated and dosed for postmenopausal women with HSDD. In many other places, including the U.S., clinicians adapt male preparations, which can produce wide variation in dosing and uncertain effects.
Experts warn that doses appropriate for men are often far too high for female patients. Excess testosterone can cause unwanted masculinizing changes such as voice deepening, clitoral enlargement, rapid facial and body hair growth, and hair thinning or loss. Even at lower doses, trials have reported mild acne, oily skin and some increased hair growth.
Longer-term consequences — including effects on cardiovascular disease and breast cancer risk — are poorly understood. An FDA spokesperson told Live Science that off-label use means safety, efficacy and dosing for these indications have not been evaluated or approved by the agency, and that male formulations may not be suitable for women.
Santoro described an anecdotal case in which a patient who received very high testosterone from an implanted device experienced significant masculinizing changes, including hair loss, clitoral enlargement and breast tissue reduction.
What clinicians recommend now
Specialists emphasize the importance of honest, evidence-based discussions with patients navigating menopause. Good care should consider lifestyle factors such as diet and exercise and the social pressures that affect how patients experience this life stage, not only the latest hormonal intervention.
When it comes to testosterone, clinicians advise caution. As Davis put it, individuals should be wary of anyone promising a single, definitive solution for complex menopausal symptoms.
