Twenty years after Europe licensed a testosterone treatment for women, the US Food and Drug Administration has asked for evidence on a use it has never approved. A new unreviewed study, meanwhile, raises questions about heart safety.
In July 2006, the European Commission authorised Intrinsa, a testosterone treatment for women. It was licensed for hypoactive sexual desire disorder (HSDD), a persistent lack of sexual desire that causes distress, in women whose ovaries and uterus had been surgically removed. Six years later, its maker withdrew it for commercial reasons.
The US has never approved testosterone for menopausal women. Its Food and Drug Administration (FDA) is now asking whether that should change. The agency’s Office of Women’s Health and its drug evaluation centre held a public meeting on 17 September 2026.
The meeting examined evidence on testosterone’s role in sexual function, cognition, mood and muscle and bone health. It also covered the difficulty of measuring testosterone levels in women. The FDA flagged a lack of long-term safety data, especially on heart disease and breast cancer.
Off-label gels and pharmacy-made doses
Women in the US who use testosterone receive it off-label. “There are no FDA approved indications for testosterone therapy for menopausal women,” the agency said in its Federal Register notice. Clinicians prescribe male products at lower doses or use compounded preparations made up by pharmacies.
Pelin Batur directs the Women’s Comprehensive Health and Research Center at Cleveland Clinic. “Most of the time, we’re using the 1% gel because it’s the easiest to work with,” she told the meeting, Contemporary OB/GYN reported. She noted that correct dosing with male products is difficult.
FDA officials said the agency “stands ready to have discussions with drug sponsors,” according to a summary by the law firm Holland & Knight. They named heart disease, breast cancer and safety beyond 24 months as areas needing stronger data.
Four countries with a licensed product
Testosterone is approved for HSDD in women in Australia, New Zealand, the UK and South Africa, the FDA notice says. In Australia, a 1% testosterone cream called AndroFeme 1 is indicated for postmenopausal women with HSDD. It is used only after other factors, such as physical health or relationship issues, have been addressed.
Eleven medical societies, led by the International Menopause Society, set out a shared position in a 2019 consensus statement, still the most recent international consensus. It says “the only evidence-based indication for testosterone for women is for HSDD.” The evidence did not support testosterone for depressed mood, general wellbeing or bone density, and was insufficient for cognition. The Endocrine Society said HSDD is thought to affect around 32% of women at midlife.
Safety data at these doses did not extend beyond 24 months, the statement said. Women at high risk of heart and metabolic disease were largely excluded from the trials.
A heart safety signal awaiting review
Xuezhi Daniel Jiang of Drexel University College of Medicine led an analysis of health records from more than 6,300 postmenopausal women. Women starting testosterone had a combined heart and stroke event rate of 3.8%, compared with 0.5% in matched women, Medical Daily reported. The study is due at The Menopause Society’s annual meeting in San Diego, from 20 to 24 October.
These results come from a conference abstract and press release, and neither has been peer reviewed. Because the study is observational, it cannot prove that testosterone caused the events. Few events occurred, so the estimate is imprecise. Medical Daily notes that the release gives no details of doses, products or how long women used them.
Questions to ask before trying testosterone
The 2019 consensus limits testosterone to postmenopausal women with HSDD after assessment by a clinician. It advises doses that match the natural levels of women before menopause. Australia’s product information for AndroFeme 1 calls for HSDD to be properly assessed and other causes ruled out first. Women considering testosterone can ask a menopause specialist to check both.
The FDA says the meeting will inform future research and potential drug development.
This article is for information only and does not replace advice from a qualified health professional.
Header image: Centre for Ageing Better on Unsplash