The FDA held a public workshop on Thursday, September 17, on testosterone use in women after menopause. At the workshop, agency officials urged drugmakers to run the studies that could lead to the first US testosterone product made for women. No such product is approved today, so doctors who prescribe it use low doses of men’s products or compounded versions.
If you use testosterone or are thinking about it, the evidence behind it is narrow. Specialists at the meeting said it is supported for one condition, low sexual desire after menopause, and not for mood, thinking, or general well-being. So the first question for your doctor is whether you have that condition. Then ask which form and dose you would get, and how your cholesterol and side effects will be checked. This news does not change what is safe for you today, and it is not a reason to start, stop, or change a dose on your own.
Key takeaways
- No testosterone product is FDA-approved for women in the US. The UK, Australia, New Zealand, and South Africa have approved or licensed products made for women.
- Specialists said the evidence supports testosterone only for low sexual desire after menopause. Pills are not recommended because of their effects on cholesterol.
- The FDA is taking public comments until October 19, 2026, under docket FDA-2026-N-5479.
What happened
The FDA said the workshop was meant to look at the current evidence and the “critical knowledge gaps” to guide future research and drug development.
According to the FDA, those gaps include testosterone’s role in sexual function, thinking, mood, and muscle and bone health. They also include how hard it is to measure and interpret testosterone levels, and the lack of long-term safety data, “especially regarding cardiovascular and breast cancer risks.”
FDA officials said companies could possibly use data from testosterone products approved overseas, Reuters reported, but those products would still have to meet US standards.
Assistant Secretary for Health Admiral Brian Christine said in his opening remarks that it was unacceptable that US women lack a testosterone therapy approved for them while such treatments are available in Australia.
According to Reuters, doctors who prescribe testosterone to women usually give low doses of products approved for men, often dividing up products such as AbbVie’s AndroGel and Keenova Therapeutics’ Testim, or use compounded formulas. The FDA has reviewed testosterone for women several times and never approved it, because of the lack of long-term safety data and concerns about heart and breast cancer risk.
Before the meeting, the FDA’s call for comments drew hundreds of submissions, many from women describing better libido, energy, and quality of life on testosterone.
Dr. Kumar’s take
The access gap is real. When the only option is a men’s gel split into smaller amounts, the dose depends on how carefully someone measures it. A product made and tested for women would fix that, and accepting overseas data could speed it up.
But a women’s product would not change what testosterone does. Rajita Patil, who directs UCLA’s menopause care program, told the meeting that evidence supports it only for postmenopausal women with low sexual desire, known as hypoactive sexual desire disorder (HSDD). She said the data are not good enough to recommend it for mood, thinking, or general well-being. Social media claims go much further. Midlife mood changes have other causes worth looking at, and I cover one of them in why perimenopause triggers first-time depression.
The form matters. Patil said oral testosterone is not recommended because of its harmful effects on cholesterol. Compounded products are not FDA-approved, so they have not gone through FDA review of their dose and quality. That makes their dosing harder to predict.
Some side effects do not go away. Physicians told Reuters that too much testosterone can cause acne and extra hair growth. Rarer effects, such as a deeper voice and hair loss, may be permanent. Testosterone is generally not recommended for women with a history of breast cancer, because the body can convert it to estrogen, which can fuel some cancers.
The biggest unanswered question is long-term heart and breast safety, which the FDA itself lists as a gap. Personal accounts of better energy, and online “hormone optimization” claims, are not controlled trials.
What it means for you
Nothing changes at the pharmacy yet. If you use testosterone or are considering it after menopause, ask your doctor:
- Do I have low sexual desire that bothers me? That is the one proven use.
- What form and dose would I get? Is it a divided men’s product or a compounded one?
- How will you check my cholesterol and watch for side effects such as acne, hair growth, or voice changes?
- Does a history of breast cancer, or anything else in my history, rule it out?
For low sexual desire, the FDA has also approved two non-testosterone drugs, Addyi and Vyleesi, for certain patients.
If you want the FDA to hear your view, you can comment at Regulations.gov under docket FDA-2026-N-5479 until 11:59 p.m. Eastern on October 19, 2026.