The FDA’s 2026 testosterone workshop: what the evidence for menopausal women actually shows

On September 17, 2026, the FDA’s Office of Women’s Health and Center for Drug Evaluation and Research convened a public workshop at the agency’s White Oak campus titled “Testosterone Use in Menopausal Women.”^[1] The event followed an August 18, 2026 Federal Register notice that opened a public docket for comments on the risks and benefits of testosterone use in this population, with a 60-day comment period running through October 19, 2026.^[2] The stated purpose was narrow and specific: to examine current scientific evidence and critical knowledge gaps in order to inform future research and potential drug development.^[1]

That framing matters. A workshop that reviews evidence gaps is a different kind of event from an approval decision, and treating the two as equivalent is the most common way this story gets misread. For the parallel situation on the men’s side, where the FDA has made actual label changes rather than holding an evidence-gathering workshop, see our companion article, Testosterone therapy: what the evidence actually shows.

The clearest evidence-based indication for testosterone in women is hypoactive sexual desire disorder (HSDD): persistent, distressing low sexual desire, diagnosed through a full biopsychosocial assessment rather than a lab value. The 2019 Global Consensus Position Statement on testosterone therapy for women, endorsed by ten professional societies including the Endocrine Society, the International Menopause Society, and the North American Menopause Society, identifies HSDD in postmenopausal women as the only indication with adequate supporting data.^[5]

Everything outside that specific indication rests on noticeably weaker ground. The Endocrine Society’s clinical practice guideline explicitly recommends against using testosterone in women for infertility, sexual dysfunction other than HSDD, or cognitive, cardiovascular, metabolic, bone, or general well-being purposes, and against routine use of DHEA.^[6]

The best single source on efficacy is a 2019 systematic review and meta-analysis in The Lancet Diabetes & Endocrinology, which pooled 36 randomized, placebo- or comparator-controlled trials totaling 8,480 women.^[4] Compared with placebo or a comparator such as estrogen with or without progestogen, testosterone produced statistically significant improvements across several sexual function measures in postmenopausal women: satisfying sexual event frequency, sexual desire, pleasure, arousal, orgasm, responsiveness, and self-image, alongside reduced sexual concerns and distress.^[4]

The same analysis found a different picture for non-sexual outcomes. No significant effects were reported for body composition, musculoskeletal variables, or cognitive measures, though the authors note that relatively few trial participants contributed data for those outcomes, so absence of proof is not the same as proof of no effect.^[4] Testosterone also raised average weight and was associated with a greater likelihood of acne and hair growth, though no serious adverse events were recorded in the pooled trials.^[4]

Route of administration mattered for one hard safety measure: oral testosterone significantly raised LDL cholesterol and lowered total cholesterol, HDL cholesterol, and triglycerides, while non-oral administration, such as transdermal patches or creams, did not produce that lipid shift.^[4]

The authors’ own interpretation is the sentence worth sitting with: testosterone is effective for postmenopausal women with distressing low sexual desire, with non-oral routes preferred for their neutral lipid profile, but effects on individual well-being, musculoskeletal and cognitive health, and long-term safety all warrant further investigation.^[4]That is a 2019 conclusion. It is also, per the FDA’s own September 2026 workshop framing, still the state of the evidence today.

While the evidence base has moved slowly, real-world use has not. A 2026 analysis published in JACC: Advances examined testosterone prescribing across Epic Cosmos, a national electronic health record network covering more than 300 million patients across roughly 1,915 hospitals and 42,600 clinics in all 50 states.^[3] Prescribing among women rose 2.6-fold between 2016 and 2025, from 50.0 to 130.8 per 100,000 women, with rates roughly flat through 2021 before accelerating at about 31.8% annually from 2022 through 2025, including a 58.7% jump from 2024 to 2025 alone.^[3]

The population receiving those prescriptions carries real cardiovascular exposure. Among women prescribed testosterone in 2025, 51.2% already had at least one documented cardiometabolic risk factor (hypertension, dyslipidemia, or type 2 diabetes), 44% had a documented family history of heart disease, and 62.2% of all prescriptions went to women aged 45 to 64, a period the study authors describe as critical for the development of atherosclerotic disease.^[3] The authors call for careful cardiovascular risk assessment and shared decision-making before prescribing, and for sex-specific cardiovascular safety studies that do not yet exist.^[3]

This is the gap the FDA workshop was built around. The agency identified testosterone’s role in sexual function, cognition, mood, and musculoskeletal health, along with the challenge of measuring and interpreting testosterone levels in women, and the absence of long-term safety data, particularly for cardiovascular disease and breast cancer, as the central knowledge gaps motivating the workshop.^[1]

Cardiovascular disease is the leading cause of death in women and breast cancer is the most common cancer in postmenopausal women, which is precisely why an absence of dedicated long-term safety data is not a minor omission. The randomized trials behind the efficacy evidence above were not designed or powered to detect rare or delayed cardiovascular or cancer events; they were designed to measure sexual function over months, not disease incidence over decades. A prescribing trend accelerating faster than the safety evidence is precisely the mismatch a regulator is supposed to notice, and the workshop is that noticing, not yet a resolution.

No testosterone product is currently FDA-approved for women, for any indication.^[1]Prescribing for women therefore relies on off-label use of products approved for men, compounded formulations, or products approved in other countries, none of which come with dosing or safety data developed specifically for female physiology. The FDA has framed its interest as wanting to see sponsors bring forward the kind of dedicated, female-specific trial data that could eventually support an approved product, rather than treating off-label extension of a men’s product as an adequate substitute.^[1]

For readers weighing menopause treatment options more broadly, our companion article on menopause and hormone therapy covers the estrogen and progestogen evidence base, which is considerably more mature than the testosterone picture described here.

A recurring theme across both the Endocrine Society guideline and the FDA’s stated workshop goals is that measuring testosterone in women is harder, and less clinically meaningful on its own, than the men’s hypogonadism model might suggest. The guideline specifically recommends against diagnosing an androgen deficiency syndrome in women, on the grounds that no such syndrome has been well defined and no clear correlation exists between a given blood level and specific symptoms.^[6] The FDA separately flagged challenges in measuring and interpreting testosterone levels in women as one of the specific gaps its workshop aimed to address.^[1]

None of the trial evidence above changes the need to watch for concrete warning signs if you are already using testosterone therapy, whether prescribed on-label elsewhere, off-label, or compounded.

The FDA held a genuine, substantive workshop on testosterone use in menopausal women in September 2026, and it is worth taking seriously precisely because of what it was not: an approval, a new indication, or a verdict on safety. The trial evidence supports a real, specific benefit for hypoactive sexual desire disorder and stops well short of supporting testosterone as a general menopause or vitality treatment. Meanwhile, off-label prescribing has accelerated faster than the safety evidence needed to reassure a population that already carries meaningful cardiovascular risk. See how we grade evidence across topics in our editorial and evidence standards, and browse the rest of our Hormone & Vitality coverage as it grows.

None of this replaces an individual conversation with a clinician who knows your symptoms, cardiovascular risk factors, and full health history. It reflects what the FDA, the underlying trials, and a 2026 national prescribing analysis actually say: a real but narrow efficacy signal, and an acknowledged, still-open safety question.