Testosterone Therapy for Women: What the FDA’s 2026 Workshop Means for Menopause

On September 17 the FDA did something it had never done before: it held a public workshop devoted entirely to testosterone use in menopausal women. If you've been on hormone therapy and wondered whether testosterone belongs in it, or you've asked about it and been told no, or you're one of the women who's been quietly getting it from a wellness clinic, this is the most important regulatory conversation about your hormones in years. Here's what actually happened, what the evidence supports today, and how I'd think about it if I were you.

First, the facts

There is no FDA-approved testosterone product for women in the United States. There never has been. Every woman using it here is using it off-label — typically a fraction of a dose of a gel or cream approved for men, or a compounded preparation, or a pellet.

That hasn't slowed demand. An analysis released this month found testosterone prescriptions for women rose 146% between January 2023 and July 2026, alongside reports of pharmacies delaying or refusing to fill them. The FDA's own framing is that despite growing off-label use, critical knowledge gaps remain — around sexual function, cognition, mood, and musculoskeletal health, around how to measure testosterone in women at all, and around long-term cardiovascular and breast cancer safety.

The workshop was hosted jointly by the FDA's Office of Women's Health and its drug-evaluation center, with endocrinologists, urologists, gynecologists, and patient advocates presenting. The agency opened a public docket that stays open through October 19, 2026, and more than 1,300 comments had come in by the time the meeting convened.

What the FDA said

Three things, and they matter in different ways.

The agency wants a product to exist. This is the headline. FDA officials said they stand ready to review applications, urged manufacturers to run the studies, and suggested that data from products already approved overseas — testosterone is approved for postmenopausal women in Australia, New Zealand, the United Kingdom, and South Africa — might be leveraged, case by case, though the U.S. approval standard would still have to be met. The closing line from the agency was that menopause is inevitable but women should not have to suffer. That is not the tone of a regulator planning to shut something down.

The evidence is strongest for one thing. Every expert in the room agreed that the best data supports testosterone for hypoactive sexual desire disorder — low desire that causes distress — in postmenopausal women. That matches the 2019 Global Consensus Position Statement, endorsed by eleven medical societies including the Endocrine Society and the North American Menopause Society, which concluded that HSDD is the only evidence-based indication and that recommendations apply to physiologic doses only. For the other reasons women ask for it — energy, mood, brain fog, muscle, bone — presenters were direct: testosterone may well turn out to help, but the trials to prove it haven't been done.

The gaps are real, and so is the alarm about high dosing. The FDA named cardiovascular disease, breast cancer, and safety beyond 24 months as the areas where robust trial data is required before approval. And both the agency and the clinicians raised specific concern about supraphysiologic dosing — levels of 500 ng/dL and above, which some pellet and injection protocols produce — where long-term effects are unknown, estradiol rises, and informed consent is often thin. Pellets came in for particular scrutiny because once one is placed, it can't be removed if side effects appear.

What I take from it

I've watched testosterone go from a hormone nobody would discuss with women to one being marketed as the missing piece of every midlife problem, and neither extreme is right. The workshop landed close to where I sit.

Testosterone is the most abundant sex hormone in a premenopausal woman's body — produced at roughly three times the rate of estrogen — and it declines gradually from the thirties rather than dropping off a cliff at menopause. Low levels are associated with loss of muscle and bone, and with changes in mood, cognition, energy, and desire. Women are not wrong that something is missing. What they're often wrong about, because someone sold it to them, is that a high dose fixes it. The dose that has evidence is the one that returns a woman to the normal premenopausal range — not above it.

The measurement problem the FDA flagged is one I run into constantly. Standard testosterone assays were built for men's concentrations, and they are imprecise at the levels women actually have. There is no blood value that diagnoses "testosterone deficiency" in a woman. So the decision is clinical: the history, the symptoms, what estrogen and progesterone have and haven't resolved, and then a baseline level using the most sensitive assay available, mostly so we have something to monitor against rather than to justify the prescription.

And this belongs in a hormone conversation, not a standalone one. The compelling cases presented at the workshop were women already on estrogen and progesterone whose symptoms didn't fully resolve — where adding testosterone made the difference. In my experience that order matters: get the foundation assessed and treated first, and testosterone earns its place afterward, or it doesn't.

If you're considering it

• Be clear about what you're treating. If it's low desire with distress, the evidence is on your side. If it's energy, mood, or muscle, you're in the "plausible but unproven" territory the FDA described, and you should hear that from whoever is prescribing it.
• Insist on physiologic dosing and monitoring. Transdermal cream or gel at a female dose, a level checked before starting and again at three to six weeks, and a target within the normal premenopausal range. If a provider isn't measuring, or is aiming high on purpose, that's your answer.
• Be cautious about pellets. They deliver doses that can't be adjusted or reversed, and they are the formulation the workshop singled out. This is a personal judgment call, but it's mine.
• Know the side effects. Acne and increased facial or body hair are the common ones and reverse if the dose comes down. Voice deepening and scalp hair loss are rarer and may not.
• Expect access friction. Testosterone is a Schedule III controlled substance, which limits telehealth prescribing across state lines and lets pharmacies cap the supply they'll dispense. Several workshop participants called for that designation to be lifted for physiologic doses in women; it hasn't been yet.

If you've already been on it

Nothing in the workshop suggests women on physiologic-dose testosterone should stop. The 2019 consensus found no evidence of serious adverse events in trials at those doses over their duration. What it does suggest is worth acting on: if you've never had a level checked, get one; if your levels were pushed high on purpose, have a conversation about why; and if you were started on testosterone without estrogen and progesterone ever being evaluated, that evaluation is still the more important one.

---

The honest summary is that the FDA has opened the door, the evidence for one indication is solid, the evidence for the rest is promising and incomplete, and the danger isn't testosterone — it's testosterone without measurement, without context, and without a physician who'll say "not yet" when that's the true answer. The docket is open until October 19. I'll update this piece when the agency responds.

References

1. U.S. Food and Drug Administration. “FDA Public Meeting: Testosterone Use in Menopausal Women.” September 17, 2026. View source
2. Holland & Knight. “FDA Workshop Signals Potential Approval Pathway for Testosterone Therapy in Menopausal Women.” September 21, 2026. View source
3. Reuters. “US Regulators Urge More Research on Testosterone Therapy for Women as Experts Debate Benefits, Risks.” September 17, 2026. View source
4. Healthline. “Testosterone Prescriptions for Women Surge Amid Pharmacy Access Barriers.” September 22, 2026. View source
5. Davis SR, et al. “Global Consensus Position Statement on the Use of Testosterone Therapy for Women.” Journal of Clinical Endocrinology & Metabolism, 2019. View source
6. Islam RM, et al. “Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data.” Lancet Diabetes & Endocrinology, 2019. View source

Testosterone is not FDA-approved for any indication in women; all use described here is off-label. Regulatory status was checked against FDA materials current at the time of publication.