More than 75 years after testosterone therapy entered medicine, there is still no FDA-approved testosterone product for women. There is, however, a rapidly growing market for it. A Reuters and Truveta analysis reported by CNN found that the rate of women receiving testosterone prescriptions rose 146 percent from January 2023 to July 2026, nearly tripling in three and a half years. The demand runs through a regulatory gap: with no approved product, clinicians prescribe divided doses of men's formulations or compounded testosterone, dosing that the FDA has never evaluated for women's safety or efficacy.
The agency has now opened the question formally. The FDA held a public workshop this month to review the evidence for testosterone use in menopausal women, the kind of meeting that precedes a defined approval pathway. The workshop's job is to establish what evidence would be sufficient for marketing approval and to map the knowledge gaps. An FDA spokesperson told reporters that off-label uses in women have not been evaluated by the agency for safety, efficacy, or dosing, which is the regulatory vacuum in one sentence.
What the demand is actually for
The clinical case for testosterone in women is narrow and well documented, and the market demand is broader than the evidence. The strongest data support testosterone for hypoactive sexual desire disorder, most commonly in women whose ovaries were surgically removed, a specific population whose desire symptoms respond to physiologic testosterone in randomized trials. A meta-analysis of 36 randomized controlled trials found meaningful improvements in sexual desire, arousal, pleasure, and distress among postmenopausal women with HSDD, with acne and hair growth as the main side effects and no significant difference in serious adverse events. The Menopause Society and a half dozen other professional organizations support testosterone for this indication and roughly this one.
The demand, however, has outrun that narrow indication. Women report seeking testosterone for fatigue, mood, cognition, and body composition, claims for which the evidence is thin at best. A February commentary in Contemporary OB/GYN by Barbara Levy, MD, stated directly that there is no credible evidence physiologic-dose testosterone builds muscle, improves cognition, bone health, or mood, effects that appear only at doses approaching the male range, which carry their own significant adverse events. The gap between what patients want and what the evidence supports is the entire regulatory problem.
The safety picture is similarly split. The known risks at high doses are real and partly irreversible: voice deepening, hair loss, and clitoral enlargement, plus possible blood clot and liver effects. At the low physiologic doses used for HSDD, short-term data look substantially safer, with mostly mild and reversible effects. The long-term data that would settle the question, randomized trials following women for years at defined doses, do not exist, which is precisely what the FDA workshop exists to prompt.
Why the market runs through workarounds
Because no women's product exists, the prescribing patterns are a series of improvisations. Clinicians prescribe men's testosterone gels with instructions to divide them, a dosing practice built on fractions of products calibrated for different physiology. Patients use compounded formulations, which are not FDA-reviewed and vary in potency and purity, at around $100 for a three-month supply. Pharmacy policies add friction at the point of sale, with insurance denials and Amazon Pharmacy restrictions reported as routine by patients and clinicians alike.
The workarounds carry their own risks beyond the hormone itself. Compounded testosterone's quality depends on the compounding pharmacy, and the divided-dose approach depends on the patient's dexterity and the prescriber's arithmetic. The Reuters analysis documented the result: prescriptions rising rapidly, denials and delays rising with them, and a regulatory system that has not yet said what a legitimate version of this therapy looks like.
The workshop was promoted by figures with their own stake in the outcome, including the health secretary and the defense secretary, and the politics around hormone therapy for menopause have been unusually visible in recent months. The evenhanded reading is that the scientific question exists independently of who is asking it: women are using testosterone at scale, the evidence base is partial, and a regulated product with defined doses and studied risks is the standard way to resolve that combination. The politics will argue about who gets credit. The medicine is about what the trials show.
What the workshop could produce
A public workshop of this kind is a milestone on the path to an approval pathway, not the path itself. The agency will summarize the meeting, define the trial designs it would accept, and signal to sponsors what a successful application looks like. More than 30 trials are already underway or planned, including a Marius Pharmaceuticals sexual dysfunction program and a next-generation Aviva Bio product, which suggests the sponsors were waiting for exactly this signal.
The eventual product, if one arrives, will likely be a low-dose women's formulation for HSDD, the indication with the evidence, launched into a market that already buys the therapy through workarounds. The commercial irony is that the demand arrived first: by the time an approved product reaches the market, the market will have spent years teaching itself the therapy through divided gels and compounding pharmacies. The regulatory question is whether the approved product can displace the workarounds on safety grounds, and the workshop is the FDA beginning to answer it.
The honest summary is that the science is at an awkward moment. The evidence supports a real but narrow use, the demand runs far wider, and the risks are manageable at the doses that work and significant at the doses that do not. A workshop does not resolve any of that. It is the moment when the agency agrees the question is worth answering properly, which, after 75 years of improvisation, is a step that matters.
Primary sources
- CNN for the 146 percent prescription increase, the access problems, and the FDA workshop.
- Contemporary OB/GYN for the evidence limits and safety cautions from Dr. Barbara Levy.
- Citeline Pink Sheet for the workshop's regulatory context and the approval-pathway questions.