Testosterone therapy for women: one supported indication, and prescribing that has outgrown it

No testosterone product is FDA-approved for women in the United States. Approved testosterone products exist only for men with low testosterone and an associated medical condition [1]. Every prescription a woman receives is off-label, typically a fraction of a male dose or a compounded preparation, and use is expanding. An analysis of Epic Cosmos electronic health records found the testosterone prescribing rate among eligible US women rose from 50.0 to 130.8 per 100,000 between 2016 and 2025, about 2.6-fold, with a 32 percent annual increase from 2022 to 2025. By 2025 that was 90,482 prescriptions, up 59 percent from 2024. Recorded reasons were led by menopausal symptoms (35 percent), decreased libido (24 percent), and hormone replacement (17 percent). Hypoactive sexual desire disorder, the one indication the trial evidence supports, accounted for about 8 percent [2].

What the trials show

The evidence base is a 2019 systematic review and meta-analysis in The Lancet Diabetes and Endocrinology that pooled 46 reports from 36 randomized trials and 8,480 women [3]. In postmenopausal women, testosterone improved sexual desire, arousal, orgasm, pleasure, and self-image, reduced sexual distress, and increased satisfying sexual events by a mean difference of 0.85 per month. That is roughly one additional satisfying event a month. Only three trials with 226 premenopausal women were available, so the authors drew no conclusions for that group. The review found no benefit for cognition, bone density, body composition, or muscle strength, with the caveat that few women contributed data on those outcomes [3].

The 2019 Global Consensus Position Statement, written by Davis and colleagues and endorsed by the Endocrine Society, the International Menopause Society, the North American Menopause Society, the International Society for Sexual Medicine, the International Society for the Study of Women's Sexual Health, the European Menopause and Andropause Society, the Royal College of Obstetricians and Gynaecologists, and other societies, recognizes one evidence-based indication: hypoactive sexual desire disorder in postmenopausal women, after other contributing causes have been evaluated. It found insufficient evidence to support testosterone for cognition, bone health, general wellbeing, or depression, recommends doses that keep blood levels in the physiologic premenopausal range, and recommends against supraphysiologic dosing and against compounded testosterone [4].

There is no diagnosable testosterone deficiency in women. The Endocrine Society's 2014 guideline advises against making a diagnosis of androgen deficiency in healthy women because no defined syndrome exists and no data link blood levels to specific symptoms; baseline testosterone did not predict who responded to treatment [5]. Blood levels are therefore used to confirm the dose is not supraphysiologic, not to decide who should be treated. The guideline suggests checking levels every six months during treatment and stopping in women who have not responded by six months [5].

Dose and form decide the side effects

Trial dosing was transdermal, by patch, gel, or cream, and aimed at the normal premenopausal range [3, 4]. At those doses the recorded costs were more acne, more hair growth, and a small increase in weight; no serious adverse events were reported [3]. Route mattered for lipids. Oral testosterone raised LDL cholesterol and lowered HDL cholesterol, while non-oral routes did not, which is why the authors preferred patches and creams [3].

Injections and pellets, common in cash-pay practice, were not the formulations studied in these trials. Pellets are usually compounded, cannot be removed or adjusted once implanted, and a 2025 review of compounded hormonal pellets found no peer-reviewed studies showing they are safer or more effective than approved products; it estimated pellets account for 10 to 15 percent of testosterone prescriptions for US women [6]. Compounded products also add a potency variable. In FDA surveys of compounded drugs that included female hormone products, 34 percent of sampled products failed quality testing in 2001 and 33 percent failed in 2006, with measured potency in the 2006 sample ranging from 67.5 to 268.4 percent of the labeled amount [7, 8]. Those surveys were small and did not test testosterone pellets specifically.

The unresolved safety question

The trials were short. The consensus statement and the 2014 guideline both note that safety data for testosterone in women do not extend beyond 24 months, that the trials were too small to assess breast cancer risk, and that women at elevated cardiometabolic risk were generally excluded [4, 5]. No trial has been powered for cardiovascular or breast outcomes.

On September 17, 2026, the FDA's Office of Women's Health and Center for Drug Evaluation and Research held a public workshop, "Testosterone Use in Menopausal Women," to review the evidence and knowledge gaps and to inform future research and drug development [9]. Dr. Christina Chang, division director in CDER's urology, obstetrics and gynecology division, said the agency is aware of increasing off-label use and that no approved indication exists for menopausal women. Specialists at the meeting said questions about long-term safety remain unanswered and that many women seek testosterone for energy and mood, uses no guideline supports [10]. The public docket (FDA-2026-N-5479) closed October 19, 2026 [9]. As of this writing the FDA has announced no decision. Regulators want long-term outcome data, no sponsor has funded that trial, and off-label prescribing has filled the space in the meantime.

Where this leaves a patient

For a postmenopausal woman with distressing low desire and other causes addressed, transdermal testosterone at a physiologic dose is an evidence-based option with an expected benefit of about one additional satisfying sexual event per month, reassessed at three to six months and stopped if nothing has changed [3, 4, 5]. For energy, mood, cognition, muscle, bone, or aging, no randomized trial shows benefit, and the formulations sold most heavily for those uses, pellets and injections, are the ones with the least trial data behind them [3, 4, 6].

Sources

1. US Food and Drug Administration. Testosterone Information. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/testosterone-information
2. Avivi I, Stuenkel C, Sampath-Kumar R, et al. Accelerating Testosterone Prescribing for U.S. Women: Implications for Cardiovascular Safety. JACC: Advances. Published online May 13, 2026. doi:10.1016/j.jacadv.2026.102724
3. Islam RM, Bell RJ, Green S, Page MJ, Davis SR. Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data. The Lancet Diabetes and Endocrinology. 2019;7(10):754-766. https://pubmed.ncbi.nlm.nih.gov/31353194/
4. Davis SR, Baber R, Panay N, et al. Global Consensus Position Statement on the Use of Testosterone Therapy for Women. Journal of Clinical Endocrinology and Metabolism. 2019;104(10):4660-4666. https://pmc.ncbi.nlm.nih.gov/articles/PMC6821450/
5. Wierman ME, Arlt W, Basson R, et al. Androgen Therapy in Women: A Reappraisal: An Endocrine Society Clinical Practice Guideline. Journal of Clinical Endocrinology and Metabolism. 2014;99(10):3489-3510. https://www.endocrine.org/clinical-practice-guidelines/androgen-therapy-in-women
6. Compounded hormonal pellets: a critical review of current evidence and risks. 2025. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12341420/
7. US Food and Drug Administration. Report: Limited FDA Survey of Compounded Drug Products (2001). Archived at https://webharvest.gov/peth04/20041112082657/http:/www.fda.gov/cder/pharmcomp/survey.htm
8. US Food and Drug Administration. 2006 Limited FDA Survey of Compounded Drug Products. Archived at https://webarchive.library.unt.edu/eot2008/20090511183313/http:/www.fda.gov/cder/pharmcomp/survey_2006.htm
9. US Food and Drug Administration. FDA Public Meeting: Testosterone Use in Menopausal Women, September 17, 2026. https://www.fda.gov/consumers/womens-health-events/fda-public-meeting-testosterone-use-menopausal-women-09172026 ; Federal Register notice, August 18, 2026, Docket FDA-2026-N-5479. https://www.federalregister.gov/documents/2026/08/18/2026-16829/testosterone-use-in-menopausal-women-public-workshop-request-for-comments
10. ABC News. FDA examines use of testosterone prescriptions for menopause. September 18, 2026. https://abcnews.com/Health/fda-examines-testosterone-prescriptions-menopause/story?id=136570571