Global Consensus Position Statement on the Use of Testosterone Therapy for Women
Davis SR, Baber R, Panay N, Bitzer J, Cerdas Perez S, Islam RM, Kaunitz AM, Kingsberg SA, +8 more
Climacteric (2019)
The ten-society global consensus narrows the testosterone-for-women indication to a single use case — postmenopausal HSDD — and explicitly recommends against compounded testosterone products at supraphysiologic dosing, the framework that anchors contemporary off-label prescribing under specialist supervision.
This is the Global Consensus Position Statement on the Use of Testosterone Therapy for Women — the multi-society position document that synthesizes the clinical-trial evidence base for testosterone therapy in women and narrows the recommended indication to a single use case: postmenopausal hypoactive sexual desire disorder. The consensus was developed under the umbrella of ten international medical societies including the International Menopause Society, American College of Obstetricians and Gynecologists, North American Menopause Society, Royal College of Obstetricians and Gynaecologists, European Menopause and Andropause Society, the Endocrine Society, the International Society for Sexual Medicine, the International Society for the Study of Women's Sexual Health, the African Menopause Society, and the Asian-Pacific Menopause Federation.
The headline position is narrow and load-bearing. Testosterone can be effective at improving sexual wellbeing for postmenopausal women diagnosed with HSDD, with documented benefits in sexual desire, arousal, orgasm, and pleasure across the trial literature synthesized by Islam et al. 2019 Lancet Diabetes Endocrinol meta-analysis (36 RCTs, 8,480 women). The available evidence does not support the use of testosterone for any other symptoms or conditions in women — not fatigue, not cognitive complaints, not body-composition outcomes, not bone health as a standalone indication. Target serum testosterone is the physiologic premenopausal range; supraphysiologic dosing risks androgen-excess adverse events (hirsutism, acne, voice deepening, scalp hair loss). The consensus explicitly recommends against the use of compounded "bioidentical" testosterone products because of insufficient safety and efficacy data and the documented record of supraphysiologic exposures in compounding-channel practice — a position the companion Parish et al. 2021 ISSWSH clinical practice guideline reinforces with operational dosing recommendations using government-approved transdermal male formulations at female-physiologic fractional dosing.
The clinical relevance is structural for the broader FSD-care landscape. No FDA-approved testosterone product for women exists in the United States as of 2026; the closest formally-supported pathway is male transdermal formulations off-label at female-appropriate dosing under specialist supervision. The consensus is the load-bearing reference for the contemporary HSDD-care framework for postmenopausal women — the population for which bremelanotide is not FDA-approved (the PT-141 RECONNECT trials enrolled premenopausal women only) and flibanserin failed to extend its label despite the positive SNOWDROP postmenopausal trial readout. The consensus framework operates alongside the Clayton et al. 2018 ISSWSH Process of Care for HSDD and the McCabe et al. 2016 ICSM definitions consensus as the structural reference for the FSD-pharmacology field.
This is a consensus position document representing the integrated clinical view of the ten participating societies rather than a primary research paper or systematic review. The evidence base is the Islam et al. 2019 Lancet Diabetes Endocrinol meta-analysis and the broader trial-grade testosterone-in-women literature synthesized by Davis and Wahlin-Jacobsen 2015 Lancet Diabetes Endocrinol 3:980–992; the trial follow-up windows extend to months and up to two years in most studies, with multi-year continuous-use safety data more limited. Cardiovascular and breast-cancer safety outside trial horizons remain open questions. Premenopausal women on testosterone for HSDD sit outside the consensus evidence base — the trials underwriting the position are predominantly postmenopausal — and the female sexual dysfunction beyond Vyleesi dossier walks the premenopausal evidence gap. The consensus has been influential at the regulatory level but has not produced an FDA-approved female testosterone product in the U.S.; the Australian AndroFeme transdermal product and several European formulations represent the closest internationally-approved options. The recommendation against compounded testosterone products is operationally important — compounded testosterone supraphysiologic dosing is documented in the wellness-channel literature and represents the modal safety-failure mode in current off-label practice. Industry support and individual disclosures are reported in the publication. The framework is the load-bearing global reference for the contemporary testosterone-in-women clinical landscape and has been operationalized in the major sexual-medicine fellowship curricula and in society-level guidelines internationally.
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