The clinical societies and the regulators are not in the same place, and women are prescribed in the gap between them.
On one side: a Global Consensus Position Statement on the Use of Testosterone Therapy for Women, published in 2019 with endorsement across the major international endocrine and menopause societies, built on a systematic review and meta-analysis of the randomised trial data.[1][2]
On the other: no correspondingly broad set of approved female testosterone products. Approval status varies by country and indication, and in many places there is no licensed product formulated for women.
Why the gap exists
Approval requires trials designed for registration — specific indication, specific formulation, specific population, adequate size and duration. The randomised evidence pooled in the 2019 meta-analysis is what exists,[2] and it was not generated as a registration package for a female product.
So the societies could reach a position on what the evidence supports without that evidence being the kind that produces a licence. Both things are true simultaneously, and neither party is behaving unreasonably.
What this means for a woman being prescribed
Three practical consequences.
Off-label is not the same as unsupported. Prescribing outside a licensed indication is legal, common, and in this case backed by an international consensus.[1] It does mean the specific product was not approved for this use in this population.
Compounded preparations vary. They are not manufactured to the consistency standards of an approved product, which makes the actual delivered dose less certain.
Monitoring matters more, not less. Without a licensed dose and label to work from, the burden of getting it right sits with the prescriber and the follow-up.
The comparison that makes the point
The male side has an Endocrine Society clinical practice guideline specifying a diagnostic pathway, a target range, contraindications and a first-year monitoring plan — all built on approved products with labels.[3]
The female side has an international consensus statement and no equivalent product infrastructure.[1] Same hormone, same physiological importance, entirely different apparatus around it.
Frequently asked questions
Is it legal to prescribe testosterone to women? Off-label prescribing is legal and, for the indication the consensus statement addresses, supported by international specialist agreement.[1] Regulatory specifics vary by country.
Should I avoid compounded testosterone? It is a real consideration to raise with your prescriber — consistency of the delivered dose is the issue. Whether an approved alternative exists depends on where you are.
Why hasn't a product been approved? Registration requires trials designed for that purpose. The available randomised evidence was not generated as a registration package.[2]
Where do I find the clinical guidance rather than the history? Testosterone therapy for women, on the women's pillar — and the trial evidence quantified, 36 randomised trials and 8,480 women.
Next in this series
If the products are designed for men, the dosing question becomes the practical crux.
Continue with dosing women differently.
References
3 sources
- Davis SR, Baber R, Panay N, et al. Global Consensus Position Statement on the Use of Testosterone Therapy for Women. J Clin Endocrinol Metab. 2019;104(10):4660–4666. doi:10.1210/jc.2019-01603 · PMID 31498871
- Islam RM, Bell RJ, Green S, et al. Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data. Lancet Diabetes Endocrinol. 2019;7(10):754–766. doi:10.1016/S2213-8587(19)30189-5 · PMID 31353194
- Bhasin S, Brito JP, Cunningham GR, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715–1744. doi:10.1210/jc.2018-00229 · PMID 29562364
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