Testosterone therapy for female sexual dysfunction: a systematic review of the literature demonstrating outcomes in premenopausal and postmenopausal women

Postmenopausal testosterone therapy has 7 RCTs behind it, premenopausal use has just 2

Journal: The Journal of Sexual Medicine | Published: 2026-07-03 | Type: Journal Article, Systematic Review | PMID: 42430779 Authors: Furlan Vada A, Hammad Muhammed A M, Quesada S, Nguyen S, Yih J (Department of Urology, University of California, Irvine) Funding/COI: Not listed

Summary

This is a systematic review, not a meta-analysis, pooling 33 studies on testosterone therapy for female sexual dysfunction and splitting results by menopausal status. Postmenopausal women have a real evidence base: 7 RCTs, including one with over 800 participants, showing improved sexual desire and HSDD symptoms with transdermal testosterone at 300 μg/day. Premenopausal women have almost nothing: 2 RCTs with 31 to 261 participants, described as "promising" but nowhere near sufficient to support the guideline-level claims made for the postmenopausal group.

Claims

• 810 records identified across Scopus, PubMed, and CINAHL; 33 studies included after deduplication and screening
• 7 RCTs in postmenopausal women, including one with more than 800 participants, found significant improvements in sexual desire and HSDD symptoms with transdermal testosterone (300 μg/day)
• 2 RCTs in premenopausal women, sample sizes 31 to 261, found improved libido, satisfactory sexual event frequency, and sexual satisfaction with transdermal or vaginal testosterone
• Androgen levels and long-term safety data were inconsistently reported across included studies

Study Quality

The review followed PRISMA reporting guidelines and searched three databases, which is a reasonable minimum for a review of this scope. But the abstract never names a formal risk-of-bias or quality-appraisal tool (no AMSTAR, no Cochrane RoB, no GRADE), only that "study quality and design were considered in the synthesis" — that phrase does no work without specifics. It's also not a meta-analysis: no pooled effect sizes are reported, so "significant improvements" for the postmenopausal group is an unquantified summary across 7 heterogeneous trials, and the premenopausal claims rest on language like "improved" and "promising" rather than numbers.

The asymmetry in the evidence itself is the real finding here. Of 33 included studies, only 9 were RCTs, and just 2 of those enrolled premenopausal women. Treating that as sufficient basis for even a hedged efficacy claim in premenopausal women overstates what 2 trials can support, regardless of how the authors phrase it.

Red Flags

• Funding source and conflicts of interest are both listed as not disclosed for a paper concluding that a drug therapy is effective
• No named risk-of-bias or quality-assessment tool in the methods as reported
• No effect sizes, confidence intervals, or p-values given for either subgroup, just qualitative language
• Premenopausal efficacy conclusion is built on only 2 RCTs
• Long-term safety and androgen level monitoring were inconsistently reported across studies, and the review doesn't quantify how many studies actually tracked safety

Strengths

• PRISMA-guided methodology with three-database search and a defined screening pipeline
• Explicit subgroup analysis by menopausal status, which addresses a genuine gap in how this evidence is usually discussed
• Includes a large postmenopausal RCT (>800 participants), a rare sample size in this literature
• Transparent about sample size range (31-261) for the weaker premenopausal trials rather than burying it

Verdict

Worth a skim for the postmenopausal summary, skip the premenopausal conclusions. The postmenopausal evidence synthesis reflects a genuinely more mature trial base and lines up with existing guideline support. But the paper's framing treats premenopausal and postmenopausal evidence as two flavors of the same finding when they're not remotely comparable in size or maturity, and the missing funding/COI disclosure on a testosterone-therapy paper is the kind of omission this journal should be catching before publication.