Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data.
Level 1 - systematic review of randomized trials
Systematic review and meta-analysis of blinded randomized controlled trials
PubMed 31353194 · doi:10.1016/S2213-8587(19)30189-5
What was done
Authors conducted a systematic review and meta-analysis of blinded randomized controlled trials (lasting >=12 weeks, published 1990–2018, including FDA/EMA regulatory filings) evaluating testosterone versus placebo or active comparators in women. Primary outcomes were sexual function, cardiometabolic variables, cognitive measures, and musculoskeletal health across 36 RCTs totaling 8,480 participants.
What was found
In postmenopausal women, testosterone significantly increased satisfactory sexual event frequency (mean difference [MD] 0.85, 95% CI 0.52 to 1.18), sexual desire (standardized mean difference [SMD] 0.36, 95% CI 0.22 to 0.50), pleasure (MD 6.86, 95% CI 5.19 to 8.52), arousal (SMD 0.28, 95% CI 0.21 to 0.35), orgasm (SMD 0.25, 95% CI 0.18 to 0.32), responsiveness (SMD 0.28, 95% CI 0.21 to 0.35), and self-image (MD 5.64, 95% CI 4.03 to 7.26). It significantly reduced sexual concerns (MD 8.99, 95% CI 6.90 to 11.08) and distress (SMD -0.27, 95% CI -0.36 to -0.17). Oral testosterone raised LDL-cholesterol and lowered total cholesterol, HDL-cholesterol, and triglycerides, whereas non-oral routes did not adversely alter lipid profiles. Weight increased overall, and rates of acne and hair growth were elevated, but no serious adverse events were reported. No effects were found for body composition, musculoskeletal variables, or cognitive measures.
Why it matters
This review establishes that non-oral testosterone effectively improves sexual function and reduces distress in postmenopausal women without inducing the detrimental lipid changes associated with oral administration.
Limits
Data for body composition, musculoskeletal health, and cognition were limited by small sample sizes across contributing trials. Long-term safety beyond typical trial durations remains unmeasured.
Cited by
- supports Testosterone therapy in women is currently only scientifically proven to be effective for treating low sexual desire and low libido.