A systematic review of randomized controlled trials investigating the efficacy and safety of testosterone therapy for female sexual dysfunction in postmenopausal women Anastasia Dimakopoulou , Channa N Jayasena, Fatima M Alkaabi, Curtis S Liebers, Thomas Handley, Stephen Franks & Waljit S Dhillo

Introduction: Over half of postmenopausal women suffer symptoms which can sometimes be non-responsive to hormone replacement therapy (HRT). Testosterone is implicated in regulating urogenital and sexual function in women. However, using testosterone therapy in postmenopausal women remains highly controversial, principally due to the lack of syndromic relationship between serum testosterone levels and onset of sexual dysfunction during menopause. Clinical practice is therefore highly variable worldwide.

Aim: Objectively summarise published literature investigating the effectiveness and safety of testosterone replacement for sexual dysfunction in postmenopausal women.

Methods: Searches of CENTRAL, EMBASE, MEDLINE and PubMed were conducted. Search was in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology to find all randomized placebo controlled (RCT) studies of testosterone therapy in women.

Results: A total of 26 randomized placebo controlled (RCT) studies suggest that testosterone therapy significantly improves symptoms of sexual dysfunction. However, eight RCTs showed no significant difference for menopausal symptoms between testosterone therapy and placebo groups. Most studies conclude that testosterone therapy has no significant beneficial effect on reducing hot flash frequency and severity. Finally, exogenous testosterone increases haematocrit and there is hardly any long-term safety data on thromboembolic disease in postmenopausal women using testosterone.

Conclusion: Majority of RCTs suggest that testosterone therapy significantly improves sexual function in postmenopausal women with sexual dysfunction or hypoactive sexual desire disorder. Testosterone therapy in postmenopausal women is well-tolerated in the short-term however, there is a paucity of long-term safety data. We recommend that testosterone therapy could be considered for the minority of postmenopausal women for whom other management strategies have failed.