Dapoxetine for the Treatment of Premature Ejaculation: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial in 22 Countries

Abstract: Background: Dapoxetine is being developed for the on-demand treatment of premature ejaculation (PE). Previous clinical trials have demonstrated its safety and efficacy. Objective: To evaluate the long-term efficacy and safety of dapoxetine in men with PE. Design, setting, and participants: This randomized, double-blind, parallel-group, placebo-controlled, phase 3 trial, conducted in 22 countries, enrolled men (N =1162) ≥18 yr of age who met the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for PE for ≥6 mo, with an intravaginal ejaculatory latency time (IELT) ≤2min in ≥75% of intercourse episodes at baseline. Intervention: Dapoxetine 30mg or dapoxetine 60mg or placebo on demand (1–3h before intercourse) for 24 wk. Measurements: Stopwatch-measured IELT, Premature Ejaculation Profile (PEP), Clinical Global Impression (CGI) of change, adverse events (AEs). Results and limitations: The study was completed by 618 men. Mean average IELT increased from 0.9min at baseline (all groups) to 1.9min, 3.2min, and 3.5min with placebo and dapoxetine 30mg and dapoxetine 60mg, respectively, at study end point; geometric mean IELT increased from 0.7min at baseline to 1.1min, 1.8min, and 2.3min, respectively, at study end point. All PEP measures and IELTs improved significantly with dapoxetine versus placebo at week 12 and week 24 (p <0.001 for all). The most common AEs were nausea, dizziness, diarrhea, and headache. AEs led to discontinuation in 1.3%, 3.9%, and 8.2% of subjects with placebo and dapoxetine 30mg and dapoxetine 60mg, respectively. Limitations of this study included the exclusion of men who were not in long-term monogamous relationships. Conclusions: Dapoxetine significantly improved all aspects of PE and was generally well tolerated in this broad population. [Copyright &y& Elsevier]