Perceived control over ejaculation is central to treatment benefit in men with premature ejaculation: results from phase III trials with dapoxetine
Abstract
OBJECTIVES: To assess the utility of perceived control over ejaculation ('control') in the evaluation of treatment benefit in men with premature ejaculation (PE), and to compare effects associated with a two-category or greater increase in this variable between men receiving dapoxetine and placebo. PATIENTS AND METHODS: This subanalysis used combined data from all treatment groups in an integrated analysis of two identically designed, 12-week, double-blind, randomized, placebo-controlled trials of dapoxetine. Men (2614) met the Diagnostic and Statistical Manual of Mental Disorders (fourth edition, text revision) criteria for PE, had a stopwatch-measured intravaginal ejaculatory latency time (IELT) of or =75% of events in a 2-week baseline period, and self-reported moderate or severe PE. Men received placebo or dapoxetine 30 or 60 mg, 1-3 h before intercourse. The stopwatch-measured IELT was recorded for each episode; the patient-reported global impression of change (PGI; 7-point scale, 'much worse' to 'much better'), control and satisfaction with sexual intercourse (5-point scales, 'very poor' to 'very good') were assessed monthly. The utility of a two-category or greater increase in control was evaluated by examining the relationship of this variable with IELT and satisfaction with sexual intercourse. RESULTS: Of 2341 men with baseline and endpoint assessments, 96.8% reported 'very poor' or 'poor' control at baseline, and 748 (32%) reported a two-category or greater…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 2,341 participants or records.
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