Efficacy and safety of fluoxetine, sertraline and clomipramine in patients with premature ejaculation: a double-blind, placebo controlled study.

PURPOSE: We compared the efficacy and safety of fluoxetine, sertraline, clomipramine and placebo for the oral pharmacotherapy of premature ejaculation.
MATERIALS AND METHODS: The study included 36 men (mean age 44 years) who had intravaginal ejaculation latency of less than 2 minutes. Patients took each of 3 drugs and the placebo consecutively during a 4-week period per each agent. Efficacy and side effects data were obtained by a self-reported patient questionnaire that rated intravaginal ejaculation latency, sexual satisfaction of patient and partner, and possible side effects.
RESULTS: After 4 weeks of treatment with placebo, fluoxetine, sertraline and clomipramine the mean intravaginal ejaculation latency time was significantly increased from 46 seconds to 2.27 minutes, 2.30 minutes, 4.27 minutes and 5.75 minutes, respectively (all p <0.01). However, treatment with clomipramine or sertraline caused a greater increase in mean intravaginal ejaculation latency time than fluoxetine or placebo (p <0.01). Patient sexual satisfaction rate after treatment with clomipramine was significantly higher (p <0.05) than with sertraline, fluoxetine or placebo. Partner sexual satisfaction rate was also higher with clomipramine than with sertraline or fluoxetine but no statistical difference was found. The incidence of side effects with clomipramine was significantly higher (p <0.05) compared to that of fluoxetine, sertraline and placebo, while no significant difference among sertraline, fluoxetine and placebo was noted.
CONCLUSIONS: In men with premature ejaculation clomipramine was the most useful drug in terms of efficacy. Treatment with sertraline was nearly as effective and had a lower incidence of side effects.

RCT Entities:   Population Interventions Outcomes