Safety and efficacy of venlafaxine in the treatment of premature ejaculation: a double-blind, placebo-controlled, fixed-dose, randomised study.

Venlafaxine is a serotonin-noradrenaline reuptake inhibitor antidepressant. Two hundred and twenty-two married men (mean age, 34 years) with premature ejaculation (PE) were randomly assigned to receive 75 mg of venlafaxine extended release (n = 112) (group 1) or placebo (n = 110) (group 2) for 12 weeks. Pre-treatment evaluation included history and physical examination, geometric mean intravaginal ejaculatory latency time (IELT) and International Index of Erectile Function (IIEF). The efficacy of two treatments was assessed every 2 weeks during treatment, and at the end of study, using responses to IIEF, IELT evaluation, mean intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects. At the end of treatment period, the geometric mean IELT in venlafaxine and placebo group demonstrated 1.7-fold (95% CI: 0.76-1.96) and 1.6-fold (95% CI: 0.87-1.84) increase respectively (P = 0.1). The mean weekly intercourse episodes increased from pre-treatment values of 1.2 and 1.18 to 2.1 and 1.9 for venlafaxine and placebo respectively (P = 0.08). Baseline mean intercourse satisfaction domain values of IIEF 12 and 12 reached to 13 and 12 at 12-week treatment in groups 1 and 2 respectively (P = 0.07). Mean number of adverse events was 32 for venlafaxine and 8 for placebo (P = 0.02). Venlafaxine is not better than placebo in treatment of PE.