Dapoxetine taken on demand before intercourse improved all outcome measures, compared with placebo.

Dapoxetine shows efficacy in the treatment of premature ejaculation (PE), according to a new study that researchers say is the most comprehensive to date examining a pharmacologic treatment for PE.

In a randomized, double-blind, placebo-controlled phase 3 trial conducted in 22 countries, dapoxetine, a short-acting selective serotonin reuptake inhibitor, significantly improved all aspects of PE and was generally well tolerated, investigators reported in European Urology (2009; published online ahead of print).

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Jacques Buvat, MD, of Centre ETPARP, in Lille, France, and colleagues studied 1,162 men aged 18 years and older who had PE for at least six months. The investigators randomized subjects to receive placebo or dapoxetine 30 or 60 mg on demand (one to three hours prior to intercourse) for 24 weeks.

At baseline, all men had an intravaginal ejaculatory latency time (IELT) of two minutes or less in 75% or more intercourse episodes. Subjects’ IELT was measured by their partners using a stopwatch. At baseline, all groups had an average IELT of 0.9 minutes. A total of 618 men completed the study.

At study end point, the mean average IELT increased to 1.9, 3.2, and 3.5 minutes, respectively, for the placebo and 30 and 60 mg dapoxatine groups. The geometric mean IELT rose from 0.7 minutes at baseline to 1.1, 1.8, and 2.3 minutes, respectively.

All Premature Ejaculation Profile (PEP) measures and IELTs improved significantly with dapoxetine compared with placebo at week 12 and week 24. PEP measures asked patients to evaluate their perceived control over ejaculation, satisfaction with sexual intercourse, personal distress related to ejaculation, and interpersonal difficulty related to ejaculation.

The investigators also evaluated outcomes using a Clinical Global Impression question that asked men how they would describe their PE problem at the end of the study compared with the start of the study. By this measure, 30.6% and 39.2% of subjects in the 30- and 60-mg dapoxetine groups, respectively, reported that their PE was at least “better,” compared with 15.6% of placebo recipients, Dr. Buvat’s team noted.

The most common adverse events (AEs) observed were nausea, dizziness, diarrhea, and headache. AEs led to study discontinuation by 1.3%, 3.9%, and 8.2% of subjects in the placebo and dapoxetine 30- and 60-mg groups, respectively.

The researchers defined PE according to criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision.