On-demand Take of Dapoxetine for the Treatment of Lifelong Premature Ejaculation: Prospective, Randomized, Placebo Controlled Study

Abstract

The objective of this study is to assess the safety and efficacy of on-demand use of dapoxetine in treating lifelong premature ejaculation.This is a prospective, single center ,single blind, placebo controlled study. During the period of months between january 2015 and july 2015,60 patients diagnosed with lifelong premature ejaculation(LPE) in outpatient department of China and Japan Union Hospital Of Jilin University, were randomized to receive different sequences of the two medications equally: placebo(group A), 30mg or 60mg of dapoxetine(group B) according to the efficacy at 8th week.Every patient received each medication for 12 weeks.Intravaginal ejaculatory latency time(IELT), premature ejaculation diagnostic tools(PEDT) score , sexual satisfaction score of patients and sexual partners were recorded during the study period. Successful of LPE is defined whether IELT exceed 120s. Meanwhile we observed the occurrence of adverse events in two groups.55 patients enrolled in our study completed the study over12 weeks,27 cases receive placebo and 28 cases receive 30mg or 60mg dapoxetine. Patients in group B had a significantly longer mean IELT than group A(120.4s vs 42.1s,P<0.01). The average PEDT score in group B was different with group A(9.9 vs 13.7,P<0.01). Both of patients and sexual partners in group B felt more satisfied with their sexual life , which were better than group A(3.1 vs 1.8,2.8 vs 1.9,respectively,P<0.01). 3 cases appeared dizziness and 1 case appeared nausea.There was no serious adverse event in any subjects. On-demand use of dapoxetine may be considered a safe and effective way in treating lifelong premature ejaculation.The long-term benefits need further study. Premature ejaculation(PE) is the most common type of male sexual dysfunction disease,impacting 35% of global male,and the prevalence in china is between 35% and 50%(1).The data may have deviation due to the definition of premature ejaculation , clinic rate and so on. PE divided into lifelong premature ejaculation(LPE) and acquired premature ejaculation(APE) by early scholars. Recently, studies put forward variable PE (VPE) and subjective PE (SPE) after the two types above (2).According to the diagnostic criteria of PE published by international society of sexual medicine(ISSM) , LPE characterized by: