Conclusions PDE5Is were significantly more effective than placebo or SSRIs for treating PE , while SSRIs were better than placebo .
The combined treatment had better efficacy than PDE5Is or SSRIs alone
Purpose To clarify the efficacy of phosphodiesterase-5 inhibitors ( PDE5Is ) and selective serotonin reuptake inhibitors ( SSRIs ) in men with premature ejaculation ( PE ) .
Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries.
BACKGROUND Dapoxetine is being developed for the on-dem and treatment of premature ejaculation ( PE ) . Previous clinical trials have demonstrated its safety and efficacy . OBJECTIVE To evaluate the long-term efficacy and safety of dapoxetine in men with PE . DESIGN , SETTING , AND PARTICIPANTS This r and omized , double-blind , parallel-group , placebo-controlled , phase 3 trial , conducted in 22 countries , enrolled men ( N=1162 ) > or = 18 yr of age who met the Diagnostic and Statistical Manual of Mental Disorders , fourth edition , text revision criteria for PE for > or = 6 mo , with an intravaginal ejaculatory latency time ( IELT ) < or = 2 min in > or = 75 % of intercourse episodes at baseline . INTERVENTION Dapoxetine 30 mg or dapoxetine 60 mg or placebo on dem and ( 1 - 3 h before intercourse ) for 24 wk . MEASUREMENTS Stopwatch-measured IELT , Premature Ejaculation Profile ( PEP ) , Clinical Global Impression ( CGI ) of change , adverse events ( AEs ) . RESULTS AND LIMITATIONS The study was completed by 618 men .  Mean average IELT increased from 0.9 min at baseline ( all groups ) to 1.9 min , 3.2 min , and 3.5 min with placebo and dapoxetine 30 mg and dapoxetine 60 mg , respectively , at study end point ; geometric mean IELT increased from 0.7 min at baseline to 1.1 min , 1.8 min , and 2.3 min , respectively , at study end point . All PEP measures and IELTs improved significantly with dapoxetine versus placebo at week 12 and week 24 ( p<0.001 for all ) . The most common AEs were nausea , dizziness , diarrhea , and headache . AEs led to discontinuation in 1.3 % , 3.9 % , and 8.2 % of subjects with placebo and dapoxetine 30 mg and dapoxetine 60 mg , respectively . Limitations of this study included the exclusion of men who were not in long-term monogamous relationships . CONCLUSIONS Dapoxetine significantly improved all aspects of PE and was generally well tolerated in this broad population
Conclusions PDE5Is were significantly more effective than placebo or SSRIs for treating PE , while SSRIs were better than placebo .
The combined treatment had better efficacy than PDE5Is or SSRIs alone
Purpose To clarify the efficacy of phosphodiesterase-5 inhibitors ( PDE5Is ) and selective serotonin reuptake inhibitors ( SSRIs ) in men with premature ejaculation ( PE ) .