title: Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries.
abstract: BACKGROUND
  Dapoxetine is being developed for the on-demand 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.
  
  
  METHODS
  This randomized, 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.
  
  
  METHODS
  Dapoxetine 30 mg or dapoxetine 60 mg or placebo on demand (1-3 h before intercourse) for 24 wk.
  
  
  METHODS
  Stopwatch-measured IELT, Premature Ejaculation Profile (PEP), Clinical Global Impression (CGI) of change, adverse events (AEs).
  
  
  CONCLUSIONS
  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.
authors.affiliation: CETPARP/Le grand Hunier, Lille, France. jacques@buvat.org
authors.forename: Jacques
authors.initials: J
authors.lastname: Buvat
authors.forename: Fisseha
authors.initials: F
authors.lastname: Tesfaye
authors.forename: Margaret
authors.initials: M
authors.lastname: Rothman
authors.forename: David A
authors.initials: DA
authors.lastname: Rivas
authors.forename: François
authors.initials: F
authors.lastname: Giuliano
mesh_terms: D000328:Adult; D001596:Benzylamines / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004542:Ejaculation; D006801:Humans; D008297:Male; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy*
chemical_list: D001596:Benzylamines; D009281:Naphthalenes; D017367:Selective Serotonin Reuptake Inhibitors; C080598:dapoxetine