title: A randomized double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of two doses of the tramadol orally disintegrating tablet for the treatment of premature ejaculation within less than 2 minutes.
abstract: BACKGROUND
  Premature ejaculation (PE) is a widely observed male sexual dysfunction with a major impact on quality of life for many men and their sexual partners.
  
  
  OBJECTIVE
  To assess the safety of tramadol orally disintegrating tablet (ODT) (Zertane) and its efficacy in prolonging intravaginal ejaculation latency time (IELT) and improving Premature Ejaculation Profile (PEP) scores.
  
  
  METHODS
  We conducted an integrated analysis of two identical 12-wk randomized double-blind, placebo-controlled phase 3 trials across 62 sites in Europe. Healthy men 18-65 yr of age with a history of lifelong PE according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision, and an IELT ≤ 120 s were included. There were 604 intent-to-treat subjects included in the analysis.
  
  
  METHODS
  Subjects were randomized to receive 1:1:1 placebo (n=200), 62 mg tramadol ODT (n=206), or 89 mg tramadol ODT (n=198).
  
  
  METHODS
  We measured overall change and fold increase in median IELT and the mean change in all four measures of the PEP. Differences across treatment groups were analyzed using Wilcoxon rank-sum tests, analysis of variance, and chi-square analyses.
  
  
  CONCLUSIONS
  Tramadol ODT resulted in significant increases in median IELT compared with placebo; increases were 0.6 min (1.6 fold), 1.2 min (2.4 fold), and 1.5 min (2.5 fold) for placebo, 62 mg tramadol ODT, and 89 mg tramadol ODT, respectively (p<0.001 for all comparisons). Men saw significantly greater improvement in all four measures of the PEP in both doses compared with placebo (p<0.05 for all comparisons). Tramadol ODT was well tolerated; study discontinuation occurred in 0%, 1.0%, and 1.6% of subjects in placebo, 62 mg, and 89 mg tramadol ODT groups, respectively. Limitations include study inclusion for men with IELT up to 120 s.
  
  
  CONCLUSIONS
  On-demand 62mg tramadol ODT is an effective treatment for PE in a low and safe therapeutic dose and provides a new option for managing mild to severe PE.
authors: Trauma Research Department, Swedish Medical Center, Englewood, CO 80113, USA. dbaror@ampiopharma.com
authors: David
authors: D
authors: Bar-Or
authors: Kristin M
authors: KM
authors: Salottolo
authors: Alessandro
authors: A
authors: Orlando
authors: James V
authors: JV
authors: Winkler
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000704:Analysis of Variance; D004311:Double-Blind Method; D004542:Ejaculation / Q000187:drug effects*; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D010919:Placebos; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy* / Q000503:physiopathology; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy* / Q000503:physiopathology; D012995:Solubility; D011795:Surveys and Questionnaires; D013607:Tablets; D013997:Time Factors; D014147:Tramadol / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D010919:Placebos; D013607:Tablets; D014147:Tramadol