Clinical Trial: Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Parallel Randomized Double Blind Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature E

Brief Summary: As study to investigate the efficacy and safety of daily doses of paroxetine of 15 and 20 mg for the treatment of premature ejaculation

Detailed Summary: Randomized, double blind, placebo controlled, prospective and parallel trial. Men with premature ejaculation using the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for at least 6 months, with an intravaginal ejaculatory latency time (IELT) ≤ 3 minutes. Three treatments are to be compared: placebo, 15 mg or 20 mg paroxetine for 12 weeks.
Sponsor: MorePharma Corporation

Current Primary Outcome: Intravaginal Ejaculatory Latency Time (IELT) [ Time Frame: Visit 2 Baseline, Visit 3 and Visit end of treatment, at 2, 6 and 12 weeks after entry to study respectively ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Score of the control domain of the Index of Premature Ejaculation [ Time Frame: Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively ]
  • Score of the sexual satisfaction domain of the Index of Premature Ejaculation [ Time Frame: Visit 1 Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively ]
  • Score of the distress with ejaculation domain of the Index of Premature Ejaculation [ Time Frame: Visit 1 Screning, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively ]
  • Erectile function domain of the International Index of Erectile Function [ Time Frame: Visit 1 Screening, Visit 2 Baseline, Visit 3 and Viit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively ]
  • Sexual desire domain of the International Index of Erectile Function [ Time Frame: Visit 1 Screening,Visit 2 Baseline,Visit 3 and Visit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively ]


Original Secondary Outcome: Same as current

Information By: MorePharma Corporation

Dates:
Date Received: November 30, 2009
Date Started: August 2008
Date Completion:
Last Updated: December 1, 2009
Last Verified: December 2009