A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Dapoxetine in Men With Premature Ejaculation and Concomitant Erectile Dysfunction Treated With a Phosphodiesterase-5 Inhibitor.

Trial Profile

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Dapoxetine in Men With Premature Ejaculation and Concomitant Erectile Dysfunction Treated With a Phosphodiesterase-5 Inhibitor.

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Aug 2014

At a glance

  • Drugs Dapoxetine (Primary)
  • Indications Premature ejaculation
  • Focus Registrational; Therapeutic Use
  • Acronyms COUPLE
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 12 Jan 2012 Actual patient number is 495 according to ClinicalTrials.gov.
    • 12 Jan 2012 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 14 Jul 2011 Planned end date changed from Jan 2012 to Sep 2011 as reported by ClinicalTrials.gov.
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