A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Hydrochloride Orally Disintegrating Tablets in Male Subjects With Premature Ejaculation.

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Hydrochloride Orally Disintegrating Tablets in Male Subjects With Premature Ejaculation.

Discontinued
Phase of Trial: Phase III

Latest Information Update: 22 Apr 2015

At a glance

  • Drugs Tramadol (Primary)
  • Indications Premature ejaculation
  • Focus Registrational; Therapeutic Use
  • Sponsors Biovail Technologies; Valeant Pharmaceuticals International
  • Most Recent Events

    • 22 Apr 2015 Primary endpoint 'Increase in IELT (Intravaginal ejaculatory time) for 89 mg dose' has been met, according to the Aytu Bioscience company pipeline.
    • 22 Apr 2015 Primary endpoint 'Premature Ejaculation Profile questionnaire' has been met, according to an Aytu Bioscience company pipeline.
    • 28 Oct 2010 Planned End Date changed from 1 May 2011 to 1 Sep 2010 as reported by ClinicalTrials.gov.
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