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.
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History