Clinical Trial: Study to Evaluate Efficacy and Safety in Males Subjects With Premature Ejaculation

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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

Brief Summary: The purpose of this clinical trial is to test an experimental drug therapy called Tramadol Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) ("Tramadol HCl ODT" or the "study drug"). The subject and his partner are being asked to be in this clinical trial because they have a condition called premature ejaculation.

Detailed Summary:
Sponsor: Valeant Pharmaceuticals International, Inc.

Current Primary Outcome: Increase in IELT (Intravaginal ejaculatory time) [ Time Frame: Per attempt at sexual intercourse ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Efficacy of using Tramadol for Premature Ejaculation. [ Time Frame: At each attempt ]

Original Secondary Outcome: Same as current

Information By: Valeant Pharmaceuticals International, Inc.

Dates:
Date Received: September 22, 2009
Date Started: August 2009
Date Completion:
Last Updated: August 24, 2012
Last Verified: October 2010