NCT00983736

Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,050 (estimated)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 patient and the patient's partner are being asked to be in this clinical trial because they have a condition called Premature Ejaculation.

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
DRUG	Tramadol Hydrochloride	89 mg or a lesser dose of 62 mg if side effects are experienced one tablet at least two hours before sexual intercourse (maximum of one tablet every 20 hours). Subject will take the study drug for about 27 weeks.
DRUG	Placebo	89 mg or a lesser dose of 62 mg if side effects are experienced one tablet at least two hours before sexual intercourse (maximum of one tablet every 20 hours). Subject will take the study drug for about 27 weeks.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-09-24
• Last updated: 2012-08-27

Locations

48 sites across 5 countries: Bulgaria, Czechia, Hungary, Poland, Romania