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

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.

Timeline

Start

2009-10

Primary completion

2010-09

Completion

2010-09

Outcome

Met primary endpoint

Stopped (Enrollment): “This study was terminated because of recruitment difficulties.”

paper Tramadol ODT resulted in significant increases in median IELT compared with placebo; PMID 21889833 ↗

paper p<0.001 for all comparisons PMID 21889833 ↗

Publications

• Bar-Or D, Salottolo KM, Orlando A, Winkler JV; Tramadol ODT Study Group. A randomized double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of two doses of the tramadol orally disintegrating tablet for the treatment of premature ejaculation within less than 2 minutes. Eur Urol. 2012 Apr;61(4):736-43. doi: 10.1016/j.eururo.2011.08.039. Epub 2011 Aug 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tramadol	Other / unclassified	62 mg	Oral
Subject	Tramadol	Other / unclassified	89 mg	Oral

Indications