drugset / Trial / NCT00682019

Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks

NCT00682019

Phase 3 Completed 383 enrolled Bayer GlaxoSmithKline · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.

Timeline

Start
2003-12
Primary completion
Completion
2004-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Vardenafil Small molecule 5 mg
Subject Vardenafil Small molecule 10 mg
Subject Vardenafil Small molecule 20 mg

Indications