NCT00492635

Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving ED

A Randomized, Double-blind, Double-dummy, Multicenter Parallel Group Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil Versus Vardenafil PRN Versus Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving Erectile Function

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 628 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed' (immediately before intended sexual activity) compared to placebo, to evaluate its tolerability and if it can help in recovery of erections after a nerve sparing radical prostatectomy.

Conditions

• Erectile Dysfunction
• Sexual Dysfunction, Physiological

Interventions

Type	Name	Description
DRUG	Levitra (Vardenafil, BAY38-9456)	9 months DAILY dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
DRUG	Levitra (Vardenafil, BAY38-9456)	9 months PRN dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
DRUG	Placebo	9 months placebo (double blind)2 months single-blind placebo wash-out period (subject only is blinded)2 months open-label PRN treatment with active medication

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2007-06-27
• Last updated: 2014-10-28

Locations

86 sites across 15 countries: United States, Austria, Belgium, Canada, Finland, France, Germany, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, United Kingdom