Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse

Phase 4

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: Levitra (Vardenafil, BAY38-9456); Drug: Placebo

• Registration Number: NCT00667979
• Lead Sponsor: Bayer

Brief Summary

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. However, there remains no prospectively obtained data on the maximal time of effectiveness of vardenafil. The goal of the current study was to determine if vardenafil will significantly increase the percentage of successful intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12, 18, and 24 hours were assessed in this pilot study to better quantify the effect of vardenafil.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study Completion: 2004-12
• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-27
• Study First Posted: 2008-04-28
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-29
• Last Update Posted: 2009-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 264

Inclusion Criteria

• Men >/= 18 years of age
• ED >/= 6 months
• Stable sexual relationship for > 6 months

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Exclusion Criteria

• Primary hypoactive sexual desire
• History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
• Nitrate therapy
• Other exclusion criteria apply according to the Summary of Product Characteristics

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Levitra (Vardenafil, BAY38-9456)	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Sexual encounter profile Question 3	6 weeks

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability	6 weeks