Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil

Phase 3

Completed

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

• Registration Number: NCT00661297
• Lead Sponsor: Bayer

Brief Summary

Study to investigate the efficacy and safety of Vardenafil

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study Completion: 2004-01
• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-18
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 523

Inclusion Criteria

• Heterosexual males
• >/= 18 years old with ED for more than six months
• Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation

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

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 2 (SEP 2)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability	12 weeks
Sexual Encounter Profile question 3 (SEP 3)	12 weeks
International Index of Erectile Function (IIEF) - EF (Erectile Function) domain	12 weeks