Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours

Phase 3

Completed

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

• Registration Number: NCT00668018
• Lead Sponsor: Bayer

Brief Summary

Assess efficacy of vardenafil within 6 hours after intake

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-27
• Study First Posted: 2008-04-28
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 887

Inclusion Criteria

• Age: 18 years and older
• Males with erectile dysfunction
• Stable heterosexual relationship

Exclusion Criteria

• Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
• Nitrate use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake	12 weeks

Secondary Outcome Measures

Name	Time	Method
Other diary responses	12 weeks
Global Assessment Question (GAQ)	12 weeks
General Safety	12 weeks
International Index of Erectile Function	12 weeks