Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

Phase 2

Completed

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

• Registration Number: NCT00786253
• Lead Sponsor: Bayer

Brief Summary

Compare once daily vs on demand treatment in men with erectile dysfunction.

Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks + 4 weeks wash-out:

A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at bedtime for 24 weeksC: PRN for 24 weeks

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-10
• Study Completion: 2007-01
• Study First Submitted: 2008-02-25
• Study First Submitted QC: 2008-11-05
• Study First Posted: 2008-11-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-27
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 236

Inclusion Criteria

• Males 18-64 years of age
• Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
• History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
• Stable, heterosexual relationship for more than six 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.

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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	Levitra (Vardenafil, BAY38-9456)	-

Primary Outcome Measures

Name	Time	Method
Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF)	12- 24 weeks

Secondary Outcome Measures

Name	Time	Method
SEP 3	12- 24 weeks
SEP 2	12- 24 weeks