Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

Phase 4

Completed

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

• Registration Number: NCT00668135
• Lead Sponsor: Bayer

Brief Summary

To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Study First Submitted: 2008-04-25
• Study First Submitted QC: 2008-04-28
• Study First Posted: 2008-04-29
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 348

Inclusion Criteria

• Age: 20 years and older- Males with erectile dysfunction
• Stable heterosexual relationship

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Exclusion Criteria

• Primary hypoactive sexual desire
• History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use
• 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 2	Placebo	-
Arm 1	Vardenafil (Levitra, BAY38-9456)	-

Primary Outcome Measures

Name	Time	Method
International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Other diary responses	12 weeks
Safety and tolerability	12 weeks
Global Assessment Question	12 weeks