Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Phase 4

Completed

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

• Registration Number: NCT00662441
• Lead Sponsor: Bayer

Brief Summary

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The purpose was the evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile Dysfunction (ED).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study Completion: 2004-06
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-18
• Study First Posted: 2008-04-21
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-19
• Last Update Posted: 2009-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 102

Inclusion Criteria

• Men >/= 18 years of age
• Erectile Dysfunction

Exclusion Criteria

• 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: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
International Index of Erectile Function- Erectile Function domain	8 weeks

Secondary Outcome Measures

Name	Time	Method
Global Assessment Questionnaire (GAQ)	8 weeks
Safety and tolerability	8 weeks