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

Phase 4

Completed

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

• Registration Number: NCT00681772
• 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 aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Study Completion: 2003-11
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 333

Inclusion Criteria

• Men >/= 18 years of age,
• ED 6 months or longer
• Stable sexual relationship for > 6 month.

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: SINGLE_GROUP

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	12 weeks

Secondary Outcome Measures

Name	Time	Method
Sexual Encounter Profile Question 2 and 3	12 weeks
Global Assessment Question	12 weeks
Other diary based variables	12 weeks
Safety and tolerability	12 weeks