Levitra® - Real Life Safety and Efficacy of Levitra

Phase 4

Completed

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

• Registration Number: NCT00663598
• Lead Sponsor: Bayer

Brief Summary

Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction (ED)

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study Completion: 2004-09
• Study First Submitted: 2008-04-17
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-22
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30825

Inclusion Criteria

• Male outpatients >/= 18 years of age with a diagnosis of ED according to the 1992 US National Institutes of Health (NIH) Consensus Statement (the inability to achieve and maintain penile erection sufficient to complete satisfactory intercourse), and independent of any previous ED treatment

Exclusion Criteria

• Exclusion according to US PI

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
Improvement of Erectile Disfunction	8 weeks
Second successful intercourse	8 weeks
Onset of Drug Effect	8 weeks

Secondary Outcome Measures

Name	Time	Method
General Safety Parameters	8 weeks