Vardenafil Treatment Of Erectile Dysfunction In Depressive And Non-Depressive Men

Completed

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

• Registration Number: NCT00470873
• Lead Sponsor: Bayer

Brief Summary

The primary aim of this open, uncontrolled, prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. The secondary aim of this study is to assess the influence of the treatment with Levitra on self-esteem (depressive symptomology) in men with ED.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-05-07
• Study First Submitted QC: 2007-05-07
• Study First Posted: 2007-05-08
• Study Completion: 2008-02
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-26
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 2471

Inclusion Criteria

• Age over 18
• Erectile dysfunction untreated or ineffectively treated with other than vardenafil PDE5 inhibitors

Exclusion Criteria

• Treatment with nitrates
• Allergy to vardenafil or other tablets ingredients
• Treatment with CYP3A4 inhibitors (e.g. indinavir, ritonavir, ketoconazole, itraconazole, erythromycin)
• Cardiovascular status excluding any sexual activity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Efficacy, safety, tolerance of the treatment with Vardenafil reported by the physician	At the patients control visit (approx. 3 months from the initial)

Secondary Outcome Measures

Name	Time	Method
Influence of vardenafil on depressive symptoms and self-esteem measured with CES-D and Rosenberg scale	At the patients control visit (approx. 3 months from the initial)