A Non-Interventional, Post-Marketing Surveillance Phase IV Study to Obtain Data on Safety and Efficacy of Levitra® in Routine Treatment of Erectile Dysfunction in Depressive and Non-Depressive Men.

Bayer0 sites2,471 target enrollmentJanuary 2007

ConditionsErectile Dysfunction

InterventionsLevitra (Vardenafil, BAY38-9456)

DrugsLevitra (Vardenafil, BAY38-9456)

Overview

Phase: Not Applicable
Intervention: Levitra (Vardenafil, BAY38-9456)
Conditions: Erectile Dysfunction
Sponsor: Bayer
Enrollment: 2471
Primary Endpoint: Efficacy, safety, tolerance of the treatment with Vardenafil reported by the physician
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

February 2008

Last Updated

11 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Group 1

Intervention: Levitra (Vardenafil, BAY38-9456)

Outcomes

Primary Outcomes

Efficacy, safety, tolerance of the treatment with Vardenafil reported by the physician

Time Frame: At the patients control visit (approx. 3 months from the initial)

Secondary Outcomes

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))