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

Bayer2,471 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,471

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

Primary care erectile dysfunction patients for whom physician decided to start the treatment with vardenafil

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Many Locations, Poland

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

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

Data from ClinicalTrials.gov

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