Therapeutic Effectiveness of Vardenafil in Patients With Erectile Dysfunction and Metabolic Syndrome in Daily Clinical Practice

Completed

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

• Registration Number: NCT01106118
• Lead Sponsor: Bayer

Brief Summary

The primary goal of this international non-interventional study is to investigate the therapeutic effectiveness of vardenafil (film-coated tablet) in Erectile Dysfunction patients with the Metabolic Syndrome in daily clinical practice. It will include a large number of patients with various underlying conditions with different cultural and demographic backgrounds from different geographic areas.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-04-16
• Study First Posted: 2010-04-19
• Primary Completion: 2012-12
• Study Completion: 2013-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 2289

Inclusion Criteria

• Erectile Dysfunction (ED) patient who has newly been prescribed vardenafil (Levitra film-coated tablet) in accordance with the terms of the local marketing authorization.
• Diagnosis of erectile dysfunction at the discretion of the physician, based on the patients ED history.
• No use of any Phosphodiesterase Type 5 (PDE5) inhibitor within 1 month of study entry.
• Documented Metabolic Syndrome (MetS), preferably according to the definition of the International Diabetes Foundation.

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Exclusion Criteria

• Do not follow the contraindications and warnings of the Summary of Product Characteristics.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The percentage of patients with a clinically relevant, intra-individual improvement in erectile function defined as an increase of 4 points in the erectile function domain of the International Index of Erectile Function (IIEF)	After approx 12 weeks

Secondary Outcome Measures

Name	Time	Method
Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeks	After approx. 12 weeks
Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) After approx. 12 weeks	After approx. 12 weeks
Patients with an increase of 5 points in the Erectile Dysfunction domain of the IIEF after approx. 12 weeks	After approx. 12 weeks
Optional by country, the effect of vardenafil on health-related quality of life (HRQoL) using the Aging Males Symptoms (AMS) Scale	After approx. 12 weeks