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

Condition(s) targeted: Erectile Dysfunction

Intervention: Vardenafil (Levitra, BAY38-9456) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

Official title: Therapeutic Effectiveness of Vardenafil in ED Patients With the Metabolic Syndrome in Daily Clinical Practice

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: 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)

Secondary outcome:

Patients with an increase of 5 points in the Erectile Dysfunction domain of the IIEF after approx. 12 weeks

Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeks

Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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.

Exclusion Criteria:

- Do not follow the contraindications and warnings of the Summary of Product

Characteristics.

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Many Locations, Egypt; Recruiting

Many Locations, Israel; Recruiting

Many Locations, Kazakhstan; Recruiting

Many Locations, Korea, Republic of; Recruiting

Many Locations, Kyrgyzstan; Recruiting

Many Locations, Lebanon; Recruiting

Many Locations, Libyan Arab Jamahiriya; Recruiting

Many Locations, Russian Federation; Recruiting

Many Locations, Saudi Arabia; Recruiting

Many Locations, Singapore; Recruiting

Many Locations, Ukraine; Recruiting

Many Locations, Yemen; Recruiting

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Starting date: February 2010
Last updated: August 1, 2012