Erectile Dysfunction
Conditions
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.
Interventions
Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment as prescribed by physician
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Patients with an increase of 5 points in the Erectile Dysfunction domain of the IIEF after approx. 12 weeks | After approx. 12 weeks |
| 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 |
| 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 |
Countries
Egypt, Israel, Kazakhstan, Kyrgyzstan, Lebanon, Russia, Saudi Arabia, Singapore, South Korea, Ukraine
Outcome results
None listed