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.
Study Type
OBSERVATIONAL
Enrollment
2,289
Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment as prescribed by physician
Unnamed facility
Many Locations, Egypt
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Many Locations, Israel
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Many Locations, Kazakhstan
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Many Locations, Kyrgyzstan
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)
Time frame: After approx 12 weeks
Patients with an increase of 5 points in the Erectile Dysfunction domain of the IIEF after approx. 12 weeks
Time frame: After approx. 12 weeks
Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeks
Time frame: After approx. 12 weeks
Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) After approx. 12 weeks
Time frame: 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
Time frame: After approx. 12 weeks
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Unnamed facility
Many Locations, Lebanon
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Many Locations, Russia
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Many Locations, Saudi Arabia
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Many Locations, Singapore
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Many Locations, South Korea
Unnamed facility
Many Locations, Ukraine