Trial Condition(s):
Erectile Dysfunction
Therapeutic effectiveness of vardenafil in patients with erectile dysfunction and metabolic syndrome in daily clinical practice (REVITALISE)
Bayer Identifier:
14872
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Israel | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Kazakhstan | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Russia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Ukraine | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Singapore | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Saudi Arabia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Lebanon | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Kyrgyzstan | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Egypt | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Therapeutic effectiveness of vardenafil in ED patients with the metabolic syndrome in daily clinical practice
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
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)Timeframe: After approx 12 weeks
Secondary Outcome
- Patients with an increase of 5 points in the Erectile Dysfunction domain of the IIEF after approx. 12 weeksTimeframe: After approx. 12 weeks
- Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeksTimeframe: After approx. 12 weeks
- Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) After approx. 12 weeksTimeframe: After approx. 12 weeks
- Optional by country, the effect of vardenafil on health-related quality of life (HRQoL) using the Aging Males Symptoms (AMS) ScaleTimeframe: After approx. 12 weeks
Additional Information
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