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:

NCT01106118

EudraCT Number:

Not Available

Study Completed

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
2289
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Israel

Status
Completed
 
Locations

Investigative Site

Many Locations, Kazakhstan

Status
Completed
 
Locations

Investigative Site

Many Locations, Russia

Status
Completed
 
Locations

Investigative Site

Many Locations, Ukraine

Status
Completed
 
Locations

Investigative Site

Many Locations, Singapore

Status
Completed
 
Locations

Investigative Site

Many Locations, Saudi Arabia

Status
Completed
 
Locations

Investigative Site

Many Locations, Lebanon

Status
Completed
 
Locations

Investigative Site

Many Locations, Kyrgyzstan

Status
Completed
 
Locations

Investigative Site

Many Locations, South Korea

Status
Completed
 
Locations

Investigative Site

Many Locations, Egypt

Status
Completed
 

Trial Design