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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 16, 2010
Last updated: October 14, 2016
Last verified: October 2016
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.

Condition Intervention
Erectile Dysfunction Drug: Vardenafil (Levitra, BAY38-9456)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Therapeutic Effectiveness of Vardenafil in ED Patients With the Metabolic Syndrome in Daily Clinical Practice

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

Enrollment: 2289
Study Start Date: January 2010
Study Completion Date: August 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Vardenafil (Levitra, BAY38-9456)
Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment as prescribed by physician


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01106118

Many Locations, Egypt
Many Locations, Israel
Many Locations, Kazakhstan
Korea, Republic of
Many Locations, Korea, Republic of
Many Locations, Kyrgyzstan
Many Locations, Lebanon
Russian Federation
Many Locations, Russian Federation
Saudi Arabia
Many Locations, Saudi Arabia
Many Locations, Singapore
Many Locations, Ukraine
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01106118     History of Changes
Other Study ID Numbers: 14872
LV0901 ( Other Identifier: Company internal )
Study First Received: April 16, 2010
Last Updated: October 14, 2016

Additional relevant MeSH terms:
Metabolic Syndrome X
Erectile Dysfunction
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on September 21, 2017