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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01106118
Recruitment Status : Completed
First Posted : April 19, 2010
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Erectile Dysfunction Drug: Vardenafil (Levitra, BAY38-9456)

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Study Type : Observational
Actual Enrollment : 2289 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Therapeutic Effectiveness of Vardenafil in ED Patients With the Metabolic Syndrome in Daily Clinical Practice
Study Start Date : January 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : August 2013

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeks [ Time Frame: After approx. 12 weeks ]
  3. Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) After approx. 12 weeks [ Time Frame: After approx. 12 weeks ]
  4. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01106118

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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
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Study Director: Bayer Study Director Bayer
Publications of Results:
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Responsible Party: Bayer Identifier: NCT01106118    
Other Study ID Numbers: 14872
LV0901 ( Other Identifier: Company internal )
First Posted: April 19, 2010    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Erectile Dysfunction
Metabolic Syndrome
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