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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.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01106118
First received: April 16, 2010
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  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.


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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeks [ Time Frame: After approx. 12 weeks ] [ Designated as safety issue: No ]
  • Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) After approx. 12 weeks [ Time Frame: After approx. 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

n.a


Enrollment: 2289
Study Start Date: May 2010
Study Completion Date: December 2012
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106118

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Affairs Theapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT01106118     History of Changes
Other Study ID Numbers: 14872, LV0901
Study First Received: April 16, 2010
Last Updated: February 19, 2013
Health Authority: Israel: Ethics Commission
Kazakhstan: National Center for Expertise of medicinal drugs, medical equipment and medical devices
Korea: Food and Drug Administration
Lebanon: Institutional Review Board
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Ukraine: State Pharmacological Center - Ministry of Health
Russia: Ethics Committee
Kyrgyzstan: National Center for Expertise of medicinal drugs, medical equipment and medical devices

Additional relevant MeSH terms:
Erectile Dysfunction
Metabolic Syndrome X
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
 Metabolic Diseases
Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013