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

Overview

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.

Full Title of Study: “Therapeutic Effectiveness of Vardenafil in ED Patients With the Metabolic Syndrome in Daily Clinical Practice”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2012

Interventions

  • Drug: Vardenafil (Levitra, BAY38-9456)
    • Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment as prescribed by physician

Arms, Groups and Cohorts

  • Group 1

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

Citations Reporting on Results

Shabsigh R, Mattern A; REVITALISE Study Group. REVITALISE: A Large Observational Study Assessing the Safety and Effectiveness of Vardenafil in Men With Erectile Dysfunction and Metabolic Syndrome. Sex Med. 2016 Sep;4(3):e135-44. doi: 10.1016/j.esxm.2016.03.027. Epub 2016 Apr 14.

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