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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:
ClinicalTrials.gov Identifier:
NCT01106118
First Posted: April 19, 2010
Last Update Posted: October 17, 2016
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.
Information provided by (Responsible Party):
Bayer
April 16, 2010
April 19, 2010
October 17, 2016
January 2010
December 2012   (Final data collection date for primary outcome measure)
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 ]
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 IIEF [ Time Frame: After approx 12 weeks ]
Complete list of historical versions of study NCT01106118 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Therapeutic Effectiveness of Vardenafil in Patients With Erectile Dysfunction and Metabolic Syndrome in Daily Clinical Practice
Therapeutic Effectiveness of Vardenafil in ED Patients With the Metabolic Syndrome in Daily Clinical Practice
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:
n.a
Non-Probability Sample
Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment
Erectile Dysfunction
Drug: Vardenafil (Levitra, BAY38-9456)
Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment as prescribed by physician
Group 1
Intervention: Drug: Vardenafil (Levitra, BAY38-9456)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2289
August 2013
December 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Egypt,   Israel,   Kazakhstan,   Korea, Republic of,   Kyrgyzstan,   Lebanon,   Russian Federation,   Saudi Arabia,   Singapore,   Ukraine
Jordan,   Libyan Arab Jamahiriya,   Vietnam,   Yemen
 
NCT01106118
14872
LV0901 ( Other Identifier: Company internal )
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2016