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 (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01106118
First received: April 16, 2010
Last updated: February 19, 2014
Last verified: February 2014

April 16, 2010
February 19, 2014
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ 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 ]
  • 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 ]
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)
Not Provided

*   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.
Male
18 Years and older
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
 
NCT01106118
14872, LV0901
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP