check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

14872

ClinicalTrials.gov Identifier:

NCT01106118

EudraCT Number:

Not Available

EU CT Number:

Not Available
Therapeutic effectiveness of vardenafil in patients with erectile dysfunction and metabolic syndrome in daily clinical practice

Trial 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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - 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.
  • - Do not follow the contraindications and warnings of the Summary of Product Characteristics.

Trial summary

Enrollment Goal
2289
Trial Dates
January 2010 - August 2013
Phase
N/A
Could I Receive a placebo
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Israel
Completed
Many Locations, Kazakhstan
Completed
Many Locations, Russia
Completed
Many Locations, Ukraine
Completed
Many Locations, Singapore
Completed
Many Locations, Saudi Arabia
Completed
Many Locations, Lebanon
Completed
Many Locations, Kyrgyzstan
Completed
Many Locations, Korea, Republic Of
Completed
Many Locations, Egypt
Withdrawn
Many Locations, Yemen
Withdrawn
Many Locations, Libya

Primary Outcome

  • 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)
    date_rangeTime Frame:
    After approx 12 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Patients with an increase of 5 points in the Erectile Dysfunction domain of the IIEF after approx. 12 weeks
    date_rangeTime Frame:
    After approx. 12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeks
    date_rangeTime Frame:
    After approx. 12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) After approx. 12 weeks
    date_rangeTime Frame:
    After approx. 12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Optional by country, the effect of vardenafil on health-related quality of life (HRQoL) using the Aging Males Symptoms (AMS) Scale
    date_rangeTime Frame:
    After approx. 12 weeks
    enhanced_encryption
    Safety Issue:
    no

Trial design

Therapeutic effectiveness of vardenafil in ED patients with the metabolic syndrome in daily clinical practice
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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