Study 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

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.

Trial summary

Enrollment Goal

2289

Trial Dates

January 2010 - August 2013

Phase

N/A

Could I Receive a placebo

Products

Levitra (Vardenafil, BAY38-9456)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
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Withdrawn		Many Locations, Yemen
Withdrawn		Many Locations, Libya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)
Time Frame:
After approx 12 weeks
Safety Issue:
No

Secondary Outcome

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
Safety Issue:
no
Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeks
Time Frame:
After approx. 12 weeks
Safety Issue:
no
Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) After approx. 12 weeks
Time Frame:
After approx. 12 weeks
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
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

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.