Trial Condition(s):

Erectile Dysfunction

Investigate the responsiveness of the Erectile Quality Scale to vardenafil flexible dose vs placebo in males with Erectile Dysfunction (ED)

Bayer Identifier:

11561

ClinicalTrials.gov Identifier:

NCT00665340

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This study was conducted to evaluate in adult men with erectile dysfunction (often called impotence), the effect of vardenafil HCl on the quality of their erections. Many men experience occasional erectile problems during their lives. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to study the responsiveness of the erection quality scale (EQS) to vardenafil HCl. In this study, vardenafil HCl will be compared to placebo. Placebo is a pill which looks like the real drug but it is not. It contains no active ingredients.

Inclusion Criteria
- Males who have had ED for at least six months- Heterosexual relationship.- Males 18 and older.
Exclusion Criteria
- Primary hypoactive sexual desire.- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.- Stable heterosexual relationship for > 6 month- Other exclusion criteria apply according to the US Product Information

Trial Summary

Enrollment Goal
219
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Hudson Valley Urology Center

Poughkeepsie, United States, 12601

Status
Completed
 
Locations

New Havover Medical Research Associates

Wilmington, United States, 28401

Status
Completed
 
Locations

The Lipid Center

Statesville, United States, 28677

Status
Completed
 
Locations

Lawrenceville Urology

Lawrenceville, United States, 08648

Status
Completed
 
Locations

California Professional Research

Newport Beach, United States, 92660

Status
Completed
 
Locations

Clinical Research Consultants, Inc.

Trumbull, United States, 06611

Status
Completed
 
Locations

South Florida Medical Research

Aventura, United States, 33180

Status
Completed
 
Locations

Arizona Research Center, Inc.

Phoenix, United States, 85023

Status
Completed
 
Locations

Urology Research Options

Aurora, United States, 80012

Status
Completed
 
Locations

The Male Clinic

Beverly Hills, United States, 90212

Status
Completed
 
Locations

Clinical Research Associates, Inc.

Nashville, United States, 37203

Status
Terminated
 
Locations

South Coast Urological Medical Group

Laguna Hills, United States, 92653

Status
Completed
 

Trial Design