check_circleStudy Completed
Erectile Dysfunction
Bayer Identifier:
11561
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Investigate the responsiveness of the Erectile Quality Scale to vardenafil flexible dose vs placebo in males with Erectile Dysfunction (ED)
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.
Key Participants Requirements
Sex
MaleAge
18 - 64 YearsTrial summary
Enrollment Goal
219Trial Dates
July 2004 - January 2005Phase
Phase 4Could I Receive a placebo
YesProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hudson Valley Urology Center | Poughkeepsie, 12601, United States |
Completed | New Havover Medical Research Associates | Wilmington, 28401, United States |
Completed | The Lipid Center | Statesville, 28677, United States |
Completed | Lawrenceville Urology | Lawrenceville, 08648, United States |
Completed | California Professional Research | Newport Beach, 92660, United States |
Completed | Clinical Research Consultants, Inc. | Trumbull, 06611, United States |
Completed | South Florida Medical Research | Aventura, 33180, United States |
Completed | Arizona Research Center, Inc. | Phoenix, 85023, United States |
Completed | Urology Research Options | Aurora, 80012, United States |
Completed | The Male Clinic | Beverly Hills, 90212, United States |
Terminated | Clinical Research Associates, Inc. | Nashville, 37203, United States |
Completed | South Coast Urological Medical Group | Laguna Hills, 92653, United States |
Primary Outcome
- Erection Quality Scaledate_rangeTime Frame:Week 8enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Erection Quality Scaledate_rangeTime Frame:Week 4 and 8enhanced_encryptionnoSafety Issue:
- International Index of Erectile Function- Erectile Function domain scoredate_rangeTime Frame:Week 4 and 8enhanced_encryptionnoSafety Issue:
- Per-subject success rates based on Sexual Encounter Profile, Question 2date_rangeTime Frame:Week 4, 8 Week 8enhanced_encryptionnoSafety Issue:
- Safety and tolerabilitydate_rangeTime Frame:Week 8enhanced_encryptionyesSafety Issue:
- Patient Diary Questionsdate_rangeTime Frame:Weeks 4, 8 Week 8enhanced_encryptionnoSafety Issue:
- Global Assessment Question (GAQ)date_rangeTime Frame:Weeks 4, 8 of treatment and Week 8enhanced_encryptionnoSafety Issue:
- Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25)date_rangeTime Frame:Week 8-LOCFenhanced_encryptionnoSafety Issue:
- Penetration (SEP2) and Maintenance (SEP3) reliabilitydate_rangeTime Frame:Week 8-LOCFenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2