Back to resultsInvestigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
Levitra (Vardenafil, BAY38-9456)
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, Vardenafil
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Erection Quality Scale
Secondary Outcome Measures
Erection Quality Scale
International Index of Erectile Function- Erectile Function domain score
Per-subject success rates based on Sexual Encounter Profile, Question 2
Safety and tolerability
Patient Diary Questions
Global Assessment Question (GAQ)
Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25)
Penetration (SEP2) and Maintenance (SEP3) reliability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00665340
Brief Title
Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)
Official Title
A Randomized, Double Blind, Placebo-controlled, Parallel Group, Multi-center Study to Investigate the Responsiveness of the Erectile Quality Scale (EQS) to Vardenafil HCl Flexible Dose Versus Placebo in Males With Erectile Dysfunction.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile Dysfunction, Vardenafil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
219 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Placebo Comparator
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Levitra (Vardenafil, BAY38-9456)
Intervention Description
5m, 10 mg and 20 mg 1 h prior to sexual intercourse
Primary Outcome Measure Information:
Title
Erection Quality Scale
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Erection Quality Scale
Time Frame
Week 4 and 8
Title
International Index of Erectile Function- Erectile Function domain score
Time Frame
Week 4 and 8
Title
Per-subject success rates based on Sexual Encounter Profile, Question 2
Time Frame
Week 4, 8 Week 8
Title
Safety and tolerability
Time Frame
Week 8
Title
Patient Diary Questions
Time Frame
Weeks 4, 8 Week 8
Title
Global Assessment Question (GAQ)
Time Frame
Weeks 4, 8 of treatment and Week 8
Title
Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25)
Time Frame
Week 8-LOCF
Title
Penetration (SEP2) and Maintenance (SEP3) reliability
Time Frame
Week 8-LOCF
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
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Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)
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