Erectile Dysfunction Clinical Trial
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.
Verified date | October 2013 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 219 |
Est. completion date | January 2005 |
Est. primary completion date | January 2005 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 64 Years |
Eligibility | 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Erection Quality Scale | Week 8 | No | |
Secondary | Erection Quality Scale | Week 4 and 8 | No | |
Secondary | International Index of Erectile Function- Erectile Function domain score | Week 4 and 8 | No | |
Secondary | Per-subject success rates based on Sexual Encounter Profile, Question 2 | Week 4, 8 Week 8 | No | |
Secondary | Safety and tolerability | Week 8 | Yes | |
Secondary | Patient Diary Questions | Weeks 4, 8 Week 8 | No | |
Secondary | Global Assessment Question (GAQ) | Weeks 4, 8 of treatment and Week 8 | No | |
Secondary | Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25) | Week 8-LOCF | No | |
Secondary | Penetration (SEP2) and Maintenance (SEP3) reliability | Week 8-LOCF | No |
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