NCT00665340
Completed
Phase 4
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.
ConditionsErectile Dysfunction
Overview
- Phase
- Phase 4
- Intervention
- Placebo
- Conditions
- Erectile Dysfunction
- Sponsor
- Bayer
- Enrollment
- 219
- Primary Endpoint
- Erection Quality Scale
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
Arms & Interventions
Arm 1
Intervention: Placebo
Arm 2
Intervention: Levitra (Vardenafil, BAY38-9456)
Outcomes
Primary Outcomes
Erection Quality Scale
Time Frame: Week 8
Secondary Outcomes
- Erection Quality Scale(Week 4 and 8)
- International Index of Erectile Function- Erectile Function domain score(Week 4 and 8)
- Patient Diary Questions(Weeks 4, 8 Week 8)
- Penetration (SEP2) and Maintenance (SEP3) reliability(Week 8-LOCF)
- Per-subject success rates based on Sexual Encounter Profile, Question 2(Week 4, 8 Week 8)
- Safety and tolerability(Week 8)
- Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25)(Week 8-LOCF)
- Global Assessment Question (GAQ)(Weeks 4, 8 of treatment and Week 8)
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