Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)
Phase 4
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00665340
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 219
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Levitra (Vardenafil, BAY38-9456) - Arm 1 Placebo -
- Primary Outcome Measures
Name Time Method Erection Quality Scale Week 8
- Secondary Outcome Measures
Name Time Method 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 Erection Quality Scale Week 4 and 8 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