Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: Placebo
* Drug: Levitra (Vardenafil, BAY38-9456)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 1<br> | Drug: Placebo<br>* Matching placebo<br>|
| Experimental: Arm 2<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* 5m, 10 mg and 20 mg 1 h prior to sexual intercourse<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erection Quality Scale |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erection Quality Scale |  | Week 4 and 8 | 
| International Index of Erectile Function- Erectile Function domain score |  | 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 | 
| Patient Diary Questions |  | Weeks 4, 8 Week 8 | 
| Global Assessment Question (GAQ) |  | Weeks 4, 8 of treatment and Week 8 | 
| Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25) |  | Week 8-LOCF | 
| Penetration (SEP2) and Maintenance (SEP3) reliability |  | Week 8-LOCF | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction, Vardenafil