BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.

Study Overview
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Brief Summary
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This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.

Official Title
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Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction

Conditions
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Erectile Dysfunction

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance. Stable heterosexual relationship Exclusion Criteria: Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4) Nitrate use Other exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 22 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* 5 mg Vardenafil orally 1 hour prior to sexual intercourse<br>|
| Experimental: Arm 2<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* 10 mg Vardenafil orally 1 hour prior to sexual intercourse<br>|
| Experimental: Arm 3<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* 20 mg Vardenafil orally 1 hour prior to sexual intercourse<br>|
| Placebo Comparator: Arm 4<br> | Drug: Placebo<br>* 5 mg matching placebo<br>|
| Placebo Comparator: Arm 5<br> | Drug: Placebo<br>* 10 mg matching placebo<br>|
| Placebo Comparator: Arm 6<br> | Drug: Placebo<br>* 20 mg matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment Questionnaire |  | 12 weeks | 
| Erectile Function domain score of the International Index of Erectile Function |  | 12 weeks | 
| Safety and tolerability |  | 12 weeks | 

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