BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction

Study Overview
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Brief Summary
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Purpose of the study is:- To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo- To assess the influence of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile dysfunction following treatment with vardenafil as compared to placebo

Official Title
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Multi-centre, Randomized, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy and Tolerability of Vardenafil and Its Influence on Self-esteem and Self Confidence in Subjects With Erectile Dysfunction.

Conditions
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Erectile Dysfunction

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men with heterosexual relationships aged 18 - 64 years suffering from ED for more than 6 months according to the NIH Consensus Statement (i.e. inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance). At least 4 attempts at sexual intercourse (according to the question in the subject diary) on 4 separate days during the 4-week untreated baseline period. At least 50% of attempts during this period had to be unsuccessful according to the subject diary. Exclusion Criteria: Presence of penile anatomical abnormalities (eg penile fibrosis or Peyronie's disease) that in the investigator's opinion would significantly impair sexual performance. Primary hypoactive sexual desire.-Spinal cord injury-History of surgical prostatectomy (transurethral interventions not excluded). Unstable angina pectoris. History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months. Uncontrolled atrial fibrillation/flutter at screening visit (ventricular response rate >100 BPM).

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: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LOCF improved compared to baseline GAQ results at the end of the study |  | baseline versus visit 2 visit 5 or premature termination visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF scores |  | visits 3, 4 and 5 | 
| OF, SD, IS scores in IIEF Questionnaire |  | visits 2, 3, 4, 5 or at premature termination visit | 
| Scores of all individual questions on IIEF questionnaire |  | visits 2, 3, 4, 5 or at premature termination visit | 
| Subject's diary response |  | baseline and after randomization per visit period | 
| SSES-E scores |  | visits 2 and 5 or premature termination visit | 
| Summary score from the responses to SSES-E |  | visits 2 and 5 or premature termination visit | 
| Response scores and summary score from the responses to the SF-36 |  | visits 2 and 5 or premature termination visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vardenafil, Erectile dysfunction, SSES-E (sexual self-efficacy scale - erectile function)