To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.

Study Overview
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Brief Summary
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To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.

Official Title
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A Randomised, Double Blind, Placebo Controlled, Multi-center, Fixed Dose, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil (BAY 38-9456) in Men 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 21 years or above with ED for more than 6 months with normal libido and stable heterosexual relationship of at least 6 months having at least a 50% failure rate of sexual intercourse attempts during the run-in phase Exclusion Criteria: Subjects with penile abnormalities, hypogonadism, history of unstable angina pectoris for 6 months or less, myocardial infarction, life threatening arrhythmia and history of unresponsiveness to sildenafil were excluded. Diabetic subjects with hemoglobin A1c (HbA1c) more than 12% were also excluded. Subjects could not be on androgens/anti-androgens or alpha blockers.

Ages Eligible for Study
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Minimum Age: 21 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>* Vardenafil 10 mg. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Placebo. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15 |  | At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success in penetration and maintenance as recorded in subject diaries |  | At Weeks 4, 8 and 12 (as observed and at LOCF) | 
| Scores for questions 3 and 4 of the IIEF |  | At Weeks 4, 8 and 12 (as observed and at LOCF) | 
| Other IIEF domain scores |  | At Week 12 (observed and at LOCF) | 
| Global Assessment Question (GAQ) responses |  | At Weeks 4, 8 and 12 (as observed and at LOCF) | 
| Rates of premature termination, adverse events, laboratory abnormalities, ECG abnormalities, and concomitant medication use. |  | At Weeks 4, 8 and 12 (as observed and at LOCF) | 

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