Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome

Study Overview
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Brief Summary
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This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re nata)

Official Title
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Double-blind, Placebo Controlled, Randomized Study of Vardenafil to Determine Efficacy on Erectile Dysfunction (ED) in Men With ED and Metabolic Syndrome (ED-METABOLIC)

Conditions
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Erectile Dysfunction, Metabolic Syndrome

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable heterosexual relationship History of erectile dysfunction for at least 6 months IIEF- EF Domain entry score (at Visit 2): >21 points Documented metabolic syndrome according to the IDF (International Diabetes Foundation) Subjects motivated for erectile dysfunction treatment Documented, dated, written informed consent Exclusion Criteria: Any underlying cardiovascular condition History of myocardial infarction Uncontrolled atrial fibrillation Resting hypotension Postural hypotension within 6 months of Visit 1 History of congenital QT prolongation Bleeding disorder History of prostatectomy because of prostate cancer Hereditary degenerative retinal disorders History of loss of vision because of NAION (non-arteritic anterior ischemic optic neuropathy) 29 Additional Exclusion Criteria

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: Vardenafil (Levitra, BAY38-9456)<br>Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks | Drug: Vardenafil (Levitra, BAY38-9456)<br>* Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks<br>|
| Placebo Comparator: Placebo<br>Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks | Drug: Placebo<br>* Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF) | The primary variable was the least square (LS)-mean difference between treatment groups in the IIEF-EF domain score (6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no erectile dysfunction [ED]'). The target variable is the LS-mean difference between treatment groups at endpoint. The LS-means of both treatment groups are derived from a baseline-adjusted endpoint measure (week 8/last observation carried forward [LOCF]) as calculated via an ANCOVA. | baseline and up to 8 weeks or LOCF | 
| Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8 | Percent successful penetrations were calculated per participant as the number of successful sexual attempts (penetrations) divided by the total number of attempts. The mean percent successful penetrations was then calculated across all participants. | Baseline and 8 weeks | 
| Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8 | Percent successful maintenance of erection were calculated per participant as the number of successful attempts (maintenance of erection) divided by the total number of attempts. The mean percent successful maintenance of erection was then calculated across all participants. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Back to Normal Erectile Function at Week 8 or Last Observation Carried Forward (LOCF) | Responders: percentage of participants achieving an IIEF-EF score >25.(IIEF-EF domain score: 6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no ED') | up to 8 weeks or LOCF | 
| Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8 | Percent successful erections were calculated per participant as the number of successful attempts (achievement of erection) divided by the total number of attempts. The mean percent successful erections was then calculated across all participants. | Baseline and 8 weeks | 
| Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8 | Percent successful ejaculations were calculated per participant as the number of successful attempts (achievement of ejaculation) divided by the total number of attempts. The mean percent successful ejaculations was then calculated across all participants. | Baseline and 8 weeks | 
| Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata)) | Number of participants with no recorded titration of Vardenafil after visit 3. | week 4 and week 8 | 

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