A Double-blind Preferred Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction

Study Overview
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Brief Summary
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To find out more information on how treating impotence with vardenafil in comparison to placebo affects the quality of life (QoL) of men and their partners. Subjects will receive 10mg vardenafil or placebo for 4 weeks followed by an 8 week period when the dose of vardenafil may be reduced to 5mg or increased to 20mg. Subjects will then receive their 'preferred' dose for 14 weeks. During this time Quality of Life Measures will be collected via questionnaires

Official Title
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A Double-blind Preferred Vardenafil Dose Study of QoL and Functional Outcomes in Males 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: Males with erectile dysfunction for more than six months according to the NIH Consensus Statement (the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance) Stable, heterosexual relationship for more than six months Documented written Informed Consent, from both the patient and his partner, after receiving adequate previous information and prior to any study specific procedures. An ED-EQoL score < or = 15.- An IIEF score < or = 25. Exclusion Criteria: Presence of penile anatomical abnormalities (eg. penile fibrosis or Peyronie's disease) that would significantly impair erectile function. History of radical prostatectomy. - Retinitis pigmentosa. History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C.- Unstable angina pectoris. History of myocardial infarction, stroke, electrocardiographic ischaemia (except stable angina), or life-threatening arrhythmia within the prior 6 months. Atrial tachyarrhythmia (eg. atrial fibrillation/flutter) with a heart rate of >100 beats per minute at screening. Child-Pugh class B liver disease or liver function abnormalities. Clinically significant chronic haematological disease or bleeding disorder History of significant peptic ulcer disease within one year before Visit 1 Resting hypotension (a resting systolic blood pressure of <90 mm Hg) or hypertension (a resting systolic blood pressure >170 mm Hg or a resting diastolic blood pressure >110 mm Hg). Symptomatic postural hypotension within the six months of Visit 1. Uncontrolled diabetes mellitus (haemoglobin A1c > 12%). Patients who are taking nitrates or nitric oxide donors (e.g. molsidomine). Patients who are taking anticoagulants, with the exception of anti-platelet agents. Patients who are taking androgens (e.g. testosterone), trazodone or anti-androgens. Patients who are taking the following inhibitors of cytochrome P 450 CYP 3A4: potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* 10mg placebo for 4 weeks followed by an 8 week titration period when subjects may be titrated up to 20mg placebo or down to 5mg placebo followed by 14 weeks placebo at preferred dose<br>|
| Experimental: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* 10mg Vardenafil for 4 weeks followed by an 8 week titration period when subjects may be titrated up to 20mg Vardenafil or down to 5mg Vardenafil followed by 14 weeks treatment at preferred dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy comparison is EF domain of the IIEF, vardenafil preferred dose versus placebo at week 18 (after 4 weeks of preferred treatment). |  | At week 18 (after 4 weeks of preferred treatment). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between the change from baseline score for; EF domain, SEP2, SEP3 and GEQ with that for ED-QoL and EDITS will be explored for the vardenafil 10mg and 20mg groups respectively |  | Baseline and at week 18 (after 4 weeks of preferred treatment). | 
| Global Assessment Question (GAQ) responses |  | At weeks 4, 8, 12, 18 and 26 | 
| Treatment groups will be compared with respect to the incidence rates of premature termination, adverse events, lab abnormalities, ECG abnormalities, and concomitant medication use |  | Baseline and at weeks 4, 8, 12, 18 and 26 | 
| Measurements and changes from baseline in vital signs (blood pressure and pulse rate), continuous laboratory variables, ECG cardiac cycle measurements, and ECG heart rate |  | Baseline and Week 26 | 
| Measurements and changes from baseline in vital signs (blood pressure and pulse rate), continuous laboratory variables, |  | Baseline and at weeks 4, 8, 12, 18 and 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction, Quality of Life