Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction

Study Overview
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Brief Summary
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The purpose of the study is to assess the correlation of FMD of brachial artery and carotid intima media thickness with ED severity and clinical response to vardenafil in hypertensive men.

Detailed Description
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To achieve this objective, a prospective study will be conducted, with hypertensive patients ranging from 50 to 70 years, presenting vasculogenic erectile dysfunction for over six months and sexually actives. All patients will be assessed for clinical and laboratorial data, endothelial dysfunction, endothelium independent vasodilation and carotid intima media thickness at the inclusion of the study. They will receive medical orientations from the same urologist and will return after four attempts with 20 mg of vardenafil.

Official Title
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Correlation of Flow Mediated Dilation of Brachial Artery and Carotid Intima Media Thickness With Erectile Dysfunction Severity and Clinical Response to PDE 5 Inhibitor in Hypertensive Men

Conditions
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Erectile Dysfunction, Arterial Hypertension, Endothelial Dysfunction

Intervention / Treatment
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* Drug: Vardenafil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: arterial hypertension and erectile dysfunction of vascular origin for at least 6 month Exclusion Criteria: other condition that cause erectile dysfunction such as depression, hypogonadism, surgery, trauma, major cardiovascular event

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: vardenafil on demand<br>four sexual attempts with 20 mg vardenafil during next four weeks | Drug: Vardenafil<br>* vardenafil 20 mg on demand or vardenafil daily or placebo<br>* Other names: Levitra;|
| Placebo Comparator: placebo<br>placebo of vardenafil during four weeks | Drug: Vardenafil<br>* vardenafil 20 mg on demand or vardenafil daily or placebo<br>* Other names: Levitra;|
| Active Comparator: daily vardenafil<br>10 mg of vardenafil each day during four weeks | Drug: Vardenafil<br>* vardenafil 20 mg on demand or vardenafil daily or placebo<br>* Other names: Levitra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical response to vardenafil | SEP 2; SEP 3 and IIEF variation | four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial dysfunction | variation of FMD of brachial artery from baseline | four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erectile dysfunction, arterial hypertension, flow mediated vasodilation, endothelial dysfunction, carotid intima media thickness, vardenafil