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
Overview
- Phase
- Phase 4
- Intervention
- Vardenafil
- Conditions
- Erectile Dysfunction
- Sponsor
- Hospital Universitario Pedro Ernesto
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- clinical response to vardenafil
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
vardenafil on demand
four sexual attempts with 20 mg vardenafil during next four weeks
Intervention: Vardenafil
placebo
placebo of vardenafil during four weeks
Intervention: Vardenafil
daily vardenafil
10 mg of vardenafil each day during four weeks
Intervention: Vardenafil
Outcomes
Primary Outcomes
clinical response to vardenafil
Time Frame: four weeks
SEP 2; SEP 3 and IIEF variation
Secondary Outcomes
- endothelial dysfunction(four weeks)