Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction

Phase 4

Completed

• Conditions: Erectile Dysfunction; Arterial Hypertension; Endothelial Dysfunction
• Interventions: Drug: Vardenafil

• Registration Number: NCT01084187
• Lead Sponsor: Hospital Universitario Pedro Ernesto

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Primary Completion: 2010-12
• Study Completion: 2011-02
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-15
• Last Update Posted: 2011-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Vardenafil	placebo of vardenafil during four weeks
vardenafil on demand	Vardenafil	four sexual attempts with 20 mg vardenafil during next four weeks
daily vardenafil	Vardenafil	10 mg of vardenafil each day during four weeks

Primary Outcome Measures

Name	Time	Method
clinical response to vardenafil	four weeks	SEP 2; SEP 3 and IIEF variation

Secondary Outcome Measures

Name	Time	Method
endothelial dysfunction	four weeks	variation of FMD of brachial artery from baseline

Trial Locations

Locations (1)

Hospital Universitário Pedro Ernesto; 🇧🇷 Rio de Janeiro, Brazil