Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction

Sponsor

Hospital Universitario Pedro Ernesto (Other)

Overall Status

Completed

CT.gov ID

NCT01084187

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction Arterial Hypertension Endothelial Dysfunction	Drug: Vardenafil	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: vardenafil on demand four sexual attempts with 20 mg vardenafil during next four weeks	Drug: Vardenafil vardenafil 20 mg on demand or vardenafil daily or placebo Other Names: Levitra
Placebo Comparator: placebo placebo of vardenafil during four weeks	Drug: Vardenafil vardenafil 20 mg on demand or vardenafil daily or placebo Other Names: Levitra
Active Comparator: daily vardenafil 10 mg of vardenafil each day during four weeks	Drug: Vardenafil vardenafil 20 mg on demand or vardenafil daily or placebo Other Names: Levitra

Arm

Intervention/Treatment

Active Comparator: vardenafil on demand

four sexual attempts with 20 mg vardenafil during next four weeks

Drug: Vardenafil

vardenafil 20 mg on demand or vardenafil daily or placebo

Other Names:

Levitra

Placebo Comparator: placebo

placebo of vardenafil during four weeks

Drug: Vardenafil

vardenafil 20 mg on demand or vardenafil daily or placebo

Other Names:

Levitra

Active Comparator: daily vardenafil

10 mg of vardenafil each day during four weeks

Drug: Vardenafil

vardenafil 20 mg on demand or vardenafil daily or placebo

Other Names:

Levitra

Outcome Measures

Primary Outcome Measures

clinical response to vardenafil [four weeks]
SEP 2; SEP 3 and IIEF variation

Secondary Outcome Measures

endothelial dysfunction [four weeks]
variation of FMD of brachial artery from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitário Pedro Ernesto	Rio de Janeiro		Brazil	20551030

Sponsors and Collaborators

Hospital Universitario Pedro Ernesto

Investigators

Study Chair: Mario F Neves, MD, PhD., Hospital Universitario Pedro Ernesto
Principal Investigator: Valter Javaroni, MD, MSc, State University of Rio de Janeiro
Study Director: Wille Oigman, MD, PhD, State University of Rio de Janeiro