Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction - Full Text View

Purpose

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	Intervention	Phase
Erectile Dysfunction Arterial Hypertension Endothelial Dysfunction	Drug: Vardenafil	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction High Blood Pressure

Drug Information available for: Vardenafil Vardenafil hydrochloride Vardenafil dihydrochloride Vardenafil hydrochloride trihydrate

U.S. FDA Resources

Further study details as provided by Hospital Universitario Pedro Ernesto:

Primary Outcome Measures:

clinical response to vardenafil [ Time Frame: four weeks ] [ Designated as safety issue: No ]
SEP 2; SEP 3 and IIEF variation

Secondary Outcome Measures:

endothelial dysfunction [ Time Frame: four weeks ] [ Designated as safety issue: No ]
variation of FMD of brachial artery from baseline

Enrollment:	100
Study Start Date:	January 2010
Study Completion Date:	February 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Levitra
Placebo Comparator: placebo placebo of vardenafil during four weeks	Drug: Vardenafil vardenafil 20 mg on demand or vardenafil daily or placebo Other Name: 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 Name: Levitra

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.

Eligibility

Ages Eligible for Study:	50 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084187

Locations

Brazil
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 Universitário 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

More Information

No publications provided

Responsible Party:	Valter Javaroni, Hospital Universitário Pedro Ernesto
ClinicalTrials.gov Identifier:	NCT01084187 History of Changes
Other Study ID Numbers:	EDAH2010
Study First Received:	March 9, 2010
Last Updated:	April 15, 2011
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Universitario Pedro Ernesto:

erectile dysfunction
arterial hypertension
flow mediated vasodilation

endothelial dysfunction
carotid intima media thickness
vardenafil

Additional relevant MeSH terms:

Hypertension
Erectile Dysfunction
Vascular Diseases
Cardiovascular Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013