Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier:
NCT01084187
First received: March 9, 2010
Last updated: April 15, 2011
Last verified: April 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Urological Agents

ClinicalTrials.gov processed this record on September 18, 2014