Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction

April 15, 2011 updated by: Hospital Universitario Pedro Ernesto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20551030
        • Hospital Universitário Pedro Ernesto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical response to vardenafil
Time Frame: four weeks
SEP 2; SEP 3 and IIEF variation
four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endothelial dysfunction
Time Frame: four weeks
variation of FMD of brachial artery from baseline
four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Estimate)

April 18, 2011

Last Update Submitted That Met QC Criteria

April 15, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDAH2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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