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Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01084187
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : April 18, 2011
Information provided by:
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.

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : February 2011

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 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

Primary Outcome Measures :
  1. clinical response to vardenafil [ Time Frame: four weeks ]
    SEP 2; SEP 3 and IIEF variation

Secondary Outcome Measures :
  1. endothelial dysfunction [ Time Frame: four weeks ]
    variation of FMD of brachial artery from baseline

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01084187

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Hospital Universitário Pedro Ernesto
Rio de Janeiro, Brazil, 20551030
Sponsors and Collaborators
Hospital Universitario Pedro Ernesto
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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
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Responsible Party: Valter Javaroni, Hospital Universitário Pedro Ernesto Identifier: NCT01084187    
Other Study ID Numbers: EDAH2010
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: April 18, 2011
Last Verified: April 2011
Keywords provided by Hospital Universitario Pedro Ernesto:
erectile dysfunction
arterial hypertension
flow mediated vasodilation
endothelial dysfunction
carotid intima media thickness
Additional relevant MeSH terms:
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Erectile Dysfunction
Vascular Diseases
Cardiovascular Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents