Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction

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.

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Key information

Conditions

Erectile Dysfunction Arterial Hypertension Cardiovascular Diseases Endothelial Dysfunction Genital Diseases Genital Diseases, Male Hypertension Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases Vascular Diseases

Age range

50 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitário Pedro Ernesto

Rio de Janeiro, 20551030, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vardenafil

Drug

vardenafil 20 mg on demand or vardenafil daily or placebo

Other names: Levitra

Primary outcomes

clinical response to vardenafil

Time frame: four weeks

SEP 2; SEP 3 and IIEF variation

Secondary outcomes

endothelial dysfunction

Time frame: four weeks

variation of FMD of brachial artery from baseline

Sponsors and collaborators

Lead sponsor

Hospital Universitario Pedro Ernesto

Other

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2011
First posted: Mar 10, 2010
Registry last updated: Apr 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed