Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction
Information source: Hospital Universitario Pedro Ernesto
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction; Arterial Hypertension; Endothelial Dysfunction
Intervention: Vardenafil (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Hospital Universitario Pedro Ernesto Official(s) and/or principal investigator(s):
Mario F Neves, MD, PhD., Study Chair, Affiliation: Hospital Universitário Pedro Ernesto
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.
Clinical Details
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 design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: clinical response to vardenafil
Secondary outcome: endothelial dysfunction
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
Minimum age: 50 Years.
Maximum age: 70 Years.
Gender(s): Male.
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
Locations and Contacts
Hospital Universitário Pedro Ernesto, Rio de Janeiro 20551030, Brazil; Recruiting
Valter Javaroni, MD, MSc, Phone: 552125876631, Email: drjavaroni2000@yahoo.com.br
Valter Javaroni, MD, MSc, Principal Investigator
Additional Information
Starting date: January 2010
Last updated: March 9, 2010
|
