Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084187
• Other study ID #: EDAH2010
• Status: Completed
• Phase: Phase 4
• First received: March 9, 2010
• Last updated: April 15, 2011
• Start date: January 2010
• Est. completion date: February 2011

Study information

• Verified date: April 2011
• Source: Hospital Universitario Pedro Ernesto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Hypertension
• Endothelial Dysfunction
• Erectile Dysfunction
• Hypertension

Intervention

Drug:
• Vardenafil
vardenafil 20 mg on demand or vardenafil daily or placebo

Locations

Country	Name	City	State
Brazil	Hospital Universitário Pedro Ernesto	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Pedro Ernesto

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical response to vardenafil	SEP 2; SEP 3 and IIEF variation	four weeks	No
Secondary	endothelial dysfunction	variation of FMD of brachial artery from baseline	four weeks	No