Back to resultsCorrelation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction
Primary Purpose
Erectile Dysfunction, Arterial Hypertension, Endothelial Dysfunction
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Vardenafil
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring erectile dysfunction, arterial hypertension, flow mediated vasodilation, endothelial dysfunction, carotid intima media thickness, vardenafil
Eligibility 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
Sites / Locations
- Hospital Universitário Pedro Ernesto
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
vardenafil on demand
placebo
daily vardenafil
Arm Description
four sexual attempts with 20 mg vardenafil during next four weeks
placebo of vardenafil during four weeks
10 mg of vardenafil each day during four weeks
Outcomes
Primary Outcome Measures
clinical response to vardenafil
SEP 2; SEP 3 and IIEF variation
Secondary Outcome Measures
endothelial dysfunction
variation of FMD of brachial artery from baseline
Full Information
NCT ID
NCT01084187
First Posted
March 9, 2010
Last Updated
April 15, 2011
Sponsor
Hospital Universitario Pedro Ernesto
1. Study Identification
Unique Protocol Identification Number
NCT01084187
Brief Title
Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction
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 Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Universitario Pedro Ernesto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Arterial Hypertension, Endothelial Dysfunction
Keywords
erectile dysfunction, arterial hypertension, flow mediated vasodilation, endothelial dysfunction, carotid intima media thickness, vardenafil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vardenafil on demand
Arm Type
Active Comparator
Arm Description
four sexual attempts with 20 mg vardenafil during next four weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo of vardenafil during four weeks
Arm Title
daily vardenafil
Arm Type
Active Comparator
Arm Description
10 mg of vardenafil each day during four weeks
Intervention Type
Drug
Intervention Name(s)
Vardenafil
Other Intervention Name(s)
Levitra
Intervention Description
vardenafil 20 mg on demand or vardenafil daily or placebo
Primary Outcome Measure Information:
Title
clinical response to vardenafil
Description
SEP 2; SEP 3 and IIEF variation
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
endothelial dysfunction
Description
variation of FMD of brachial artery from baseline
Time Frame
four weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario F Neves, MD, PhD.
Organizational Affiliation
Hospital Universitario Pedro Ernesto
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Valter Javaroni, MD, MSc
Organizational Affiliation
State University of Rio de Janeiro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wille Oigman, MD, PhD
Organizational Affiliation
State University of Rio de Janeiro
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitário Pedro Ernesto
City
Rio de Janeiro
ZIP/Postal Code
20551030
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction
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