Arterial Hypertension, Endothelial Dysfunction, Erectile Dysfunction
Conditions
Keywords
erectile dysfunction, arterial hypertension, flow mediated vasodilation, endothelial dysfunction, carotid intima media thickness, vardenafil
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.
Interventions
DRUGVardenafil
vardenafil 20 mg on demand or vardenafil daily or placebo
Sponsors
Hospital Universitario Pedro Ernesto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
50 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical response to vardenafil | four weeks | SEP 2; SEP 3 and IIEF variation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| endothelial dysfunction | four weeks | variation of FMD of brachial artery from baseline |
Countries
Brazil
Outcome results
None listed