Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction

Hospital Universitario Pedro Ernesto

Status and phase: Completed; Phase 4

Conditions: Endothelial Dysfunction; Erectile Dysfunction; Arterial Hypertension

Treatments: Drug: Vardenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT01084187

EDAH2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Male

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups, including a placebo group

vardenafil on demand

Active Comparator group

Description:

four sexual attempts with 20 mg vardenafil during next four weeks

Treatment:

Drug: Vardenafil

placebo

Placebo Comparator group

Description:

placebo of vardenafil during four weeks

Treatment:

Drug: Vardenafil

daily vardenafil

Active Comparator group

Description:

10 mg of vardenafil each day during four weeks

Treatment:

Drug: Vardenafil