Effects of Sildenafil on Penile Vascular Function in Hypertensive Men With Erectile Dysfunction

NCT ID: NCT02620995

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2018-01-31

Brief Summary

The study will evaluate the effects of a chronic 30-day treatment with sildenafil citrate on penile and systemic microvascular function as well as in blood pressure.

A control group of normotensive age-matched healthy subjects will serve as a comparator group for normal penile and systemic microvascular function.

Detailed Description

Vasculogenic erectile dysfunction (ED) is a highly prevalent health problem that is directly related with increased cardiovascular risk. In this context, phosphodiesterase type 5 inhibitors (PDE5 inhibitors) are indicated in the treatment of ED because these drugs increase bioavailability of the endothelial-dependent potent vasodilator nitric oxide. Thus, these drugs could also induce a reduction in arterial pressure and improve microvascular endothelial function in hypertensive patients.

The primary aim of the study is to investigate the acute and chronic effects of sildenafil citrate (®Viagra) on penile and systemic microvascular function of hypertensive patients presenting with ED. The secondary aim is to evaluate the effects of the treatment on arterial pressure.

The study design is a prospective 2 x 2 cross-over, randomized, double blind clinical trial that will include 75 sexually active hypertensive men (age between 50-70 years) under anti-hypertensive treatment (arterial pressure < 160/100 mmHg) presenting with ED. Erectile function will be evaluated using the International Index of Erectile Function (IIEF-5) questionnaire. Patients with non-vasculogenic ED or diabetes will be excluded from the study. Forty-five age-matched healthy subjects will be included as a comparator group.

The evaluation of systemic microvascular function will be performed in the skin of the forearm and penile microvascular function in the skin of the base of the penis using the non-invasive methodology of laser speckle flowmetry coupled to cutaneous iontophoresis of a vasodilator (acetylcholine).

In the acute protocol, microvascular evaluation will be carried out before and one hour after the oral administration of 100 mg of sildenafil citrate. In the chronic protocol, only hypertensive men will be randomized to receive either or placebo sildenafil 50 mg twice daily for 30 days. After a 30-day washout period the patients will receive the complementary treatment.

The evaluation of penile and systemic microvascular function, as well as ambulatory blood pressure monitoring, will be performed before randomization and in the end of each treatment period.

Conditions

Arterial Hypertension; Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

hypertensive patients

Hypertensive patients will receive a single oral dose of sildenafil citrate (100 mg) - acute protocol - and a chronic 30-day treatment with sildenafil citrate (50 mg twice daily) - chronic protocol. Penile and systemic microvascular function will be evaluated before and one hour after acute sildenafil administration and in the end of each treatment period.

Group Type: EXPERIMENTAL

sildenafil citrate

Intervention Type: DRUG

the hypertensive patients with erectile dysfunction will be treated with sildenafil citrate (100 mg daily) or placebo (crossover design)

comparator group

Normotensive individuals age-matched to the hypertensive patients will receive only a single dose of sildenafil citrate (100 mg) - acute protocol. Penile and systemic microvascular function will be evaluated before and one hour after sildenafil administration.

Group Type: SHAM_COMPARATOR

comparator group

Intervention Type: OTHER

Normotensive individuals age-matched to the hypertensive patients will receive only a single dose of sildenafil citrate (100 mg) - acute protocol. Penile and systemic microvascular function will be evaluated before and one hour after sildenafil administration.

Interventions

sildenafil citrate

the hypertensive patients with erectile dysfunction will be treated with sildenafil citrate (100 mg daily) or placebo (crossover design)

Intervention Type: DRUG

comparator group

Normotensive individuals age-matched to the hypertensive patients will receive only a single dose of sildenafil citrate (100 mg) - acute protocol. Penile and systemic microvascular function will be evaluated before and one hour after sildenafil administration.

Intervention Type: OTHER

Other Intervention Names

Viagra

Eligibility Criteria

Inclusion Criteria

• arterial hypertension stage I or II
• erectile dysfunction (vasculogenic)

Exclusion Criteria

• diabetes
• kidney, liver, neurologic and psychiatric diseases

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Cardiology, Laranjeiras, Brazil

OTHER_GOV

Sponsor Role: lead

Responsible Party

Eduardo Tibirica, MD, PhD

Senior researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eduardo V Tibirica, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cardiology - Ministry of Health -Brazil

Locations

National Institute of Cardiology, Ministry of Health, Brazil

Rio de Janeiro, , Brazil

Countries

Brazil

Other Identifiers

CAAE 17663813.4.0000.5272

Identifier Type: -

Identifier Source: org_study_id