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

March 5, 2018 updated by: Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil

Evaluation of Systemic and Penile Microvascular Endothelial Function and Arterial Pressure After Chronic Administration of Sildenafil in Hypertensive Men With Erectile Dysfunction

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Rio de Janeiro, Brazil, 22240-006
        • National Institute of Cardiology, Ministry of Health, Brazil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • diabetes
  • kidney, liver, neurologic and psychiatric diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
the hypertensive patients with erectile dysfunction will be treated with sildenafil citrate (100 mg daily) or placebo (crossover design)
Other Names:
  • Viagra
Sham Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Penile microvascular vasodilatory capacity
Time Frame: at the end of a 30-day treatment
at the end of a 30-day treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure levels evaluated using ambulatory blood pressure monitoring
Time Frame: at the end of a 30-day treatment
at the end of a 30-day treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eduardo V Tibirica, MD, PhD, National Institute of Cardiology - Ministry of Health -Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 6, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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