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Completed

NCT Number: NCT02620995

Effects of Sildenafil on Penile Vascular Function 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.

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Key information

Conditions

Arterial Hypertension Cardiovascular Diseases Erectile Dysfunction Genital Diseases Genital Diseases, Male Hypertension Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases Vascular Diseases

Age range

50 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

National Institute of Cardiology, Ministry of Health, Brazil

Rio de Janeiro, 22240-006, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • diabetes
  • kidney, liver, neurologic and psychiatric diseases

Treatment and study plan

sildenafil citrate

Drug

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

Other names: Viagra

comparator group

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.

Primary outcomes

  1. Penile microvascular vasodilatory capacity

    Time frame: at the end of a 30-day treatment

Secondary outcomes

  1. Blood pressure levels evaluated using ambulatory blood pressure monitoring

    Time frame: at the end of a 30-day treatment

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Laranjeiras, Brazil

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 3, 2015
Registry last updated
Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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