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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02620995
Recruitment Status : Completed
First Posted : December 3, 2015
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil

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.


Condition or disease Intervention/treatment Phase
Arterial Hypertension Erectile Dysfunction Drug: sildenafil citrate Other: comparator group Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Systemic and Penile Microvascular Endothelial Function and Arterial Pressure After Chronic Administration of Sildenafil in Hypertensive Men With Erectile Dysfunction
Study Start Date : October 2014
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Penile microvascular vasodilatory capacity [ Time Frame: at the end of a 30-day treatment ]

Secondary Outcome Measures :
  1. Blood pressure levels evaluated using ambulatory blood pressure monitoring [ Time Frame: at the end of a 30-day treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • diabetes
  • kidney, liver, neurologic and psychiatric diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620995


Locations
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Brazil
National Institute of Cardiology, Ministry of Health, Brazil
Rio de Janeiro, Brazil, 22240-006
Sponsors and Collaborators
National Institute of Cardiology, Laranjeiras, Brazil
Investigators
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Principal Investigator: Eduardo V Tibirica, MD, PhD National Institute of Cardiology - Ministry of Health -Brazil
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Responsible Party: Eduardo Tibirica, MD, PhD, Senior researcher, National Institute of Cardiology, Laranjeiras, Brazil
ClinicalTrials.gov Identifier: NCT02620995    
Other Study ID Numbers: CAAE 17663813.4.0000.5272
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Keywords provided by Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil:
hypertension
endothelial dysfunction
erectile dysfunction
sildenafil
Additional relevant MeSH terms:
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Erectile Dysfunction
Hypertension
Vascular Diseases
Cardiovascular Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents