- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02620995
Effects of Sildenafil on Penile Vascular Function in Hypertensive Men With Erectile Dysfunction
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Rio de Janeiro, Brazil, 22240-006
- National Institute of Cardiology, Ministry of Health, Brazil
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- arterial hypertension stage I or II
- erectile dysfunction (vasculogenic)
Exclusion Criteria:
- diabetes
- kidney, liver, neurologic and psychiatric diseases
Study Plan
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.
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the hypertensive patients with erectile dysfunction will be treated with sildenafil citrate (100 mg daily) or placebo (crossover design)
Other Names:
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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.
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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.
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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
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at the end of a 30-day treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Blood pressure levels evaluated using ambulatory blood pressure monitoring
Time Frame: at the end of a 30-day treatment
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at the end of a 30-day treatment
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Collaborators and Investigators
Investigators
- Principal Investigator: Eduardo V Tibirica, MD, PhD, National Institute of Cardiology - Ministry of Health -Brazil
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Sexual Dysfunctions, Psychological
- Sexual Dysfunction, Physiological
- Hypertension
- Erectile Dysfunction
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Sildenafil Citrate
Other Study ID Numbers
- CAAE 17663813.4.0000.5272
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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