Erectile Dysfunction Clinical Trial
Official title:
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.
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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