Erectile Dysfunction Clinical Trial
Official title:
Nebivolol Effects on Endothelial Function and Erectile Function in Non-smoking Pre-hypertensive and Newly Diagnosed Stage 1 Hypertensive Men With Erectile Dysfunction.
The study will take part at The Men's Health Center It will involve men who have a diagnosis
of erectile dysfunction and also have high blood pressure.
High blood pressure can affect the lining of the arteries and cause stiffness in the
arteries. The arteries and veins throughout the body have a lining called the endothelium
which gives them the ability to stretch. If the lining of the penile arteries becomes
impaired, it can decrease the stretching of the artery and decrease blood flow. Decreased
blood flow in the penile arteries can cause problems obtaining an erection.
The study medication Nebivolol controls blood pressure by relaxing smooth muscle around the
lining of the arteries, thereby improving stretch and blood flow.
The primary objective is to determine if treatment with nebivolol improves endothelial
function and erectile function in men with pre-hypertension and stage 1 hypertension
70 men will be enrolled into the study. Half of the subjects will receive active medication
and half will receive a placebo. All men will receive educational informational handouts
about blood pressure and behavior modifications to improve blood pressure. The study will
last for 3 months for each subject. The expected recruitment time is one year, with a 2 year
study completion goal. Subjects will have approximately 5 study visits.
Subjects will have initial/final blood work, a Rigiscan test (a take home penile erection
test), two EndoPat tests to assess endothelium function, 3 SphygmoCor tests to assess
central blood pressure, 2 sexual health questionnaires at 2 visits. Vital signs will be
monitored at each visit to assess safety and effectiveness of the study medication.
Randomized double-blind placebo-controlled study of 70 non-smoking pre-hypertensive men (BP 120-139 / 80-89) or with newly diagnosed stage 1 hypertension (BP > 140 but < 159/ 90-99) with erectile dysfunction receiving nebivolol (5-20mg) or placebo, along with lifestyle modifications, daily for 3 months to titrate BP to 120/80 or less. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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