Nebivolol Effects on Endothelial Function and Erectile Function
Status:
Unknown status
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
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.