Nebivolol Effects on Endothelial Function and Erectile Function
| Status: | Completed |
|---|---|
| Conditions: | Erectile Dysfunction |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 25 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | March 2013 |
| End Date: | June 2014 |
| Contact: | Laurie A Given, BSN, RN |
| Email: | lgiven@lifespan.org |
| Phone: | 401-793-4835 |
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.
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.
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.
Inclusion Criteria:
Inclusion Criteria:
- Males 25-65
- Male Patients with ED (IIEF-5 ) Score > 13 and < 21
o If a subject is using PDE5's( phosphodiesterase type 5 inhibitors), there must be a
two week washout of PDE5 use, then in two weeks without PDE5 use; 4 attempts at
sexual activity and an IIEF score < 21 on at least 2 of the four efforts
- Treatment naïve patients with Pre-hypertension (BP 120-139/80-89) or
- Stage 1 hypertension (BP > 140 but < 159/ 90-99)
- Patients in a stable, monogamous relationship
- Patients are able to comprehend and satisfactorily comply with protocol requirements
- Eugonadal Men : Total Testosterone 300 ng/dL-1000 ng/dL or greater, as well as men
who are eugonadal with treatment.
- Non-smoker
Exclusion Criteria:
- Men with concomitant Type 1 or Type 2 Diabetes Mellitus
- Normal RigiScan at Baseline
- Concomitant use of ACE/ ARB (angiotensin receptor blocker)/ Beta-blocking agents/CCB
(calcium channel blocker) / alpha-blocker
- Concomitant use of PDE5'S
- Currently Smoking
- Meeting any exclusion criteria for beta blocker use as stated in the nebivolol
package insert
- Patients who have a medical condition that, in the Investigator's opinion, would
expose them to an increased risk of a significant adverse event or interfere with
assessments of safety and efficacy during the course of the trial.
- Patients with any current malignancy, or any clinically significant hematological,
endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease.
If there is a history of such disease but the condition has been stable for at least
the past year and is judged by the investigator not to interfere with the patient's
participation in the study, the patient may be included.
- Patients who are unable to speak, read, and understand English or are judged by the
investigator to be unable or unlikely to follow the study protocol and complete all
scheduled visits.
We found this trial at
3
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials