Clinical trial NCT01885988: Nebivolol Effects on Endothelial Function and Erectile Function
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2013-06-25
Enrollment: 70
Sex: MALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary objective is to determine if treatment with nebivolol improves endothelial function and erectile function in men with pre-hypertension and stage 1 hypertension. This will be assessed by change in IIEF-5 at baseline, 2 and 3 months
timeFrame: baseline, 2 and 3 months
Secondary outcomes:
measure: Change in Endopat score
timeFrame: Measurement at baseline, and 3 months
measure: Change in SphygmoCor results
timeFrame: SphygmoCor Measured at Baseline, 2 and 3 months
measure: Change in SQOLM score
timeFrame: questionnaire administered at SphygmoCor Measured at Baseline, 2 and 3 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: University Medicine
state: Rhode Island
city: Providence
country: United States
facility: Miriam Cardiology
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital / The Men's Health Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital, a Lifespan partner
name: Martin M Miner, MD
role: PRINCIPAL_INVESTIGATOR
References: