Nebivolol Effects on Endothelial Function and Erectile Function

Erectile Dysfunction Clinical Trial

— NEB-ED  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01885988
• Other study ID #: BYS-IT-74
• Status: Recruiting
• Phase: Phase 4
• First received: June 14, 2013
• Last updated: June 21, 2013
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2013
• Source: The Miriam Hospital
• Contact: Laurie A Given, BSN, RN
• Phone: 401-793-4835
• Email: lgiven[@]lifespan.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Nebivolol
Nebivolol 5, 10 or 20 mg tablet, oral, daily for 3 months. Nebivolol dosage will be titrated per blood pressure results.
• Sugar Pill
Sugar pill 5, 10 or 20mg taken by mouth, daily. Sugar pill dosage will be titrated per blood pressure results.

Locations

Country	Name	City	State
United States	Miriam Cardiology	Providence	Rhode Island
United States	The Miriam Hospital / The Men's Health Center	Providence	Rhode Island
United States	University Medicine	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Martin M. Miner, MD	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The evaluation of the effect of the study medication will be assessed with IIEF questionnaire. This will be assessed by change in IIEF-5.	baseline, 2 and 3 months	No
Secondary	Change in Endopat score	EndoPat test measures Endothelial function	Measurement at baseline, and 3 months	No
Secondary	Change in SphygmoCor results	Sphygmocor will measure change in pulse wave velocity and central blood pressure	SphygmoCor Measured at Baseline, 2 and 3 months	No
Secondary	Change in SQOLM score	SQOLM is the Sexual Quality of Life Male questionnaire.	questionnaire administered at SphygmoCor Measured at Baseline, 2 and 3 months	No