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Nebivolol Effects on Endothelial Function and Erectile Function

NCT01885988 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-06-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nebivolol

Nebivolol 5, 10 or 20 mg tablet, oral, daily for 3 months. Nebivolol dosage will be titrated per blood pressure results.

DRUG

Sugar Pill

Sugar pill 5, 10 or 20mg taken by mouth, daily. Sugar pill dosage will be titrated per blood pressure results.

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Martin M. Miner, MD

    lead OTHER

Principal Investigators

  • Martin M Miner, MD · The Miriam Hospital, a Lifespan partner

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-03-31
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01885988 on ClinicalTrials.gov