NCT01885988

Nebivolol Effects on Endothelial Function and Erectile Function

Nebivolol Effects on Endothelial Function and Erectile Function in Non-smoking Pre-hypertensive and Newly Diagnosed Stage 1 Hypertensive Men With Erectile Dysfunction.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Martin M. Miner, MD · Academic / Other
• Sex: Male
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-03-01
• Completion: 2014-06-01
• First posted: 2013-06-25
• Last updated: 2013-06-25

Locations

3 sites across 1 country: United States