Nebivolol Effects on Endothelial Function and Erectile Function

NCT01885988 | Unknown Phase 4

• 1 other identifier: BYS-IT-74
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

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.

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in Endopat score

  Measurement at baseline, and 3 months

• Change in SphygmoCor results

  SphygmoCor Measured at Baseline, 2 and 3 months

• Change in SQOLM score

  questionnaire administered at SphygmoCor Measured at Baseline, 2 and 3 months

Study Arms (2)

Nebivolol

ACTIVE COMPARATOR

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

Drug: Nebivolol

Sugar pill

PLACEBO COMPARATOR

Sugar pill 5, 10 or 20 mg tablet, orally, daily. Sugar pill dosage will be titrated per blood pressure results.

Drug: Sugar Pill

Interventions

Nebivolol DRUG

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

Also known as: Bystolic

Nebivolol

Sugar Pill DRUG

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

Also known as: placebo

Sugar pill

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Martin M. Miner, MD: lead
• Forest Laboratories: collaborator

Study Sites (3)

University Medicine

Providence, Rhode Island, 02903, United States

RECRUITING

Miriam Cardiology

Providence, Rhode Island, 02906, United States

RECRUITING

The Miriam Hospital / The Men's Health Center

Providence, Rhode Island, 02906, United States

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Nebivolol; Sugars

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Study Officials

• Martin M Miner, MD

  The Miriam Hospital, a Lifespan partner

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie A Given, BSN, RN

CONTACT

401-793-4835; lgiven@lifespan.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Director Men's Health Center

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 25, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

US (3)