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Nebivolol Effects on Endothelial Function and Erectile Function (NEB-ED)

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ClinicalTrials.gov Identifier: NCT01885988
Recruitment Status : Unknown
Verified June 2013 by Martin M. Miner, MD, The Miriam Hospital.
Recruitment status was:  Recruiting
First Posted : June 25, 2013
Last Update Posted : June 25, 2013
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Martin M. Miner, MD, The Miriam Hospital

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.


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Nebivolol Drug: Sugar Pill Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2013
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nebivolol
Nebivolol 5, 10 or 20 mg tablet, oral, daily for 3 months. Nebivolol dosage will be titrated per blood pressure results.
Drug: Nebivolol
Nebivolol 5, 10 or 20 mg tablet, oral, daily for 3 months. Nebivolol dosage will be titrated per blood pressure results.
Other Name: Bystolic

Placebo Comparator: Sugar pill
Sugar pill 5, 10 or 20 mg tablet, orally, daily. Sugar pill 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.
Other Name: placebo




Primary Outcome Measures :
  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 [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in Endopat score [ Time Frame: Measurement at baseline, and 3 months ]
    EndoPat test measures Endothelial function

  2. Change in SphygmoCor results [ Time Frame: SphygmoCor Measured at Baseline, 2 and 3 months ]
    Sphygmocor will measure change in pulse wave velocity and central blood pressure

  3. Change in SQOLM score [ Time Frame: questionnaire administered at SphygmoCor Measured at Baseline, 2 and 3 months ]
    SQOLM is the Sexual Quality of Life Male questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885988


Contacts
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Contact: Laurie A Given, BSN, RN 401-793-4835 lgiven@lifespan.org

Locations
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United States, Rhode Island
University Medicine Recruiting
Providence, Rhode Island, United States, 02903
Contact: Tony Wu, MD         
Sub-Investigator: Tony Wu, MD         
Miriam Cardiology Recruiting
Providence, Rhode Island, United States, 02906
Contact: Lori Desimone, BSN, RN    401-793-7646    ldesimone@lifespan.org   
Sub-Investigator: Douglas Burtt, MD         
The Miriam Hospital / The Men's Health Center Recruiting
Providence, Rhode Island, United States, 02906
Contact: Laurie A Given, BSN    401-793-4835    lgiven@lifespan.org   
Principal Investigator: Martin M Miner, MD         
Sponsors and Collaborators
Martin M. Miner, MD
Forest Laboratories
Investigators
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Principal Investigator: Martin M Miner, MD The Miriam Hospital, a Lifespan partner
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Responsible Party: Martin M. Miner, MD, Co-Director Men's Health Center, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01885988    
Other Study ID Numbers: BYS-IT-74
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013
Keywords provided by Martin M. Miner, MD, The Miriam Hospital:
Erectile dysfunction
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Nebivolol
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs