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

Primary Purpose

Erectile Dysfunction

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nebivolol
Sugar Pill
Sponsored by
Martin M. Miner, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University MedicineRecruiting
  • Miriam CardiologyRecruiting
  • The Miriam Hospital / The Men's Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nebivolol

Sugar pill

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Endopat score
EndoPat test measures Endothelial function
Change in SphygmoCor results
Sphygmocor will measure change in pulse wave velocity and central blood pressure
Change in SQOLM score
SQOLM is the Sexual Quality of Life Male questionnaire.

Full Information

First Posted
June 14, 2013
Last Updated
June 21, 2013
Sponsor
Martin M. Miner, MD
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01885988
Brief Title
Nebivolol Effects on Endothelial Function and Erectile Function
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Martin M. Miner, MD
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nebivolol
Arm Type
Active Comparator
Arm Description
Nebivolol 5, 10 or 20 mg tablet, oral, daily for 3 months. Nebivolol dosage will be titrated per blood pressure results.
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Sugar pill 5, 10 or 20 mg tablet, orally, daily. Sugar pill dosage will be titrated per blood pressure results.
Intervention Type
Drug
Intervention Name(s)
Nebivolol
Other Intervention Name(s)
Bystolic
Intervention Description
Nebivolol 5, 10 or 20 mg tablet, oral, daily for 3 months. Nebivolol dosage will be titrated per blood pressure results.
Intervention Type
Drug
Intervention Name(s)
Sugar Pill
Other Intervention Name(s)
placebo
Intervention Description
Sugar pill 5, 10 or 20mg taken by mouth, daily. Sugar pill dosage will be titrated per blood pressure results.
Primary Outcome Measure Information:
Title
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
Description
The evaluation of the effect of the study medication will be assessed with IIEF questionnaire. This will be assessed by change in IIEF-5.
Time Frame
baseline, 2 and 3 months
Secondary Outcome Measure Information:
Title
Change in Endopat score
Description
EndoPat test measures Endothelial function
Time Frame
Measurement at baseline, and 3 months
Title
Change in SphygmoCor results
Description
Sphygmocor will measure change in pulse wave velocity and central blood pressure
Time Frame
SphygmoCor Measured at Baseline, 2 and 3 months
Title
Change in SQOLM score
Description
SQOLM is the Sexual Quality of Life Male questionnaire.
Time Frame
questionnaire administered at SphygmoCor Measured at Baseline, 2 and 3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurie A Given, BSN, RN
Phone
401-793-4835
Email
lgiven@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin M Miner, MD
Organizational Affiliation
The Miriam Hospital, a Lifespan partner
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medicine
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Wu, MD
First Name & Middle Initial & Last Name & Degree
Tony Wu, MD
Facility Name
Miriam Cardiology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Desimone, BSN, RN
Phone
401-793-7646
Email
ldesimone@lifespan.org
First Name & Middle Initial & Last Name & Degree
Douglas Burtt, MD
Facility Name
The Miriam Hospital / The Men's Health Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurie A Given, BSN
Phone
401-793-4835
Email
lgiven@lifespan.org
First Name & Middle Initial & Last Name & Degree
Martin M Miner, MD

12. IPD Sharing Statement

Learn more about this trial

Nebivolol Effects on Endothelial Function and Erectile Function

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