Recruiting

Nebivolol

Sponsor:

Martin M. Miner, MD

Code:

NCT01885988

Conditions

Erectile Dysfunction

Eligibility Criteria

Sex: Male

Age: 25 - 65

Healthy Volunteers: Not accepted

Interventions

Nebivolol

Sugar Pill

Study Details

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

Study ID

NCT01885988

Start date

Mar, 2013

Status verified date

Jun, 2013

Completion date

Jun, 2014

Anticipated

Primary completion date

Mar, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 25 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Nebivolol

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

placebo comparator: Sugar pill

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

Interventions

Nebivolol

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

Sugar Pill

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Laurie A Given, BSN, RN

401-793-4835lgiven@lifespan.org

Locations

University Medicine

Recruiting

Providence, Rhode Island, United States, 02903

Miriam Cardiology

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

The Miriam Hospital / The Men's Health Center

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

Principal Investigator:

Martin M Miner, MD

More Information

Sponsor

Martin M. Miner, MD

Last update posted

Jun 25, 2013

Last verified

Jun, 2013

Keywords

  • Erectile dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Martin M. Miner, MD on 2013-06-25.