Erectile Dysfunction
Conditions
Keywords
Erectile dysfunction
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.
Interventions
DRUGNebivolol
Nebivolol 5, 10 or 20 mg tablet, oral, daily for 3 months. Nebivolol dosage will be titrated per blood pressure results.
DRUGSugar Pill
Sugar pill 5, 10 or 20mg taken by mouth, daily. Sugar pill dosage will be titrated per blood pressure results.
Sponsors
Forest Laboratories
Martin M. Miner, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
25 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Endopat score | Measurement at baseline, and 3 months | EndoPat test measures Endothelial function |
| Change in SphygmoCor results | SphygmoCor Measured at Baseline, 2 and 3 months | Sphygmocor will measure change in pulse wave velocity and central blood pressure |
| Change in SQOLM score | questionnaire administered at SphygmoCor Measured at Baseline, 2 and 3 months | SQOLM is the Sexual Quality of Life Male questionnaire. |
Countries
United States
Contacts
Primary ContactLaurie A Given, BSN, RN
Outcome results
None listed