Status:
UNKNOWN
Nebivolol Effects on Endothelial Function and Erectile Function
Lead Sponsor:
Martin M. Miner, MD
Collaborating Sponsors:
Forest Laboratories
Conditions:
Erectile Dysfunction
Eligibility:
MALE
25-65 years
Phase:
PHASE4
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 th...
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 dy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01885988
Start Date
March 1 2013
End Date
June 1 2014
Last Update
June 25 2013
Active Locations (3)
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1
University Medicine
Providence, Rhode Island, United States, 02903
2
Miriam Cardiology
Providence, Rhode Island, United States, 02906
3
The Miriam Hospital / The Men's Health Center
Providence, Rhode Island, United States, 02906