A 20-Week Study of a New Treatment for Men With Benign Prostatic Hyperplasia (BPH).
A 20-Week Study of a New Treatment for Men With Benign Prostatic Hyperplasia (BPH).
Patients who are currently symptomatic and have been diagnosed with BPH by a physician may
 qualify for this 20-week study. Patients must not be diabetic, must not have prostate cancer
 and must not have had any surgery to repair your prostate or treat your BPH. Patients will
 first undergo a phone screening to confirm their eligibility and interest and to rule out any
 exclusionary history or medications. Eligible patients will be scheduled to come in to the
 clinic to sign an Informed Consent Form. Patients will then undergo blood and urine tests, a
 complete physical examination and history and answer several questionnaires to determine
 their eligibility. Patients will have a total of at least 7-8 visits over 20 weeks to the
 clinic during this study.Qualified patients receive free study medication, free medical care
 (physical examinations, EKG, laboratory tests) for the duration of the study.
Patients must be willing to discontinue their current medications being taken for BPH for
 specified time periods before they become eligible. These include: Proscar, Saw Palmetto, and
 any "alpha-blocker" drugs.

 Patients with high blood pressure must be on an acceptable medication that controls this
 condition.

 Medications for other conditions may disqualify a patient from eligibility.Patients who are
 diabetic are not eligible for this study.

 All patients will, at some time during the study, receive placebo (inactive substance). The
 study medication is given twice a day in liquid form under the tongue. There is a 33% chance
 that you would receive placebo for the duration of the study. Neither you nor your doctor
 will know which treatment you are receiving.
-  Have an enlarged prostate by DRE (digital rectal examination);

 -  Have a diagnosis of BPH;

 -  Have documented symptoms (frequency; urgency; nighttime urination; reduced flow);

 -  Have a documented urinary flow rate as required