A 20-Week Study of a New Treatment for Men With Benign Prostatic Hyperplasia (BPH).
- Conditions
- Prostatic Hyperplasia
- Registration Number
- NCT00044226
- Lead Sponsor
- Milkhaus Laboratory
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 350
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Donald Bergner, MD
🇺🇸Clearwater, Florida, United States
Charles White, MD
🇺🇸Mobile, Alabama, United States
Rodney Anderson, MD
🇺🇸Stanford, California, United States
Douglas Young, MD
🇺🇸Fair Oaks, California, United States
Eugene Dula, MD
🇺🇸Van Nuys, California, United States
Joel Kaufman, MD
🇺🇸Aurora, Colorado, United States
Ira Klimberg, MD
🇺🇸Ocala, Florida, United States
Gary Friedlander, MD
🇺🇸Rockville, Maryland, United States
Edward Loizides, MD
🇺🇸Bay Shore, New York, United States
Richard Landau, MD
🇺🇸Sellersville, Pennsylvania, United States
H. Pat Hezmall, MD
🇺🇸Fort Worth, Texas, United States
Michael Godschalk, MD
🇺🇸Richmond, Virginia, United States
Roger Fincher, MD
🇺🇸Spokane, Washington, United States
Sheldon Freedman, MD
🇺🇸Las Vegas, Nevada, United States