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A 20-week study of a new treatment for men with Benign Prostatic Hyperplasia (BPH).
This study is currently recruiting patients.
Sponsored by: | Milkhaus Laboratory |
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Information provided by: | Milkhaus Laboratory |
Purpose
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.
Condition | Treatment or Intervention | Phase |
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Prostatic Hyperplasia |
Drug: ML-04A |
Phase II |
MedlinePlus related topics: Prostate Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Clinical trial to Evaluate the Efficacy and Safety of Two Dosing Regimens of ML-04A in Subjects with Symptomatic Benign Prostatic Hyperplasia
Expected Total Enrollment: 350
Study start: April 2002;
Study completion: October 2002
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.
Eligibility
Ages Eligible for Study: 45 Years - 80 Years, Genders Eligible for Study: Male
Accepts Healthy Volunteers
Criteria
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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