Prostatic Hyperplasia Clinical Trial
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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