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
45 Years
80 Years
Male
Prostatic Hyperplasia
Trial Information
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 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.
Inclusion Criteria
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
ML-BPH-01
NCT ID:
NCT00044226
Start Date:
April 2002
Completion Date:
October 2002
Related Keywords:
- Prostatic Hyperplasia
- BPH
- Benign Prostatic Hyperplasia
- Benign Prostatic Hypertrophy
- Enlarged Prostate
- Prostatic Hyperplasia
- Hyperplasia
Name | Location |
|---|---|
| Charles White, MD | Mobile, Alabama 36608 |
| Douglas Young, MD | Fair Oaks, California 95628 |
| Rodney Anderson, MD | Stanford, California 94305 |
| Eugene Dula, MD | Van Nuys, California 91405 |
| Joel Kaufman, MD | Aurora, Colorado 80012 |
| Donald Bergner, MD | Clearwater, Florida 33761 |
| Ira Klimberg, MD | Ocala, Florida 34474 |
| Gary Friedlander, MD | Rockville, Maryland 20850 |
| Sheldon Freedman, MD | Las Vegas, Nevada 89109 |
| Edward Loizides, MD | Bay Shore, New York 11706 |
| Richard Landau, MD | Sellersville, Pennsylvania 18960 |
| H. Pat Hezmall, MD | Fort Worth, Texas 73104 |
| Michael Godschalk, MD | Richmond, Virginia 23249 |
| Roger Fincher, MD | Spokane, Washington 99202 |
