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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


Phase 2
45 Years
80 Years
Open (Enrolling)
Male
Prostatic Hyperplasia

Thank you

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, MDMobile, Alabama  36608
Douglas Young, MDFair Oaks, California  95628
Rodney Anderson, MDStanford, California  94305
Eugene Dula, MDVan Nuys, California  91405
Joel Kaufman, MDAurora, Colorado  80012
Donald Bergner, MDClearwater, Florida  33761
Ira Klimberg, MDOcala, Florida  34474
Gary Friedlander, MDRockville, Maryland  20850
Sheldon Freedman, MDLas Vegas, Nevada  89109
Edward Loizides, MDBay Shore, New York  11706
Richard Landau, MDSellersville, Pennsylvania  18960
H. Pat Hezmall, MDFort Worth, Texas  73104
Michael Godschalk, MDRichmond, Virginia  23249
Roger Fincher, MDSpokane, Washington  99202