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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
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
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

Further Study Details: 

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

Martha J. DuRuz-Lynch, BA      414.425.6566 

Alabama
      Charles White, MD, Mobile,  Alabama,  36608,  United States; Recruiting
Julie Clark  251-639-1661 

California
      Rodney Anderson, MD, Stanford,  California,  94305,  United States; Recruiting
Nushin Namazi  650-724-0084 

      Eugene Dula, MD, Van Nuys,  California,  91405,  United States; Recruiting
Sandro Gomez  818-901-8541 
Bunny Petretti  818.901.8541 

      Douglas Young, MD, Fair Oaks,  California,  95628,  United States; Recruiting
Stephanie Lanam  916-961-7593 

Colorado
      Joel Kaufman, MD, Aurora,  Colorado,  80012,  United States; Recruiting
Jamie Yingst  303-755-1625 

Florida
      Donald Bergner, MD, Clearwater,  Florida,  33761,  United States; Recruiting
Shirley Spiot  727-724-3316 
Becky  727.724.3316 

      Ira Klimberg, MD, Ocala,  Florida,  34474,  United States; Recruiting
Rustina Jones  352-237-3949 

Maryland
      Gary Friedlander, MD, Rockville,  Maryland,  20850,  United States; Recruiting
Wendy Clover  301-315-6081 

Nevada
      Sheldon Freedman, MD, Las Vegas,  Nevada,  89109,  United States; Recruiting
Lisa Boyak  702-732-0282 
Cynthia Freedman  702.732.0282 

New York
      Edward Loizides, MD, Bay Shore,  New York,  11706,  United States; Recruiting
Diana Mauceri, RN  631-665-3737  Ext. 132 
Kerri Weingard, NP  631.665.3737 

Pennsylvania
      Richard Landau, MD, Sellersville,  Pennsylvania,  18960,  United States; Recruiting
LouAnn Crist, RN  215-257-3066 
Trista Rochon  215.540.5870 

Texas
      H. Pat Hezmall, MD, Fort Worth,  Texas,  73104,  United States; Recruiting
Kathy Marshall  817-332-8595 

Virginia
      Michael Godschalk, MD, Richmond,  Virginia,  23249,  United States; Recruiting
Tammy Creasy, RN  804-675-5705 

Washington
      Roger Fincher, MD, Spokane,  Washington,  99202,  United States; Recruiting
Sarah Collins  509-747-7900 

More Information

Study ID Numbers:  ML-BPH-01
Record last reviewed:  August 2002
Record first received:  August 22, 2002
ClinicalTrials.gov Identifier:  NCT00044226
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-29
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