Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A 20-Week Study of a New Treatment for Men With Benign Prostatic Hyperplasia (BPH).

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2002 by Milkhaus Laboratory.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Milkhaus Laboratory
ClinicalTrials.gov Identifier:
NCT00044226
First received: August 22, 2002
Last updated: June 23, 2005
Last verified: August 2002
  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 Intervention Phase
Prostatic Hyperplasia
Drug: ML-04A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Milkhaus Laboratory:

Estimated Enrollment: 350
Study Start Date: April 2002
Estimated Study Completion Date: October 2002
Detailed Description:

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 to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044226

Locations
United States, Alabama
Charles White, MD
Mobile, Alabama, United States, 36608
United States, California
Douglas Young, MD
Fair Oaks, California, United States, 95628
Rodney Anderson, MD
Stanford, California, United States, 94305
Eugene Dula, MD
Van Nuys, California, United States, 91405
United States, Colorado
Joel Kaufman, MD
Aurora, Colorado, United States, 80012
United States, Florida
Donald Bergner, MD
Clearwater, Florida, United States, 33761
Ira Klimberg, MD
Ocala, Florida, United States, 34474
United States, Maryland
Gary Friedlander, MD
Rockville, Maryland, United States, 20850
United States, Nevada
Sheldon Freedman, MD
Las Vegas, Nevada, United States, 89109
United States, New York
Edward Loizides, MD
Bay Shore, New York, United States, 11706
United States, Pennsylvania
Richard Landau, MD
Sellersville, Pennsylvania, United States, 18960
United States, Texas
H. Pat Hezmall, MD
Fort Worth, Texas, United States, 73104
United States, Virginia
Michael Godschalk, MD
Richmond, Virginia, United States, 23249
United States, Washington
Roger Fincher, MD
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Milkhaus Laboratory
  More Information

ClinicalTrials.gov Identifier: NCT00044226     History of Changes
Other Study ID Numbers: ML-BPH-01 
Study First Received: August 22, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Milkhaus Laboratory:
BPH
Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy
Enlarged Prostate

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on December 05, 2016