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

The recruitment status of this study is unknown because the information has not been verified recently.
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
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

Contacts
Contact: Martha J. DuRuz-Lynch, BA 414.425.6566

Locations
United States, Alabama
Charles White, MD Recruiting
Mobile, Alabama, United States, 36608
Contact: Julie Clark    251-639-1661      
United States, California
Douglas Young, MD Recruiting
Fair Oaks, California, United States, 95628
Contact: Stephanie Lanam    916-961-7593      
Rodney Anderson, MD Recruiting
Stanford, California, United States, 94305
Contact: Nushin Namazi    650-724-0084      
Eugene Dula, MD Recruiting
Van Nuys, California, United States, 91405
Contact: Sandro Gomez    818-901-8541      
Contact: Bunny Petretti    818.901.8541      
United States, Colorado
Joel Kaufman, MD Recruiting
Aurora, Colorado, United States, 80012
Contact: Jamie Yingst    303-755-1625      
United States, Florida
Donald Bergner, MD Recruiting
Clearwater, Florida, United States, 33761
Contact: Shirley Spiot    727-724-3316      
Contact: Becky    727.724.3316      
Ira Klimberg, MD Recruiting
Ocala, Florida, United States, 34474
Contact: Rustina Jones    352-237-3949      
United States, Maryland
Gary Friedlander, MD Recruiting
Rockville, Maryland, United States, 20850
Contact: Wendy Clover    301-315-6081      
United States, Nevada
Sheldon Freedman, MD Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Lisa Boyak    702-732-0282      
Contact: Cynthia Freedman    702.732.0282      
United States, New York
Edward Loizides, MD Recruiting
Bay Shore, New York, United States, 11706
Contact: Diana Mauceri, RN    631-665-3737 ext 132      
Contact: Kerri Weingard, NP    631.665.3737      
United States, Pennsylvania
Richard Landau, MD Recruiting
Sellersville, Pennsylvania, United States, 18960
Contact: LouAnn Crist, RN    215-257-3066      
Contact: Trista Rochon    215.540.5870      
United States, Texas
H. Pat Hezmall, MD Recruiting
Fort Worth, Texas, United States, 73104
Contact: Kathy Marshall    817-332-8595      
United States, Virginia
Michael Godschalk, MD Recruiting
Richmond, Virginia, United States, 23249
Contact: Tammy Creasy, RN    804-675-5705      
United States, Washington
Roger Fincher, MD Recruiting
Spokane, Washington, United States, 99202
Contact: Sarah Collins    509-747-7900      
Sponsors and Collaborators
Milkhaus Laboratory
  More Information

No publications provided

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:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014