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

June 23, 2005 updated by: Milkhaus Laboratory

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 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

350

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Martha J. DuRuz-Lynch, BA
  • Phone Number: 414.425.6566

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milkhaus Laboratory

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion

October 1, 2002

Study Registration Dates

First Submitted

August 22, 2002

First Submitted That Met QC Criteria

August 22, 2002

First Posted (Estimate)

August 23, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

August 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML-BPH-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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