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

Primary Purpose

Prostatic Hyperplasia

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ML-04A
Sponsored by
Milkhaus Laboratory
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia focused on measuring BPH, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Enlarged Prostate

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Charles White, MDRecruiting
  • Douglas Young, MDRecruiting
  • Rodney Anderson, MDRecruiting
  • Eugene Dula, MDRecruiting
  • Joel Kaufman, MDRecruiting
  • Donald Bergner, MDRecruiting
  • Ira Klimberg, MDRecruiting
  • Gary Friedlander, MDRecruiting
  • Sheldon Freedman, MDRecruiting
  • Edward Loizides, MDRecruiting
  • Richard Landau, MDRecruiting
  • H. Pat Hezmall, MDRecruiting
  • Michael Godschalk, MDRecruiting
  • Roger Fincher, MDRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 22, 2002
Last Updated
June 23, 2005
Sponsor
Milkhaus Laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT00044226
Brief Title
A 20-Week Study of a New Treatment for Men With Benign Prostatic Hyperplasia (BPH).
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Unknown status
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Milkhaus Laboratory

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia
Keywords
BPH, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Enlarged Prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
350 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ML-04A

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martha J. DuRuz-Lynch, BA
Phone
414.425.6566
Facility Information:
Facility Name
Charles White, MD
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Clark
Phone
251-639-1661
Facility Name
Douglas Young, MD
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Lanam
Phone
916-961-7593
Facility Name
Rodney Anderson, MD
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nushin Namazi
Phone
650-724-0084
Facility Name
Eugene Dula, MD
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandro Gomez
Phone
818-901-8541
First Name & Middle Initial & Last Name & Degree
Bunny Petretti
Phone
818.901.8541
Facility Name
Joel Kaufman, MD
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Yingst
Phone
303-755-1625
Facility Name
Donald Bergner, MD
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirley Spiot
Phone
727-724-3316
First Name & Middle Initial & Last Name & Degree
Becky
Phone
727.724.3316
Facility Name
Ira Klimberg, MD
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rustina Jones
Phone
352-237-3949
Facility Name
Gary Friedlander, MD
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Clover
Phone
301-315-6081
Facility Name
Sheldon Freedman, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Boyak
Phone
702-732-0282
First Name & Middle Initial & Last Name & Degree
Cynthia Freedman
Phone
702.732.0282
Facility Name
Edward Loizides, MD
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Mauceri, RN
Phone
631-665-3737
Ext
132
First Name & Middle Initial & Last Name & Degree
Kerri Weingard, NP
Phone
631.665.3737
Facility Name
Richard Landau, MD
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LouAnn Crist, RN
Phone
215-257-3066
First Name & Middle Initial & Last Name & Degree
Trista Rochon
Phone
215.540.5870
Facility Name
H. Pat Hezmall, MD
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Marshall
Phone
817-332-8595
Facility Name
Michael Godschalk, MD
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammy Creasy, RN
Phone
804-675-5705
Facility Name
Roger Fincher, MD
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Collins
Phone
509-747-7900

12. IPD Sharing Statement

Learn more about this trial

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

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