Recruiting
Phase 2

New Treatment

Sponsor:

Milkhaus Laboratory

Code:

NCT00044226

Conditions

Prostatic Hyperplasia

Eligibility Criteria

Sex: Male

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

ML-04A

Study Details

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.

Conditions

Prostatic Hyperplasia

Study ID

NCT00044226

Start date

Apr, 2002

Status verified date

Aug, 2002

Completion date

Oct, 2002

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 45 - 70+

Healthy Volunteers: Accepted

  • 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 Design

Enrollment

350 participants

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

ML-04A

Central Contacts and Locations

Central contacts

Martha J. DuRuz-Lynch, BA

414.425.6566

Locations

Charles White, MD

Recruiting

Mobile, Alabama, United States, 36608

Contacts

Julie Clark

251-639-1661

Douglas Young, MD

Recruiting

Fair Oaks, California, United States, 95628

Contacts

Stephanie Lanam

916-961-7593

Rodney Anderson, MD

Recruiting

Stanford, California, United States, 94305

Contacts

Nushin Namazi

650-724-0084

Eugene Dula, MD

Recruiting

Van Nuys, California, United States, 91405

Contacts

Sandro Gomez

818-901-8541

Bunny Petretti

818.901.8541

Joel Kaufman, MD

Recruiting

Aurora, Colorado, United States, 80012

Contacts

Jamie Yingst

303-755-1625

Donald Bergner, MD

Recruiting

Clearwater, Florida, United States, 33761

Contacts

Shirley Spiot

727-724-3316

Becky

727.724.3316

Ira Klimberg, MD

Recruiting

Ocala, Florida, United States, 34474

Contacts

Rustina Jones

352-237-3949

Gary Friedlander, MD

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Wendy Clover

301-315-6081

Sheldon Freedman, MD

Recruiting

Las Vegas, Nevada, United States, 89109

Contacts

Lisa Boyak

702-732-0282

Cynthia Freedman

702.732.0282

Edward Loizides, MD

Recruiting

Bay Shore, New York, United States, 11706

Contacts

Diana Mauceri, RN

631-665-3737

Kerri Weingard, NP

631.665.3737

Richard Landau, MD

Recruiting

Sellersville, Pennsylvania, United States, 18960

Contacts

LouAnn Crist, RN

215-257-3066

Trista Rochon

215.540.5870

H. Pat Hezmall, MD

Recruiting

Fort Worth, Texas, United States, 73104

Contacts

Kathy Marshall

817-332-8595

Michael Godschalk, MD

Recruiting

Richmond, Virginia, United States, 23249

Contacts

Tammy Creasy, RN

804-675-5705

Roger Fincher, MD

Recruiting

Spokane, Washington, United States, 99202

Contacts

Sarah Collins

509-747-7900

More Information

Sponsor

Milkhaus Laboratory

Last update posted

Jun 24, 2005

Last verified

Aug, 2002

Keywords

  • BPH
  • Benign Prostatic Hyperplasia
  • Benign Prostatic Hypertrophy
  • Enlarged Prostate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Milkhaus Laboratory on 2005-06-24.