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| Sponsor: | Milkhaus Laboratory |
|---|---|
| Information provided by: | Milkhaus Laboratory |
| ClinicalTrials.gov Identifier: | NCT00044226 |
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 II |
| 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 |
| Estimated Enrollment: | 350 |
| Study Start Date: | April 2002 |
| Estimated Study Completion Date: | October 2002 |
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 |
Contacts and Locations| Contact: Martha J. DuRuz-Lynch, BA | 414.425.6566 |
| 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 | |
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 |
|
BPH Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy Enlarged Prostate |
|
Prostatic Hyperplasia Hyperplasia Prostatic Diseases Genital Diseases, Male Pathologic Processes |
