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

Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00044226
• Other study ID #: ML-BPH-01
• Status: Recruiting
• Phase: Phase 2
• First received: August 22, 2002
• Last updated: June 23, 2005
• Start date: April 2002
• Est. completion date: October 2002

Study information

• Verified date: August 2002
• Source: Milkhaus Laboratory
• Contact: Martha J. DuRuz-Lynch, BA
• Phone: 414.425.6566
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: October 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• ML-04A

Locations

Country	Name	City	State
United States	Joel Kaufman, MD	Aurora	Colorado
United States	Edward Loizides, MD	Bay Shore	New York
United States	Donald Bergner, MD	Clearwater	Florida
United States	Douglas Young, MD	Fair Oaks	California
United States	H. Pat Hezmall, MD	Fort Worth	Texas
United States	Sheldon Freedman, MD	Las Vegas	Nevada
United States	Charles White, MD	Mobile	Alabama
United States	Ira Klimberg, MD	Ocala	Florida
United States	Michael Godschalk, MD	Richmond	Virginia
United States	Gary Friedlander, MD	Rockville	Maryland
United States	Richard Landau, MD	Sellersville	Pennsylvania
United States	Roger Fincher, MD	Spokane	Washington
United States	Rodney Anderson, MD	Stanford	California
United States	Eugene Dula, MD	Van Nuys	California

Sponsors (1)

Lead Sponsor	Collaborator
Milkhaus Laboratory

Country where clinical trial is conducted

United States,