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

Sponsor

Milkhaus Laboratory (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00044226

Collaborator

(none)

350

Enrollment

Locations

Duration (Months)

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia	Drug: ML-04A	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

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

Study Start Date :

Apr 1, 2002

Study Completion Date :

Oct 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charles White, MD	Mobile	Alabama	United States	36608
2	Douglas Young, MD	Fair Oaks	California	United States	95628
3	Rodney Anderson, MD	Stanford	California	United States	94305
4	Eugene Dula, MD	Van Nuys	California	United States	91405
5	Joel Kaufman, MD	Aurora	Colorado	United States	80012
6	Donald Bergner, MD	Clearwater	Florida	United States	33761
7	Ira Klimberg, MD	Ocala	Florida	United States	34474
8	Gary Friedlander, MD	Rockville	Maryland	United States	20850
9	Sheldon Freedman, MD	Las Vegas	Nevada	United States	89109
10	Edward Loizides, MD	Bay Shore	New York	United States	11706
11	Richard Landau, MD	Sellersville	Pennsylvania	United States	18960
12	H. Pat Hezmall, MD	Fort Worth	Texas	United States	73104
13	Michael Godschalk, MD	Richmond	Virginia	United States	23249
14	Roger Fincher, MD	Spokane	Washington	United States	99202