Clinical trial NCT00044226: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostatic Hyperplasia
Keywords: BPH
Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy
Enlarged Prostate
Lead sponsor: Milkhaus Laboratory
Sponsor class: INDUSTRY
First posted: 2002-08-23
Enrollment: 350
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Charles White, MD
state: Alabama
city: Fair Oaks
country: United States
facility: Douglas Young, MD
state: California
city: Stanford
country: United States
facility: Rodney Anderson, MD
state: California
city: Van Nuys
country: United States
facility: Eugene Dula, MD
state: California
city: Aurora
country: United States
facility: Joel Kaufman, MD
state: Colorado
city: Clearwater
country: United States
facility: Donald Bergner, MD
state: Florida
city: Ocala
country: United States
facility: Ira Klimberg, MD
state: Florida
city: Rockville
country: United States
facility: Gary Friedlander, MD
state: Maryland
city: Las Vegas
country: United States
facility: Sheldon Freedman, MD
state: Nevada
city: Bay Shore
country: United States
facility: Edward Loizides, MD
state: New York
city: Sellersville
country: United States
facility: Richard Landau, MD
state: Pennsylvania
city: Fort Worth
country: United States
facility: H. Pat Hezmall, MD
state: Texas
city: Richmond
country: United States
facility: Michael Godschalk, MD
state: Virginia
city: Spokane
country: United States
facility: Roger Fincher, MD
state: Washington
Study officials:
References: