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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2002-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostatic Hyperplasia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

BPH Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy Enlarged Prostate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ML-04A

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Reach out to these primary contacts for questions about participation or study logistics.

Martha J. DuRuz-Lynch, BA

Sarah Collins

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ML-BPH-01

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

ML-04A

Eligibility Criteria

Inclusion Criteria

Sponsors

Milkhaus Laboratory

Locations

Charles White, MD

Douglas Young, MD

Rodney Anderson, MD

Eugene Dula, MD

Joel Kaufman, MD

Donald Bergner, MD

Ira Klimberg, MD

Gary Friedlander, MD

Sheldon Freedman, MD

Edward Loizides, MD

Richard Landau, MD

H. Pat Hezmall, MD

Michael Godschalk, MD

Roger Fincher, MD

Countries

Central Contacts

Martha J. DuRuz-Lynch, BA

Facility Contacts

Julie Clark

Stephanie Lanam

Nushin Namazi

Sandro Gomez

Bunny Petretti

Jamie Yingst

Shirley Spiot

Becky

Rustina Jones

Wendy Clover

Lisa Boyak

Cynthia Freedman

Diana Mauceri, RN

Kerri Weingard, NP

LouAnn Crist, RN

Trista Rochon

Kathy Marshall

Tammy Creasy, RN

Sarah Collins

Other Identifiers

ML-BPH-01