A 20-Week Study of a New Treatment for Men With Benign Prostatic Hyperplasia (BPH).
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
1 other identifier
interventional
350
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2002
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 22, 2002
CompletedFirst Posted
Study publicly available on registry
August 23, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2002
CompletedJune 24, 2005
August 1, 2002
August 22, 2002
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (14)
Charles White, MD
Mobile, Alabama, 36608, United States
Douglas Young, MD
Fair Oaks, California, 95628, United States
Rodney Anderson, MD
Stanford, California, 94305, United States
Eugene Dula, MD
Van Nuys, California, 91405, United States
Joel Kaufman, MD
Aurora, Colorado, 80012, United States
Donald Bergner, MD
Clearwater, Florida, 33761, United States
Ira Klimberg, MD
Ocala, Florida, 34474, United States
Gary Friedlander, MD
Rockville, Maryland, 20850, United States
Sheldon Freedman, MD
Las Vegas, Nevada, 89109, United States
Edward Loizides, MD
Bay Shore, New York, 11706, United States
Richard Landau, MD
Sellersville, Pennsylvania, 18960, United States
H. Pat Hezmall, MD
Fort Worth, Texas, 73104, United States
Michael Godschalk, MD
Richmond, Virginia, 23249, United States
Roger Fincher, MD
Spokane, Washington, 99202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 22, 2002
First Posted
August 23, 2002
Study Start
April 1, 2002
Study Completion
October 1, 2002
Last Updated
June 24, 2005
Record last verified: 2002-08