Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
NCT ID: NCT00237536
Last Updated: 2009-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
240 participants
INTERVENTIONAL
2005-06-30
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Lonidamine
Eligibility Criteria
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Inclusion Criteria
2. Male 65-80 years of age (or 40-80 with vasectomy). Vasectomized men must have documentation of azoospermia.
3. Presence of LUTS (lower urinary tract symptoms) for at least 3 months
4. Prostate volume measured by TRUS (transrectal ultrasound) \> 30 cc
5. Qmax \< 15 mL/sec when measured by uroflowmetry (minimum of 125 mL must be voided)
6. IPSS (International Prostate Symptom Score) \> 12
7. PSA \> 1.0 ng/mL
8. Must ensure and consent to use medically acceptable methods of contraception throughout the entire study with sexual partners of childbearing potential
9. Able to comply with the prescribed treatment protocol and evaluations
Exclusion Criteria
2. Prior surgery of the prostate (except biopsies; subject is eligible to enroll one month after full recovery from prostate biopsy.)
3. Current or past evidence of malignant disease of the prostate or prostatic intraepithelial neoplasia (For subjects with PSA between 4 - 10 ng/mL, prostate cancer must be ruled out to the satisfaction of the Principal Investigator. Subjects with PSA \>10 ng/mL are excluded).
4. Active urinary tract infections (UTI)
5. Active cardiac, renal or hepatic disease as evidenced by:
1. Serum creatinine \> 1.8 mg/dL
2. ALT or AST \> 2.5x the upper limit of normal
3. History of active myocardial infarction, unstable cardiac arrhythmias, or stroke within 6 months prior to screening
4. Uncontrolled congestive heart failure
6. Uncontrolled diabetes mellitus (fasting blood glucose \> 200 mg/dL)
7. Use of systemic steroids for any reason (systemic steroid usage is not allowed during the study). Inhaled and/or topical steroids are allowed.
8. Concurrent participation or participation in an investigational drug study within the past 30 days prior to screening
9. Concomitant disease or condition that could interfere with the conduct of the study, or would in the opinion of the Investigator, pose an unacceptable risk to the subject
65 Years
80 Years
MALE
No
Sponsors
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Threshold Pharmaceuticals
INDUSTRY
Locations
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Advanced Clinical Therapeutics
Tucson, Arizona, United States
Chris B. Threatt, MD Inc.
Atherton, California, United States
Urological Sciences Research Foundation
Culver City, California, United States
Atlantic Urological Medical Group
Long Beach, California, United States
California Professional Research
Newport Beach, California, United States
San Diego Uro-Research
San Diego, California, United States
Stanford University Hospital
Stanford, California, United States
Urology Research Options
Aurora, Colorado, United States
Connecticut Clinical Research Center Urology Specialists
Waterbury, Connecticut, United States
South Florida Medical Research
Aventura, Florida, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
Florida Healthcare Research
Ocala, Florida, United States
Midwest Prostate & Urology Health Center
Chicago, Illinois, United States
Specialty Care Research
Peoria, Illinois, United States
Northeast Indiana research, LLC
Fort Wayne, Indiana, United States
Metropolitan Urology
Jeffersonville, Indiana, United States
Werner, Murdock & Francis, PA, Urology Associates
Greenbelt, Maryland, United States
Sheldon J. Freedman, MD Ltd.
Las Vegas, Nevada, United States
Delaware Valley Clinical Research
Cherry Hill, New Jersey, United States
Lawrenceville Urology
Lawrenceville, New Jersey, United States
Urology Healthcare Associates
Woodlane, New Jersey, United States
Accumed Research Associates
Garden City, New York, United States
New York University School of Medicine
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Radiant Research. Columbus
Columbus, Ohio, United States
Urological Associates of Lancaster
Lancaster, Pennsylvania, United States
State College Urologic Associates
State College, Pennsylvania, United States
University Urological Research Institute
Providence, Rhode Island, United States
Radiant Research, Greer
Greer, South Carolina, United States
UT Southwestern Medical Center at Dallas, Dept of Urology
Dallas, Texas, United States
Accelovance
Houston, Texas, United States
Baylor College of Medicine, Scott Department of Urology
Houston, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
Integrity Medical Research, LLC
Mountlake Terrace, Washington, United States
Countries
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Other Identifiers
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TH-CR-203
Identifier Type: -
Identifier Source: org_study_id
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