Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
- Conditions
- Benign Prostatic Hyperplasia
- Registration Number
- NCT00237536
- Lead Sponsor
- Threshold Pharmaceuticals
- Brief Summary
The purpose of this trial is to evaluate the dose response relationship of lonidamine and the primary efficacy endpoint, International Prostate Symptom Score (IPSS), in subjects with symptomatic benign prostatic hyperplasia (BPH).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 240
- Capable of understanding the purpose and risks of the study and sign a statement of informed consent
- Male 65-80 years of age (or 40-80 with vasectomy). Vasectomized men must have documentation of azoospermia.
- Presence of LUTS (lower urinary tract symptoms) for at least 3 months
- Prostate volume measured by TRUS (transrectal ultrasound) > 30 cc
- Qmax < 15 mL/sec when measured by uroflowmetry (minimum of 125 mL must be voided)
- IPSS (International Prostate Symptom Score) > 12
- PSA > 1.0 ng/mL
- Must ensure and consent to use medically acceptable methods of contraception throughout the entire study with sexual partners of childbearing potential
- Able to comply with the prescribed treatment protocol and evaluations
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Prior treatment for BPH with alpha blockers and/or herbal supplements for the treatment of BPH in the past 2 weeks (alpha-blockers and/or herbal supplements for the treatment of BPH are not allowed during the study). Prior treatment with 5-alpha reductase inhibitors is allowed if discontinued at least 3 months prior to enrollment.
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Prior surgery of the prostate (except biopsies; subject is eligible to enroll one month after full recovery from prostate biopsy.)
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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).
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Active urinary tract infections (UTI)
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Active cardiac, renal or hepatic disease as evidenced by:
- Serum creatinine > 1.8 mg/dL
- ALT or AST > 2.5x the upper limit of normal
- History of active myocardial infarction, unstable cardiac arrhythmias, or stroke within 6 months prior to screening
- Uncontrolled congestive heart failure
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Uncontrolled diabetes mellitus (fasting blood glucose > 200 mg/dL)
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Use of systemic steroids for any reason (systemic steroid usage is not allowed during the study). Inhaled and/or topical steroids are allowed.
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Concurrent participation or participation in an investigational drug study within the past 30 days prior to screening
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method IPSS
- Secondary Outcome Measures
Name Time Method Maximum urinary flow rate (Qmax) Post-void residual urine volume (PVR) Prostate volume Prostate specific antigen (PSA)
Trial Locations
- Locations (34)
Stanford University Hospital
🇺🇸Stanford, California, United States
Specialty Care Research
🇺🇸Peoria, Illinois, United States
Werner, Murdock & Francis, PA, Urology Associates
🇺🇸Greenbelt, Maryland, United States
Advanced Clinical Therapeutics
🇺🇸Tucson, Arizona, United States
Florida Healthcare Research
🇺🇸Ocala, Florida, United States
Urology Healthcare Associates
🇺🇸Westampton, New Jersey, United States
Connecticut Clinical Research Center Urology Specialists
🇺🇸Waterbury, Connecticut, United States
Metropolitan Urology
🇺🇸Jeffersonville, Indiana, United States
Accumed Research Associates
🇺🇸Garden City, New York, United States
Radiant Research, Greer
🇺🇸Greer, South Carolina, United States
Atlantic Urological Medical Group
🇺🇸Long Beach, California, United States
University Urological Research Institute
🇺🇸Providence, Rhode Island, United States
Delaware Valley Clinical Research
🇺🇸Cherry Hill, New Jersey, United States
Lawrenceville Urology
🇺🇸Lawrenceville, New Jersey, United States
New York University School of Medicine
🇺🇸New York, New York, United States
California Professional Research
🇺🇸Newport Beach, California, United States
San Diego Uro-Research
🇺🇸San Diego, California, United States
Urology Research Options
🇺🇸Aurora, Colorado, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Tampa Bay Medical Research
🇺🇸Clearwater, Florida, United States
Midwest Prostate & Urology Health Center
🇺🇸Chicago, Illinois, United States
Northeast Indiana research, LLC
🇺🇸Fort Wayne, Indiana, United States
Sheldon J. Freedman, MD Ltd.
🇺🇸Las Vegas, Nevada, United States
Radiant Research. Columbus
🇺🇸Columbus, Ohio, United States
State College Urologic Associates
🇺🇸State College, Pennsylvania, 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
Chris B. Threatt, MD Inc.
🇺🇸Atherton, California, United States
Urological Sciences Research Foundation
🇺🇸Culver City, California, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Urological Associates of Lancaster
🇺🇸Lancaster, Pennsylvania, United States
Integrity Medical Research, LLC
🇺🇸Mountlake Terrace, Washington, United States