Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
A Randomized, Double-Blind, Placebo-Controlled, Dose Comparison Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
1 other identifier
interventional
240
1 country
34
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2005
Shorter than P25 for phase_2
34 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
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 10, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedApril 29, 2009
April 1, 2009
1.2 years
October 10, 2005
April 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IPSS
Secondary Outcomes (4)
Maximum urinary flow rate (Qmax)
Post-void residual urine volume (PVR)
Prostate volume
Prostate specific antigen (PSA)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- Prior surgery of the prostate (except biopsies; subject is eligible to enroll one month after full recovery from prostate biopsy.)
- 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).
- Active urinary tract infections (UTI)
- 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
- Uncontrolled diabetes mellitus (fasting blood glucose \> 200 mg/dL)
- Use of systemic steroids for any reason (systemic steroid usage is not allowed during the study). Inhaled and/or topical steroids are allowed.
- Concurrent participation or participation in an investigational drug study within the past 30 days prior to screening
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Advanced Clinical Therapeutics
Tucson, Arizona, 85712, United States
Chris B. Threatt, MD Inc.
Atherton, California, 94027, United States
Urological Sciences Research Foundation
Culver City, California, 90232, United States
Atlantic Urological Medical Group
Long Beach, California, 90806, United States
California Professional Research
Newport Beach, California, 92660, United States
San Diego Uro-Research
San Diego, California, 92103, United States
Stanford University Hospital
Stanford, California, 94305, United States
Urology Research Options
Aurora, Colorado, 80012, United States
Connecticut Clinical Research Center Urology Specialists
Waterbury, Connecticut, 06708, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
Florida Healthcare Research
Ocala, Florida, 34474, United States
Midwest Prostate & Urology Health Center
Chicago, Illinois, 60640, United States
Specialty Care Research
Peoria, Illinois, 61614, United States
Northeast Indiana research, LLC
Fort Wayne, Indiana, 46825, United States
Metropolitan Urology
Jeffersonville, Indiana, 47130, United States
Werner, Murdock & Francis, PA, Urology Associates
Greenbelt, Maryland, 20770, United States
Sheldon J. Freedman, MD Ltd.
Las Vegas, Nevada, 89109, United States
Delaware Valley Clinical Research
Cherry Hill, New Jersey, 08003, United States
Lawrenceville Urology
Lawrenceville, New Jersey, 08648, United States
Urology Healthcare Associates
Woodlane, New Jersey, 08060, United States
Accumed Research Associates
Garden City, New York, 11530, United States
New York University School of Medicine
New York, New York, 10016, United States
Weill Medical College of Cornell University
New York, New York, 10021, United States
Radiant Research. Columbus
Columbus, Ohio, 43212, United States
Urological Associates of Lancaster
Lancaster, Pennsylvania, 17604, United States
State College Urologic Associates
State College, Pennsylvania, 16801, United States
University Urological Research Institute
Providence, Rhode Island, 02904, United States
Radiant Research, Greer
Greer, South Carolina, 29651, United States
UT Southwestern Medical Center at Dallas, Dept of Urology
Dallas, Texas, 75390, United States
Accelovance
Houston, Texas, 77024, United States
Baylor College of Medicine, Scott Department of Urology
Houston, Texas, 77030, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
Integrity Medical Research, LLC
Mountlake Terrace, Washington, 98043, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 10, 2005
First Posted
October 12, 2005
Study Start
June 1, 2005
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
April 29, 2009
Record last verified: 2009-04