Clinical trial NCT00237536: Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose Comparison Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia
BPH
Enlarged Prostate
Lead sponsor: Threshold Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 240
Sex: MALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. Capable of understanding the purpose and risks of the study and sign a statement of informed consent
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:

1. 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.
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

Primary outcomes:
measure: IPSS
Secondary outcomes:
measure: Maximum urinary flow rate (Qmax)
measure: Post-void residual urine volume (PVR)
measure: Prostate volume
measure: Prostate specific antigen (PSA)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Advanced Clinical Therapeutics
state: Arizona
city: Atherton
country: United States
facility: Chris B. Threatt, MD Inc.
state: California
city: Culver City
country: United States
facility: Urological Sciences Research Foundation
state: California
city: Long Beach
country: United States
facility: Atlantic Urological Medical Group
state: California
city: Newport Beach
country: United States
facility: California Professional Research
state: California
city: San Diego
country: United States
facility: San Diego Uro-Research
state: California
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
city: Aurora
country: United States
facility: Urology Research Options
state: Colorado
city: Waterbury
country: United States
facility: Connecticut Clinical Research Center Urology Specialists
state: Connecticut
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Ocala
country: United States
facility: Florida Healthcare Research
state: Florida
city: Chicago
country: United States
facility: Midwest Prostate & Urology Health Center
state: Illinois
city: Peoria
country: United States
facility: Specialty Care Research
state: Illinois
city: Fort Wayne
country: United States
facility: Northeast Indiana research, LLC
state: Indiana
city: Jeffersonville
country: United States
facility: Metropolitan Urology
state: Indiana
city: Greenbelt
country: United States
facility: Werner, Murdock & Francis, PA, Urology Associates
state: Maryland
city: Las Vegas
country: United States
facility: Sheldon J. Freedman, MD Ltd.
state: Nevada
city: Cherry Hill
country: United States
facility: Delaware Valley Clinical Research
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrenceville Urology
state: New Jersey
city: Westampton
country: United States
facility: Urology Healthcare Associates
state: New Jersey
city: Garden City
country: United States
facility: Accumed Research Associates
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Columbus
country: United States
facility: Radiant Research. Columbus
state: Ohio
city: Lancaster
country: United States
facility: Urological Associates of Lancaster
state: Pennsylvania
city: State College
country: United States
facility: State College Urologic Associates
state: Pennsylvania
city: Providence
country: United States
facility: University Urological Research Institute
state: Rhode Island
city: Greer
country: United States
facility: Radiant Research, Greer
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas, Dept of Urology
state: Texas
city: Houston
country: United States
facility: Accelovance
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine, Scott Department of Urology
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research, LLC
state: Washington
Study officials:
References: