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

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).

Study Overview

• Status: Terminated
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Lonidamine

• Study Type: Interventional
• Enrollment: 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Advanced Clinical Therapeutics
  • California
    • Atherton, California, United States, 94027
      • Chris B. Threatt, MD Inc.
    • Culver City, California, United States, 90232
      • Urological Sciences Research Foundation
    • Long Beach, California, United States, 90806
      • Atlantic Urological Medical Group
    • Newport Beach, California, United States, 92660
      • California Professional Research
    • San Diego, California, United States, 92103
      • San Diego Uro-Research
    • Stanford, California, United States, 94305
      • Stanford University Hospital
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Urology Research Options
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Connecticut Clinical Research Center Urology Specialists
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research
    • Ocala, Florida, United States, 34474
      • Florida Healthcare Research
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Midwest Prostate & Urology Health Center
    • Peoria, Illinois, United States, 61614
      • Specialty Care Research
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Northeast Indiana Research, LLC
    • Jeffersonville, Indiana, United States, 47130
      • Metropolitan Urology
  • Maryland
    • Greenbelt, Maryland, United States, 20770
      • Werner, Murdock & Francis, PA, Urology Associates
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Sheldon J. Freedman, MD Ltd.
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08003
      • Delaware Valley Clinical Research
    • Lawrenceville, New Jersey, United States, 08648
      • Lawrenceville Urology
    • Westampton, New Jersey, United States, 08060
      • Urology Healthcare Associates
  • New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
    • New York, New York, United States, 10016
      • New York University School of Medicine
    • New York, New York, United States, 10021
      • Weill Medical College of Cornell University
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Radiant Research. Columbus
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Urological Associates of Lancaster
    • State College, Pennsylvania, United States, 16801
      • State College Urologic Associates
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • University Urological Research Institute
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Radiant Research, Greer
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center at Dallas, Dept of Urology
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine, Scott Department of Urology
    • Houston, Texas, United States, 77024
      • Accelovance
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research
  • Washington
    • Mountlake Terrace, Washington, United States, 98043
      • Integrity Medical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
IPSS

Secondary Outcome Measures

Outcome Measure
Maximum urinary flow rate (Qmax)
Post-void residual urine volume (PVR)
Prostate volume
Prostate specific antigen (PSA)

Collaborators and Investigators

• Sponsor: Threshold Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (ACTUAL): August 1, 2006
• Study Completion (ACTUAL): August 1, 2006

Study Registration Dates

• First Submitted: October 10, 2005
• First Submitted That Met QC Criteria: October 10, 2005
• First Posted (ESTIMATE): October 12, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): April 29, 2009
• Last Update Submitted That Met QC Criteria: April 28, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia; BPH; Enlarged Prostate
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Contraceptive Agents; Reproductive Control Agents; Antiprotozoal Agents; Antiparasitic Agents; Trypanocidal Agents; Contraceptive Agents, Male; Antispermatogenic Agents; Lonidamine
• Other Study ID Numbers: TH-CR-203