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Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia

Primary Purpose

Benign Prostatic Hyperplasia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lonidamine
Sponsored by
Threshold Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia, BPH, Enlarged Prostate

Eligibility Criteria

65 Years - 80 Years (Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Advanced Clinical Therapeutics
  • Chris B. Threatt, MD Inc.
  • Urological Sciences Research Foundation
  • Atlantic Urological Medical Group
  • California Professional Research
  • San Diego Uro-Research
  • Stanford University Hospital
  • Urology Research Options
  • Connecticut Clinical Research Center Urology Specialists
  • South Florida Medical Research
  • Tampa Bay Medical Research
  • Florida Healthcare Research
  • Midwest Prostate & Urology Health Center
  • Specialty Care Research
  • Northeast Indiana research, LLC
  • Metropolitan Urology
  • Werner, Murdock & Francis, PA, Urology Associates
  • Sheldon J. Freedman, MD Ltd.
  • Delaware Valley Clinical Research
  • Lawrenceville Urology
  • Urology Healthcare Associates
  • Accumed Research Associates
  • New York University School of Medicine
  • Weill Medical College of Cornell University
  • Radiant Research. Columbus
  • Urological Associates of Lancaster
  • State College Urologic Associates
  • University Urological Research Institute
  • Radiant Research, Greer
  • UT Southwestern Medical Center at Dallas, Dept of Urology
  • Accelovance
  • Baylor College of Medicine, Scott Department of Urology
  • Urology San Antonio Research
  • Integrity Medical Research, LLC

Outcomes

Primary Outcome Measures

IPSS

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2005
Last Updated
April 28, 2009
Sponsor
Threshold Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00237536
Brief Title
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

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Terminated
Study Start Date
June 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Threshold Pharmaceuticals

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Benign Prostatic Hyperplasia, BPH, Enlarged Prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
240 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lonidamine
Primary Outcome Measure Information:
Title
IPSS
Secondary Outcome Measure Information:
Title
Maximum urinary flow rate (Qmax)
Title
Post-void residual urine volume (PVR)
Title
Prostate volume
Title
Prostate specific antigen (PSA)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Advanced Clinical Therapeutics
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Chris B. Threatt, MD Inc.
City
Atherton
State/Province
California
ZIP/Postal Code
94027
Country
United States
Facility Name
Urological Sciences Research Foundation
City
Culver City
State/Province
California
ZIP/Postal Code
90232
Country
United States
Facility Name
Atlantic Urological Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
California Professional Research
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
San Diego Uro-Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Stanford University Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Urology Research Options
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Connecticut Clinical Research Center Urology Specialists
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Tampa Bay Medical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Florida Healthcare Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Midwest Prostate & Urology Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Specialty Care Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Northeast Indiana research, LLC
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Metropolitan Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Werner, Murdock & Francis, PA, Urology Associates
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Sheldon J. Freedman, MD Ltd.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Delaware Valley Clinical Research
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Lawrenceville Urology
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Urology Healthcare Associates
City
Westampton
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Accumed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Radiant Research. Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Urological Associates of Lancaster
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
State College Urologic Associates
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
University Urological Research Institute
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
Radiant Research, Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas, Dept of Urology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Accelovance
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Baylor College of Medicine, Scott Department of Urology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Integrity Medical Research, LLC
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia

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