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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00237536
First Posted: October 12, 2005
Last Update Posted: April 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Threshold Pharmaceuticals
  Purpose
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).

Condition Intervention Phase
Benign Prostatic Hyperplasia Drug: Lonidamine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Threshold Pharmaceuticals:

Primary Outcome Measures:
  • IPSS

Secondary Outcome Measures:
  • Maximum urinary flow rate (Qmax)
  • Post-void residual urine volume (PVR)
  • Prostate volume
  • Prostate specific antigen (PSA)

Estimated Enrollment: 240
Study Start Date: June 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00237536


  Show 34 Study Locations
Sponsors and Collaborators
Threshold Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00237536     History of Changes
Other Study ID Numbers: TH-CR-203
First Submitted: October 10, 2005
First Posted: October 12, 2005
Last Update Posted: April 29, 2009
Last Verified: April 2009

Keywords provided by Threshold Pharmaceuticals:
Benign Prostatic Hyperplasia
BPH
Enlarged Prostate

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Lonidamine
Antineoplastic Agents
Antispermatogenic Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents