Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
This study has been terminated.
Information provided by:
First received: October 10, 2005
Last updated: April 28, 2009
Last verified: April 2009
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).
Benign Prostatic Hyperplasia
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||A Randomized, Double-Blind, Placebo-Controlled, Dose Comparison Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
Primary Outcome Measures:
Secondary Outcome Measures:
- Maximum urinary flow rate (Qmax)
- Post-void residual urine volume (PVR)
- Prostate volume
- Prostate specific antigen (PSA)
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2006 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||65 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237536
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 10, 2005
||April 28, 2009
||United States: Food and Drug Administration
Keywords provided by Threshold Pharmaceuticals:
Benign Prostatic Hyperplasia
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 02, 2015
Genital Diseases, Male
Contraceptive Agents, Male
Physiological Effects of Drugs
Reproductive Control Agents