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

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the efficacy of lonidamine (50mg, 150mg) compared to placebo in subjects with symptomatic BPH.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Threshold Pharmaceuticals
• Collaborator: PRA Health Sciences
• Treatments: Lonidamine

Criteria

Inclusion Criteria:

• Capable of understanding the purpose and risks of the study and sign a statement of informed consent

• Male 50-80 years of age

• 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)

• I-PSS (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 in the past 2 weeks (alpha-blockers and 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:

1. Serum creatinine > 1.8 mg/dL

2. ALT or AST > 2.5x the upper limit of normal at screen

3. History of active myocardial infarction,unstable cardiac arrhythmias or stroke within 6 months prior to screening

4. Uncontrolled congestive heart failure

• Uncontrolled diabetes mellitus (fasting blood glucose > 200 mg/dL)

• Use of systemic teriods 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 unnaceptabele risk to the subject