A Randomised Phase 3, Double Blind, Placebo-Controlled Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: EUCTR2005-001073-94-HU
• Lead Sponsor: Threshold Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 480

Inclusion Criteria

Eligible subjects will meet all of the following criteria:
1. Capable of understanding the purpose and risks of the study and sign a statement of informed consent
2. Male 50 –80 years of age
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
6. I-PSS (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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will be ineligible for this study based on any one of the following criteria:
1. Prior treatment for BPH other than alpha blockers (alpha-blockers are not allowed during the study)
2. Prior surgery of the prostate (except biopsies)
3. Current or past evidence of malignant disease of the prostate or prostatic intraepithelial neoplasia (subjects with PSA > 4 ng/mL must have had a negative biopsy within one year prior to enrollment or should undergo ultrasound–guided prostate biopsy to rule out malignant or pre-malignant prostate disease. Subject is eligible to enroll after one month from full recovery)
4. Active urinary tract infections (UTI)
5. 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 at screen • History of active myocardial infarction, unstable cardiac arrhythmias or stroke within 6 months prior to screening • Uncontrolled congestive heart failure
6. Uncontrolled diabetes mellitus (fasting blood glucose > 200 mg/dL)
7. Use of steroids for any reason (steroid usage is not allowed during the study)
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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified