Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
- Conditions
- Benign Prostatic HyperplasiaEnlarged Prostate
- Registration Number
- NCT00435448
- Lead Sponsor
- Threshold Pharmaceuticals
- Brief Summary
The purpose of this study is to evaluate the efficacy of lonidamine (50mg, 150mg) compared to placebo in subjects with symptomatic BPH.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 480
- 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
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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.)
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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.)
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Active urinary tract infections (UTI)
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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
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Uncontrolled diabetes mellitus (fasting blood glucose > 200 mg/dL)
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Use of systemic teriods for any reason (systemic steroid usage is not allowed during the study). Inhaled and/or topical steroids are allowed.
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Concurrent participation or participation in an investigational drug study within the past 30 days prior to screening
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method International prostate symptom score (I-PSS)
- Secondary Outcome Measures
Name Time Method Qmax on uroflowmetry Post micturitional residue Volume of the prostate PSA
Trial Locations
- Locations (58)
Vivantes Klinikum am Urban, Klinik für Urologie
🇩🇪Berlin, Germany
ClinPharm International GmbH & Co KG--Chemnitz
🇩🇪Chemnitz, Germany
ClinPharm International GmbH & Co KG--Dresden
🇩🇪Dresden, Germany
niversitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Urologie
🇩🇪Dresden, Germany
Gemeinschaftspraxis Jacobi - Hellmis
🇩🇪Duisburg, Germany
ClinPharm International GmbH & Co KG--Frankfurt/Main
🇩🇪Frankfurt, Germany
ClinPharm International GmbH & Co KG--Gorlitz
🇩🇪Gorlitz, Germany
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Urologie
🇩🇪Hamburg, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Urologie und Kinderurologie
🇩🇪Kiel, Germany
Universitätsklinik Köln, Klinik und Poliklinik für Urologie
🇩🇪Köln, Germany
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