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Sponsored by: |
Threshold Pharmaceuticals |
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Information provided by: | Threshold Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00237536 |
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 |
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Benign Prostatic Hyperplasia |
Drug: Lonidamine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 65 Years to 80 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Active cardiac, renal or hepatic disease as evidenced by:
Study ID Numbers: | TH-CR-203 |
Study First Received: | October 10, 2005 |
Last Updated: | February 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00237536 |
Health Authority: | United States: Food and Drug Administration |
Benign Prostatic Hyperplasia BPH Enlarged Prostate |
Hyperplasia Prostatic Diseases Prostatic Hyperplasia Lonidamine Genital Diseases, Male |
Anti-Infective Agents Trypanocidal Agents Antiprotozoal Agents Antineoplastic Agents Contraceptive Agents Physiological Effects of Drugs Reproductive Control Agents |
Contraceptive Agents, Male Pharmacologic Actions Antiparasitic Agents Pathologic Processes Radiation-Sensitizing Agents Therapeutic Uses Antispermatogenic Agents |