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Clinical Trial Summary

This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy of ozarelix compared to placebo in the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) in men as assessed by the International Prostate Symptom Score (IPSS) at Week 14.


Clinical Trial Description

This is a multi-center, randomized, double-blind, placebo-controlled study. Participants who meet the entry IPSS inclusion criteria at Week 0 will be randomized and enroll in the double-blind treatment period. Participants will be randomized to one of three treatment arms and will receive two 6-month courses of study drug administered on Days 0 and 14 of each 6-month course. Treatment arms include: ozarelix 30mg + 15mg, ozarelix 15mg + 15mg or placebo + placebo. Safety and efficacy assessments will be performed at defined intervals throughout the study. At Week 52 all participants on study will be eligible to receive ozarelix for two additional courses in the open-label treatment period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00743184
Study type Interventional
Source Spectrum Pharmaceuticals, Inc
Contact
Status Terminated
Phase Phase 2
Start date December 4, 2008
Completion date January 20, 2010

See also
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