AEterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today reported Phase 3 results for its North American efficacy trial Z-033 and the safety trial Z-041 in benign prostatic hyperplasia , with its lead endocrinology compound for urology, cetrorelix pamoate. As announced on March 6, 2009, sanofi-aventis U.S. LLC entered into an agreement with AEterna Zentaris for the development, registration and marketing of cetrorelix in BPH for the U.S. market.
The first multi-center efficacy trial Z-033 was conducted in 53 sites in the United States and Canada, with 8 additional sites in Europe. The study involved 667 patients under the supervision of lead investigator, Herbert Lepor, M.D., Professor and Chairman, Department of Urology, at NYU School of Medicine, New York. Patients entered a 1- to 4-week screening period to confirm severity and stability of voiding symptoms based on the International Prostate Symptom Score . Patients were then randomly allocated to cetrorelix or placebo in a double-blind fashion. Patients were administered cetrorelix by intra-muscular injection at Week 0, 2, 26 and 28 (for treatment Arm A, those in Arm B received IM injection at week 0, 2 and 26 followed by placebo at Week 28). Patients in treatment Arm C received placebo injections at Week 0, 2, 26 and 28. All patients were followed up to Week 52.
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