To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month
depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A
formulation will be deemed successful if the percentage of subjects with suppression of
testosterone to <= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of
the 2-sided 90% confidence interval), a protocol-specified criterion.