Evidence of brain metastasis, spinal cord compression, or urinary tract obstruction

Serum Testosterone levels below 150 ng/dL at Screening visit

Medical or radiological prostate cancer treatments within 2 months prior to the Screening visit

Surgical treatment of prostate cancer within 2 weeks prior to the Screening visit

Prior orchiectomy, hypophysectomy, or adrenalectomy

Prior use of LHRH agonists within 12 months prior to the Screening visit and during the study

Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer