GP Pharm SA

主要目标 通过药效学参数比较在健康受试者中新型醋酸亮丙瑞林缓释微球3.75mg和注射用醋酸亮丙瑞林微球3.75mg的睾酮抑制作用，比较两组受试者4周末血清睾丸酮达到去势水平比率。 次要目标 评价醋酸亮丙瑞林缓释微球3.75mg的安全性和耐受性；评价醋酸亮丙瑞林缓释微球3.75mg的血药代动力学参数。

Some patients with prostate cancer benefit from androgen deprivation therapy which reduces levels of testosterone. Leuprolide is a synthetic Luteinizing hormone releasing hormone (LHRH) analogue which upon administration can decrease testosterone levels to ≤0.5 ng/mL. Leuprolide Acetate 22.5 mg Depot is a microencapsulated formulation of leuprolide which is released slowly over time and effectively reduces testosterone levels in many patients to ≤0.5 ng/mL for up to three months. In this study Leuprolide acetate 22.5 mg Depot will be administered by intramuscular injection twice over a period of 6 months. The proportion of patients with testosterone ≤0.5 ng/mL evaluated over a period of 168 days.

This is a multi-center, open-label study of 2 doses of leuprolide acetate 17 mg depot, administered three months apart, in subjects with prostate cancer who might benefit from medical androgen deprivation therapy