Efficacy and Safety of Leuprolide Acetate 22.5 mg Depot in Treatment of Prostate Cancer
Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
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.