Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer

NCT00128531 ↗

Phase 3 Completed 120 enrolled GP-Pharm

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to look at the efficacy and safety of leuprolide acetate in patients with prostate cancer.

Timeline

Start: 2005-09
Primary completion: —
Completion: 2007-11

Outcome

Met primary endpoint

paper The proportion of successful patients over the total number of evaluable patients was 96.8% (152/157; 95% CI,92.7%-99.0%). PMID 20435244 ↗

paper Leuprolide acetate 3.75-mg depot was effective in achieving and maintaining testosterone suppression and was well tolerated throughout the study in this cohort of patients with prostate cancer. PMID 20435244 ↗

Publications

Marberger M, Kaisary AV, Shore ND, Karlin GS, Savulsky C, Mis R, Leuratti C, Germa JR. Effectiveness, pharmacokinetics, and safety of a new sustained-release leuprolide acetate 3.75-mg depot formulation for testosterone suppression in patients with prostate cancer: a Phase III, open-label, international multicenter study. Clin Ther. 2010 Apr;32(4):744-57. doi: 10.1016/j.clinthera.2010.04.013.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Leuprolide	Other / unclassified	3.75 mg	Intramuscular