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Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:
An Open-Label, Single-Arm Study of The Efficacy, Safety, and Pharmacokinetic Behavior of Leuprolide Mesylate Injectable Suspension (LMIS 25 mg) in Subjects With Prostate Cancer

Clinical Trial Summary

The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with prostate cancer, when administered as two injections twelve weeks apart.

Clinical Trial Description

This is a multi-national, multi-center, open-label, single-arm study. All subjects will be males with prostate cancer judged to be candidates for medical androgen ablation therapy and all will receive two injections of LMIS 25 mg twelve-week apart in an unblinded fashion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03261999
Study type Interventional
Source Foresee Pharmaceuticals Co., Ltd.
Contact
Status Completed
Phase Phase 3
Start date September 26, 2017
Completion date February 1, 2019
View Details
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