Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer

Summary

This is a Randomized, Active Controlled, Comparative, Open-Label, Multi-Center, Phase 3 clinical study to compare the efficacy, safety, and pharmacokinetics of leuprolide acetate for injection 3.75mg (depot) of two brands (Luprodex and Lucrin) administered in subjects with advanced adenocarcinoma of the prostate. Approximately 168 subjects (males )of age above 18 years fulfilling the eligibility criteria will be enrolled. The IP will be given as a monthly dose for two cycles on day 0 and day 28. The pharmacokinetic analysis will be done for 12 patients receiving Luprodex. The primary and secondary outcomes will be captured on days as per protocol. Adverse events will be noted for safety evaluation.

Timeline

Start

2021-07-01

Primary completion

2022-09-29

Completion

2022-09-29

Drugs

Indications