NCT04914195

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

Efficacy, Safety, and Pharmaco-kinetics of Leuprolide Acetate for Injection 3.75mg (Depot) (Leuprorelin) Administered in Subjects With Advanced Adenocarcinoma of Prostate: A Randomized, Active Controlled, Comparative, Open-Label, Multi-Center, Phase 3 Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Bharat Serums and Vaccines Limited · Industry
• Sex: Male
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Leuprolide Acetate 3.75 MG/ML	Leuprolide Acetate/ Leuprorelin is a depot injection administered as a subcutaneous injection once every month.

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-09-29
• Completion: 2022-09-29
• First posted: 2021-06-04
• Last updated: 2023-08-01

Locations

2 sites across 1 country: India