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

NCT04914195 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2023-08-01

No results posted yet for this study

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

DRUG

Leuprolide Acetate 3.75 MG/ML

Leuprolide Acetate/ Leuprorelin is a depot injection administered as a subcutaneous injection once every month.

Sponsors & Collaborators

  • Bharat Serums and Vaccines Limited

    lead INDUSTRY

Principal Investigators

  • Anirban Roy Chowdhury · Bharat Serums and Vaccines Ltd

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-09-29
Completion
2022-09-29

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04914195 on ClinicalTrials.gov