drugset / Trial / NCT06449027

Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.

NCT06449027

Phase 3 Active not recruiting 211 enrolled Changchun GeneScience Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.

Timeline

Start
2024-08-21
Primary completion
2025-11
Completion
2026-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Leuprolide Other / unclassified 11.25 mg
Subject Leuprolide Other / unclassified 42 mg
Background Tamoxifen Small molecule 10 mg

Indications