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

What Was Tested

The trial (phase 3) is built around Leuprolide.

It had two arms (groups): Leuprolide Injectable Emulsion (experimental) and Leuprorelin Acetate Microspheres for Injection (active comparator).

The registry classes the interventions as drug.

More on the Plan

All premenopausal women breast cancer subjects were randomly allocated to either the study group or control group in a 1:1 ratio.

Furthermore, all subjects received tamoxifen citrate treatment throughout the entire duration of the study.

Who Took Part

The registry lists 211 actual participants took part.

It was open to women only aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Premenopausal female subjects aged 18 to 55 years old. Histological or cytological confirmation of HR+，HER2- premenopausal breast cancer. Subjects have any breast cancer surgery before informing, and no clinical residual local regional lesions were found after the surgery. Life expectancy is not less than 12 weeks. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: history of evidence of distant metastatic lesions;; active hepatitis b, hepatitis c or hiv in screening.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Leuprolide group and the comparison group ran side by side rather than switching.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-08-21 with completion listed for 2025-11.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Observe the concentration of LH, FSH, E2 after treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 211 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.