A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty

What Was Tested

In this phase 4 trial, researchers set out to test Leuprolide.

The main aim is to see how leuprolide works to treat central precocious puberty in children.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

More on the Plan

The drug being tested in this study is called leuprorelin acetate depot 3M.

Leuprorelin acetate depot 3M will be tested to treat children who have central precocious puberty.

The study will enroll approximately 80 participants with CPP.

This multi-center trial will be conducted in China.

Who Took Part

Enrollment: 79 actual participants took part.

It was open to people of any sex aged up to 10 years.

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

Examples of who could join: Maximum age to participate is this study is up to 10 years (child). Early appearance of secondary sexual characteristics: Girls ≤8 years, Boys ≤9years. Body weight ≥20 kg.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: the participant has received gnrha treatment in a previous clinical study or as a therapeutic agent; the participant has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound; the participant has a diagnosis of peripheral precocious puberty.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Leuprolide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-03-12 with completion listed for 2024-12-19.

It ran at 5 sites in China (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants With Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24 (time frame: Week 24).

It also tracked 5 secondary outcomes, for example Percentage of Participants With Tanner Stage Regression or No Progression at Week 24, Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) and Number of Participants With Treatment-Emergent Adverse Events (TEAE).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Leuprolide in 79 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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