Efficacy and Safety of Leuprolide Acetate [amount hidden] in Subjects With Central Precocious Puberty

What Was Tested

The trial (phase 4) is built around Leuprolide.

Screening tests are performed after the subject agrees in writing to participate in the clinical trial, and subjects who meet the inclusion criteria and do not fall under the exclusion criteria are enrolled in the study.

The target patients in this study are pediatric patients who have been diagnosed with CPP but have not yet received GnRH agonist treatment, and all subjects perform GnRH stimulation tests to confirm their CPP diagnosis.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to people of any sex aged from 4 years up to 9 years.

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

Examples of who could join: Based on baseline visit (Day 0), those under the age of 10 for boys and those under the age of 9 for girls. Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP. Children with a body weight of more than 20 kg at screening. Children have a bone age that is ≥1 year older than their chronological age at screening. A signed written consent form by a legal representative who has been informed about this study.

The full record lists 7 inclusion and 19 exclusion criteria; among the exclusions: gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion; prior or current gnrh treatment for cpp; non-progressing isolated premature thelarche.

How the Study Was Run

It was run as a single-group and open-label study.

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 2024-12-12 with completion listed for 2026-06-15.

It ran at 9 sites in South Korea (9).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The percentage (%) of subjects with serum LH concentrations < [amount hidden]/L following an GnRH stimulation test.

It also tracked 5 secondary outcomes, for example The percentage of subject of Tanner stage (including menstruation), Height velocity (growth rate) and The ratio of bone age and chronological age.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Leuprolide in 50 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.