Evaluate the Efficacy and Safety of DWJ108J

What Was Tested

This registered phase 3 trial tested Leuprolide.

It had 1 arm (groups): Experimental: Leuprorelin (experimental).

The registry classes the interventions as drug.

More on the Plan

The drug in this study is called leuprorelin.

It is administered as a 3 month subcutaneous depot injection.

Leuprorelin is used to treat children who have Central Precocious Puberty.

This study will look at whether leuprorelin can stop early Central Precocious Puberty.

Who Took Part

The registry lists 79 planned participants were the target.

It was open to people of any sex aged from 4 years up to 10 years.

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

Examples of who could join: Diagnosis of central precocious puberty. For boys, those under 10 years old and for girls, those under 9 years old, based on Visit 2 (Enrollment), with Tanner Stage 2 or above. Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year. In cases where the legal guardian of the child listened to the explanation of this clinical trial and provided written consent.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: following conditions at visit 1(screening) :; requires treatment within 6 months of receiving a registration number during the trial period that could affect the hypothalamic-pituitary-gonadal axis; prior treatment with gnrh analogues.

How the Study Was Run

The set-up was 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 2023-08-01 with completion listed for 2025-02-28.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months (time frame: 6 months).

It also tracked 7 secondary outcomes, for example Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 3 Months, Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration, Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration, Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration and Average Tanner Stage at 6 months after administration, and the changes compared to before administration.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Leuprolide in 79 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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