A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants

What Was Tested

This registered phase 4 trial tested Leuprolide.

It had 1 arm (groups): 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 1 month subcutaneous depot injection.

Leuprorelin is used to treat children who have CPP.

This study will look at whether leuprorelin can stop early puberty in pre-pubertal children.

Who Took Part

Enrollment: 307 actual participants took part.

It was open to people of any sex aged from 1 Year up to 9 years.

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

Examples of who could join: In the opinion of the investigator, the participant and/or parent(s) or legal guardian are capable of understanding and complying with protocol requirements. Has anticipated treatment duration of at least 2 year in investigator's judgment.

The full record lists 10 inclusion and 15 exclusion criteria; among the exclusions: has received any investigational compound within 30 days prior to screening; has received gonadotropin-releasing hormone analog (gnrha) treatment in a previous clinical study or as a therapeutic agent; has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

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

It started in 2015-08-07 with completion listed for 2018-11-23.

It ran at 9 sites in China (9).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 up to Week 100).

It also tracked 1 secondary outcome, for example Percentage of Participants With Regression or no Progression in Tanner Staging at Week 96.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Leuprolide in 307 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.