A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.

What Was Tested

In this phase 3 trial, researchers set out to test Triptorelin.

GnRH (Gonadotropin-releasing Hormone) stimulation at Month 6 (Day 169) in Chinese children with CPP (Central Precocious Puberty).

It had 1 arm (groups): Triptorelin formulation for Intramuscular injection (IM). (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 66 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: Participant must present evidence of CPP documented by:. Difference between bone age (BA) and CA \>1 year.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: gonadotropin-independent (peripheral) precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion; non-progressing isolated premature thelarche; presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. participants with hamartomas not requiring surgery are eligible.

How the Study Was Run

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

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

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

It started in 2021-08-10 with completion listed for 2022-08-21.

It ran at 14 sites in China (14).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants With Luteinising Hormone (LH) Suppression (time frame: At Month 6).

It also tracked 16 secondary outcomes, for example Percentage of Participants With LH Response to GnRH Test, Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels, Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test, Percentage of Participants With Prepubertal Levels of Sex Steroids, Change From Baseline in Mean Height for Age (Z-Score) and Change From Baseline in Percentile for Height for Age.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Triptorelin in 66 people.

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

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