Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.

What Was Tested

The trial (phase 3) is built around Triptorelin.

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

Triptorelin was injected at day 1 and month 3. If participants were willing to enter the extension phase, two additional Triptorelin injections were given at month 6 and month 9.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 32 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: Difference between bone age (BA) (according to Greulich and Pyle method) and chronological age (CA) \>1 year. Age \< 9 years old for girls and \< 10 years old for boys at initiation of triptorelin treatment. Weight at least 20 kg.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: gonadotropin-independent (peripheral) precocious puberty: extra pituitary 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

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

Nothing was hidden in this open-label Triptorelin 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 2021-03-27 with completion listed for 2022-02-09.

It ran at 7 sites in China (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Participants With Luteinising Hormone (LH) Suppression After Gonadotropin-Releasing Hormone (GnRH) Stimulation (time frame: At Month 3).

It also tracked 16 secondary outcomes, for example Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels, Percentage of Participants With LH Suppression After GnRH Stimulation, Change From Baseline in Peak LH and FSH Level After GnRH Stimulation, Percentage of Participants With Prepubertal Levels of Sex Steroids, Change From Baseline in Estradiol Levels and Change From Baseline in Testosterone Levels.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Triptorelin in 32 people.

Its size is small, so on its own it can only give an early look.

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.