Efficacy, Metabolism and BMD of the 3-month TP Compared to the 1-month TP in ICPP

What Was Tested

This registered phase 4 trial tested Triptorelin.

It had two arms (groups): 3-month triptorelin (experimental) and 1-month triptorelin (active comparator).

Triptorelin pamoate is administered via intramuscular injection once every three months.

The registry classes the interventions as drug.

More on the Plan

Idiopathic central precocious puberty (CPP) is an important treatable disease causing pubertal growth disorders.

Gonadotropin-releasing hormone analogs (GnRHa) are the first-line drugs for treating idiopathic central precocious puberty (ICPP).

In currently reported safety events both domestically and internationally, there are no reports on the effects of the 3-month formulation of triptorelin on patients' glucose and lipid metabolism, body composition, and bone density.

Additionally, the researchers will assess the short-term effects of the 3-month formulation of triptorelin on glucose and lipid metabolism, body composition, and bone density in ICPP patients.

Who Took Part

The registry lists 134 planned participants were the target.

It was open to people of any sex aged from 2 years up to 10 years.

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

Examples of who could join: Early appearance of secondary sexual characteristics, specifically breast development in girls before 8 years old or menarche before 10 years old, and testicular enlargement in boys before 9 years old. Bone age (BA) exceeds chronological age (CA) by 1 year or more (based on bone age assessment during the screening period at this center). Accelerated linear growth, with an annual growth rate higher than that of healthy children of the same age. No prior treatment with gonadotropin-releasing hormone agonists. Body weight of at least 20 kg.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: target diseases:; treatment history, medical history, and concomitant medical conditions:; known hypersensitivity to any investigational substance or related compounds.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2024-07-01 with completion listed for 2026-12-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The proportion of LH of ≤ [amount hidden]/L.

It also tracked 11 secondary outcomes, for example Basal LH（ IU/L),Basal FSH（IU/L), Estradiol (female) (pg/mL)and testosterone (male)(pg/mL), Tanner stage, Uterine length (female)（mL) and testicular volume (male)(mL), Growth velocity (cm/y), BA/CA and PAH(cm).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Triptorelin in 134 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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