Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty

What Was Tested

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

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

The registry classes the interventions as drug.

Who Took Part

37 actual participants took part.

It was open to people of any sex.

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

Examples of who could join: Onset of sex characteristics (Tanner method) breast development in girls or testicular enlargement in boys before the age of 8 years in girls and 9 years in boys. Weight ≥ 20 kg. Proven central precocious puberty defined as onset of sex characteristics development (according to Tanner method) diagnosed before the age of 8 years in girls and 9 years in boys. Age at evaluation less than 9 years for girls and 10 years for boys. Difference Bone age (BA) (according to Greulich et Pyle method) - Chronological age (CA) \> 1 year.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion; patient with a cerebral tumour requiring a neurosurgery or cerebral irradiation; the patient has received a previous treatment with a gnrh analogue, or medroxyprogesterone or cyproterone acetate.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Triptorelin 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 2007-10 with completion listed for 2010-10.

It ran at 18 sites in France (18).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With a GnRH-stimulated LH Level ≤[amount hidden]/L.

It also tracked 14 secondary outcomes, for example Follicle Stimulating Hormone (FSH) Level Following GnRH Test, Basal FSH Level, Basal LH Level, Number of Girls With Oestradiol Levels ≤ 20 pg/ml, Testosterone Level and Number of Girls With Inhibin B Levels < 6 pg/ml.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Triptorelin in 37 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.