Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty

What Was Tested

This registered phase 3 trial tested Leuprolide.

It had 1 arm (groups): Assigned Intervention (experimental).

The registry classes the interventions as drug.

More on the Plan

Leuprolide acetate is a GnRH agonist that inhibits pituitary gonadotropin secretion by binding to the GnRH receptors and blocking downstream hormone synthesis.

Who Took Part

Enrollment: 64 actual participants took part.

It was open to people of any sex aged from 2 years up to 9 years.

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

Examples of who could join: Females age 2 to 8 years (inclusive) or males age 2 to 9 years (inclusive). Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP. Pubertal-type LH response following an abbreviated GnRHa stimulation test before treatment initiation. Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: gonadotropin-independent (peripheral) precocious puberty; prior or current gnrh treatment for cpp; prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (igf-1).

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Leuprolide 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 2015-08-31 with completion listed for 2018-09-05.

It ran at 20 sites in United States (10), Canada (3), Chile (3), Mexico (2), Argentina (1) and New Zealand (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months (time frame: 6 months).

It also tracked 10 secondary outcomes, for example Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels, Changes in Height Velocity (Growth Rate), Bone Age Ratio to Chronological Age at Time of Measurement, Percent Change From Baseline in Height, Tanner Scores: Boys - Development of External Genitalia and Tanner Scores: Boys - Development of External Genitalia (Change From Baseline).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Leuprolide in 64 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.