A Study of Leuprolide [amount hidden] Administered Every 3 Months to Treat Central Precocious Puberty

What Was Tested

This registered phase 3 trial tested Leuprolide.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

This study was conducted at 18 sites in the United States and 4 sites in Puerto Rico.

Who Took Part

The registry lists 84 actual participants took part.

It was open to people of any sex aged from 2 years up to 11 years.

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

Examples of who could join: Subject has a clinical diagnosis of CPP. Eligible to receive at least 6 mo of therapy to treat CPP after study entry. Bone age advanced at least 1 year beyond the chronological age at time of diagnosis or first treatment. Girls 2-8 years inclusive or Boys 2-9 years inclusive at Day 1. Has pretreatment pubertal response to leuprolide acetate stimulation (luteinizing hormone ≥8 mIU/mL) at Screening.

The full record lists 10 inclusion and 17 exclusion criteria; among the exclusions: incomplete precocious puberty (premature thelarche, premature adrenarche); peripheral precocious puberty: gonadal or adrenal tumors, congenital adrenal hyperplasia, testotoxicosis in boys, human chorionic gonadotropin secreting tumor or mccune-albright syndrome in girls; evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal function other than premature secretion of gonadotropins not adequately controlled.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

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

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

It started in 2008-06 with completion listed for 2010-01.

It ran at 25 sites in United States (21) and Puerto Rico (4).

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 (<4 mIU/mL) From Month 2 Through Month 6 (time frame: Month 2 through 6).

It also tracked 7 secondary outcomes, for example Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit, Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit, Peak-stimulated Luteinizing Hormone Concentration by Visit, Percentage of Participants With Suppression of the Physical Signs of Puberty (Breast Development) at Month 6, Percentage of Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) at Month 6 and Change From Baseline in Incremental Growth Rate (cm/Year) at Month 6.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 84 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.