Study of Lupron Depot In The Treatment of Central Precocious Puberty

What Was Tested

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

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

The registry classes the interventions as drug.

More on the Plan

This protocol will also capture data from the final questionnaire about female reproductive status at adulthood including the presence of regular menses and number of pregnancies.

Who Took Part

Enrollment: 55 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.

The full record lists 6 inclusion and 2 exclusion criteria; among the exclusions: irradiation to the central nervous system; prior therapy with medroxyprogesterone acetate and/or with any gnrh analog (including prior treatment with daily subcutaneous and depot formulations of leuprolide acetate).

How the Study Was Run

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

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 1991-01 with completion listed for 2009-04.

It ran at 9 sites in United States (9).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) (time frame: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit). Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males) (time frame: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit).

It also tracked 4 secondary outcomes, for example Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations, Mean Stimulated Estradiol Concentrations in Females, Mean Stimulated Testosterone Concentrations in Males and Mean Ratio of Bone Age to Chronological Age.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Leuprolide in 55 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.