Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of 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 includes a 36-month Study Drug Treatment Period (3-month treatment cycles), and a Safety Follow-up Period (12 weeks following the Month 36 visit).

Each injection will be administered 3 months apart for up to 36 months of treatment.

Study visits will occur on Day 1, Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30 and 33 (1st through the 12th leuprolide acetate depot injections, respectively), Month 36, and 12 weeks later for the Safety Follow-up Visit.

Who Took Part

Enrollment: 72 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: Subject is expected to receive at least 12 months of therapy to treat Central Precocious Puberty after study entry.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: bone age ≥14 years for girls and ≥15 years for boys (based on the month 6 lead in study, l-cp07-167, radiographic results); chronic illness requiring treatment that may interfere with growth, ie, chronic steroid use, renal failure, moderate to severe scoliosis; current therapy with medroxyprogesterone acetate.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

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

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.

It started in 2008-12 with completion listed for 2012-10.

It ran at 20 sites in United States (16) and Puerto Rico (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone (time frame: Day 1, Months 6, 12, 24, and 36).

It also tracked 8 secondary outcomes, for example Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1), Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2), Percentage of Male Participants With Suppression of Basal Testosterone, Mean Peak-stimulated Luteinizing Hormone Concentration by Visit, Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development) and Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Leuprolide in 72 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.