Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty

What Was Tested

In this phase 4 trial, researchers set out to test Leuprolide.

This is a prospective, multicentric, comparative, non-randomized interventional study in which subjects diagnosed with central precocious puberty (CPP) and early puberty (EP) were treated for 6 months to compare the effect with GnRHa and traditional Chinese medicines.

It had three arms (groups): GnRHa(Triptorlin or Leuprorelin) (experimental), Traditional Chinese Medicines (active comparator) and blank group (no intervention).

Without therapy.

The registry classes the interventions as drug.

More on the Plan

740 girls with CPP and EP participated in this study, all participates were divided into GnRHa group, traditional chinese medicines group and blank group.

After at least six months therapy with GnRHa or traditional Chinese medicines, the investigators compare clinical parameters, sex hormone, bone age and ovarian ultrasound in three groups.

Who Took Part

The registry lists 740 actual participants took part.

It was open to women only aged from 2 years up to 14 years.

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

Examples of who could join: Premature appearance of secondary sexual characteristics: girls present with development of secondary sexual characteristics before 8, with breast induration as the earliest manifestation. Accelerated linear growth: the annual growth rate is higher than normal. Advanced bone age: the bone age is 1 or years more than the actual age. HPGA functions have been primed; serum gonadotropin and sexual hormone levels reach pubertal values. Subjects should be willing and able to follow the study protocol during the study period.

The full record lists 7 inclusion and 3 exclusion criteria; among the exclusions: patients with central nervous system diseases and thyroid diseases;; patients with cha-induced precocious puberty;; patients with poor compliance.

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 2012-09 with completion listed for 2015-08.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Comparisons of the height SDS'changes between GnRHa group and traditional chinese medicines group in 6 months (time frame: 6 months).

It also tracked 1 secondary outcome, for example Comparisons of the breast stages'changes between GnRHa group and traditional chinese medicines group in 6 months.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Leuprolide in 740 people.

With 740 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.