Follicle-Stimulating Hormone (FSH) and the Onset of Puberty

What Was Tested

This registered early phase 1 trial tested Leuprolide.

The purpose of this study is to determine if the timing of the onset of puberty may be affected by FSH-regulatory peptides.

The researchers will determine how these peptides relate to FSH production in prepubertal and pubertal children by comparing the regulation of FSH control in children with precocious (early) puberty and delayed puberty.

In this pilot study, the researchers will stimulate the pubertal axis using an agonist of GnRH to determine the pubertal response of activin-A, inhibin-A and -B and follistatin.

It had four arms (groups): 1 (experimental), 2 (experimental), 3 (experimental) and 4 (experimental).

Girls with Early Puberty receive ganirelix and leuprolide acetate to determine effect of ganirelix on gonadotropin secretion.

Girls with Delayed Puberty receive ganirelix and leuprolide acetate to determine effect of ganirelix on gonadotropin secretion.

Boys with Early Puberty receive ganirelix and leuprolide acetate to determine effect of ganirelix on gonadotropin secretion.

The registry classes the interventions as drug.

More on the Plan

The reasons for sex differences in the timing of puberty and sex-based variation in expression of pubertal disorders are not known.

It has been thought that sex differences in central nervous system restraint of GnRH and subsequently of LH secretion account for the differences in timing of onset of puberty in boys and girls.

Follicle-stimulating hormone (FSH) secretion is readily detected prior to the onset of puberty and exhibits sexual dimorphism in basal and GnRH-stimulated concentrations.

Thus, assessment of factors regulating FSH secretion during childhood may enhance their understanding of sex differences in pubertal development and the pathogenesis of precocious puberty.

Who Took Part

The registry lists 11 actual participants took part.

It was open to people of any sex aged from 6 years up to 17 years.

Healthy volunteers could join, not only people with the condition.

How the Study Was Run

The set-up was 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 2006-03 with completion listed for 2010-11.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Determine the ability of the GnRH antagonist, ganirelix, to suppress nocturnal gonadotropin secretion in peripubertal boys and girls.

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Leuprolide in 11 people.

Its size is small, so on its own it can only give an early look.

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.