drugset / Trial / NCT00734279

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

NCT00734279

Non-randomizedParallel-groupOpen-labelBasic science

Summary

The purpose of this study is to determine if the timing of the onset of puberty may be affected by FSH-regulatory peptides. We 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, we will stimulate the pubertal axis using an agonist of GnRH to determine the pubertal response of activin-A, inhibin-A and -B and follistatin. To determine baseline FSH secretion and FSH-regulatory peptide tone, we will block GnRH with a specific antagonist. These studies should lead to a better understanding of the role of FSH in controlling the onset of puberty and the pathogenesis of pubertal disorders.

Timeline

Start
2006-03
Primary completion
2010-11
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ganirelix Protein / enzyme biologic 2.5 ug/kg Subcutaneous
Subject Leuprolide Other / unclassified 10 ug/kg Subcutaneous