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

NCT00734279 EARLY_PHASE1 COMPLETED

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.

Details

Lead sponsor	University of Utah
Phase	EARLY_PHASE1
Status	COMPLETED
Enrolment	11
Start date	2006-03
Completion	2010-12

Conditions

• Delayed Puberty
• Precocious Puberty

Interventions

• Leuprolide Acetate - Early Puberty Leuprolide Visit
• Ganirelix - Early Puberty Ganirelix Visit
• Ganirelix - Delayed Puberty Ganirelix Visit
• Leuprolide Acetate- Delayed Puberty Leuprolide Visit

Primary outcomes

• Determine the ability of the GnRH antagonist, ganirelix, to suppress nocturnal gonadotropin secretion in peripubertal boys and girls — Sample analysis is conducted after the leuprolide portion of the study and the ganirelix portion of the study have been completed for the first 6 patients

Countries

United States