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

NCT00734279 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-12-26

No results posted yet for this study

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.

Conditions

  • Delayed Puberty
  • Precocious Puberty

Interventions

DRUG

Leuprolide Acetate - Early Puberty Leuprolide Visit

Dose of 10 mcg/kg Sub cutaneous once at 0800 on day 2 of the Early Puberty Luprolide Visit

DRUG

Ganirelix - Early Puberty Ganirelix Visit

Dose of 2.5 mcg/kg Sub-cutaneous once at 17:30 on day 1 of the Early Puberty Ganirelix Visit and once at 08:00 on day 2 of the Early Puberty Ganirelix Visit

DRUG

Ganirelix - Delayed Puberty Ganirelix Visit

Ganirelix is administered at a dose of 2.5 mcg/kg sub cutaneous at 17:30 on day 1 and once at 08:00 on day 2 of the Ganirelix Delayed Puberty Visit

DRUG

Leuprolide Acetate- Delayed Puberty Leuprolide Visit

Leuprolide acetate is given at a dose of10 mcg/kg at 0800 on day 2 of the Delayed Puberty Leuprolide Visit

Sponsors & Collaborators

Principal Investigators

  • Carol M Foster, MD · University of Utah, Department of Pediatric Endocrinology

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00734279 on ClinicalTrials.gov