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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Utah
• Collaborators: University of Chicago; University of Michigan
• Treatments: Follicle Stimulating Hormone; Ganirelix; Hormones; Leuprolide

Criteria

Inclusion Criteria:

Early Puberty Children who have early puberty may participate in this study. Children must be between 6 and 10 years of age and be healthy with the exception of having early puberty. For early puberty, girls should have had the onset of breast development prior to 8 years of age and boys should have the onset of pubic hair growth or genital growth prior to 9 years of age.

Inclusion Criteria for Delayed Puberty Children who have late (delayed) puberty may participate in this study. Children must be between 12 and 17 years of age and be healthy with the exception of having late puberty. In order to have late puberty, boys and girls should have short stature compared to their family with at least one year delay in bone age as determined by bone age x-ray and/or have the onset of secondary sexual characteristics (breast and pubic hair growth) at 12 years of age or later for a girl or 13 years of age or later for a boy.

Exclusion Criteria:

Early Puberty Children with known genetic disorders, chronic medical conditions requiring the use of steroids, and use of medication for puberty within the last 3 months are excluded.

Delayed Puberty Children with known genetic disorders with the exception of possible hypogonadotropic hypogonadism, chronic medical conditions requiring the use of steroids, and use of medication for puberty within the last 3 months are excluded.

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