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

NCT00734279 | Completed Early Phase 1

• 2 other identifiers: 05-31255M01RR000064
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Puberty; Delayed; Early; Precocious; Peripubertal; Gonadotropin; FSH; LH

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

1

EXPERIMENTAL

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

Drug: Leuprolide Acetate - Early Puberty Leuprolide Visit; Drug: Ganirelix - Early Puberty Ganirelix Visit

2

EXPERIMENTAL

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

Drug: Ganirelix - Delayed Puberty Ganirelix Visit; Drug: Leuprolide Acetate- Delayed Puberty Leuprolide Visit

3

EXPERIMENTAL

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

Drug: Leuprolide Acetate - Early Puberty Leuprolide Visit; Drug: Ganirelix - Early Puberty Ganirelix Visit

4

EXPERIMENTAL

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

Drug: Ganirelix - Delayed Puberty Ganirelix Visit; Drug: Leuprolide Acetate- Delayed Puberty Leuprolide Visit

Interventions

Leuprolide Acetate - Early Puberty Leuprolide Visit DRUG

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

Also known as: Leuprolide Injection, Lupron, Lupron SQ, Lupron Injection, Leuprolide SQ

1; 3

Ganirelix - Early Puberty Ganirelix Visit DRUG

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

Also known as: Ganirelix SQ, Ganirelix Acetate

1; 3

Ganirelix - Delayed Puberty Ganirelix Visit DRUG

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

Also known as: Ganirelix SQ, Ganirelix Acetate

2; 4

Leuprolide Acetate- Delayed Puberty Leuprolide Visit DRUG

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

Also known as: Leuprolide Injection, Lupron, Lupron SQ, Lupron Injection, Leuprolide SQ

2; 4

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• University of Michigan: collaborator
• University of Chicago: collaborator

Study Sites (1)

Utah Diabetes Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Puberty, Delayed; Puberty, Precocious

Interventions

Leuprolide; ganirelix

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Carol M Foster, MD

  University of Utah, Department of Pediatric Endocrinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: August 14, 2008
• Study Start: March 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 26, 2017

Record last verified: 2017-12

Locations

US (1)