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

This study has suspended participant recruitment.
(Lack of funding)
Sponsor:
Collaborators:
University of Michigan
University of Chicago
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00734279
First received: July 23, 2008
Last updated: August 13, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Delayed Puberty
Precocious Puberty
Drug: Leuprolide Acetate - Early Puberty Leuprolide Visit
Drug: Ganirelix - Early Puberty Ganirelix Visit
Drug: Ganirelix - Delayed Puberty Ganirelix Visit
Drug: Leuprolide Acetate- Delayed Puberty Leuprolide Visit

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follicle-Stimulating Hormone (FSH) and the Onset of Puberty

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Determine the ability of the GnRH antagonist, ganirelix, to suppress nocturnal gonadotropin secretion in peripubertal boys and girls [ Time Frame: 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 ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: March 2006
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Girls with Early Puberty
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
Other Names:
  • Leuprolide Injection
  • Lupron
  • Lupron SQ
  • Lupron Injection
  • Leuprolide SQ
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
Other Names:
  • Ganirelix SQ
  • Ganirelix Acetate
2
Girls with Delayed Puberty
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
Other Names:
  • Ganirelix SQ
  • Ganirelix Acetate
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
Other Names:
  • Leuprolide Injection
  • Lupron
  • Lupron SQ
  • Lupron Injection
  • Leuprolide SQ
3
Boys with Early Puberty
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
Other Names:
  • Leuprolide Injection
  • Lupron
  • Lupron SQ
  • Lupron Injection
  • Leuprolide SQ
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
Other Names:
  • Ganirelix SQ
  • Ganirelix Acetate
4
Boys with Delayed Puberty
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
Other Names:
  • Ganirelix SQ
  • Ganirelix Acetate
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
Other Names:
  • Leuprolide Injection
  • Lupron
  • Lupron SQ
  • Lupron Injection
  • Leuprolide SQ

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Girls with early puberty 6 to 8 years of age with early breast development. Girls with delayed adolescence 11 to 14 years of age with bone age delay of at least 2 standard deviations and/or delay in age-appropriate pubertal development.

Boys with early puberty 6 to 9 years of age with advancement of pubic hair growth.

Boys with delayed adolescence 12 to 17 years of age and bone age delay of at least 2 standard deviations and/or delay in age-appropriate pubertal development.

Children will need a weight > 20 kg and hematocrit > 34% to participate safely.

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734279

Locations
United States, Utah
Utah Diabetes Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
University of Michigan
University of Chicago
Investigators
Principal Investigator: Carol M Foster, MD University of Utah, Department of Pediatric Endocrinology
  More Information

No publications provided

Responsible Party: Carol M. Foster, MD, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT00734279     History of Changes
Other Study ID Numbers: 05-3125
Study First Received: July 23, 2008
Last Updated: August 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Puberty
Delayed
Early
Precocious
Peripubertal
Gonadotropin
FSH
LH

Additional relevant MeSH terms:
Puberty, Delayed
Puberty, Precocious
Endocrine System Diseases
Gonadal Disorders
Follicle Stimulating Hormone
Ganirelix
Leuprolide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Fertility Agents
Fertility Agents, Female
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014