Follicle-Stimulating Hormone (FSH) and the Onset of Puberty
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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 |
- 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:
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:
|
|
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:
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:
|
|
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:
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:
|
|
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:
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:
|
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 |
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.
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| United States, Utah | |
| Utah Diabetes Center | |
| Salt Lake City, Utah, United States, 84108 | |
| Principal Investigator: | Carol M Foster, MD | University of Utah, Department of Pediatric Endocrinology |
More Information
Additional 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 Gonadal Disorders Endocrine System Diseases Hormones Follicle Stimulating Hormone Ganirelix Leuprolide Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Pharmacologic Actions Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Fertility Agents, Female Fertility Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on June 18, 2013