Follicle-Stimulating Hormone (FSH) and the Onset of Puberty
NCT ID: NCT00734279
Last Updated: 2017-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
11 participants
INTERVENTIONAL
2006-03-31
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The reasons for sex differences in the timing of puberty and sex-based variation in expression of pubertal disorders are not known.
Puberty is heralded by an increase in the episodic release of luteinizing hormone (LH) under the control of increased gonadotropin-releasing hormone (GnRH) release. It has been thought that sex differences in central nervous system restraint of GnRH and subsequently of LH secretion account for the differences in timing of onset of puberty in boys and girls.
Follicle-stimulating hormone (FSH) secretion is readily detected prior to the onset of puberty and exhibits sexual dimorphism in basal and GnRH-stimulated concentrations. Thus, assessment of factors regulating FSH secretion during childhood may enhance our understanding of sex differences in pubertal development and the pathogenesis of precocious puberty.
Although FSH is secreted under the control of GnRH, FSH is also secreted constitutively under the control of a group of peptides collectively known as the FSH-regulatory proteins. These peptides include activins, peptides that increase FSH secretion and inhibins and follistatins, peptides that suppress FSH secretion.
Gonadal inhibins inhibit FSH via endocrine negative feedback, but their production during puberty is only beginning to be understood. Activin and follistatin have been thought to have a principle paracrine role in FSH regulation but recent data have demonstrated these peptides have an endocrine role as well.
We hypothesize that differences in elaboration of activins, inhibins, and follistatin that alter FSH constitutive secretion underlie precocious and delayed puberty in boys and girls and account, in part, for sex differences in pubertal timing.
Specifically we expect that the inhibitory regulators, inhibins and/or follistatins, will be lower while the stimulatory regulator, activin, will be higher in early compared to delayed puberty.
FSH and the Onset of Puberty is a case control study comparing boys with precocious puberty to boys with delayed adolescence and girls with precocious puberty to girls with delayed adolescence.
Hypothesis: Basal and GnRH agonist-stimulated activin concentrations will be greater and inhibin concentrations lower in children with early puberty than in children with delayed adolescence, and the GnRH antagonist, ganirelix, will decrease activin concentrations in children with early puberty but not in delayed adolescence.
Specific Aim 1: Determine the degree to which FSH-regulatory peptides, compared to gonadotropin-releasing hormone (GnRH), control FSH secretion in children by suppressing GnRH with ganirelix in children with early and delayed adolescence.
Specific Aim 2: Determine the role of FSH-regulatory peptides in control of timing of onset of puberty by comparing their concentrations with and without GnRH stimulation of FSH in children with precocious puberty and delayed adolescence.
Specific Aim 3: Determine the role of GnRH in control of the FSH-regulatory peptides by comparing activin, inhibin and follistatin concentrations in children with delayed adolescence due to constitutional growth delay to those with delayed adolescence from hypogonadotropic hypogonadism
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Girls with Early Puberty receive ganirelix and leuprolide acetate to determine effect of ganirelix on gonadotropin secretion
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
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
2
Girls with Delayed Puberty receive ganirelix and leuprolide acetate to determine effect of ganirelix on gonadotropin secretion
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
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
3
Boys with Early Puberty receive ganirelix and leuprolide acetate to determine effect of ganirelix on gonadotropin secretion
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
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
4
Boys with Delayed Puberty receive ganirelix and leuprolide acetate to determine effect of ganirelix on gonadotropin secretion
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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
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
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
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.
\-
6 Years
17 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Michigan
OTHER
University of Chicago
OTHER
University of Utah
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carol Foster
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carol M Foster, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah, Department of Pediatric Endocrinology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Utah Diabetes Center
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
05-3125
Identifier Type: -
Identifier Source: org_study_id