Precocious Puberty Clinical Trial
Official title:
Follicle-Stimulating Hormone (FSH) and the Onset of Puberty
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.
Girls begin puberty earlier and have as much as a 5-fold increase in incidence of precocious
puberty as do boys, while boys are more likely to have delayed adolescence compared to girls.
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
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT01944488 -
LH Response to GnRH Test in Prepubescent Girls Under 6 Years
|
N/A | |
Not yet recruiting |
NCT01944475 -
Follow-up of Girls With Premature Thelarche and Precocious Puberty
|
N/A | |
Completed |
NCT00564850 -
Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
|
Phase 3 | |
Completed |
NCT00001181 -
Testolactone for the Treatment of Girls With LHRH Resistant Precocious Puberty
|
Phase 2 | |
Recruiting |
NCT04113070 -
Overweight and Obesity and Puberty Development Cohort Study
|
||
Recruiting |
NCT01601171 -
Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and/or Palate
|
||
Recruiting |
NCT05338411 -
Effect of Exogenous Growth Hormone on Ocular Findings
|
||
Recruiting |
NCT06280807 -
Observation of Environment and Reproductive-Endocrine Effects
|
||
Completed |
NCT00004344 -
Purification of Testis-Stimulating Factor in Precocious Puberty
|
N/A | |
Completed |
NCT00001202 -
Treatment of Boys With Precocious Puberty
|
Phase 2 | |
Completed |
NCT04665713 -
Effect of Prevalence of BMI on Efficacy of Herbal Medicines in Girls' Sexual Precocity
|
||
Completed |
NCT02199587 -
The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or GH Provocation Test
|
N/A | |
Terminated |
NCT04502836 -
Evaluation of the Correlation Between Psychological Intervention, Including Providing Knowledge and Tools for Problems Solving, and the Anxiety Level of Female Patients Arriving to ACTH LRH Test - Pilot Study
|
N/A | |
Completed |
NCT00006174 -
Effects of Letrozole on Precocious Puberty Due to McCune Albright Syndrome
|
Phase 1 | |
Completed |
NCT02650141 -
Clinical Trial of Experienced Chinese Herbal Formulas on Different Types of Precocious Puberty
|
N/A | |
Completed |
NCT00909844 -
Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study
|
Phase 3 | |
Completed |
NCT00004335 -
Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle
|
N/A |