Kisspeptin in the Evaluation of Delayed Puberty

  • STATUS
    Recruiting
  • End date
    Nov 27, 2023
  • participants needed
    60
  • sponsor
    Massachusetts General Hospital
Updated on 27 January 2021
insulin
body mass index
electrolytes
insulin-like growth factor
thyroxine
testosterone
testosterone level
prolactin
free thyroxine
estradiol
testicular
thyroid stimulating hormone
kisspeptin
insulin-like growth factor 1 (igf-1)

Summary

Some children with delayed puberty will eventually enter puberty on their own. However, some children with delayed puberty have a permanent condition and require medical treatment to undergo puberty. Right now, there is no reliable diagnostic tool to tell whether a child's delayed puberty will be self-resolving or permanent. The hormone kisspeptin has the potential to prospectively diagnose adolescents with self-resolving or permanent delayed puberty.

Description

The investigators are seeking boys (ages 13.5-17 years) and girls (ages 12-17) years with a diagnosis of delayed puberty. Study participation involves 2 outpatient visits and two hospital admissions (one 11-hour, overnight admission and one 6-hour day admission) when subjects will receive two investigational drugs, the naturally occurring hormones kisspeptin and gonadotropin-releasing hormone (GnRH). Subjects will then be followed every 6 months until they reach 18 years of age to determine if their pubertal delay was self-resolved or permanent. Individuals interested in learning more may call 617-726-8484.

Details
Condition Kallmann's Syndrome, Hypogonadism, Klinefelter's Syndrome, Delayed Puberty, GnRH Deficiency, hypogonadotropic hypogonadism, klinefelter syndrome, delay puberty, secondary hypogonadism, kallmann syndrome
Treatment kisspeptin 112-121, GnRH
Clinical Study IdentifierNCT01438034
SponsorMassachusetts General Hospital
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 12 yrs and 17 yrs?
Gender: Male or Female
Do you have any of these conditions: GnRH Deficiency or Klinefelter's Syndrome or Hypogonadism or Kallmann's Syndrome or Delayed Puberty?
Do you have any of these conditions: GnRH Deficiency or delay puberty or Klinefelter's Syndrome or hypogonadotropic hypogonadism or klinefelter syndrome or Hypogonadism or kallmann syndro...?
Do you have any of these conditions: kallmann syndrome or klinefelter syndrome or Klinefelter's Syndrome or secondary hypogonadism or Delayed Puberty or GnRH Deficiency or Hypogonadism or...?
Do you have any of these conditions: hypogonadotropic hypogonadism or Hypogonadism or Kallmann's Syndrome or GnRH Deficiency or kallmann syndrome or klinefelter syndrome or Delayed Pubert...?
Adolescent Boys
ages 13.5-17 years
testicular volume <4 mL OR 4-8 ml with no change in the past 6 months by Prader orchidometer
first morning (before 9AM) LH <2 mIU/mL and testosterone <50 ng/dL
Adolescent Girls
ages 12-17 years
Tanner stage I OR II breast development with no change in the past 6 months
first morning (before 9AM) LH <2 mIU/mL and estradiol <20 pg/ml
All Subjects
bone age less than chronological age
weight 28 kg
body mass index >10th percentile and <+3 SDS for bone age
blood pressure >5th percentile and <95th percentile for bone age and height
white blood cell counts, platelet counts, electrolytes, thyroid stimulating hormone (TSH), free thyroxine (T4) within reference range for age
erythrocyte sedimentation rate <2X the upper limit of the reference range for age
hemoglobin within reference range for girls of the same chronological age
blood urea nitrogen (BUN), creatinine, prolactin not elevated
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no more than 2X the upper limit of the reference range
Insulin-like growth factor 1 (IGF-1) within reference range for bone age

Exclusion Criteria

All Subjects
history or presence of underlying condition that could cause delayed puberty (chronic illness, weight loss, abnormal cranial magnetic resonance imaging (MRI))
history of an allergic drug reaction
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