Kisspeptin in the Evaluation of Delayed Puberty
Kisspeptin in the Evaluation of Delayed Puberty
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.
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.
Inclusion Criteria:

 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