Last updated on June 2019

Kisspeptin in the Evaluation of Delayed Puberty

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Delayed Puberty | Hypogonadism | GnRH Deficiency | Klinefelter's Syndrome | Kallmann's Syndrome
  • Age: Between 12 - 17 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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