Office for Human Research Protections (OHRP)

Requesting IRB:

University of Chicago

Study Summary:

The above-referenced research protocol proposes to assess whether a challenge dose of a gonadotropin releasing hormone agonist (leuprolide 10 mcg/kg) followed by serial assessments of luteinizing hormone, follicle stimulating hormone, testosterone (males) and estradiol (females), can distinguish among causes of precocious puberty and delayed puberty in children and young adults. Other procedures conducted during the study include overnight serial blood sampling for baseline sex hormone levels prior to the leuprolide injection, bone age radiographs if not done for clinical purposes within 3 months of study entry, and blood sampling for DNA testing. Serial blood draws will be done through an indwelling venous catheter using an automated pump. The proposed study will be an open label, non-randomized study in which approximately 280 children with and without a disorder of puberty will be followed over a two day period.

Funding Source:

National Center for Research Resources, National Institutes of Health