RATIONALE: The body's response to one injection of leuprolide may provide more information
than the standard test for gonadotropin deficiency in determining whether the cause of
gonadotropin deficiency is related to the hypothalamus or the pituitary gland.
PURPOSE: Randomized double-blinded clinical trial to study the effectiveness of leuprolide
in determining the cause of gonadotropin deficiency.
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to
receive leuprolide acetate or gonadotropin releasing hormone (GnRH) first, then cross over
to receive the other test.
Patients receive one subcutaneous injection of leuprolide acetate or GnRH, then have blood
samples drawn periodically. One month later, patients receive the other test.
Another cohort of patients are randomized to receive leuprolide acetate once daily on days
0, 4, and 8, or days 0, 5, and 10.
Patients are followed for up to 2 years.
Completion date provided represents the completion date of the grant per OOPD records
PROTOCOL ENTRY CRITERIA:
- Prepubertal children with constitutionally delayed puberty At least 2 years
retardation of bone age Spontaneously progress into puberty within 1 year Boys:
Testes long diameter 2.5-3.5 cm and plasma testosterone 40-300 ng/dL Girls: Breast
development, but premenarcheal OR Hypogonadotropinism Delayed onset of pubertal
milestones associated with anterior panhypopituitarism OR Kallman's syndrome No
spontaneous progression into puberty within 2 years after 6 months replacement sex
- At least 2 months since prior sex hormone treatment
- Age: 14-18 for children with hypogonadotropinism 9-13 for normal children
- Other: No chronic systemic disease No metabolic disease No endocrine disease No
growth hormone deficiency