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.

Condition	Treatment or Intervention
Hypogonadism	Drug: gonadotropin releasing hormone  Drug: leuprolide

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.

Ages Eligible for Study:  9 Years   -   18 Years,  Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• 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 steroid treatment

--Prior/Concurrent Therapy--

• At least 2 months since prior sex hormone treatment

--Patient Characteristics--

• 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

Illinois
      University of Chicago Children's Hospital, Chicago,  Illinois,  60637,  United States; Recruiting

Study chairs or principal investigators

Robert L. Rosenfield,  Study Chair,  University of Chicago   

Study ID Numbers:  199/13361; UCCH-FDR001012
Record last reviewed:  January 2000
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004426
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09