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Leuprolide in Determining the Cause of Gonadotropin Deficiency

Information source: FDA Office of Orphan Products Development
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism

Intervention: gonadotropin releasing hormone (Drug); leuprolide (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Robert L. Rosenfield, Study Chair, Affiliation: University of Chicago

Summary

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.

Clinical Details

Official title: Study of Gonadotropin Releasing Hormone Agonist Test Using Leuprolide Acetate in Patients With Gonadotropin Deficiency

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Detailed description: 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

Eligibility

Minimum age: 9 Years. Maximum age: 18 Years. Gender(s): 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

Locations and Contacts

University of Chicago Children's Hospital, Chicago, Illinois 60637, United States
Additional Information

Starting date: August 1994
Last updated: March 25, 2015

Page last updated: August 23, 2015

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