Back to resultsLeuprolide in Determining the Cause of Gonadotropin Deficiency
Primary Purpose
Hypogonadism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
gonadotropin releasing hormone
leuprolide
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism focused on measuring endocrine disorders, hypogonadism, rare disease
Eligibility 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
Sites / Locations
- University of Chicago Children's Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00004426
Brief Title
Leuprolide in Determining the Cause of Gonadotropin Deficiency
Official Title
Study of Gonadotropin Releasing Hormone Agonist Test Using Leuprolide Acetate in Patients With Gonadotropin Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
January 2000
Overall Recruitment Status
Completed
Study Start Date
August 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 1998 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Chicago
4. Oversight
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
endocrine disorders, hypogonadism, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gonadotropin releasing hormone
Intervention Type
Drug
Intervention Name(s)
leuprolide
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. Rosenfield
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Leuprolide in Determining the Cause of Gonadotropin Deficiency
We'll reach out to this number within 24 hrs