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Home > "L" Clinical Trials Conditions > Leuprolide in Determining the Cause of Gonadotropin Deficiency  Leuprolide in Determining the Cause of Gonadotropin Deficiency
Leuprolide in Determining the Cause of Gonadotropin Deficiency
For Condition: Hypogonadism
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , University of Chicago
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 9 Years/18 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 90
Location and Contact Information:
Overall Study Official:
RobertRosenfield, Study Chair, University of Chicago
University of Chicago Children's Hospital *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Robert Rosenfield 773-702-6432
Additional Information:
Study ID Numbers: 199/13361; UCCH-FDR001012
Study Start Date: December 1999
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004426
Other Hypogonadism Studies:
1. Testosterone and Growth Hormone for Bone Loss in Men
2. The Effects of Reproductive Hormones on Brain Function
3. Ovarian Follicle Function in Patients with Premature Ovarian Failure
4. Effects on the Brain of Lupron Induced Hypogonadotropic Hypogonadism with and without Testosterone Replacement
5. Prevention of Osteoporosis in Men with Prostate Cancer
Related Studies:
Other Hypogonadism Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Leuprolide in Determining the Cause of Gonadotropin Deficiency
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