Leuprolide in Determining the Cause of Gonadotropin Deficiency
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|ClinicalTrials.gov Identifier: NCT00004426|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 26, 2015
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 or disease||Intervention/treatment||Phase|
|Hypogonadism||Drug: gonadotropin releasing hormone Drug: leuprolide||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Official Title:||Study of Gonadotropin Releasing Hormone Agonist Test Using Leuprolide Acetate in Patients With Gonadotropin Deficiency|
|Study Start Date :||August 1994|
|Study Completion Date :||September 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004426
|United States, Illinois|
|University of Chicago Children's Hospital|
|Chicago, Illinois, United States, 60637|
|Study Chair:||Robert L. Rosenfield||University of Chicago|