Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004426
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
1999-10-18
Brief Title:
Leuprolide in Determining the Cause of Gonadotropin Deficiency
Sponsor:
University of Chicago
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Study of Gonadotropin Releasing Hormone Agonist Test Using Leuprolide Acetate in Patients With Gonadotropin Deficiency
Status:
COMPLETED
Status Verified Date:
2000-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE The bodys 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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCCH-FDR001012 | None | None | None |