Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UCCH-FDR001012 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gonadotropin releasing hormone | Drug | |||
| leuprolide | Drug |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert L. Rosenfield | University of Chicago | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Children's Hospital | Chicago | Illinois | 60637 | United States |
Not provided
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D004700 | Endocrine System Diseases |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |