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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.
U.S. FDA Resources
Further study details as provided by FDA Office of Orphan Products Development:
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. Eligibility
Criteria PROTOCOL ENTRY CRITERIA: --Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00004426 Locations
Sponsors and Collaborators
Investigators
More Information
Keywords provided by FDA Office of Orphan Products Development:
Study placed in the following topic categories:
Additional relevant MeSH terms:
Source: National Library of Medicine (NLM) July 03, 2008 |
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