Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004344
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Purification of Testis-Stimulating Factor in Precocious Puberty
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-02
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:
OBJECTIVES
Purify and characterize a testis-stimulating factor in the blood of adult volunteers who had precocious puberty as boys
Purify and characterize a testis-stimulating factor in the blood of adult volunteers who had precocious puberty as boys
Detailed Description:
PROTOCOL OUTLINE Subjects are treated for 2 months with depot injections of leuprolide acetate every 4 weeks and testosterone replacement every 2 weeks Hormone levels are tested every other week
If luteinizing hormone and follicular-stimulating hormone levels are at or below detection on day 56 blood is drawn for a testis-stimulating factor bioassay and subsequent factor purification and characterization
Volunteers are asked to repeat this 2-month procedure no more than 2 times every 12 months
If luteinizing hormone and follicular-stimulating hormone levels are at or below detection on day 56 blood is drawn for a testis-stimulating factor bioassay and subsequent factor purification and characterization
Volunteers are asked to repeat this 2-month procedure no more than 2 times every 12 months
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 |
|---|---|---|---|
| OHSU-3328 | None | None | None |