Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004330
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Studies in Porphyria IV Gonadotropin-Releasing Hormone GnRH Analogues for Prevention of Cyclic Attacks
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-12
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
Assess whether chronic administration of gonadotropin-releasing hormone analogues is safe and effective for the prevention of cyclic attacks of acute porphyria in women
Assess whether chronic administration of gonadotropin-releasing hormone analogues is safe and effective for the prevention of cyclic attacks of acute porphyria in women
Detailed Description:
PROTOCOL OUTLINE All patients receive a gonadotropin-releasing hormone GnRH analogue Treatment begins on days 1 to 3 of a menstrual cycle
Low-dose estrogen begins at approximately 3 months All patients must have a daily calcium intake of at least 1 gram supplements are allowed
Patients are followed for at least 1 year
Low-dose estrogen begins at approximately 3 months All patients must have a daily calcium intake of at least 1 gram supplements are allowed
Patients are followed for at least 1 year
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 |
|---|---|---|---|
| UTMB-312 | None | None | None |
| UTMB-445 | None | None | None |