Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-31 @ 10:44 AM
Study NCT ID:
NCT00109512
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2005-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometriosis Trial: Study of NBI-56418 in Endometriosis
Sponsor:
Abbott
Organization:
Study Overview
Official Title:
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of NBI-56418 in Endometriosis
Status:
COMPLETED
Status Verified Date:
2012-02
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:
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with subjects randomized to one of three treatment groups, placebo, 75 mg and 150 mg in a 1:1:1 ratio. Study drug was administered once daily for 12 weeks. After the last dose at the end of Week 12, follow-up continued every 4 weeks for 12 weeks.
Detailed Description:
None
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?: