Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156182
Status:
COMPLETED
Last Update Posted:
2009-03-04
First Post:
2005-09-07
Brief Title:
A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Phase 2 Long-Term Open-Label Safety Extension Study of Asoprisnil J867 in Patients With Uterine Leiomyomata
Status:
COMPLETED
Status Verified Date:
2008-05
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 study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144
Detailed Description:
No medical therapy is currently available for the long-term treatment of uterine fibroids The objective of this study is to determine the long-term safety of asoprisnil 10 mg daily for 6 months after an initial 12 weeks in study M99-144 in women with one or more uterine fibroids confirmed by ultrasound in study M99-144 The safety endpoints for this study will be based on ultrasound and endometrial biopsy results adverse events and any changes from baseline laboratory values and vital signs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None