Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156156
Status:
COMPLETED
Last Update Posted:
2008-05-28
First Post:
2005-09-07
Brief Title:
Study of Asoprisnil in the Treatment of Uterine Fibroids
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Phase 3 Continuation Study to Evaluate the Long-Term Safety of Asoprisnil in Subjects 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:
The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids
Detailed Description:
No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief The objective of this study is to determine the long-term safety of two asoprisnil doses 10 and 25 mg tablets administered daily to women who received asoprisnil in one of the asoprisnil long-term studies study C03-062 or study M01-391 The safety endpoints for this study will include the affects of asoprisnil on the endometrium ovaries bone a subset of study M01-391 subjects lipid profiles adverse events and changes from baseline lab values and vital signs
Some subjects receiving asoprisnil developed endometrial changes As a result dosing was prematurely discontinued for all subjects To ensure safety subjects will remain on study and will undergo scheduled study procedures In most subjects endometrial changes reversed after asoprisnil discontinuation
Some subjects receiving asoprisnil developed endometrial changes As a result dosing was prematurely discontinued for all subjects To ensure safety subjects will remain on study and will undergo scheduled study procedures In most subjects endometrial changes reversed after asoprisnil discontinuation
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