Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-02-22 @ 5:24 PM
Study NCT ID:
NCT00156195
Status:
COMPLETED
Last Update Posted:
2008-05-29
First Post:
2005-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids
Sponsor:
Abbott
Organization:
Study Overview
Official Title:
A Phase 3, 12-Month, Extension Study to Evaluate the 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 asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory 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:
True
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?: