Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156208
Status:
COMPLETED
Last Update Posted:
2008-05-29
First Post:
2005-09-07
Brief Title:
Safety of Treatment of Uterine Fibroids With Asoprisnil
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Phase III 18-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 symptomatic uterine fibroids who completed the 6 month Study C02-037
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 administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037 The safety endpoints for this study will be based on assessments of the endometrium ovarian cysts lipid profiles adverse events and clinical laboratory evaluations
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