Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00152269
Status:
COMPLETED
Last Update Posted:
2008-05-29
First Post:
2005-09-07
Brief Title:
Treatment of Uterine Fibroids With AsoprisnilJ867
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Phase III 12-Month Randomized Double-Blind Study to Evaluate the Efficacy and Safety Including Bone Density Assessment of Two Doses of J867 Versus Placebo 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 safety and effectiveness of asoprisnil in symptomatic 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 safety and efficacy of asoprisnil 10 mg and 25 mg tablets compared to placebo administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids by assessing whether asoprisnil administration prevents surgical andor invasive intervention in the study population Women who meet the predefined uterine bleeding criteria for surgical andor invasive intervention hysterectomy myomectomy uterine artery embolization who are willing to undergo surgical andor invasive intervention if the study medication fails will be enrolled in this study
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