Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00152282
Status:
COMPLETED
Last Update Posted:
2008-05-29
First Post:
2005-09-07
Brief Title:
A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Phase II Pilot Study to Evaluate the Safety and Efficacy of J867 Administered With Estrogen to Postmenopausal Women
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 3 asoprisnil doses when administered to postmenopausal women with Premarin 0625 mg
Detailed Description:
The objective of this study is to determine the safety and effectiveness of asoprisnil 5 10 and 25 mg compared to placebo when administered to postmenopausal women with Premarin 0625 mg for 12 weeks Pharmacodynamic effects to be assessed include bleeding pattern endometrial biopsy results and endometrial thickness Safety assessments will include clinical laboratory results physical examination with vital signs pelvic and breast examinations ultrasound results and adverse events
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