Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00160420
Status:
COMPLETED
Last Update Posted:
2008-05-29
First Post:
2005-09-08
Brief Title:
A Long-Term Study to Evaluate the Safety of Asoprisnil in the Treatment of Women With Endometriosis From Study M01-398
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Phase 2 12-Month Open Label Extension Study to Evaluate the Safety of J8675 mg QD in Subjects With Endometriosis
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 5 mg for 12 months in women with endometriosis from study M01-398
Detailed Description:
Endometriosis the presence of endometrial tissue outside the uterus is a progressive estrogen-dependent disease that occurs in menstruating women of reproductive age Although all major endometriosis therapies are effective for the treatment of pain no single treatment is superior to others in terms of efficacy The major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis The objective of this study is to determine the long-term safety of asoprisnil 5 mg daily for 12 months in women with endometriosis after an initial 12 weeks in study M01-398 The safety will be based on assessments of the endometrium lipid profiles adverse events and changes from baseline laboratory values and vital signs
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