Ignite Creation Date:
2024-05-05 @ 10:04 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01028781
Status:
TERMINATED
Last Update Posted:
2011-12-20
First Post:
2009-12-07
Brief Title:
Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis
Status:
TERMINATED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty finding eligible participants and lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients will undergo a standard history and physical examination detailing objective clinical exam findings performed by one of the co-investigators The research coordinator will obtain baseline values for intensity of pain quality of life and coping strategies Baseline serum levels inflammatory markers will then be measured Over the course of 12 weeks Thalidomide will be titrated as tolerated to achieve a minimum of a 30 reduction of pain on VAS from week 2
Detailed Description:
None
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