Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115661
Status:
TERMINATED
Last Update Posted:
2012-10-17
First Post:
2005-06-23
Brief Title:
Use of Rosiglitazone in the Treatment of Endometriosis
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Treatment of Endometriosis Pain With Rosiglitazone A Prospective Phase 2 Clinical Trial
Status:
TERMINATED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the meta-analysis about CV adverse effects of rosiglitazone
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to perform a pilot study on the efficacy of rosiglitazone in reducing pelvic pain in early stage endometriosis patients
Detailed Description:
There is no current pain control in women with minimal-mild endometriosis that concomitantly allows them the chance to conceive Women between the ages of 18 and 45 years with minimal to mild endometriosis and pelvic pain of greater than three months duration will be enrolled into a 6-month prospective phase 2 clinical trial
Comparison Following enrollment one week after the last menstrual period eligible participants will be randomized to a 6-month treatment of rosiglitazone 4 mgday Efficacy comparisons will be made utilizing visual analog scale diaries Short-Form McGill Pain Questionnaires and physical component summary scores of the SF-36 Secondary measures will include cytokine quantification proteomics gene array analyses and serious adverse effects
Comparison Following enrollment one week after the last menstrual period eligible participants will be randomized to a 6-month treatment of rosiglitazone 4 mgday Efficacy comparisons will be made utilizing visual analog scale diaries Short-Form McGill Pain Questionnaires and physical component summary scores of the SF-36 Secondary measures will include cytokine quantification proteomics gene array analyses and serious adverse effects
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23HD043952-01A2 | NIH | None | httpsreporternihgovquickSearch1K23HD043952-01A2 |