Ignite Creation Date:
2024-05-05 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 9:40 AM
Study NCT ID:
NCT00584610
Status:
UNKNOWN
Last Update Posted:
2010-01-18
First Post:
2007-12-20
Brief Title:
The Effect of a Levonorgestrel-releasing Intrauterine Device IUD Versus a Copper Containing IUD on Risk of Blood Clots
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
The Effect of a Levonorgestrel-releasing Intrauterine Device Versus a Copper Containing Intrauterine Device on Coagulation Parameters
Status:
UNKNOWN
Status Verified Date:
2010-01
Last Known Status:
RECRUITING
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:
This is a randomized controlled trial to assess the effect of a levonorgesterel-releasing intrauterine device LNG IUD Mirena versus a copper IUD Paraguard on coagulation parameters known to be associated with risk of thrombosis blood clots Both the LNG IUD and the copper IUD are FDA approved devices for contraception
Women enrolled in this study will be randomized to receive either the LNG IUD or the copper IUD They will complete a one month bleeding diary prior to insertion of the IUD and again for one month while the IUD is in place They will undergo phlebotomy blood draw at baseline prior to insertion of the IUD two and four months Stored samples will be used to measure D-dimer C-reactive protein CRP antithrombin AT factor VIIIc activated partial thromboplastin time aPTT and activated partial thromboplastin time plus activated protein C aPTT APC Both groups will undergo a GYN exam with screening for bacterial vaginosis and gonorrheachlamydia cultures prior to insertion of the IUD A brief survey to assess the womens experience with the IUD including symptomatology and satisfaction with the device will be conducted at the four months after insertion
Women enrolled in this study will be randomized to receive either the LNG IUD or the copper IUD They will complete a one month bleeding diary prior to insertion of the IUD and again for one month while the IUD is in place They will undergo phlebotomy blood draw at baseline prior to insertion of the IUD two and four months Stored samples will be used to measure D-dimer C-reactive protein CRP antithrombin AT factor VIIIc activated partial thromboplastin time aPTT and activated partial thromboplastin time plus activated protein C aPTT APC Both groups will undergo a GYN exam with screening for bacterial vaginosis and gonorrheachlamydia cultures prior to insertion of the IUD A brief survey to assess the womens experience with the IUD including symptomatology and satisfaction with the device will be conducted at the four months after insertion
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