Ignite Creation Date:
2024-05-05 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00580424
Status:
TERMINATED
Last Update Posted:
2010-06-28
First Post:
2007-12-18
Brief Title:
The Effect of the Mini-pill on Blood Factors in Women at Increased Risk for Forming Blood Clots
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
The Effect of Oral Norethindrone on Coagulation Parameters in Women at Increased Risk for Venous Thromboembolic Events
Status:
TERMINATED
Status Verified Date:
2007-12
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:
We propose a prospective cohort study to assess the effect of the progesterone only contraceptive pill minipill on coagulation parameters known to be associated with risk of thrombosis blood clots in women who are at increased risk for forming blood clots We plan to recruit women with a history of venous thromboembolism VTE blood clot in a vein and women with a history of blood tests which demonstrate an increased risk of thrombosis who desire contraception
Women enrolled in this study will undergo phlebotomy blood draw at baseline prior to starting the minipill one and three months Stored samples will be used to measure D-dimer C-reactive protein CRP antithrombin AT factor VIII free and total protein S fibrinogen von Willebrand factor vWF and normalized activated protein C sensitivity ratio nAPCsr Both groups will undergo a general physical and GYN exam prior to enrollment This exam and the blood testing will be provided free of charge Patients will not be prescribed the minipill after completion of the study and will be advised to consult with their primary care physician or hematologist if they wish to continue this medication
Women enrolled in this study will undergo phlebotomy blood draw at baseline prior to starting the minipill one and three months Stored samples will be used to measure D-dimer C-reactive protein CRP antithrombin AT factor VIII free and total protein S fibrinogen von Willebrand factor vWF and normalized activated protein C sensitivity ratio nAPCsr Both groups will undergo a general physical and GYN exam prior to enrollment This exam and the blood testing will be provided free of charge Patients will not be prescribed the minipill after completion of the study and will be advised to consult with their primary care physician or hematologist if they wish to continue this medication
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