An interventional study of Norethindrone in Women's Health and Blood Coagulation Disorders, sponsored by University of Vermont. Terminated at 1 site in United States. Open to female participants aged 18 Years to 52 Years. Per ClinicalTrials.gov, last updated 2010-06-28.
Sponsored by University of Vermont · Not applicable, Interventional, and Prevention
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.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's planned enrollment of 20 is below the median of 51 across 253 interventional studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Blood tests which demonstrate an increased risk of thrombosis include the following:
Exclusion Criteria:
Norethindrone 0.35 mg orally daily
Also known as: Minipill
The primary outcome of this study will be change in coagulation parameters. The proposed sample size of 20 subjects was derived based on having sufficient power to detect a 40% change in the variable D-dimer, a lab measurement.
Time frame: 2 years
This study is terminated, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.
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University of Vermont