NCT00580424

The Effect of the Mini-pill on Blood Factors in Women at Increased Risk for Forming Blood Clots

The Effect of Oral Norethindrone on Coagulation Parameters in Women at Increased Risk for Venous Thromboembolic Events

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Vermont · Academic / Other
• Sex: Female
• Age: 18 Years – 52 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Women's Health
• Blood Coagulation Disorders

Interventions

Type	Name	Description
DRUG	Norethindrone	Norethindrone 0.35 mg orally daily

Timeline

• Start date: 2007-12-01
• Completion: 2009-07-01
• First posted: 2007-12-24
• Last updated: 2010-06-28

Locations

1 site across 1 country: United States