The Effect of Oral Norethindrone on Coagulation Parameters in Women at Increased Risk for Venous Thromboembolic Events
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •Blood tests which demonstrate an increased risk of thrombosis include the following:
- •Hyperhomocysteinemia/MTHFR mutation
- •Prothrombin gene mutation
- •Factor V Leiden heterozygotes
- •Factor V Leiden homozygotes, antithrombin III mutation
- •Protein S deficiency and Protein C deficiency.
排除标准
- •Women on current anticoagulation therapy
- •Women with a history of oral contraceptive related thrombotic events
- •Active or history of cigarette smoking within the past 6 months
- •Pregnancy
- •Active lactation
- •Known hypersensitivity to progestin
- •Any history of malignancy
- •History within the last three months of surgery or planning surgery during the study period
- •Undiagnosed vaginal bleeding
- •Active liver disease and history within the last 5 years of alcoholism or drug abuse.
- •Additionally, women must be greater than 3 months postpartum and have had two months without contraceptive hormones (such as the birth control pill) and 6 months without Depo-Provera use prior to enrollment.
结局指标
主要结局
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.
时间窗: 2 years
次要结局
未报告次要终点