NCT03949985已完成不适用
Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives: a Prospective Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Change in normalized APC sensitivity ratio
研究概览
简要总结
This prospective cohort evaluates the longitudinal profile of hemostatic biomarkers during the first 3 months after having stopped a combined oral contraceptive.
详细描述
Women using a combined oral contraceptive (COC) and who have decided to stop it or switch it to a non-estrogenic contraceptive are included. At baseline, before the COC is stopped, and at multiple time points during the 3 months of follow-up, blood will be drawn to evaluate the hemostatic profile. Findings are compared with a control group of women without an estrogenic contraceptive, who are also followed for 3 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-50 years
- •current use (for at least 3 months) of an estrogenic contraceptive with the decision to stop it or replace it with a non-estrogenic contraceptive (estrogen group)
- •no current use of an estrogenic contraceptive (control group)
排除标准
- •personal history of VTE
- •known thrombophilia
- •recent medical event (hospitalization, surgery, cancer)
- •pregnancy, post-partum period, current breastfeeding
结局指标
主要结局
Change in normalized APC sensitivity ratio
时间窗: Three months
次要结局
- Change in individual coagulation factors(Three months)
- Change in concentrations of sex hormone-binding globulin(Three months)
- Change in fibrinolysis assay(Three months)
- Contraception-related satisfaction(Three months)
- Change in Endogenous Thrombin Potential (Thrombin Generation Assay)(Three months)
研究者
Marc Blondon
Co-Principal Investigator
University Hospital, Geneva
研究点 (1)
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