Use of OCs Containing Dienogest and Risk of Venous Thromboembolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,400
- 试验地点
- 1
- 主要终点
- Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC)
研究概览
简要总结
The objective of this study is to compare the risk of venous thromboembolism (VTE) of oral contraceptives with non-use, focusing specifically on Valette® compared to other users of low estrogen dose combined oral contraceptives.
详细描述
This is a population-based case-control study in Germany.
Cases are women who are between 15 and 49 years old with a diagnosis of venous thromboembolism (VTE). The VTE is diagnosed in Germany between January 2002 und December 2007.
Controls are women who are between 15 and 49 years old without a VTE diagnosis. About 4 controls matched by year of birth and region will be allocated to each case.
Both cases and controls will receive a similar self-administered questionnaire except of some case-specific questions which are not applicable for the controls.
Study participants will be asked for their informed consent. Data confidentiality will be ensured by the Berlin Center for Epidemiology and Health Research.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •cases: women with a venous thromboembolism who are between 15 and 49 years old
- •control: women without a venous thromboembolism diagnosis who are between 15 and 49 years old
排除标准
- •women outside the defined age range
- •women with severe language problems
- •women who are not willing to participate
结局指标
主要结局
Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC)
时间窗: 01/2002 - 01/2008
The time frame is the time when venous thromboembolism (VTE) was diagnosed in the cases group. VTE includes deep venous thrombosis and pulmonary embolism. These clinical endpoints were established by magnetic resonance imaging, spiral computer tomography, duplex sonography, and lung scintigraphy.
次要结局
未报告次要终点