International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 101,000
- 试验地点
- 1
- 主要终点
- Incidence rate of Venous Thromboembolism (VTE)
研究概览
简要总结
Multinational, comparative, prospective, active surveillance study that follows two cohorts.
The primary objective of the study is to characterize and compare the risks of E4/Drospirenone (DRSP) with levonorgestrel-containing combined oral contraceptives (EE/LNG) in a study population that is representative of the actual users of these preparations. The main clinical outcome of interest is venous thromboembolism (VTE), specifically deep venous thrombosis (DVT) and pulmonary embolism (PE). Secondary objectives include measuring the occurrence of unintended pregnancy, assessing the risk of arterial thromboembolism (ATE), describing the drug utilization pattern, describing the baseline risk profile for VTE and ATE, and investigating outcomes associated with foetal exposure to E4/DRSP.
详细描述
Rationale and background:
The combined oral contraceptive (COC) containing estetrol (E4) and drospirenone (DRSP) (E4/DRSP) is a novel oral contraceptive containing a fixed dose of E4 (14.2 mg) and DRSP (3 mg). E4 is a natural oestrogen only produced during pregnancy by the foetal liver. When combined with the progestin DRSP, ovulation is inhibited. The E4/DRSP combination may have less impact on hepatic and haemostasis parameters in comparison to combinations of ethinyl estradiol (EE) and levonorgestrel (LNG) or EE and DRSP. Yet, it is unknown whether this regimen has an impact on the cardiovascular risk associated with the use of hormonal contraceptives.
Study design:
Multinational, comparative, prospective, active surveillance study that follows two cohorts. The cohorts consist of new users (starters and restarters ) of two different groups of hormonal contraceptives: E4/DRSP and EE/LNG. The study is taking a non-interventional approach to provide comprehensive information on these treatments in a routine clinical practice setting. Study participants will be enrolled via an international network of COC-prescribing health care professionals (HCPs) and then followed up for one to two years. All outcomes of interest will be captured by direct contact with the study participants. Reported outcomes of interest will be validated via attending physicians and relevant source documents. The classification of outcomes of interest into 'confirmed' and 'not confirmed' will be verified by blinded independent adjudication.
Population:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •New users of E4/DRSP New users of EE/LNG Germany: only recruitment of study participants who are prescribed the COC within on-label use
排除标准
- 未提供
结局指标
主要结局
Incidence rate of Venous Thromboembolism (VTE)
时间窗: Up to 24 months post baseline
* Occurrence (or absence) of a new (non-recurrent) confirmed Deep Venous Thrombosis (DVT) of the lower extremities (International Classification of Diseases, 10th revision (ICD-10) codes: I80.1 and I80.2) and, * Occurrence (or absence) of a new (non-recurrent) confirmed Pulmonary Embolism (PE) (ICD-10 codes: I26.0 and I26.9)
次要结局
- Incidence rate of all VTEs, including thromboses of the renal, mesenteric, portal, cerebral and retinal veins(Up to 24 months post baseline)
- Incidence rate of Arterial Thromboembolism (ATE), including acute myocardial infarction (AMI) and cerebrovascular accidents (CVA)(Up to 24 months post baseline)
- Incident rate of unintended pregnancy(Up to 24 months post baseline)
- Incident rate of neonatal malformations associated with foetal exposure to E4/DRSP and EE/LNG in E4/DRSP users and users of EE/LNG(Up to 24 months post baseline)
- Compare drug utilization pattern between users of both cohorts(Up to 24 months post baseline)