Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34,100
- 试验地点
- 1
- 主要终点
- Number of Participants With Venous Thromboembolism (VTE)
研究概览
简要总结
The objective of this study is to characterize and compare the risks of short- and long-term use of NuvaRing® with marketed combined oral contraceptives.
详细描述
This is a large, multinational, controlled, prospective, active surveillance study of women who are prescribed NuvaRing® or an oral contraceptive (OC). The study follows two cohorts. The cohorts consist of new users (starters and switchers) of two different groups of hormonal contraceptives:
- NuvaRing®
- marketed combined OCs (combined oral contraceptives)
NuvaRing® is a transparent and flexible contraceptive vaginal ring containing etonogestrel and ethinylestradiol (EE). The ring releases 15 mcg EE and 120 mcg etonogestrel daily. After insertion it remains in the upper part of the vagina for 21 days, followed by 7 ring-free days before a new ring is inserted.
The primary objective of this study is to characterize and compare the risks of short- and long-term use of NuvaRing® with marketed combined OCs. The main clinical outcomes of interest for the short and long-term follow-up are:
- Deep Venous Thrombosis (DVT)
- Pulmonary Embolism (PE)
- Acute Myocardial Infarction (AMI)
- Cerebrovascular Accidents (CVA)
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
- •women who are prescribed NuvaRing® or a combined oral contraceptive and who are new users (Starters, restarters or switchers) of the formulation
排除标准
- •women who do not consent to participate in the study
结局指标
主要结局
Number of Participants With Venous Thromboembolism (VTE)
时间窗: Time to event analysis within 48 months
Venous thromboembolism (VTE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.
Number of Participants With Arterial Thromboembolism (ATE)
时间窗: Time to event analysis within 48 months
Arterial Thromboembolism (ATE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.
次要结局
未报告次要终点
研究者
Juergen Dinger, MD, PhD
Principal Investigator
Center for Epidemiology and Health Research, Germany