European Active Surveillance Study of LCS12
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 97,265
- 试验地点
- 2
- 主要终点
- Contraceptive failure (LCS12 vs. Mirena and copper IUDs)
研究概览
简要总结
This study is designed to investigate whether LCS12 is associated with an increased risk of unintended pregnancy compared to Mirena and to copper IUDs. The objective is to assess among new users the risks of certain events (e.g. contraceptive failure rate, ectopic pregnancy, uterine perforation, and PID) associated with the use of LCS12 compared with the established hormonal IUD Mirena, and compared with established copper IUDs during standard clinical practice. In addition, drug utilization patterns will be described.
详细描述
Intrauterine contraceptive methods, such as Mirena and copper IUDs, have a high contraceptive efficacy. LCS12 is a new intrauterine system which, like Mirena, contains levonorgestrel (LNG), but the T-body dimensions and insertion tube diameter of LCS12 are smaller.
Because there is a lack of comparative data between LCS12 and other intrauterine contraceptives, it is unclear whether there are differences in contraceptive failure rates between LCS12 and either Mirena or copper IUDs. In addition, any transcervical procedure, including the insertion of an intrauterine device, is potentially associated with the risk of infection/inflammation.
EURAS-LCS12 is a prospective, controlled, non-interventional, active surveillance cohort study with three user cohorts: LCS12, Mirena and copper IUDs. Study participants will be recruited by a network of health care professionals and will be followed up through active surveillance to collect information regarding the outcomes of interest and major safety outcomes.
All self-reported clinical outcomes of interest will be validated by health care professionals. The primary endpoint is unintended pregnancy. Secondary endpoints are ectopic pregnancy, uterine perforation, and pelvic inflammatory disease (PID).
Study Amendment (Approved by PRAC on September 29, 2016):
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
- — 至 39 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged below 40 years who have a new IUD inserted (LCS12, Kyleena, Mirena, copper IUD, or any other hormonal IUD)
- •Women who are willing to participate in the active surveillance
排除标准
- •Women aged 40 or older at insertion day
- •Women who are currently enrolled in an interventional trial on IUD use can not participate
研究组 & 干预措施
LCS12
New users of LCS12
Mirena
New users of Mirena
Copper IUD
New users of copper IUDs
Kyleena
New users of Kyleena
Other hormonal IUD (OHIUD)
New users of other hormonal IUDs (e.g. Levosert, Fibroplant)
结局指标
主要结局
Contraceptive failure (LCS12 vs. Mirena and copper IUDs)
时间窗: within 3 years
次要结局
- Ectopic pregnancy(within 3 - 5 years)
- Uterine perforations(within 3 - 5 years)
- Contraceptive failure (Kyleena vs. Mirena and copper IUDs)(within 5 years)
- Pelvic inflammatory disease (PID)(within 3 - 5 years)