MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 600
- 主要终点
- Percentage continuation rate of LNG IUS at end of observation period.
研究概览
简要总结
The study is designed as non interventional to observe the continuation rate and the patient satisfaction in women who have a LNG-IUS (Levonorgestrel releasing Intrauterine system) inserted for contraception over the period of 12 months under real life condition in India.The study will begin after the study approval by ethics committee.All Indian women aged between 18-49 years who are initiating LNG IUS therapy for contraception will be included in study after taking the informed consent.Patients will be observed for upto 12 months.The study involves general examination of patients, collection of data like medical history, previous contraceptive use,concomitant medication etc.The study is planned to enroll 600 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.
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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject aged between 18-49 years who are initiating LNG IUS therapy for contraception.
- •Subject willing to provide informed consent and comply with study procedure.
排除标准
- •Exclusion criteria must be read in conjunction with the local product information.
研究组 & 干预措施
Group 1
BAY 86-5028; Levonorgestrel- Intra Uterine System
干预措施: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena) (Drug)
结局指标
主要结局
Percentage continuation rate of LNG IUS at end of observation period.
时间窗: 12 months
Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied
时间窗: 12 months
次要结局
- Cumulative discontinuation rate for non-medical reasons(12 months)
- Cumulative discontinuation rate for pregnancy(12 months)
- Cumulative discontinuation rate for other medical reasons(12 months)
- Mean percentage of women with amenorrhea(12 months)
- Mean percent of women with spotting, inter-menstrual bleeding(12 months)
- Distribution of contraceptive usage patterns(12 months)
- Incidence rate of drug-related adverse events(12 months)