Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses ( in vitro12 µg/24h and 16 µg/24h) of the Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) for a Maximum of 3 Years in Women 18 to 35 Years of Age and an Extension Phase of the 16µg/24h Dose Group (LCS16 Arm) up to 5 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 2,885
- 主要终点
- Pearl Index up to 3 Years
研究概览
简要总结
This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years
详细描述
Drop out-rate will be covered in Participant flow section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 35 years (inclusive), in good general health and requesting contraception.
- •Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).
排除标准
- •Known or suspected pregnancy or is lactating.
- •History of ectopic pregnancies.
- •Any genital infection (until successfully treated).
- •Abnormal uterine bleeding of unknown origin.
研究组 & 干预措施
LCS12
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
干预措施: LCS12 (Drug)
LCS16
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
干预措施: LCS16 (Drug)
结局指标
主要结局
Pearl Index up to 3 Years
时间窗: Up to 3 years
The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were at risk of getting pregnant.
Pearl Index for LCS16 up to 5 Years
时间窗: Up to 5 years
The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
次要结局
- Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1(Day 1 to Day 90)
- Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2(Day 91 to Day 180)
- Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3(Day 181 to Day 270)
- Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4(Day 271 to Day 360)
- Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12(Day 991 to Day 1080)
- Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1(Day 1 to Day 30)
- Classification of Endometrium - Year 3 / End of Study(At Year 3 / End of study)
- Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2(Day 31 to Day 60)
- Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3(Day 61 to Day 90)
- Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4(Day 91 to Day 120)
- Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12(Day 331 to Day 360)
- Number of Participants With/Without Ovulation - Year 1(For six weeks in the second half of Year 1)
- Number of Participants With/Without Ovulation - Year 2(For six weeks in the second half of Year 2)
- Number of Participants With/Without Ovulation - Year 3(For six weeks in the second half of Year 3)
- Average Total Cervical Score - Year 1(For six weeks in the second half of Year 1)
- Average Total Cervical Score - Year 2(For six weeks in the second half of Year 2)
- Average Total Cervical Score - Year 3(For six weeks in the second half of Year 3)
- Classification of Endometrium - Year 1(At Year 1)
- Classification of Endometrium - Year 2(At Year 2)
- Degree of User Overall Satisfaction With Study Treatment(At the end of study/Year 3)
- Number of Participants With Partial or Total Expulsion(Up to 3 years)
- Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13(Day 1081 to Day 1170)
- Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20(Day 1711 to Day 1800)
- Degree of User Overall Satisfaction With Study Treatment up to 5 Years(At the end of study/Year 5)
- Number of Participants With Partial or Total Expulsion up to 5 Years(Up to 5 years)