A Phase 3, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Medicines360
- 入组人数
- 1,910
- 试验地点
- 1
- 主要终点
- Cumulative Pearl Index
研究概览
简要总结
The primary objective of this study is to assess the efficacy of a levonorgestrel-releasing intrauterine system (LNG20) in nulliparous and parous females of child-bearing potential who request long-term, reversible contraception for up to 10 years.
详细描述
This is a Phase 3, randomized, open-label, multicenter evaluation of the efficacy of a levonorgestrel-releasing intrauterine system (LNG20). The goals of the study include provision of information to understand efficacy and safety within the widest range of possible users of the LNG20. Typically, intrauterine contraceptive studies only include women 18-35 years of age for efficacy and safety, and place limits on parity and larger body size. Women outside of these characteristics also desire an effective intrauterine contraceptive. Accordingly, this study will include women who are both nulliparous and parous as well as women less than 18 years of age in the primary efficacy and safety analyses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women requesting contraception
- •16-35 years old
- •Cohort 36-45 years old
- •Sexually active
排除标准
- •Currently pregnant, pregnant within 4 weeks prior to study entry or planning pregnancy within 24 months of study entry
- •Currently breastfeeding
- •Current persistent, abnormal vaginal bleeding
研究组 & 干预措施
LNG20 (16-35 Year Olds)
LNG20 levonorgestrel-releasing intrauterine system in subjects 16-35 years of age
干预措施: LNG20 (Drug)
Mirena
Levonorgestrel-releasing intrauterine system for contraception
干预措施: Mirena (Drug)
LNG20 (36-45 Year Olds)
LNG20 levonorgestrel-releasing intrauterine system in subjects 36-45 years of age
干预措施: LNG20 (Drug)
结局指标
主要结局
Cumulative Pearl Index
时间窗: 8 years
The Pearl Index (PI) is an estimate of the number of pregnancies per 100 women-years of contraceptive exposure. The Pearl Index is calculated as the number of "on treatment" pregnancies in the study divided by the total number of complete 28-day cycles of use in the study multiplied by 1,300 (13 cycles/yr x 100 years). Cycles where other birth control methods were used were excluded from this measure. The Pearl Index for MIRENA was not a pre-specified primary outcome measure and is therefore not included. There is only 8 years of data due to the early termination of the study.
Number of Pregnancies Per Year
时间窗: 10 years
Number of pregnancies per year in each treatment arm.
次要结局
- Incidence of Bleeding and/or Spotting(8 Years)
- Return of Menses After Discontinuation(5 months)
- Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy(5 Years)
- Changes in Endometrial Thickness Based on Transvaginal Ultrasonography at One Year, Five Years and Ten Years(10 Years)
- Ex Vivo Analysis of IUSs That Are Removed or Expelled During the Study(8 Years)
- Expulsion Rate(10 years)
- Continuation Rates(10 Years)
- Safety and Tolerability(10 Years)
- Return to Fertility After Discontinuation(12 months)
- Distribution of Bleeding Amenorrhea by 90 Day Interval(8 Years)
- Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120(month 36 through 120)
- Cumulative Pregnancy Rates(8 years)
- Change in Hemoglobin Values(10 years)
- Discontinuation for Safety Reasons(10 years)