Multi-center, Open, Randomized, Dose Finding Phase II Study to Investigate Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) Releasing Different Amounts of Levonorgestrel Compared to MIRENA in Nulliparous and Parous Women in Need of Contraception.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 742
- 主要终点
- Pearl Index
研究概览
简要总结
The purpose of this study is to investigate if drug doses lower than the one released from Mirena® would be as effective for contraception as Mirena®. Subjects participating in the study will be randomly assigned to be inserted with any of the three different intrauterine systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from them is different.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Although the title of the study describes "open", it was in fact single-blinded.
Issues on side effects are addressed in the Adverse Event 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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with or without children and good general health and in need of contraception.
- •Regular menstrual cycle without hormonal contraceptives.
排除标准
- •Pregnant or lactating.
- •Last delivery or abortion less than 12 weeks ago.
- •Previous pregnancies outside the womb.
- •Previous pelvic infections.
- •Abnormal bleeding.
- •Abnormal uterine cavity.
- •Climacteric signs.
- •Genital cancer.
- •Liver diseases.
- •Alcoholism or drug abuse.
研究组 & 干预措施
LCS12
Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
干预措施: Levonorgestrel IUS (BAY86-5028, G04209B) (Drug)
LCS16
Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
干预措施: Levonorgestrel IUS (BAY86-5028, G04209C) (Drug)
IUS20 (Mirena)
Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
干预措施: Levonorgestrel IUS (Mirena, BAY86-5028) (Drug)
结局指标
主要结局
Pearl Index
时间窗: Up to 3 years
The 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 under risk of getting pregnant.
次要结局
- Bleeding Pattern by 90-day Reference Periods - Reference Period 12(day 991 to day 1080)
- Bleeding Pattern by 90-day Reference Periods - Reference Period 2(day 91 to day 180)
- Bleeding Pattern by 90-day Reference Periods - Reference Period 4(day 271 to day 360)
- Number of Subjects With Total or Partial Expulsions(Up to 3 years)
- Bleeding Pattern by 90-day Reference Periods - Reference Period 1(day 1 to day 90)
- Bleeding Pattern by 90-day Reference Periods - Reference Period 3(day 181 to day 270)