Multi-center, Open-label, Uncontrolled Study to Assess Contraceptive Efficacy and Safety of Mirena During Extended Use Beyond 5 Years in Women 18 to 35 Years of Age Including a Subgroup Evaluation of Treatment Effect on Heavy Menstrual Bleeding
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 364
- 主要终点
- Number of Pregnancies Per 100 Women Years (Pearl Index [PI]) Within Years 6 Thru 8 of Mirena Use
研究概览
简要总结
The study is performed to assess if Mirena is effective and safe as a birth control method beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted for the indication heavy menstrual bleeding [HMB]) and safety will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Signed and dated informed consent
- •Women, 18 to 35 years of age at the time of screening (visit 1) who are currently using Mirena for contraception or for contraception and heavy menstrual bleeding. The duration of use of the current Mirena has to be at least 4 years 6 months at the start of screening phase but not more than 5 years at visit 2 and the woman is willing to continue with its use and has a continuing need for contraception.
- •Normal or clinically insignificant cervical smear not requiring further follow up
排除标准
- •Menopausal symptoms with Follicle-stimulating hormone>30 mIU/ml
- •Pregnancy or suspicion of pregnancy
- •Uterine bleeding of unknown etiology
- •Untreated acute cervicitis or vaginitis or other lower genital tract infections
- •Increased susceptibility to pelvic infection
- •Acute pelvic inflammatory disease (PID) or a history of PID unless successfully treated and which, in the investigator's opinion, has not negatively affected subject's fertility
- •Congenital or acquired uterine anomaly if it distorts the uterine cavity
- •History of, diagnosed or suspected genital or other malignancy and untreated cervical dysplasia
- •Any active acute liver disease or liver tumor (benign or malignant)
- •Clinically significant endometrial polyp(s)
研究组 & 干预措施
Levonorgestrel IUS (Mirena, BAY86-5028)
Mirena during extended use (Years 6 to 8).
干预措施: Levonorgestrel IUS (Mirena, BAY86-5028) (Drug)
结局指标
主要结局
Number of Pregnancies Per 100 Women Years (Pearl Index [PI]) Within Years 6 Thru 8 of Mirena Use
时间窗: Years 6 to 8 of Mirena use
The Pearl Index (PI) is defined as the number of pregnancies per 100 women years. The 3-year PI (Years 6 to 8) was obtained by dividing the number of pregnancies the occurred during that time (starting at Day 1 Year 6 and up to Day 365 of Year 8) by the time (in 100 women years) that the women were at risk of getting pregnant during that time.
次要结局
- Menstrual Blood Loss (MBL) During a 30-day Period Starting at the Baseline Visit and at the End of Years 6, 7 and 8(Baseline and end of Years 6, 7 and 8 of Mirena use)
- Number of Participants With Menstrual Blood Loss (MBL) (>= 80 ml Per 30 Days) at End of Year 6, 7 and 8 of Mirena Use(At end of Year 6, 7 and 8 of Mirena use)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Years 6 to 8 of Mirena use)