Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of Bleeding and Spotting Days
研究概览
简要总结
This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in new users of the 52mg levonorgestrel-releasing intrauterine device (IUD). Half of participants will receive a course of tamoxifen three weeks after insertion of the IUD, while the other half of participants will receive a course of placebo.
详细描述
New users of the LNG IUD will be eligible. Subjects will be randomized to receive tamoxifen 10 mg twice daily for 7 days or placebo. Study drug will be started 3 weeks after placement of the IUD. Subjects will maintain a record of daily bleeding and spotting using an electronic text messaging diary.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •initiating use of 52mg levonorgestrel-releasing IUD for contraceptive purposes
- •access to reliable cell phone
- •willing to receive and respond to daily text or email message to assess bleeding
排除标准
- •using IUD for indication other than contraception
- •postpartum within 6 months, pregnant, or breastfeeding
- •removal and replacement of IUD
- •undiagnosed abnormal uterine bleeding prior to placement of IUD
- •bleeding dyscrasia
- •anti-coagulation use
- •active cervicitis
- •allergy to tamoxifen
- •history of venous thromboembolism
- •personal history of breast or uterine malignancy
- •use of medication contraindicated with use of tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital)
研究组 & 干预措施
Tamoxifen
Tamoxifen 10mg tablet by mouth twice daily for 7 days
干预措施: Tamoxifen (Drug)
Placebo
Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days
干预措施: Placebo (for Tamoxifen) (Drug)
结局指标
主要结局
Number of Bleeding and Spotting Days
时间窗: 30 days after initiation of study drug
Mean number of bleeding and spotting days in the tamoxifen group compared to the mean number of bleeding and spotting days in the placebo group
次要结局
- IUD Satisfaction(30 days after initiation of study drug)
- Adverse Events(30 days after initiation of study drug)
- Bleeding Pattern Satisfaction(30 days after initiation of study drug)
研究者
Jeffrey Jensen
Leon Speroff Professor of Obstetrics & Gynecology
Oregon Health and Science University