Tamoxifen Versus Estradiol in the Prevention of Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Controlled Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Duration of bleeding free days
研究概览
简要总结
The purpose of this research study is to evaluate the ability of medicines called tamoxifen or estradiol to prevent annoying vaginal bleeding for arm implant users.
详细描述
This pilot study compares the use of tamoxifen to estradiol to placebo for seven days once a month up to 5 months in contraceptive implant users starting from the time of implant initiation. Participants will record bleeding and satisfaction response in a daily text 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •etonogestrel implant users
- •at time of and/or within 21 days of initial use of etonogestrel implant placement
- •must agree not to take additional hormonal therapy during the study trial period
排除标准
- •within 6 months following vaginal or cesarean delivery
- •within 6 weeks following abortion
- •currently breastfeeding
- •positive pregnancy test
- •contraindications to tamoxifen or estrogen
- •history of thromboembolism
- •undiagnosed abnormal uterine bleeding
- •active cervicitis
- •bleeding disorder
- •use of anticoagulation medications
- •an unwillingness or inability to keep a daily menstrual diary or to follow the study criteria
研究组 & 干预措施
Tamoxifen
tamoxifen 10mg daily for 7 days
干预措施: Tamoxifen Citrate 10Mg Tab (Drug)
Estradiol
estradiol 1mg daily for 7 days
干预措施: Estradiol (Drug)
placebo
placebo daily for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Duration of bleeding free days
时间窗: Up to 28 days
Number of days of no spotting or bleeding after initiation of first treatment until day of subsequent bleeding
次要结局
- Total number of re-treatments(Up to 24 weeks)
- Satisfaction with bleeding(Up to 24 weeks)
- Total number of bleeding free days(Up to 24 weeks)
- Days to first re-treatment(Up to 24 weeks)
- Affects on daily life activities(Up to 24 weeks)