Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1)
研究概览
简要总结
The etonogestrel (ENG) subdermal contraceptive implant (ENG implant) is a highly effective method of preventing pregnancy, but it has bleeding side effects that make it unappealing for many women. The only study to demonstrate a sustained reduction in bleeding lasting for two months was the selective estrogen receptor modulator (SERM) tamoxifen in users of the levonogestrel (LNG) contraceptive implant. Based on the investigators encouraging preliminary data of tamoxifen and ENG implant users, the investigators plan to perform additional studies on the impact of tamoxifen on the breakthrough bleeding experience by ENG implant users.
详细描述
The investigators will perform a 2 phase trial for treatment of women experiencing frequent or prolonged bleeding while using the ENG contraceptive implant. The first phase will consist of a randomized, controlled, double blind placebo-controlled clinical trial over a 90-day reference period and the second phase will allow both study arms to receive open-label treatment over an additional 90-day reference period. The primary outcome of the study will be the total number of consecutive bleeding-free days in first 30 days from Day 1 of first treatment (TX1).
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
- 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
- •English or Spanish speaking
- •women aged 15-45 years of age
- •Currently using the ENG-implant for at least 1 month and use proven on exam (palpation of implant at screening visit)
- •Willing to continue using the implant for at least 6 months
- •>7 days of continuous bleeding/spotting, or 2 or more episodes of bleeding/spotting in the last 30 days.
- •Cellphone that is able to receive and respond to a daily text or email message .
排除标准
- •Postpartum within six months
- •post-abortion within six weeks
- •currently pregnant
- •currently breast-feeding
- •undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant
- •bleeding dyscrasia
- •anticoagulation use
- •active cervicitis
- •allergy to tamoxifen
- •history of venous thromboembolism
- •current or past breast or uterine malignancy
- •use of medication contraindicated with tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital).
研究组 & 干预措施
Tamoxifen
Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
干预措施: Tamoxifen (Drug)
Tamoxifen
Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
干预措施: Tamoxifen (open label) (Drug)
Placebo
Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
干预措施: Placebo (Drug)
结局指标
主要结局
Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1)
时间窗: Day 1 to Day 30
Bleeding free days in the first 30 days
次要结局
- Total Number of Bleeding Free Days Over the First 90 Day Reference Period From Day 1 of Treatment 1.(Day 1 to Day 90)
研究者
Alison Edelman
Professor, OB/GYN
Oregon Health and Science University