Tamoxifen for the Treatment of Unfavorable Bleeding Patterns in Etonogestrel Contraceptive Implant Users
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Bleeding Days
研究概览
简要总结
The purpose of this study is to study whether a drug called tamoxifen can reduce vaginal bleeding in women who are using the Etonogestrel contraceptive implant.
详细描述
Nearly all of the 3 million unintended pregnancies in the United States each year result from inconsistent or non-use of contraception. Increasing use of the most effective methods of contraception will reduce unintended pregnancies and their social, medical and economic consequences. The contraceptive etonogestrel implant (ENG implant) is 20 times more effective at pregnancy prevention than oral contraceptive pills, but it has bleeding side effects that make it unappealing for many women. Tamoxifen, a selective estrogen receptor modulator (SERM) used most commonly for adjuvant treatment of breast cancer, has previously been shown to dramatically reduce bleeding in users of an older levonorgestrel-based contraceptive implant (Norplant tm). It has not been studied in newer progestin-based methods such as the ENG implant. If tamoxifen could stop bleeding in users of the ENG implant, it would give patients and physicians a valuable option for management of progestin-induced irregular bleeding. This research project will test the effectiveness of tamoxifen taken on an as-needed basis to treat abnormal bleeding in ENG implant users. If tamoxifen can be established as an effective treatment for frequent or prolonged bleeding, it will increase the acceptability of the ENG implant, increase its use and reduce unintended pregnancies. This is the first project to evaluate tamoxifen for treatment of unfavorable bleeding in users of the ENG contraceptive implant.
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
- 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
- 否
入选标准
- •Current user of the etonogestrel implant (Nexplanon, Implanon) for at least one month
- •Experiencing bleeding episodes more frequently than every 24 days, or a single episode of bleeding lasting longer than 14 days
- •English or Spanish speaking
- •Planning to continue implant use for six months
- •Access to a cell phone that can accept and send text messages
排除标准
- •Postpartum within six months
- •Post-abortion within six weeks
- •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
Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.
干预措施: Tamoxifen (Drug)
Placebo
Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.
干预措施: Placebo (Drug)
结局指标
主要结局
Bleeding Days
时间窗: 180 days
The primary objective of this study is to determine whether tamoxifen taken by users of the ENG implant on an as-needed basis for frequent or prolonged bleeding can reduce the number of bleeding days by at least 40% over 180 days, when compared to placebo.
Bleeding/Spotting Days
时间窗: 30 days
Bleeding/spotting days
Consecutive Bleeding-free Days After Study Drug
时间窗: up to 180 days
Consecutive bleeding-free days after study drug
次要结局
- Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied)(180 days)
- Number of Participants Experiencing Ovulation After First Use of Study Drug(30 days)
研究者
Katharine Simmons, MD
Fellow in Family Planning
Oregon Health and Science University