Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: a Randomized Clinical Trial of Curcumin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Total Number of Days Without Bleeding or Spotting
研究概览
简要总结
The investigators plan to study the effects of curcumin, the active ingredient in the spice turmeric, on the irregular bleeding experienced by women who use the contraceptive implant.
详细描述
The investigators are proposing a randomized, double blind placebo-controlled clinical trial over a 30-day reference period for treatment of women experiencing bothersome bleeding while using the etonogestrel (ENG) contraceptive implant. The primary outcome of the study will be the total number of amenorrhea days in a 30-day reference period. The study has a number of secondary outcomes (see study objectives) focused around the efficacy of oral curcumin to stop bleeding/spotting and for how long.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Placebo-controlled Computer-generated randomization schema
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 speaking
- •Women 15-45 years of age
- •Currently using the ENG implant for at least 30 days and use proven on exam (palpation of implant at screening visit)
- •Willing to continue using the implant for at least 30 days from study enrollment
- •>7 days of continuous bleeding/spotting in the last 30 days, OR 2 or more episodes of bleeding/spotting in the last 30 days.
- •Access to a reliable cell phone and must be willing to receive and respond to a daily text or email message to assess bleeding and use of study drug
- •Negative gonorrhea/chlamydia screening performed at screening visit
排除标准
- •Postpartum within six months
- •Post-abortion within six weeks
- •Currently pregnant
- •Currently breast-feeding (to be eligible, must be 4-6 weeks from cessation of breastfeeding)
- •Undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant
- •Bleeding dyscrasia
- •Anticoagulation use
- •Active cervicitis
- •Allergy to curcumin or turmeric
- •History of venous thromboembolism
- •Current or past breast or uterine malignancy
- •Use of P450 pathway inducing drug
- •Implant is due to be switched out in 2 months or less from enrollment
- •Currently using oral contraceptives in addition to implant (to be eligible, needs to have a 4-6 week washout period)
- •Prior pregnancy occurred while Nexplanon/Implanon was in place
研究组 & 干预措施
Curcumin group
Curcumin 600 mg (oral) once daily for 30 days to be started following 3 consecutive days of bleeding
干预措施: Curcumin (Drug)
Placebo group
Placebo (oral) once daily for 30 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 Days Without Bleeding or Spotting
时间窗: Day 1 to Day 30
Total number of days without bleeding or spotting in the 30-day reference period
次要结局
- Total Number of Bleeding/Spotting Days(Day 1 to Day 30)
- Total Number of Spotting Days(Day 1 to Day 30)
- Total Number of Bleeding Days(Day 1 to Day 30)
研究者
Alison Edelman
Professor OB/Gyn
Oregon Health and Science University