Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Amenorrhea days
研究概览
简要总结
This randomized double blinded trial seeks to determine whether tranexamic acid (TXA) is an efficacious treatment for contraceptive induced menstrual changes (CIMC) including irregular, bothersome bleeding caused by the etonogestrel subdermal contraceptive implant (ENG implant). Participants will be randomized into the TXA treatment arm or a placebo. They will begin taking the medication after three consecutive days of bleeding. Participants will track their bleeding using an automated text message service
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)
盲法说明
double-blinded
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
- •English or Spanish speaking
- •In good general health
- •Have etonogestrel (ENG) subdermal contraceptive implant (must be palpable to prove that an ENG implant is in place at time of screening and enrollment)
- •Experience frequent or prolonged bleeding while using ENG implant (>7 days of continuous bleeding/spotting in the last 30 days, or 2 or more episodes of bleeding/spotting in the last 30 days)
- •Implant use for at least 30 days prior to screening visit
- •Willing to continue using the implant for at least 30 days from study enrollment
- •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
- •Centers for Disease Control Medical Eligibility for Contraceptive use category 3 or 4 for contraceptive usage
- •Currently pregnant
- •Less than 6 months postpartum, less than 6 weeks abortion, not breast/chest feeding (cessation of lactation at least 6 weeks prior to enrollment)
- •Undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant
- •Bleeding dyscrasia
- •Anticoagulation use
- •Active cervicitis
- •Allergy to Tranexamic Acid
- •Known renal insufficiency
- •History of venous thromboembolism
- •Current or past breast or uterine malignancy
- •Concurrent use of P450 pathway inducing drug
- •Implant is due to be switched out in 2 months or less from enrollment
- •Routine or chronic use of non-steroidal anti-inflammatory drugs (NSAIDs once daily or >= 14 days per month)
- •Currently using oral contraceptives in addition to implant (to be eligible, needs to have 4-6 week washout period)
- •Prior pregnancy occurred while Nexplanon/Implanon was in place
- •Chronic use of Cannabidiol, THC, or marijuana (>3 times per week) (patients could have used Cannabidiol, THC, or marijuana chronically in the past, but must have a washout time period of no use for at least one month prior to the study)
- •Chronic use of cigarettes (>1 cigarette per week) (patients could have used cigarettes chronically in the past, but must have a washout time period of no use for at least six months prior to the study)
研究组 & 干预措施
Treatment
After three consecutive days of bleeding, five days of 1300mg TXA three times per day (TID).
干预措施: Tranexamic acid (Drug)
Placebo
After three consecutive days of bleeding, five days of placebo three times per day.
干预措施: Placebo (Other)
结局指标
主要结局
Amenorrhea days
时间窗: 30 days
The difference in mean days without bleeding across 30-day reference period between the treatment and placebo groups.
次要结局
未报告次要终点
研究者
Alison Edelman
Principal Investigator
Oregon Health and Science University