Levonorgestrel Intrauterine System Versus Oral Contraceptives for Heavy Menses
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Menstrual Bleeding Questionnaire
研究概览
简要总结
This study is a randomized clinical trial comparing the effectiveness of the levonorgestrel intrauterine system (LNG-IUS) to combined oral contraceptives (COCs) for improving quality of life among women who report heavy menstrual bleeding.
详细描述
This study is designed to be conducted within the context of a patient's standard/usual/typical care from their primary gynecologic care provider. We hypothesize that, compared to COCs, the LNG-IUS will be more effective at improving bleeding-related quality of life at 6 months and one year. To test this hypothesis, we plan to enroll 59 women from several sites who present for gynecologic care and self-report heavy menstrual bleeding into a RCT comparing LNG-IUS to COCs. The eligible study population includes women with heavy menstrual bleeding secondary to ovulatory disorders (AUB-O) or endometrial hemostatic disorders (AUB-E). Women meeting study eligibility will be randomized to receive LNG-IUS or COCs. Main study outcomes will be obtained at 6 weeks, 3 months, 6 months, and 1 year.
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
- None
入排标准
- 年龄范围
- 18 Years 至 51 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Self-reported heavy menstrual bleeding
- •Age 18-51 years
- •Etiology of heavy menstrual bleeding from either ovulatory disorders (AUB-O) or endometrial hemostatic disorders (AUB-E)
排除标准
- •Plan pregnancy in the next year
- •Menopausal
- •Currently has a copper IUD in place
- •History of ablation or hysterectomy or have any contraindications to COCs or LNG-IUS
研究组 & 干预措施
Levonorgestrel intrauterine system
levonorgestrel intrauterine system with 52 mg of levonorgestrel, levonorgestrel is released at a rate of approximately 20 μg/day. Inserted once, duration 5 years.
干预措施: Levonorgestrel intrauterine system (Device)
Combined oral contraceptives
A combined ethinyl estradiol (ee) and progestin oral contraceptive pill chosen by the participants' primary gynecologic care provider. Monophasic with 30 or 35 mcg ee administered according to pill pack instructions (21 days active pills, 7 placebo pills)
干预措施: Combined oral contraceptives (Drug)
结局指标
主要结局
Menstrual Bleeding Questionnaire
时间窗: Completed 5 times over a one year time period
We will measure bleeding-specific quality of life using the Menstrual Bleeding Questionnaire (MBQ), a validated tool to assess bleeding-related quality of life, which is the most important outcome for patients and for clinicians treating this symptom. We will measure MBQ score at randomization, and at 6 weeks, 3 month, 6 months, and 12 months post-randomization for both groups
次要结局
- Treatment Failure(Information collected at four time points during a one year period post randomization)
研究者
Kristen Matteson , M.D.
Associate Professor of Obstetrics and Gynecology
Women and Infants Hospital of Rhode Island