Cohort Study of Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,100
- 主要终点
- improvement of symptoms of adenomyosis assessed by change from baseline visual analogue scale at 5 years after placement of levonorgestrel-releasing intrauterine system
研究概览
简要总结
Objective: To investigate the effects of levonorgestrel-releasing intrauterine system (LNG-IUS) for symptomatic adenomyosis.
Methods: From December, 2006 to December, 2014, symptomatic patients of adenomyosis diagnosed (with dysmenorrhea and/or menorrhea) by transvaginal ultrasound in outpatient or inpatient clinics of Peking Union Medical College Hospital were given the treatment of LNG-IUS. Before and after placement of LNG-IUS, during each following period, all the parameters were recorded prospectively, including carrying status of IUS, symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation patterns and adverse effects.
Primary outcome measures: symptoms and scores of dysmenorrhea and menorrhea
Second outcome measures: carrying status of IUS
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with regular menses
- •Adenomyosis diagnosed via transvaginal ultrasound
- •With severe dysmenorrhea (VAS ≥ 7) and/or menorrhea (pictorial chart scores >100)
- •Duration of placement > 12 months
- •Size of uterus by physical examination less than uterus of 12-week pregnancy
排除标准
- •Desire for pregnancy or lactation
- •With diagnosis of malignancies or precancerous lesions
- •Acceptance of laparotomy
- •Contraindication of placing levonorgestrel-releasing intrauterine system
研究组 & 干预措施
patients with LNG-IUS
Placement of levonorgestrel-releasing intrauterine system
干预措施: Placement of levonorgestrel-releasing intrauterine system (Procedure)
结局指标
主要结局
improvement of symptoms of adenomyosis assessed by change from baseline visual analogue scale at 5 years after placement of levonorgestrel-releasing intrauterine system
时间窗: 5 years after placement of levonorgestrel-releasing intrauterine system
visual analogue scale for pain
次要结局
- unplanned taking-out rate in percent of levonorgestrel-releasing intrauterine system(5 years after placement of levonorgestrel-releasing intrauterine system)
- spontaneously expulsion rate in percent of levonorgestrel-releasing intrauterine system(5 years after placement of levonorgestrel-releasing intrauterine system)
- improvement of symptoms of adenomyosis assessed by verbal rating scales for pain(5 years after placement of levonorgestrel-releasing intrauterine system)
- improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea(5 years after placement of levonorgestrel-releasing intrauterine system)
- improvement of symptoms of adenomyosis assessed by pictorial chart scores for menorrhea(5 years after placement of levonorgestrel-releasing intrauterine system)
研究者
Lei Li
Associate Professor
Peking Union Medical College Hospital