NCT04080856已完成不适用
Real-World Experience of Elagolix For the Treatment of Endometriosis in Canada: An Observational Cohort Study (GRACE)
AbbVie18 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年12月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 18
- 主要终点
- Change in Dysmenorrhea Score
研究概览
简要总结
The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian women with endometriosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Prescribed elagolix as part of standard treatment
- •Naive to elagolix prior to starting this study or have stopped taking elagolix for 2 months prior to the start of this study
- •Symptomatic endometriosis (clinically or surgically diagnosed) including currently experiencing dysmenorrhea
- •Has provided written informed consent allowing the use of their data for the study
排除标准
- •Did not consent
- •Cannot fill out questionnaires
- •Prescribed elagolix for a period of 1 or 2 months only
- •Post-menopausal (naturally or surgically)
- •Symptomatic uterine fibroid(s)
- •Had medical treatment for uterine fibroids (any length of treatment)
结局指标
主要结局
Change in Dysmenorrhea Score
时间窗: From Baseline (Month 0) to Month 6
Dysmenorrhea is evaluated through 11-point numeric rating scale (NRS), where 0 = no pain and 10 = worst imaginable pain
次要结局
- Percentage of Participants With Patient Global Impression of Change (PGIC) Response(Up to approximately 18 months)
- Percentage of Participants With Clinician's Global Impression of Change (CGIC) Response(Up to approximately 18 months)
- Change From Baseline in Non-Menstrual Pelvic Pain (NMPP)(From Baseline (Week 0) to approximately 18 months)
- Change From Baseline in Dyspareunia Score(From Baseline (Week 0) to approximately 18 months)
- Change From Baseline in Pelvic Pain During Periods(From Baseline (Week 0) to approximately 18 months)
- Change from Baseline in Bleeding and Menstrual Cycle(From Baseline (Week 0) to approximately 18 months)
- Change from Baseline in Morisky Medication Adherence Scale (MMAS)(From Baseline (Week 0) to approximately 18 months)
- Change from Baseline in Endometrial Health Profile (EHP)-30(From Baseline (Week 0) to approximately 12 months)
- Change from Baseline in Work Productivity and Activity Impairment (WPAI)(From Baseline (Week 0) to approximately 18 months)
- Percentage of Participants With Change in Dosing Schedule(Up to approximately 18 months)
- Percentage of Participants Using Concomitant Medications/Treatments(Up to approximately 18 months)
- Percentage of Participants Using Other Medications/Treatments(Up to approximately 18 months)
- Percentage of Participants Using Pain/Rescue Medications(Up to approximately 18 months)
- Percentage of Participants Using Add-Back(Up to approximately 18 months)
- Change from Baseline in Endometrial Health Profile (EHP)-5(Up to approximately 6 months post-treatment (Month 12))
研究者
研究点 (18)
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