Effectiveness and Safety of Elagolix Treatment in Moderate to Severe Endometriosis-associated Pain in Routine Clinical Practice in Israel- ENDORSE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 10
- 主要终点
- Change in Dysmenorrhea (DYS), According to Patient Reported 11-Point Numeric Rating Scale (NRS)
研究概览
简要总结
Endometriosis is an abnormal, estrogen-dependent growth of endometrial tissue outside the uterus that frequently results in dysmenorrhea and pelvic pain and often causes infertility. Endometriosis is a significant burden on the quality of life of women. This study will assess the tolerability and how effective elagolix is in changing the disease symptoms in adult female participants with endometriosis.
Elagolix is an approved drug for treatment of endometriosis. Adult female participants with a diagnosis of endometriosis, who are prescribed elagolix by their physicians, in accordance with local clinical practice and label will be observed for up to 24 months. Around 80 female participants will be enrolled in the study in Israel.
Participants will receive Elagolix as prescribed by their physicians.
There may be a higher burden for participants in this study compared to standard of care. Patients report outcomes, in the form of questionnaires will be collected up to 24 months prospectively to assess the impact of elagolix on quality of life.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with endometriosis and experiencing Dysmenorrhea (DYS).
- •Naïve to elagolix prior to starting this study or have stopped taking elagolix for 2 months prior to study enrollment.
- •Prescribed elagolix as part of standard treatment for endometriosis, according to the local label.
排除标准
- •Contraindication to the use of elagolix.
- •Post-menopausal (naturally or surgically).
- •Participation in a concurrent interventional clinical trial.
结局指标
主要结局
Change in Dysmenorrhea (DYS), According to Patient Reported 11-Point Numeric Rating Scale (NRS)
时间窗: Baseline (Month 0) to Month 3
Participants rated the change in DYS using an NRS.
次要结局
- Change in Dysmenorrhea (DYS), According to Patient Reported NRS(Baseline (Month 0) through Month 24)
- Change in Quality of Life (QoL) through Endometriosis Health Profile-30 (EHP-30)(Baseline (Month 0) through Month 24)
- Change in Work Productivity- through Work Productivity and Activity Impairment Questionnaire(Baseline (Month 0) through Month 24)
- Change in Non-Menstrual Pelvic Pain (NMPP), According to Patient Reported NRS(Baseline (Month 0) through Month 24)
- Change in Healthcare Resource Utilization Questionnaire (HCRU) Associated with Endometriosis Through HCRU Questionnaire(Baseline (Month 0) through Month 24)
- Evaluation of Elagolix Dosing(Baseline (Month 0) through Month 24)
- Percentage of Participants Who Change Dose of Elagolix(Baseline (Month 0) through Month 24)
- Percentage of Participants Using Other Treatments of Endometriosis(Baseline (Month 0) through Month 24)
- Percentage of Participants Using Pain/Rescue Medications(Baseline (Month 0) through Month 24)
- Percentage of Participants Using Surgical Intervention During and Before the Course of this Observation Period(Baseline (Month 0) through Month 24)
- Percentage of Participants Using Add Back(Baseline (Month 0) through Month 24)
- Change in Dyspareunia, According to Patient Reported NRS(Baseline (Month 0) through Month 24)
- Reason Participants Change Dose of Elagolix(Baseline (Month 0) through Month 24)
- Percentage of Participants Using Physiotherapy/Cognitive-Behavioral Therapy (Physio/CBT) During and Before the Course of this Observation Period(Baseline (Month 0) through Month 24)
- Percentage of Participants Using Concomitant Medications(Baseline (Month 0) through Month 24)
- Reason for Change at Subsequent Visits in Physiotherapy/Cognitive-Behavioral Therapy (Physio/CBT) During and Before the Course of this Observation Period(Baseline (Month 0) through Month 24)
- Number of Adverse Events (AEs)(Baseline (Month 0) through Month 24)
- Change in Level of Endometriosis Pain-through Patient Global Impression of Change (PGIC)(Baseline (Month 0) through Month 24)
- Change in Treatment Satisfaction Though PGIC(Baseline (Month 0) through Month 24)
- Change in Treatment Satisfaction Though Clinician Global Impression of Change (CGIC)(Baseline (Month 0) through Month 24)