Real-World Experience Study of Elagolix For the Treatment of Endometriosis in Canada

Study Overview
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Brief Summary
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The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian women with endometriosis.

Official Title
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Real-World Experience of Elagolix For the Treatment of Endometriosis in Canada: An Observational Cohort Study (GRACE)

Conditions
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Endometriosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with endometriosis<br>Premenopausal participants with endometriosis receiving elagolix in real-world setting | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dysmenorrhea Score | Dysmenorrhea is evaluated through 11-point numeric rating scale (NRS), where 0 = no pain and 10 = worst imaginable pain | From Baseline (Month 0) to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Patient Global Impression of Change (PGIC) Response | PGIC is a questionnaire-based assessment of endometriosis-related pain is since initiation of study drug. | Up to approximately 18 months | 
| Percentage of Participants With Clinician's Global Impression of Change (CGIC) Response | CGIC score is summarized assessment of clinical diagnosis of patient's illness by clinician in relative to a baseline state. | Up to approximately 18 months | 
| Change From Baseline in Non-Menstrual Pelvic Pain (NMPP) | The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. | From Baseline (Week 0) to approximately 18 months | 
| Change From Baseline in Dyspareunia Score | Dyspareunia pain scale ranges from 0 (absent) to 3 (severe). | From Baseline (Week 0) to approximately 18 months | 
| Change From Baseline in Pelvic Pain During Periods | Change in pelvic pain is patient reported questionnaire to rate the severity of pelvic pain during periods on the scale of 0 to 10, where 0 = no pain and 10 = worst imaginable pain. | From Baseline (Week 0) to approximately 18 months | 
| Change from Baseline in Bleeding and Menstrual Cycle | Uterine bleeding was reported by participants during the study using the e-Diary. | From Baseline (Week 0) to approximately 18 months | 
| Percentage of Participants With Change in Dosing Schedule | Percentage of participants who change dose as well as the reasons for change will be tabulated. | Up to approximately 18 months | 
| Change from Baseline in Morisky Medication Adherence Scale (MMAS) | The Morisky Medication Adherence Scale (MMAS) is a 4-item questionnaire assessing the risk of non-adherence to medications. | From Baseline (Week 0) to approximately 18 months | 
| Percentage of Participants Using Concomitant Medications/Treatments | Percentage of participants using concomitant medications/treatments is assessed. | Up to approximately 18 months | 
| Percentage of Participants Using Other Medications/Treatments | Percentage of participants using other medications/treatments for endometriosis is assessed. | Up to approximately 18 months | 
| Percentage of Participants Using Pain/Rescue Medications | Percentage of participants using pain/rescue medications is assessed. | Up to approximately 18 months | 
| Percentage of Participants Using Add-Back | Percentage of participants with use of add-back is reported | Up to approximately 18 months | 
| Change from Baseline in Endometrial Health Profile (EHP)-30 | EHP-30 is a disease-specific self-administered questionnaire used to measure health related QoL in women with endometriosis. EHP-30 covers 5 dimensions: pain, control and powerlessness, social support, emotional wellbeing, and self-image. | From Baseline (Week 0) to approximately 12 months | 
| Change from Baseline in Endometrial Health Profile (EHP)-5 | EHP-5 is a disease-specific self-administered questionnaire used to measure health related QoL in women with endometriosis. | Up to approximately 6 months post-treatment (Month 12) | 
| Change from Baseline in Work Productivity and Activity Impairment (WPAI) | WPAI questionnaire is used to measure the effect of general health and symptom severity on work productivity and regular activities during the past seven days. | From Baseline (Week 0) to approximately 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, Elagolix, Real-World, Effectiveness