Endometriosis
Conditions
Keywords
Endometriosis, Elagolix, Real-World, Effectiveness
Brief summary
The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian women with endometriosis.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dysmenorrhea Score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Patient Global Impression of Change (PGIC) Response | Up to approximately 18 months | PGIC is a questionnaire-based assessment of endometriosis-related pain is since initiation of study drug. |
| Percentage of Participants With Clinician's Global Impression of Change (CGIC) Response | Up to approximately 18 months | CGIC score is summarized assessment of clinical diagnosis of patient's illness by clinician in relative to a baseline state. |
| Change From Baseline in Non-Menstrual Pelvic Pain (NMPP) | From Baseline (Week 0) to approximately 18 months | The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. |
| Change From Baseline in Dyspareunia Score | From Baseline (Week 0) to approximately 18 months | Dyspareunia pain scale ranges from 0 (absent) to 3 (severe). |
| Change From Baseline in Pelvic Pain During Periods | From Baseline (Week 0) to approximately 18 months | 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. |
| Change from Baseline in Bleeding and Menstrual Cycle | From Baseline (Week 0) to approximately 18 months | Uterine bleeding was reported by participants during the study using the e-Diary. |
| Percentage of Participants With Change in Dosing Schedule | Up to approximately 18 months | Percentage of participants who change dose as well as the reasons for change will be tabulated. |
| Change from Baseline in Work Productivity and Activity Impairment (WPAI) | From Baseline (Week 0) to approximately 18 months | 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. |
| Percentage of Participants Using Concomitant Medications/Treatments | Up to approximately 18 months | Percentage of participants using concomitant medications/treatments is assessed. |
| Percentage of Participants Using Other Medications/Treatments | Up to approximately 18 months | Percentage of participants using other medications/treatments for endometriosis is assessed. |
| Percentage of Participants Using Pain/Rescue Medications | Up to approximately 18 months | Percentage of participants using pain/rescue medications is assessed. |
| Percentage of Participants Using Add-Back | Up to approximately 18 months | Percentage of participants with use of add-back is reported |
| Change from Baseline in Endometrial Health Profile (EHP)-30 | From Baseline (Week 0) to approximately 12 months | 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. |
| Change from Baseline in Endometrial Health Profile (EHP)-5 | Up to approximately 6 months post-treatment (Month 12) | EHP-5 is a disease-specific self-administered questionnaire used to measure health related QoL in women with endometriosis. |
| Change from Baseline in Morisky Medication Adherence Scale (MMAS) | From Baseline (Week 0) to approximately 18 months | The Morisky Medication Adherence Scale (MMAS) is a 4-item questionnaire assessing the risk of non-adherence to medications. |
Countries
Canada
Outcome results
None listed