An observational study in Endometriosis, sponsored by AbbVie. Completed at 18 sites in Canada. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by AbbVie · Observational
The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian women with endometriosis.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's enrollment of 100 is below the median of 128 across 344 observational studies indexed under Endometriosis.
Browse Endometriosis studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Premenopausal participants with endometriosis
Exclusion Criteria:
Premenopausal participants with endometriosis receiving elagolix in real-world setting
Change in Dysmenorrhea Score
Dysmenorrhea is evaluated through 11-point numeric rating scale (NRS), where 0 = no pain and 10 = worst imaginable pain
Time frame: From Baseline (Month 0) to Month 6
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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline (Week 0) to approximately 18 months
Change From Baseline in Dyspareunia Score
Dyspareunia pain scale ranges from 0 (absent) to 3 (severe).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline (Week 0) to approximately 18 months
Percentage of Participants Using Concomitant Medications/Treatments
Percentage of participants using concomitant medications/treatments is assessed.
Time frame: Up to approximately 18 months
Percentage of Participants Using Other Medications/Treatments
Percentage of participants using other medications/treatments for endometriosis is assessed.
Time frame: Up to approximately 18 months
Percentage of Participants Using Pain/Rescue Medications
Percentage of participants using pain/rescue medications is assessed.
Time frame: Up to approximately 18 months
Percentage of Participants Using Add-Back
Percentage of participants with use of add-back is reported
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline (Week 0) to approximately 18 months
Plan to share: Undecided
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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