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The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian women with endometriosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with endometriosis | Premenopausal participants with endometriosis receiving elagolix in real-world setting |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Premenopausal participants with endometriosis
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Health Campus Rheumatology Clinic /ID# 213065 | Calgary | Alberta | T3M 1M4 | Canada | ||
| Aubrey D. Uretsky Professional Corporation /ID# 214753 |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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 |
| Edmonton |
| Alberta |
| T5T 1L6 |
| Canada |
| BC Women's Hospital /ID# 214561 | Vancouver | British Columbia | V6H 2N9 | Canada |
| Strand Clinic /ID# 213567 | St. John's | Newfoundland and Labrador | A1A 4Y3 | Canada |
| IWK Health Center /ID# 213066 | Halifax | Nova Scotia | B3K 6R8 | Canada |
| Medicor Research Inc /ID# 213467 | Greater Sudbury | Ontario | P3A 1W8 | Canada |
| Hamilton Health Sciences - McMaster University Medical Centre /ID# 213496 | Hamilton | Ontario | L8S 4K1 | Canada |
| Dr. George A. Vilos Medicine Professional Corporation /ID# 214497 | London | Ontario | N5X 2N7 | Canada |
| Ottawa Hospital Research Institute /ID# 213608 | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Health Sciences Ctr /ID# 214330 | Toronto | Ontario | M4N 3M5 | Canada |
| Unity Health Toronto - St. Michael's Hospital /ID# 213590 | Toronto | Ontario | M5B 1W8 | Canada |
| CISSS - Hôpital de Gatineau /ID# 212944 | Gatineau | Quebec | J8P 7H2 | Canada |
| Jessima R&D Inc. /ID# 212943 | LaSalle | Quebec | H8N 1T9 | Canada |
| Clinique de Gynecologie-Obstetrique Pierre Boucher /ID# 213064 | Longueuil | Quebec | J4N 1C2 | Canada |
| CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 213439 | Montreal | Quebec | H1T 2M4 | Canada |
| Jewish General Hospital /ID# 215728 | Montreal | Quebec | H3T 1E2 | Canada |
| Duplicate_Brunswick Medical /ID# 214743 | Montreal | Quebec | H4A 3T2 | Canada |
| CHU de Quebec-Université Laval hôpital CHUL /ID# 213677 | Québec | Quebec | G1V 4G2 | Canada |
| D000091662 | Genital Diseases |