Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-02-02 @ 8:43 AM
Study NCT ID:
NCT04080856
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2019-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Experience Study of Elagolix For the Treatment of Endometriosis in Canada
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2019-09-04', 'studyFirstSubmitQcDate': '2019-09-05', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Dysmenorrhea Score', 'timeFrame': 'From Baseline (Month 0) to Month 6', 'description': 'Dysmenorrhea is evaluated through 11-point numeric rating scale (NRS), where 0 = no pain and 10 = worst imaginable pain'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Patient Global Impression of Change (PGIC) Response', 'timeFrame': 'Up to approximately 18 months', 'description': 'PGIC is a questionnaire-based assessment of endometriosis-related pain is since initiation of study drug.'}, {'measure': "Percentage of Participants With Clinician's Global Impression of Change (CGIC) Response", 'timeFrame': 'Up to approximately 18 months', 'description': "CGIC score is summarized assessment of clinical diagnosis of patient's illness by clinician in relative to a baseline state."}, {'measure': 'Change From Baseline in Non-Menstrual Pelvic Pain (NMPP)', 'timeFrame': 'From Baseline (Week 0) to approximately 18 months', 'description': 'The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary.'}, {'measure': 'Change From Baseline in Dyspareunia Score', 'timeFrame': 'From Baseline (Week 0) to approximately 18 months', 'description': 'Dyspareunia pain scale ranges from 0 (absent) to 3 (severe).'}, {'measure': 'Change From Baseline in Pelvic Pain During Periods', 'timeFrame': 'From Baseline (Week 0) to approximately 18 months', 'description': '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.'}, {'measure': 'Change from Baseline in Bleeding and Menstrual Cycle', 'timeFrame': 'From Baseline (Week 0) to approximately 18 months', 'description': 'Uterine bleeding was reported by participants during the study using the e-Diary.'}, {'measure': 'Percentage of Participants With Change in Dosing Schedule', 'timeFrame': 'Up to approximately 18 months', 'description': 'Percentage of participants who change dose as well as the reasons for change will be tabulated.'}, {'measure': 'Change from Baseline in Morisky Medication Adherence Scale (MMAS)', 'timeFrame': 'From Baseline (Week 0) to approximately 18 months', 'description': 'The Morisky Medication Adherence Scale (MMAS) is a 4-item questionnaire assessing the risk of non-adherence to medications.'}, {'measure': 'Percentage of Participants Using Concomitant Medications/Treatments', 'timeFrame': 'Up to approximately 18 months', 'description': 'Percentage of participants using concomitant medications/treatments is assessed.'}, {'measure': 'Percentage of Participants Using Other Medications/Treatments', 'timeFrame': 'Up to approximately 18 months', 'description': 'Percentage of participants using other medications/treatments for endometriosis is assessed.'}, {'measure': 'Percentage of Participants Using Pain/Rescue Medications', 'timeFrame': 'Up to approximately 18 months', 'description': 'Percentage of participants using pain/rescue medications is assessed.'}, {'measure': 'Percentage of Participants Using Add-Back', 'timeFrame': 'Up to approximately 18 months', 'description': 'Percentage of participants with use of add-back is reported'}, {'measure': 'Change from Baseline in Endometrial Health Profile (EHP)-30', 'timeFrame': 'From Baseline (Week 0) to approximately 12 months', 'description': '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.'}, {'measure': 'Change from Baseline in Endometrial Health Profile (EHP)-5', 'timeFrame': 'Up to approximately 6 months post-treatment (Month 12)', 'description': 'EHP-5 is a disease-specific self-administered questionnaire used to measure health related QoL in women with endometriosis.'}, {'measure': 'Change from Baseline in Work Productivity and Activity Impairment (WPAI)', 'timeFrame': 'From Baseline (Week 0) to approximately 18 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endometriosis', 'Elagolix', 'Real-World', 'Effectiveness'], 'conditions': ['Endometriosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=P19-933&Latitude=&Longitude=&LocationName=#additional-resources-section', 'label': 'clinical study report synopsis'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian women with endometriosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Premenopausal participants with endometriosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prescribed elagolix as part of standard treatment\n* Naive to elagolix prior to starting this study or have stopped taking elagolix for 2 months prior to the start of this study\n* Symptomatic endometriosis (clinically or surgically diagnosed) including currently experiencing dysmenorrhea\n* Has provided written informed consent allowing the use of their data for the study\n\nExclusion Criteria:\n\n* Did not consent\n* Cannot fill out questionnaires\n* Prescribed elagolix for a period of 1 or 2 months only\n* Post-menopausal (naturally or surgically)\n* Symptomatic uterine fibroid(s)\n* Had medical treatment for uterine fibroids (any length of treatment)'}, 'identificationModule': {'nctId': 'NCT04080856', 'acronym': 'GRACE', 'briefTitle': 'Real-World Experience Study of Elagolix For the Treatment of Endometriosis in Canada', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Real-World Experience of Elagolix For the Treatment of Endometriosis in Canada: An Observational Cohort Study (GRACE)', 'orgStudyIdInfo': {'id': 'P19-933'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with endometriosis', 'description': 'Premenopausal participants with endometriosis receiving elagolix in real-world setting'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3M 1M4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'South Health Campus Rheumatology Clinic /ID# 213065', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T5T 1L6', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Aubrey D. Uretsky Professional Corporation /ID# 214753', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6H 2N9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "BC Women's Hospital /ID# 214561", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'A1A 4Y3', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Strand Clinic /ID# 213567', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'IWK Health Center /ID# 213066', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'P3A 1W8', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Medicor Research Inc /ID# 213467', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'L8S 4K1', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences - McMaster University Medical Centre /ID# 213496', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N5X 2N7', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. George A. Vilos Medicine Professional Corporation /ID# 214497', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital Research Institute /ID# 213608', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Ctr /ID# 214330', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Unity Health Toronto - St. Michael's Hospital /ID# 213590", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'J8P 7H2', 'city': 'Gatineau', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CISSS - Hôpital de Gatineau /ID# 212944', 'geoPoint': {'lat': 45.47723, 'lon': -75.70164}}, {'zip': 'H8N 1T9', 'city': 'LaSalle', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jessima R&D Inc. /ID# 212943', 'geoPoint': {'lat': 45.43038, 'lon': -73.63518}}, {'zip': 'J4N 1C2', 'city': 'Longueuil', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique de Gynecologie-Obstetrique Pierre Boucher /ID# 213064', 'geoPoint': {'lat': 45.5152, 'lon': -73.46818}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 213439", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital /ID# 215728', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4A 3T2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Duplicate_Brunswick Medical /ID# 214743', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G2', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU de Quebec-Université Laval hôpital CHUL /ID# 213677', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}