Clinical trial NCT04080856: Real-World Experience Study of Elagolix For the Treatment of Endometriosis in Canada
Official title: Real-World Experience of Elagolix For the Treatment of Endometriosis in Canada: An Observational Cohort Study (GRACE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: Endometriosis
Elagolix
Real-World
Effectiveness
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-09-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premenopausal participants with endometriosis

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


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Dysmenorrhea Score
timeFrame: From Baseline (Month 0) to Month 6
Secondary outcomes:
measure: Percentage of Participants With Patient Global Impression of Change (PGIC) Response
timeFrame: Up to approximately 18 months
measure: Percentage of Participants With Clinician's Global Impression of Change (CGIC) Response
timeFrame: Up to approximately 18 months
measure: Change From Baseline in Non-Menstrual Pelvic Pain (NMPP)
timeFrame: From Baseline (Week 0) to approximately 18 months
measure: Change From Baseline in Dyspareunia Score
timeFrame: From Baseline (Week 0) to approximately 18 months
measure: Change From Baseline in Pelvic Pain During Periods
timeFrame: From Baseline (Week 0) to approximately 18 months
measure: Change from Baseline in Bleeding and Menstrual Cycle
timeFrame: From Baseline (Week 0) to approximately 18 months
measure: Percentage of Participants With Change in Dosing Schedule
timeFrame: Up to approximately 18 months
measure: Change from Baseline in Morisky Medication Adherence Scale (MMAS)
timeFrame: From Baseline (Week 0) to approximately 18 months
measure: Percentage of Participants Using Concomitant Medications/Treatments
timeFrame: Up to approximately 18 months
measure: Percentage of Participants Using Other Medications/Treatments
timeFrame: Up to approximately 18 months
measure: Percentage of Participants Using Pain/Rescue Medications
timeFrame: Up to approximately 18 months
measure: Percentage of Participants Using Add-Back
timeFrame: Up to approximately 18 months
measure: Change from Baseline in Endometrial Health Profile (EHP)-30
timeFrame: From Baseline (Week 0) to approximately 12 months
measure: Change from Baseline in Endometrial Health Profile (EHP)-5
timeFrame: Up to approximately 6 months post-treatment (Month 12)
measure: Change from Baseline in Work Productivity and Activity Impairment (WPAI)
timeFrame: From Baseline (Week 0) to approximately 18 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: South Health Campus Rheumatology Clinic /ID# 213065
state: Alberta
city: Edmonton
country: Canada
facility: Aubrey D. Uretsky Professional Corporation /ID# 214753
state: Alberta
city: Vancouver
country: Canada
facility: BC Women's Hospital /ID# 214561
state: British Columbia
city: St. John's
country: Canada
facility: Strand Clinic /ID# 213567
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: IWK Health Center /ID# 213066
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - McMaster University Medical Centre /ID# 213496
state: Ontario
city: London
country: Canada
facility: Dr. George A. Vilos Medicine Professional Corporation /ID# 214497
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute /ID# 213608
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research Inc /ID# 213467
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Ctr /ID# 214330
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Toronto - St. Michael's Hospital /ID# 213590
state: Ontario
city: Gatineau
country: Canada
facility: CISSS - Hôpital de Gatineau /ID# 212944
state: Quebec
city: Lasalle
country: Canada
facility: Jessima R&D Inc. /ID# 212943
state: Quebec
city: Longueuil
country: Canada
facility: Clinique de Gynecologie-Obstetrique Pierre Boucher /ID# 213064
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 213439
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital /ID# 215728
state: Quebec
city: Montréal
country: Canada
facility: Duplicate_Brunswick Medical /ID# 214743
state: Quebec
city: Québec
country: Canada
facility: CHU de Quebec-Université Laval hôpital CHUL /ID# 213677
state: Quebec
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: