Real-World Experience Study of Elagolix For the Treatment of Endometriosis in Canada

Endometriosis Clinical Trial

— GRACE  

Official title:

Real-World Experience of Elagolix For the Treatment of Endometriosis in Canada: An Observational Cohort Study (GRACE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080856
• Other study ID #: P19-933
• Status: Completed
• Start date: December 4, 2019
• Est. completion date: September 27, 2021

Study information

• Verified date: September 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
Canada	South Health Campus Rheumatology Clinic /ID# 213065	Calgary	Alberta
Canada	Aubrey D. Uretsky Professional Corporation /ID# 214753	Edmonton	Alberta
Canada	CISSS - Hôpital de Gatineau /ID# 212944	Gatineau	Quebec
Canada	IWK Health Center /ID# 213066	Halifax	Nova Scotia
Canada	Hamilton Health Sciences - McMaster University Medical Centre /ID# 213496	Hamilton	Ontario
Canada	Jessima R&D Inc. /ID# 212943	Lasalle	Quebec
Canada	Dr. George A. Vilos Medicine Professional Corporation /ID# 214497	London	Ontario
Canada	Clinique de Gynecologie-Obstetrique Pierre Boucher /ID# 213064	Longueuil	Quebec
Canada	CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 213439	Montreal	Quebec
Canada	Jewish General Hospital /ID# 215728	Montreal	Quebec
Canada	Duplicate_Brunswick Medical /ID# 214743	Montréal	Quebec
Canada	Ottawa Hospital Research Institute /ID# 213608	Ottawa	Ontario
Canada	CHU de Quebec-Université Laval hôpital CHUL /ID# 213677	Québec	Quebec
Canada	Strand Clinic /ID# 213567	St. John's	Newfoundland and Labrador
Canada	Medicor Research Inc /ID# 213467	Sudbury	Ontario
Canada	Sunnybrook Health Sciences Ctr /ID# 214330	Toronto	Ontario
Canada	Unity Health Toronto - St. Michael's Hospital /ID# 213590	Toronto	Ontario
Canada	BC Women's Hospital /ID# 214561	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	Up to approximately 18 months
Secondary	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
Secondary	Change From Baseline in Dyspareunia Score	Dyspareunia pain scale ranges from 0 (absent) to 3 (severe).	From Baseline (Week 0) to approximately 18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants Using Concomitant Medications/Treatments	Percentage of participants using concomitant medications/treatments is assessed.	Up to approximately 18 months
Secondary	Percentage of Participants Using Other Medications/Treatments	Percentage of participants using other medications/treatments for endometriosis is assessed.	Up to approximately 18 months
Secondary	Percentage of Participants Using Pain/Rescue Medications	Percentage of participants using pain/rescue medications is assessed.	Up to approximately 18 months
Secondary	Percentage of Participants Using Add-Back	Percentage of participants with use of add-back is reported	Up to approximately 18 months
Secondary	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
Secondary	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)
Secondary	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

External Links

•   clinical study report synopsis