Real-World Experience Study of Elagolix For the Treatment of Endometriosis in Canada
- Conditions
- Endometriosis
- Registration Number
- NCT04080856
- Lead Sponsor
- AbbVie
- Brief Summary
The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian women with endometriosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Dysmenorrhea Score From Baseline (Month 0) to Month 6 Dysmenorrhea is evaluated through 11-point numeric rating scale (NRS), where 0 = no pain and 10 = worst imaginable pain
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Patient Global Impression of Change (PGIC) Response Up to approximately 18 months PGIC is a questionnaire-based assessment of endometriosis-related pain is since initiation of study drug.
Percentage of Participants With Clinician's Global Impression of Change (CGIC) Response Up to approximately 18 months CGIC score is summarized assessment of clinical diagnosis of patient's illness by clinician in relative to a baseline state.
Change From Baseline in Non-Menstrual Pelvic Pain (NMPP) From Baseline (Week 0) to approximately 18 months The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary.
Change From Baseline in Dyspareunia Score From Baseline (Week 0) to approximately 18 months Dyspareunia pain scale ranges from 0 (absent) to 3 (severe).
Change From Baseline in Pelvic Pain During Periods From Baseline (Week 0) to approximately 18 months 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.
Change from Baseline in Bleeding and Menstrual Cycle From Baseline (Week 0) to approximately 18 months Uterine bleeding was reported by participants during the study using the e-Diary.
Change from Baseline in Morisky Medication Adherence Scale (MMAS) From Baseline (Week 0) to approximately 18 months The Morisky Medication Adherence Scale (MMAS) is a 4-item questionnaire assessing the risk of non-adherence to medications.
Change from Baseline in Endometrial Health Profile (EHP)-30 From Baseline (Week 0) to approximately 12 months 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.
Change from Baseline in Work Productivity and Activity Impairment (WPAI) From Baseline (Week 0) to approximately 18 months 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.
Percentage of Participants With Change in Dosing Schedule Up to approximately 18 months Percentage of participants who change dose as well as the reasons for change will be tabulated.
Percentage of Participants Using Concomitant Medications/Treatments Up to approximately 18 months Percentage of participants using concomitant medications/treatments is assessed.
Percentage of Participants Using Other Medications/Treatments Up to approximately 18 months Percentage of participants using other medications/treatments for endometriosis is assessed.
Percentage of Participants Using Pain/Rescue Medications Up to approximately 18 months Percentage of participants using pain/rescue medications is assessed.
Percentage of Participants Using Add-Back Up to approximately 18 months Percentage of participants with use of add-back is reported
Change from Baseline in Endometrial Health Profile (EHP)-5 Up to approximately 6 months post-treatment (Month 12) EHP-5 is a disease-specific self-administered questionnaire used to measure health related QoL in women with endometriosis.
Trial Locations
- Locations (18)
IWK Health Center /ID# 213066
🇨🇦Halifax, Nova Scotia, Canada
Strand Clinic /ID# 213567
🇨🇦St. John's, Newfoundland and Labrador, Canada
Jessima R&D Inc. /ID# 212943
🇨🇦Lasalle, Quebec, Canada
Clinique de Gynecologie-Obstetrique Pierre Boucher /ID# 213064
🇨🇦Longueuil, Quebec, Canada
South Health Campus Rheumatology Clinic /ID# 213065
🇨🇦Calgary, Alberta, Canada
BC Women's Hospital /ID# 214561
🇨🇦Vancouver, British Columbia, Canada
Duplicate_Brunswick Medical /ID# 214743
🇨🇦Montréal, 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
CHU de Quebec-Université Laval hôpital CHUL /ID# 213677
🇨🇦Québec, Quebec, Canada
CISSS - Hôpital de Gatineau /ID# 212944
🇨🇦Gatineau, Quebec, Canada
Dr. George A. Vilos Medicine Professional Corporation /ID# 214497
🇨🇦London, Ontario, Canada
Hamilton Health Sciences - McMaster University Medical Centre /ID# 213496
🇨🇦Hamilton, Ontario, Canada
Medicor Research Inc /ID# 213467
🇨🇦Sudbury, Ontario, Canada
Sunnybrook Health Sciences Ctr /ID# 214330
🇨🇦Toronto, Ontario, Canada
Ottawa Hospital Research Institute /ID# 213608
🇨🇦Ottawa, Ontario, Canada
Unity Health Toronto - St. Michael's Hospital /ID# 213590
🇨🇦Toronto, Ontario, Canada
Aubrey D. Uretsky Professional Corporation /ID# 214753
🇨🇦Edmonton, Alberta, Canada