EndometriosisGRACENCT04080856
Real-World Experience Study of Elagolix For the Treatment of Endometriosis in Canada
An observational study of Endometriosis, run by AbbVie at 18 sites in Canada.
Trial summary
The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian women with endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 100 participants
- Where
- 18 sitesCanada
- Study dates
- 4 Dec 2019to 27 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Premenopausal participants with endometriosis
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Canada18 sites
South Health Campus Rheumatology Clinic /ID# 213065
Calgary, Alberta, T3M 1M4
Aubrey D. Uretsky Professional Corporation /ID# 214753
Edmonton, Alberta, T5T 1L6
CISSS - Hôpital de Gatineau /ID# 212944
Gatineau, Quebec, J8P 7H2
Medicor Research Inc /ID# 213467
Greater Sudbury, Ontario, P3A 1W8
IWK Health Center /ID# 213066
Halifax, Nova Scotia, B3K 6R8
Hamilton Health Sciences - McMaster University Medical Centre /ID# 213496
Hamilton, Ontario, L8S 4K1
Jessima R&D Inc. /ID# 212943
LaSalle, Quebec, H8N 1T9
Dr. George A. Vilos Medicine Professional Corporation /ID# 214497
London, Ontario, N5X 2N7
Clinique de Gynecologie-Obstetrique Pierre Boucher /ID# 213064
Longueuil, Quebec, J4N 1C2
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 213439
Montreal, Quebec, H1T 2M4
Jewish General Hospital /ID# 215728
Montreal, Quebec, H3T 1E2
Duplicate_Brunswick Medical /ID# 214743
Montreal, Quebec, H4A 3T2
Ottawa Hospital Research Institute /ID# 213608
Ottawa, Ontario, K1H 8L6
CHU de Quebec-Université Laval hôpital CHUL /ID# 213677
Québec, Quebec, G1V 4G2
Strand Clinic /ID# 213567
St. John's, Newfoundland and Labrador, A1A 4Y3
Sunnybrook Health Sciences Ctr /ID# 214330
Toronto, Ontario, M4N 3M5
Unity Health Toronto - St. Michael's Hospital /ID# 213590
Toronto, Ontario, M5B 1W8
BC Women's Hospital /ID# 214561
Vancouver, British Columbia, V6H 2N9
About this study
Official title: Real-World Experience of Elagolix For the Treatment of Endometriosis in Canada: An Observational Cohort Study (GRACE)
The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian women with endometriosis.
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Elagolix, Real-World, Effectiveness
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with endometriosis | Premenopausal participants with endometriosis receiving elagolix in real-world setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dysmenorrhea Score
Dysmenorrhea is evaluated through 11-point numeric rating scale (NRS), where 0 = no pain and 10 = worst imaginable pain
Measured: From Baseline (Month 0) to Month 6
Secondary outcomes (15)
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.
Measured: Up to approximately 18 months
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.
Measured: 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.
Measured: From Baseline (Week 0) to approximately 18 months
Change From Baseline in Dyspareunia Score
Dyspareunia pain scale ranges from 0 (absent) to 3 (severe).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline (Week 0) to approximately 18 months
Percentage of Participants Using Concomitant Medications/Treatments
Percentage of participants using concomitant medications/treatments is assessed.
Measured: Up to approximately 18 months
Percentage of Participants Using Other Medications/Treatments
Percentage of participants using other medications/treatments for endometriosis is assessed.
Measured: Up to approximately 18 months
Percentage of Participants Using Pain/Rescue Medications
Percentage of participants using pain/rescue medications is assessed.
Measured: Up to approximately 18 months
Percentage of Participants Using Add-Back
Percentage of participants with use of add-back is reported
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline (Week 0) to approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start4 Dec 2019
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080856
- Sponsor's protocol ID
- P19-933
- Acronym
- GRACE
- Status last verified
- Sep 2022
- First submitted
- 4 Sep 2019
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Experience of Elagolix For the Treatment of Endometriosis in Canada: An Observational Cohort Study (GRACE)
- ClinicalTrials.gov ID
- NCT04080856
- Acronym / sponsor ID
- GRACE / P19-933
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Elagolix, Real-World, Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian women with endometriosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with endometriosis | – | –Premenopausal participants with endometriosis receiving elagolix in real-world setting |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Premenopausal participants with endometriosis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Dysmenorrhea Score
Time frame: 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
15 secondary outcomes
Percentage of Participants With Patient Global Impression of Change (PGIC) Response
Time frame: Up to approximately 18 months
Percentage of Participants With Clinician's Global Impression of Change (CGIC) Response
Time frame: Up to approximately 18 months
Change From Baseline in Non-Menstrual Pelvic Pain (NMPP)
Time frame: From Baseline (Week 0) to approximately 18 months
Change From Baseline in Dyspareunia Score
Time frame: From Baseline (Week 0) to approximately 18 months
Change From Baseline in Pelvic Pain During Periods
Time frame: From Baseline (Week 0) to approximately 18 months
Change from Baseline in Bleeding and Menstrual Cycle
Time frame: From Baseline (Week 0) to approximately 18 months
Percentage of Participants With Change in Dosing Schedule
Time frame: Up to approximately 18 months
Change from Baseline in Morisky Medication Adherence Scale (MMAS)
Time frame: From Baseline (Week 0) to approximately 18 months
Percentage of Participants Using Concomitant Medications/Treatments
Time frame: Up to approximately 18 months
Percentage of Participants Using Other Medications/Treatments
Time frame: Up to approximately 18 months
Percentage of Participants Using Pain/Rescue Medications
Time frame: Up to approximately 18 months
Percentage of Participants Using Add-Back
Time frame: Up to approximately 18 months
Change from Baseline in Endometrial Health Profile (EHP)-30
Time frame: From Baseline (Week 0) to approximately 12 months
Change from Baseline in Endometrial Health Profile (EHP)-5
Time frame: Up to approximately 6 months post-treatment (Month 12)
Change from Baseline in Work Productivity and Activity Impairment (WPAI)
Time frame: From Baseline (Week 0) to approximately 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by AbbVie at 18 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dysmenorrhea Score (time frame: From Baseline (Month 0) to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.