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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04080856
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

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

Condition or disease
Endometriosis

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-World Experience of Elagolix For the Treatment of Endometriosis in Canada: An Observational Cohort Study (GRACE)
Actual Study Start Date : December 4, 2019
Estimated Primary Completion Date : June 9, 2023
Estimated Study Completion Date : June 9, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Group/Cohort
Participants with endometriosis
Premenopausal participants with endometriosis receiving elagolix in real-world setting



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Percentage of Participants With Patient Global Impression of Change (PGIC) Response [ Time Frame: Up to approximately 18 months ]
    PGIC is a questionnaire-based assessment of endometriosis-related pain is since initiation of study drug.

  2. Percentage of Participants With Clinician's Global Impression of Change (CGIC) Response [ Time Frame: 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.

  3. Change From Baseline in Non-Menstrual Pelvic Pain (NMPP) [ Time Frame: 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.

  4. Change From Baseline in Dyspareunia Score [ Time Frame: From Baseline (Week 0) to approximately 18 months ]
    Dyspareunia pain scale ranges from 0 (absent) to 3 (severe).

  5. Change From Baseline in Pelvic Pain During Periods [ Time Frame: 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.

  6. Change from Baseline in Bleeding and Menstrual Cycle [ Time Frame: From Baseline (Week 0) to approximately 18 months ]
    Uterine bleeding was reported by participants during the study using the e-Diary.

  7. Percentage of Participants With Change in Dosing Schedule [ Time Frame: Up to approximately 18 months ]
    Percentage of participants who change dose as well as the reasons for change will be tabulated.

  8. Change from Baseline in Morisky Medication Adherence Scale (MMAS) [ Time Frame: 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.

  9. Percentage of Participants Using Concomitant Medications/Treatments [ Time Frame: Up to approximately 18 months ]
    Percentage of participants using concomitant medications/treatments is assessed.

  10. Percentage of Participants Using Other Medications/Treatments [ Time Frame: Up to approximately 18 months ]
    Percentage of participants using other medications/treatments for endometriosis is assessed.

  11. Percentage of Participants Using Pain/Rescue Medications [ Time Frame: Up to approximately 18 months ]
    Percentage of participants using pain/rescue medications is assessed.

  12. Percentage of Participants Using Add-Back [ Time Frame: Up to approximately 18 months ]
    Percentage of participants with use of add-back is reported

  13. Change from Baseline in Endometrial Health Profile (EHP)-30 [ Time Frame: 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.

  14. Change from Baseline in Endometrial Health Profile (EHP)-5 [ Time Frame: 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.

  15. Change from Baseline in Work Productivity and Activity Impairment (WPAI) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premenopausal participants with endometriosis
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04080856


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
Show Show 20 study locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04080856    
Other Study ID Numbers: P19-933
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Endometriosis
Elagolix
Real-World
Effectiveness
Additional relevant MeSH terms:
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Endometriosis