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Trial record 2 of 5 for:    elagolix | Recruiting Studies | endometriosis

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

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ClinicalTrials.gov Identifier: NCT04080856
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date September 4, 2019
First Posted Date September 6, 2019
Last Update Posted Date December 21, 2020
Actual Study Start Date December 4, 2019
Estimated Primary Completion Date June 9, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 5, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 5, 2019)
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • Percentage of Participants Using Concomitant Medications/Treatments [ Time Frame: Up to approximately 18 months ]
    Percentage of participants using concomitant medications/treatments is assessed.
  • 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.
  • Percentage of Participants Using Pain/Rescue Medications [ Time Frame: Up to approximately 18 months ]
    Percentage of participants using pain/rescue medications is assessed.
  • Percentage of Participants Using Add-Back [ Time Frame: Up to approximately 18 months ]
    Percentage of participants with use of add-back is reported
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
Brief Summary The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian women with endometriosis.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Premenopausal participants with endometriosis
Condition Endometriosis
Intervention Not Provided
Study Groups/Cohorts Participants with endometriosis
Premenopausal participants with endometriosis receiving elagolix in real-world setting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 5, 2019)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 9, 2023
Estimated Primary Completion Date June 9, 2023   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04080856
Other Study ID Numbers P19-933
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party AbbVie
Study Sponsor AbbVie
Collaborators Not Provided
Investigators
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date December 2020