Skip to main content
OpenTrials
Completed

NCT Number: NCT04080856

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

South Health Campus Rheumatology Clinic /ID# 213065, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: GRACE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2019
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.