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Completed

NCT Number: NCT04630990

Study Of Oral Elagolix Tablets To Assess the Tolerability and Change in Disease Symptoms in Adult Female Participants With Moderate to Severe Endometriosis-associated Pain

Endometriosis is an abnormal, estrogen-dependent growth of endometrial tissue outside the uterus that frequently results in dysmenorrhea and pelvic pain and often causes infertility. Endometriosis is a significant burden on the quality of life of women. This study will assess the tolerability and how effective elagolix is in changing the disease symptoms in adult female participants with endometriosis.

Elagolix is an approved drug for treatment of endometriosis. Adult female participants with a diagnosis of endometriosis, who are prescribed elagolix by their physicians, in accordance with local clinical practice and label will be observed for up to 24 months. Around 80 female participants will be enrolled in the study in Israel.

Participants will receive Elagolix as prescribed by their physicians.

There may be a higher burden for participants in this study compared to standard of care. Patients report outcomes, in the form of questionnaires will be collected up to 24 months prospectively to assess the impact of elagolix on quality of life.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Meir Medical Center /ID# 224766, Kfar Saba, Central District, Israel

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with endometriosis and experiencing Dysmenorrhea (DYS).
  • Naïve to elagolix prior to starting this study or have stopped taking elagolix for 2 months prior to study enrollment.
  • Prescribed elagolix as part of standard treatment for endometriosis, according to the local label.

Exclusion criteria

  • Contraindication to the use of elagolix.
  • Post-menopausal (naturally or surgically).
  • Participation in a concurrent interventional clinical trial.

Treatment and study plan

Primary outcomes

  1. Change in Dysmenorrhea (DYS), According to Patient Reported 11-Point Numeric Rating Scale (NRS)

    Time frame: Baseline (Month 0) to Month 3

    Participants rated the change in DYS using an NRS.

Secondary outcomes

  1. Change in Dysmenorrhea (DYS), According to Patient Reported NRS

    Time frame: Baseline (Month 0) through Month 24

    Participants rated the change in DYS using an NRS.

  2. Change in Non-Menstrual Pelvic Pain (NMPP), According to Patient Reported NRS

    Time frame: Baseline (Month 0) through Month 24

    Participants rated the change in NMPP using an NRS.

  3. Change in Dyspareunia, According to Patient Reported NRS

    Time frame: Baseline (Month 0) through Month 24

    Participants rated the change in Dyspareunia using an NRS.

  4. Change in Level of Endometriosis Pain-through Patient Global Impression of Change (PGIC)

    Time frame: Baseline (Month 0) through Month 24

    Participants will evaluate the change in their endometriosis-related pain since initiation of study drug, using the Patient Global Impression of Change (PGIC) questionnaire.

  5. Change in Quality of Life (QoL) through Endometriosis Health Profile-30 (EHP-30)

    Time frame: Baseline (Month 0) through Month 24

    The EHP-30 is a disease-specific self-administered questionnaire used to measure health related QoL in women with endometriosis.

  6. Change in Treatment Satisfaction Though PGIC

    Time frame: Baseline (Month 0) through Month 24

    Participants will evaluate the change in treatment satisfaction through PGIC questionnaire.

  7. Change in Treatment Satisfaction Though Clinician Global Impression of Change (CGIC)

    Time frame: Baseline (Month 0) through Month 24

    The CGIC scale requiring the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention.

  8. Change in Work Productivity- through Work Productivity and Activity Impairment Questionnaire

    Time frame: Baseline (Month 0) through Month 24

    The Work Productivity and Activity Impairment Questionnaire is used to measure the effect of general health and symptom severity on work productivity and regular activities during the past seven days.

  9. Change in Healthcare Resource Utilization Questionnaire (HCRU) Associated with Endometriosis Through HCRU Questionnaire

    Time frame: Baseline (Month 0) through Month 24

    The HCRU will record the use of health resources (emergency room, physician visit, hospitalization, etc.) prior to and during the study.

  10. Evaluation of Elagolix Dosing

    Time frame: Baseline (Month 0) through Month 24

    Elagolix dosing will be summarized by clinical diagnosis using descriptive statistics including mean, standard deviation, median, quartiles, minimum and maximum and 95% Confidence Interval (CI) for the mean.

  11. Percentage of Participants Who Change Dose of Elagolix

    Time frame: Baseline (Month 0) through Month 24

    Percentage of participants who change dose of elagolix.

  12. Reason Participants Change Dose of Elagolix

    Time frame: Baseline (Month 0) through Month 24

    Reason participants change dose of elagolix.

  13. Percentage of Participants Using Other Treatments of Endometriosis

    Time frame: Baseline (Month 0) through Month 24

    Percentage of participants using other medications or procedures for the treatment of endometriosis.

  14. Percentage of Participants Using Pain/Rescue Medications

    Time frame: Baseline (Month 0) through Month 24

    Percentage of participants using pain/rescue medications.

  15. Percentage of Participants Using Physiotherapy/Cognitive-Behavioral Therapy (Physio/CBT) During and Before the Course of this Observation Period

    Time frame: Baseline (Month 0) through Month 24

    Percentage of participants using physio/CBT during and before the course of this observation period.

  16. Reason for Change at Subsequent Visits in Physiotherapy/Cognitive-Behavioral Therapy (Physio/CBT) During and Before the Course of this Observation Period

    Time frame: Baseline (Month 0) through Month 24

    Reason for change at subsequent visits in physio/CBT during and before the course of this observation period.

  17. Percentage of Participants Using Surgical Intervention During and Before the Course of this Observation Period

    Time frame: Baseline (Month 0) through Month 24

    Percentage of participants using surgical intervention during and before the course of this observation period.

  18. Percentage of Participants Using Add Back

    Time frame: Baseline (Month 0) through Month 24

    Percentage of participants using add back.

  19. Percentage of Participants Using Concomitant Medications

    Time frame: Baseline (Month 0) through Month 24

    Percentage of participants using concomitant medications.

  20. Number of Adverse Events (AEs)

    Time frame: Baseline (Month 0) through Month 24

    An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Effectiveness and Safety of Elagolix Treatment in Moderate to Severe Endometriosis-associated Pain in Routine Clinical Practice in Israel- ENDORSE Study

Acronym: ENDORSE

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 16, 2020
Registry last updated
Apr 1, 2025

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.

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