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 (ENDORSE)

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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis

• Study Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 3515210
    • Clalit Health Services /ID# 224771
  • HaDarom
    • Ashdod, HaDarom, Israel, 7747629
      • Assuta Ashdod Medical Center /ID# 244898
    • Be'er Sheva, HaDarom, Israel, 8410101
      • Soroka University Medical Center /ID# 224774
  • HaMerkaz
    • Kfar Saba, HaMerkaz, Israel, 4428164
      • Meir Medical Center /ID# 224766
    • Rekhovot, HaMerkaz, Israel, 7660101
      • Kaplan Medical Center /ID# 224773
    • Zerifin, HaMerkaz, Israel, 70300
      • Yitzhak Shamir Medical Center /ID# 224768
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 224764
    • Tel Aviv, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 224765
    • Tel Aviv, Tel-Aviv, Israel, 6789140
      • Maccabi Health Services /ID# 224775
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 91120
      • Hadassah Medical Center-Hebrew University /ID# 224769

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult Female Participants diagnosed with endometriosis and experiencing Dysmenorrhea (DYS).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants Treated With Elagolix; Participants will receive Elagolix according to the local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dysmenorrhea (DYS), According to Patient Reported 11-Point Numeric Rating Scale (NRS)	Participants rated the change in DYS using an NRS.	Baseline (Month 0) to Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dysmenorrhea (DYS), According to Patient Reported NRS	Participants rated the change in DYS using an NRS.	Baseline (Month 0) through Month 24
Change in Non-Menstrual Pelvic Pain (NMPP), According to Patient Reported NRS	Participants rated the change in NMPP using an NRS.	Baseline (Month 0) through Month 24
Change in Dyspareunia, According to Patient Reported NRS	Participants rated the change in Dyspareunia using an NRS.	Baseline (Month 0) through Month 24
Change in Level of Endometriosis Pain-through Patient Global Impression of Change (PGIC)	Participants will evaluate the change in their endometriosis-related pain since initiation of study drug, using the Patient Global Impression of Change (PGIC) questionnaire.	Baseline (Month 0) through Month 24
Change in Quality of Life (QoL) through Endometriosis Health Profile-30 (EHP-30)	The EHP-30 is a disease-specific self-administered questionnaire used to measure health related QoL in women with endometriosis.	Baseline (Month 0) through Month 24
Change in Treatment Satisfaction Though PGIC	Participants will evaluate the change in treatment satisfaction through PGIC questionnaire.	Baseline (Month 0) through Month 24
Change in Treatment Satisfaction Though Clinician Global Impression of Change (CGIC)	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.	Baseline (Month 0) through Month 24
Change in Work Productivity- through Work Productivity and Activity Impairment Questionnaire	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.	Baseline (Month 0) through Month 24
Change in Healthcare Resource Utilization Questionnaire (HCRU) Associated with Endometriosis Through HCRU Questionnaire	The HCRU will record the use of health resources (emergency room, physician visit, hospitalization, etc.) prior to and during the study.	Baseline (Month 0) through Month 24
Evaluation of Elagolix Dosing	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.	Baseline (Month 0) through Month 24
Percentage of Participants Who Change Dose of Elagolix	Percentage of participants who change dose of elagolix.	Baseline (Month 0) through Month 24
Reason Participants Change Dose of Elagolix	Reason participants change dose of elagolix.	Baseline (Month 0) through Month 24
Percentage of Participants Using Other Treatments of Endometriosis	Percentage of participants using other medications or procedures for the treatment of endometriosis.	Baseline (Month 0) through Month 24
Percentage of Participants Using Pain/Rescue Medications	Percentage of participants using pain/rescue medications.	Baseline (Month 0) through Month 24
Percentage of Participants Using Physiotherapy/Cognitive-Behavioral Therapy (Physio/CBT) During and Before the Course of this Observation Period	Percentage of participants using physio/CBT during and before the course of this observation period.	Baseline (Month 0) through Month 24
Reason for Change at Subsequent Visits in Physiotherapy/Cognitive-Behavioral Therapy (Physio/CBT) During and Before the Course of this Observation Period	Reason for change at subsequent visits in physio/CBT during and before the course of this observation period.	Baseline (Month 0) through Month 24
Percentage of Participants Using Surgical Intervention During and Before the Course of this Observation Period	Percentage of participants using surgical intervention during and before the course of this observation period.	Baseline (Month 0) through Month 24
Percentage of Participants Using Add Back	Percentage of participants using add back.	Baseline (Month 0) through Month 24
Percentage of Participants Using Concomitant Medications	Percentage of participants using concomitant medications.	Baseline (Month 0) through Month 24
Number of Adverse Events (AEs)	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.	Baseline (Month 0) through Month 24

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): March 26, 2024
• Study Completion (Actual): March 26, 2024

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Endometriosis; Elagolix; Orilissa; ABT-620
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: P20-399

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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