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 Clinical Trial

— ENDORSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04630990
• Other study ID #: P20-399
• Status: Completed
• Start date: December 14, 2020
• Est. completion date: March 26, 2024

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: March 26, 2024
• Est. primary completion date: March 26, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
Israel	Assuta Ashdod Medical Center /ID# 244898	Ashdod	HaDarom
Israel	Soroka University Medical Center /ID# 224774	Be'er Sheva	HaDarom
Israel	Clalit Health Services /ID# 224771	Haifa
Israel	Hadassah Medical Center-Hebrew University /ID# 224769	Jerusalem	Yerushalayim
Israel	Meir Medical Center /ID# 224766	Kfar Saba	HaMerkaz
Israel	The Chaim Sheba Medical Center /ID# 224764	Ramat Gan	Tel-Aviv
Israel	Kaplan Medical Center /ID# 224773	Rekhovot	HaMerkaz
Israel	Maccabi Health Services /ID# 224775	Tel Aviv	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 224765	Tel Aviv	Tel-Aviv
Israel	Yitzhak Shamir Medical Center /ID# 224768	Zerifin	HaMerkaz

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Dysmenorrhea (DYS), According to Patient Reported NRS	Participants rated the change in DYS using an NRS.	Baseline (Month 0) through Month 24
Secondary	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
Secondary	Change in Dyspareunia, According to Patient Reported NRS	Participants rated the change in Dyspareunia using an NRS.	Baseline (Month 0) through Month 24
Secondary	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
Secondary	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
Secondary	Change in Treatment Satisfaction Though PGIC	Participants will evaluate the change in treatment satisfaction through PGIC questionnaire.	Baseline (Month 0) through Month 24
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants Who Change Dose of Elagolix	Percentage of participants who change dose of elagolix.	Baseline (Month 0) through Month 24
Secondary	Reason Participants Change Dose of Elagolix	Reason participants change dose of elagolix.	Baseline (Month 0) through Month 24
Secondary	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
Secondary	Percentage of Participants Using Pain/Rescue Medications	Percentage of participants using pain/rescue medications.	Baseline (Month 0) through Month 24
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants Using Add Back	Percentage of participants using add back.	Baseline (Month 0) through Month 24
Secondary	Percentage of Participants Using Concomitant Medications	Percentage of participants using concomitant medications.	Baseline (Month 0) through Month 24
Secondary	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

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