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 Type
OBSERVATIONAL
Enrollment
117
Meir Medical Center /ID# 224766
Kfar Saba, Central District, Israel
Kaplan Medical Center /ID# 224773
Rehovot, Central District, Israel
Yitzhak Shamir Medical Center /ID# 224768
Ẕerifin, Central District, Israel
Hadassah Medical Center-Hebrew University /ID# 224769
Jerusalem, Jerusalem, Israel
Assuta Ashdod Medical Center /ID# 244898
Ashdod, Southern District, Israel
Soroka University Medical Center /ID# 224774
Beersheba, Southern District, Israel
The Chaim Sheba Medical Center /ID# 224764
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 224765
Tel Aviv, Tel Aviv, Israel
Maccabi Health Services /ID# 224775
Tel Aviv, Tel Aviv, Israel
Clalit Health Services /ID# 224771
Haifa, Israel
Change in Dysmenorrhea (DYS), According to Patient Reported 11-Point Numeric Rating Scale (NRS)
Participants rated the change in DYS using an NRS.
Time frame: Baseline (Month 0) to Month 3
Change in Dysmenorrhea (DYS), According to Patient Reported NRS
Participants rated the change in DYS using an NRS.
Time frame: 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.
Time frame: Baseline (Month 0) through Month 24
Change in Dyspareunia, According to Patient Reported NRS
Participants rated the change in Dyspareunia using an NRS.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Month 0) through Month 24
Change in Treatment Satisfaction Though PGIC
Participants will evaluate the change in treatment satisfaction through PGIC questionnaire.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Month 0) through Month 24
Percentage of Participants Who Change Dose of Elagolix
Percentage of participants who change dose of elagolix.
Time frame: Baseline (Month 0) through Month 24
Reason Participants Change Dose of Elagolix
Reason participants change dose of elagolix.
Time frame: 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.
Time frame: Baseline (Month 0) through Month 24
Percentage of Participants Using Pain/Rescue Medications
Percentage of participants using pain/rescue medications.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Month 0) through Month 24
Percentage of Participants Using Add Back
Percentage of participants using add back.
Time frame: Baseline (Month 0) through Month 24
Percentage of Participants Using Concomitant Medications
Percentage of participants using concomitant medications.
Time frame: 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.
Time frame: Baseline (Month 0) through Month 24
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