ENDORSE: 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
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants Treated With Elagolix Participants will receive Elagolix according to the local label. |
Outcome Measures
Primary Outcome Measures
- Change in Dysmenorrhea (DYS), According to Patient Reported 11-Point Numeric Rating Scale (NRS) [Baseline (Month 0) to Month 3]
Participants rated the change in DYS using an NRS.
Secondary Outcome Measures
- Change in Dysmenorrhea (DYS), According to Patient Reported NRS [Baseline (Month 0) through Month 24]
Participants rated the change in DYS using an NRS.
- Change in Non-Menstrual Pelvic Pain (NMPP), According to Patient Reported NRS [Baseline (Month 0) through Month 24]
Participants rated the change in NMPP using an NRS.
- Change in Dyspareunia, According to Patient Reported NRS [Baseline (Month 0) through Month 24]
Participants rated the change in Dyspareunia using an NRS.
- Change in Level of Endometriosis Pain-through Patient Global Impression of Change (PGIC) [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.
- Change in Quality of Life (QoL) through Endometriosis Health Profile-30 (EHP-30) [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.
- Change in Treatment Satisfaction Though PGIC [Baseline (Month 0) through Month 24]
Participants will evaluate the change in treatment satisfaction through PGIC questionnaire.
- Change in Treatment Satisfaction Though Clinician Global Impression of Change (CGIC) [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.
- Change in Work Productivity- through Work Productivity and Activity Impairment Questionnaire [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.
- Change in Healthcare Resource Utilization Questionnaire (HCRU) Associated with Endometriosis Through HCRU Questionnaire [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.
- Evaluation of Elagolix Dosing [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.
- Percentage of Participants Who Change Dose of Elagolix [Baseline (Month 0) through Month 24]
Percentage of participants who change dose of elagolix.
- Reason Participants Change Dose of Elagolix [Baseline (Month 0) through Month 24]
Reason participants change dose of elagolix.
- Percentage of Participants Using Other Treatments of Endometriosis [Baseline (Month 0) through Month 24]
Percentage of participants using other medications or procedures for the treatment of endometriosis.
- Percentage of Participants Using Pain/Rescue Medications [Baseline (Month 0) through Month 24]
Percentage of participants using pain/rescue medications.
- Percentage of Participants Using Physiotherapy/Cognitive-Behavioral Therapy (Physio/CBT) During and Before the Course of this Observation Period [Baseline (Month 0) through Month 24]
Percentage of participants using physio/CBT during and before the course of this observation period.
- Reason for Change at Subsequent Visits in Physiotherapy/Cognitive-Behavioral Therapy (Physio/CBT) During and Before the Course of this Observation Period [Baseline (Month 0) through Month 24]
Reason for change at subsequent visits in physio/CBT 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 surgical intervention during and before the course of this observation period.
- Percentage of Participants Using Add Back [Baseline (Month 0) through Month 24]
Percentage of participants using add back.
- Percentage of Participants Using Concomitant Medications [Baseline (Month 0) through Month 24]
Percentage of participants using concomitant medications.
- Number of Adverse Events (AEs) [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed with endometriosis and experiencing Dysmenorrhea (DYS).
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Naïve to elagolix prior to starting this study or have stopped taking elagolix for 2 months prior to study enrollment.
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Prescribed elagolix as part of standard treatment for endometriosis, according to the local label.
Exclusion Criteria:
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Contraindication to the use of elagolix.
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Post-menopausal (naturally or surgically).
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Participation in a concurrent interventional clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Chaim Sheba Medical Center /ID# 224764 | Ramat Gan | Tel-Aviv | Israel | 5265601 |
| 2 | Tel Aviv Sourasky Medical Center /ID# 224765 | Tel Aviv-Yafo | Tel-Aviv | Israel | 6423906 |
| 3 | Assuta Ashdod Medical Center /ID# 244898 | Ashdod | Israel | 7747629 | |
| 4 | Clalit Health Services /ID# 224771 | Haifa | Israel | 3515210 | |
| 5 | Hadassah Medical Center-Hebrew University /ID# 224769 | Jerusalem | Israel | 91120 | |
| 6 | Meir Medical Center /ID# 224766 | Kfar Saba | Israel | 4428164 | |
| 7 | Maccabi Health Services /ID# 224775 | Tel Aviv-Yafo | Israel | 6789140 | |
| 8 | Assaf Harofeh Medical Center /ID# 224768 | Zerifin | Israel | 70300 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- P20-399