EndometriosisENDORSENCT04630990
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
An observational study of Endometriosis, run by AbbVie at 10 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- How many people
- 117 participants
- Where
- 10 sitesIsrael
- Study dates
- 14 Dec 2020to 26 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult Female Participants diagnosed with endometriosis and experiencing Dysmenorrhea (DYS).
Who may be able to join
- 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.
Who cannot join
- Contraindication to the use of elagolix.
- Post-menopausal (naturally or surgically).
- Participation in a concurrent interventional clinical trial.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Israel10 sites
Assuta Ashdod Medical Center /ID# 244898
Ashdod, Southern District, 7747629
Soroka University Medical Center /ID# 224774
Beersheba, Southern District, 8410101
Clalit Health Services /ID# 224771
Haifa, 3515210
Hadassah Medical Center-Hebrew University /ID# 224769
Jerusalem, Jerusalem, 91120
Meir Medical Center /ID# 224766
Kfar Saba, Central District, 4428164
The Chaim Sheba Medical Center /ID# 224764
Ramat Gan, Tel Aviv, 5265601
Kaplan Medical Center /ID# 224773
Rehovot, Central District, 7660101
Tel Aviv Sourasky Medical Center /ID# 224765
Tel Aviv, Tel Aviv, 6423906
Maccabi Health Services /ID# 224775
Tel Aviv, Tel Aviv, 6789140
Yitzhak Shamir Medical Center /ID# 224768
Tsrifin, Central District, 70300
About this study
Official title: 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.
Read more
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.
- Conditions
- Endometriosis
- Keywords
- Elagolix, Orilissa, ABT-620, Endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants Treated With Elagolix | Participants will receive Elagolix according to the local label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dysmenorrhea (DYS), According to Patient Reported 11-Point Numeric Rating Scale (NRS)
Participants rated the change in DYS using an NRS.
Measured: Baseline (Month 0) to Month 3
Secondary outcomes (20)
Change in Dysmenorrhea (DYS), According to Patient Reported NRS
Participants rated the change in DYS using an NRS.
Measured: 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.
Measured: Baseline (Month 0) through Month 24
Change in Dyspareunia, According to Patient Reported NRS
Participants rated the change in Dyspareunia using an NRS.
Measured: 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.
Measured: 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.
Measured: Baseline (Month 0) through Month 24
Change in Treatment Satisfaction Though PGIC
Participants will evaluate the change in treatment satisfaction through PGIC questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Month 0) through Month 24
Percentage of Participants Who Change Dose of Elagolix
Percentage of participants who change dose of elagolix.
Measured: Baseline (Month 0) through Month 24
Reason Participants Change Dose of Elagolix
Reason participants change dose of elagolix.
Measured: 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.
Measured: Baseline (Month 0) through Month 24
Percentage of Participants Using Pain/Rescue Medications
Percentage of participants using pain/rescue medications.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Month 0) through Month 24
Percentage of Participants Using Add Back
Percentage of participants using add back.
Measured: Baseline (Month 0) through Month 24
Percentage of Participants Using Concomitant Medications
Percentage of participants using concomitant medications.
Measured: 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.
Measured: Baseline (Month 0) through Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start14 Dec 2020
- Primary completion26 Mar 2024
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630990
- Sponsor's protocol ID
- P20-399
- Acronym
- ENDORSE
- Status last verified
- Mar 2025
- First submitted
- 29 Oct 2020
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Elagolix Treatment in Moderate to Severe Endometriosis-associated Pain in Routine Clinical Practice in Israel- ENDORSE Study
- ClinicalTrials.gov ID
- NCT04630990
- Acronym / sponsor ID
- ENDORSE / P20-399
- Conditions
- Endometriosis
- Keywords
- Elagolix, Orilissa, ABT-620, Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Treated With Elagolix | – | –Participants will receive Elagolix according to the local label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Female Participants diagnosed with endometriosis and experiencing Dysmenorrhea (DYS).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Contraindication to the use of elagolix.
- Post-menopausal (naturally or surgically).
- Participation in a concurrent interventional clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
20 secondary outcomes
Change in Dysmenorrhea (DYS), According to Patient Reported NRS
Time frame: Baseline (Month 0) through Month 24
Change in Non-Menstrual Pelvic Pain (NMPP), According to Patient Reported NRS
Time frame: Baseline (Month 0) through Month 24
Change in Dyspareunia, According to Patient Reported NRS
Time frame: Baseline (Month 0) through Month 24
Change in Level of Endometriosis Pain-through Patient Global Impression of Change (PGIC)
Time frame: Baseline (Month 0) through Month 24
Change in Quality of Life (QoL) through Endometriosis Health Profile-30 (EHP-30)
Time frame: Baseline (Month 0) through Month 24
Change in Treatment Satisfaction Though PGIC
Time frame: Baseline (Month 0) through Month 24
Change in Treatment Satisfaction Though Clinician Global Impression of Change (CGIC)
Time frame: Baseline (Month 0) through Month 24
Change in Work Productivity- through Work Productivity and Activity Impairment Questionnaire
Time frame: Baseline (Month 0) through Month 24
Change in Healthcare Resource Utilization Questionnaire (HCRU) Associated with Endometriosis Through HCRU Questionnaire
Time frame: Baseline (Month 0) through Month 24
Evaluation of Elagolix Dosing
Time frame: Baseline (Month 0) through Month 24
Percentage of Participants Who Change Dose of Elagolix
Time frame: Baseline (Month 0) through Month 24
Reason Participants Change Dose of Elagolix
Time frame: Baseline (Month 0) through Month 24
Percentage of Participants Using Other Treatments of Endometriosis
Time frame: Baseline (Month 0) through Month 24
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
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
Time frame: Baseline (Month 0) through Month 24
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
Time frame: Baseline (Month 0) through Month 24
Percentage of Participants Using Concomitant Medications
Time frame: Baseline (Month 0) through Month 24
Number of Adverse Events (AEs)
Time frame: Baseline (Month 0) through Month 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Related infoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by AbbVie at 10 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dysmenorrhea (DYS), According to Patient Reported 11-Point Numeric Rating Scale (NRS) (time frame: Baseline (Month 0) to Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.