Clinical trial NCT04630990: 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
Official title: Effectiveness and Safety of Elagolix Treatment in Moderate to Severe Endometriosis-associated Pain in Routine Clinical Practice in Israel- ENDORSE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: Elagolix
Orilissa
ABT-620
Endometriosis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-11-16
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Female Participants diagnosed with endometriosis and experiencing Dysmenorrhea (DYS).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Dysmenorrhea (DYS), According to Patient Reported 11-Point Numeric Rating Scale (NRS)
timeFrame: Baseline (Month 0) to Month 3
Secondary outcomes:
measure: Change in Dysmenorrhea (DYS), According to Patient Reported NRS
timeFrame: Baseline (Month 0) through Month 24
measure: Change in Non-Menstrual Pelvic Pain (NMPP), According to Patient Reported NRS
timeFrame: Baseline (Month 0) through Month 24
measure: Change in Dyspareunia, According to Patient Reported NRS
timeFrame: Baseline (Month 0) through Month 24
measure: Change in Level of Endometriosis Pain-through Patient Global Impression of Change (PGIC)
timeFrame: Baseline (Month 0) through Month 24
measure: Change in Quality of Life (QoL) through Endometriosis Health Profile-30 (EHP-30)
timeFrame: Baseline (Month 0) through Month 24
measure: Change in Treatment Satisfaction Though PGIC
timeFrame: Baseline (Month 0) through Month 24
measure: Change in Treatment Satisfaction Though Clinician Global Impression of Change (CGIC)
timeFrame: Baseline (Month 0) through Month 24
measure: Change in Work Productivity- through Work Productivity and Activity Impairment Questionnaire
timeFrame: Baseline (Month 0) through Month 24
measure: Change in Healthcare Resource Utilization Questionnaire (HCRU) Associated with Endometriosis Through HCRU Questionnaire
timeFrame: Baseline (Month 0) through Month 24
measure: Evaluation of Elagolix Dosing
timeFrame: Baseline (Month 0) through Month 24
measure: Percentage of Participants Who Change Dose of Elagolix
timeFrame: Baseline (Month 0) through Month 24
measure: Reason Participants Change Dose of Elagolix
timeFrame: Baseline (Month 0) through Month 24
measure: Percentage of Participants Using Other Treatments of Endometriosis
timeFrame: Baseline (Month 0) through Month 24
measure: Percentage of Participants Using Pain/Rescue Medications
timeFrame: Baseline (Month 0) through Month 24
measure: Percentage of Participants Using Physiotherapy/Cognitive-Behavioral Therapy (Physio/CBT) During and Before the Course of this Observation Period
timeFrame: Baseline (Month 0) through Month 24
measure: Reason for Change at Subsequent Visits in Physiotherapy/Cognitive-Behavioral Therapy (Physio/CBT) During and Before the Course of this Observation Period
timeFrame: Baseline (Month 0) through Month 24
measure: Percentage of Participants Using Surgical Intervention During and Before the Course of this Observation Period
timeFrame: Baseline (Month 0) through Month 24
measure: Percentage of Participants Using Add Back
timeFrame: Baseline (Month 0) through Month 24
measure: Percentage of Participants Using Concomitant Medications
timeFrame: Baseline (Month 0) through Month 24
measure: Number of Adverse Events (AEs)
timeFrame: Baseline (Month 0) through Month 24
Other outcomes:
Locations:
city: Ashdod
country: Israel
facility: Assuta Ashdod Medical Center /ID# 244898
state: HaDarom
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center /ID# 224774
state: HaDarom
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 224766
state: HaMerkaz
city: Rekhovot
country: Israel
facility: Kaplan Medical Center /ID# 224773
state: HaMerkaz
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center /ID# 224768
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 224764
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 224765
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Maccabi Health Services /ID# 224775
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 224769
state: Yerushalayim
city: Haifa
country: Israel
facility: Clalit Health Services /ID# 224771
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: