Back to resultsA Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain (ELARIS EM-II)
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
placebo
Elagolix
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Non-Menstrual Pelvic Pain (NMPP), Dysmenorrhea (DYS), Elagolix, Endometriosis Associated Pain, Gonadotropin-Releasing Hormone Antagonist
Eligibility Criteria
Inclusion Criteria:
- Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
- Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into the Washout Period.
- Agrees to use required birth control methods during the entire length of participation in the study.
- Subject has a Composite Pelvic Signs and Symptoms Score total score of 6 or greater at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain.
- Subjects must have at least two regular menstrual cycles with an interval of 24-38 days within the Screening Period, prior to Day 1.
Exclusion Criteria:
- Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.
- Subject has a history of previous non-response to gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot medroxyprogesterone acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain.
- Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.
- Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
- Subject has a history of osteoporosis or other metabolic bone disease.
- Subject has a current history of undiagnosed abnormal uterine bleeding.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Elagolix 150 mg QD
Elagolix 200 mg BID
Arm Description
Placebo twice daily (BID) for the 6-month Treatment Period
Elagolix 150 mg once daily (QD) for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Outcomes
Primary Outcome Measures
Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)
The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.
Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)
The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.
Secondary Outcome Measures
Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Change From Baseline to Month 6 in DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 6 in NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
Change From Baseline to Month 3 in Dyspareunia (DYSP)
The DYSP pain scale ranges from 0 (absent) to 3 (severe).
Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)
Permitted country-specific rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen. Assessment was based on average pill counts.
Percentage of Responders for Each Month, Except Month 3, in DYS
The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.
Percentage of Responders for Each Month, Except Month 3, in NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.
Percentage of Responders at Each Month for DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.29 or greater from Baseline in DYSP as well as no increased rescue analgesic use for endometriosis-associated pain.
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Each Month in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
Patient Global Impression of Change (PGIC) Questionnaire
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Change From Baseline to Each Month, Except Month 3, in NRS Scores
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period
This is assessed using Health Resource Utilization Questionnaire (HRUQ).
Number of Days of Hospitalization
This is assessed using HRUQ.
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type
This is assessed using HRUQ.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01931670
Brief Title
A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Acronym
ELARIS EM-II
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 9, 2013 (Actual)
Primary Completion Date
January 6, 2016 (Actual)
Study Completion Date
December 19, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female subjects.
Detailed Description
The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study. Subjects will be required to use nonhormonal dual contraception during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Non-Menstrual Pelvic Pain (NMPP), Dysmenorrhea (DYS), Elagolix, Endometriosis Associated Pain, Gonadotropin-Releasing Hormone Antagonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
815 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo twice daily (BID) for the 6-month Treatment Period
Arm Title
Elagolix 150 mg QD
Arm Type
Experimental
Arm Description
Elagolix 150 mg once daily (QD) for the 6-month Treatment Period
Arm Title
Elagolix 200 mg BID
Arm Type
Experimental
Arm Description
Elagolix 200 mg BID for the 6-month Treatment Period
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Type
Drug
Intervention Name(s)
Elagolix
Other Intervention Name(s)
ABT-620, elagolix sodium
Primary Outcome Measure Information:
Title
Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)
Description
The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.
Time Frame
At Month 3 of the Treatment Period
Title
Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.
Time Frame
At Month 3 of Treatment Period
Secondary Outcome Measure Information:
Title
Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores
Description
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Time Frame
Baseline, Month 3 of the Treatment Period
Title
Change From Baseline to Month 6 in DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 6 of Treatment Period
Title
Change From Baseline to Month 6 in NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 6 of Treatment Period
Title
Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics
Description
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
Time Frame
Baseline, Month 3 of Treatment Period
Title
Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics
Description
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
Time Frame
Baseline, Month 6 of Treatment Period
Title
Change From Baseline to Month 3 in Dyspareunia (DYSP)
Description
The DYSP pain scale ranges from 0 (absent) to 3 (severe).
Time Frame
Baseline, Month 3 of Treatment Period
Title
Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)
Description
Permitted country-specific rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen. Assessment was based on average pill counts.
Time Frame
Baseline, Month 3 of Treatment Period
Title
Percentage of Responders for Each Month, Except Month 3, in DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.
Time Frame
Months 1, 2, 4, 5, 6 of the Treatment Period
Title
Percentage of Responders for Each Month, Except Month 3, in NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.
Time Frame
Months 1, 2, 4, 5, 6 of the Treatment Period
Title
Percentage of Responders at Each Month for DYSP
Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.29 or greater from Baseline in DYSP as well as no increased rescue analgesic use for endometriosis-associated pain.
Time Frame
Months 1, 2, 3, 4, 5, 6 of Treatment Period
Title
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline (Prior to administering study drug), Months 1, 2, 3, 4, 5 of Treatment Period
Title
Percent Change From Baseline to Each Month in Mean Pain Score for DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Title
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Months 1, 2, 3, 4, 5 of Treatment Period
Title
Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Title
Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP
Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Time Frame
Baseline, Months 1, 2, 4, 5, 6 of Treatment Period
Title
Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics
Description
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
Time Frame
Baseline, Months 1, 2, 4, 5
Title
Patient Global Impression of Change (PGIC) Questionnaire
Description
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Time Frame
Months 1, 2, 3, 4, 5, 6 of Treatment Period
Title
Change From Baseline to Each Month, Except Month 3, in NRS Scores
Description
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Time Frame
Baseline, Months 1, 2, 4, 5, 6 of Treatment Period
Title
Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores
Description
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame
Baseline, Months 1, 3, 6 of Treatment Period
Title
Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores
Description
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame
Baseline, Months 1, 3, 6 of Treatment Period
Title
Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism
Description
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Title
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
Description
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Title
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
Description
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Title
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
Description
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Title
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
Description
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Title
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
Description
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Title
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period
Description
This is assessed using Health Resource Utilization Questionnaire (HRUQ).
Time Frame
Months 1, 2, 3, 4, 5, 6 of Treatment Period
Title
Number of Days of Hospitalization
Description
This is assessed using HRUQ.
Time Frame
Up to Month 6 of Treatment Period
Title
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type
Description
This is assessed using HRUQ.
Time Frame
Up to Month 6 of Treatment Period
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into the Washout Period.
Agrees to use required birth control methods during the entire length of participation in the study.
Subject has a Composite Pelvic Signs and Symptoms Score total score of 6 or greater at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain.
Subjects must have at least two regular menstrual cycles with an interval of 24-38 days within the Screening Period, prior to Day 1.
Exclusion Criteria:
Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.
Subject has a history of previous non-response to gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot medroxyprogesterone acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain.
Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.
Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
Subject has a history of osteoporosis or other metabolic bone disease.
Subject has a current history of undiagnosed abnormal uterine bleeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
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28525302
Citation
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Results Reference
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34878624
Citation
Beck D, Winzenborg I, Liu M, Degner J, Mostafa NM, Noertersheuser P, Shebley M. Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids. Clin Pharmacokinet. 2022 Apr;61(4):577-587. doi: 10.1007/s40262-021-01096-w. Epub 2021 Dec 8.
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Citation
Abrao MS, Surrey E, Gordon K, Snabes MC, Wang H, Ijacu H, Taylor HS. Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patients. BMC Womens Health. 2021 Jun 16;21(1):246. doi: 10.1186/s12905-021-01385-3.
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Beck D, Winzenborg I, Gao W, Mostafa NM, Noertersheuser P, Chiuve SE, Owens C, Shebley M. Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women. Clin Transl Sci. 2021 Jul;14(4):1452-1463. doi: 10.1111/cts.13006. Epub 2021 Apr 8. Erratum In: Clin Transl Sci. 2022 Mar;15(3):799.
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Pokrzywinski RM, Soliman AM, Snabes MC, Chen J, Taylor HS, Coyne KS. Responsiveness and thresholds for clinically meaningful changes in worst pain numerical rating scale for dysmenorrhea and nonmenstrual pelvic pain in women with moderate to severe endometriosis. Fertil Steril. 2021 Feb;115(2):423-430. doi: 10.1016/j.fertnstert.2020.07.013. Epub 2020 Oct 14.
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Learn more about this trial
A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
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