Back to resultsA Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain (ELARIS EM-I)
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
elagolix
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Gonadotropin-Releasing Hormone Antagonist, Endometriosis associated pain, Dysmenorrhea (DYS), Non-Menstrual Pelvic Pain (NMPP), Elagolix
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 Washout (if applicable) or Screening.
- 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 at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain. 5. Subjects must have at least two menstrual cycles 24 to 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 report of partial response to or side effects from these agents is not exclusionary).
- 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 genital bleeding.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Elagolix 150 mg QD
Elagolix 200 mg BID
Placebo
Arm Description
Elagolix 150 mg once daily (QD) for the 6-month Treatment Period
Elagolix 200 mg twice daily (BID) for the 6-month Treatment Period
Placebo 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). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
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). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
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 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 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 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 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 rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Percentage of Responders at Month 1 Based on Daily Assessment of DYS
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 2 Based on Daily Assessment of DYS
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 4 Based on Daily Assessment of DYS
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 5 Based on Daily Assessment of DYS
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 6 Based on Daily Assessment of DYS
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 1 Based on Daily Assessment of NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 2 Based on Daily Assessment of NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 4 Based on Daily Assessment of NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 5 Based on Daily Assessment of NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 6 Based on Daily Assessment of NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 1 for DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 2 for DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 4 for DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 5 for DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 6 for DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Change From Baseline to Month 1 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 2 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 3 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 4 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 5 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 1 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 2 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 3 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 4 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 5 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 6 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 1 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 2 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 3 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 4 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 5 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 1 in Mean Pain Score of DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Change From Baseline to Month 2 in Mean Pain Score of DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Change From Baseline to Month 4 in Mean Pain Score of DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Change From Baseline to Month 5 in Mean Pain Score of DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Change From Baseline to Month 6 in Mean Pain Score of DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Response to Patient Global Impression of Change (PGIC) at Month 1
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.
Response to PGIC at Month 2
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.
Response to PGIC at Month 3
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.
Response to PGIC at Month 4
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.
Response to PGIC at Month 5
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.
Response to PGIC at Month 6
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 Month 1 in NRS Scores
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Change From Baseline to Month 2 in NRS Scores
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Change From Baseline to Month 4 in NRS Scores
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Change From Baseline to Month 5 in NRS Scores
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Change From Baseline to Month 6 in NRS Scores
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30)
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 Month 3 in the Pain Domain of the EHP-30
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 Month 6 in the Pain Domain of the EHP-30
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30
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 Month 6 in the Sexual Intercourse Domain of the EHP-30
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Change From Baseline to Month 1 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 Month 2 in 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 Month 3 in 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 Month 4 in 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 Month 5 in 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 Month 6 in 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 Month 1 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 Month 2 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 Month 3 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 Month 4 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 Month 5 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 Month 6 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 Month 1 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 Month 2 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 Month 3 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 Month 4 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 Month 5 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 Month 6 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 Month 1 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 Month 2 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 Month 3 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 Month 4 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 Month 5 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 Month 6 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 Month 1 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 Month 2 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 Month 3 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 Month 4 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 Month 5 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 Month 6 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 Month 1 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.
Change From Baseline to Month 2 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.
Change From Baseline to Month 3 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.
Change From Baseline to Month 4 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.
Change From Baseline to Month 5 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.
Change From Baseline to Month 6 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
Number of Days of Hospitalization
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type
Full Information
NCT ID
NCT01620528
First Posted
May 15, 2012
Last Updated
September 14, 2018
Sponsor
AbbVie (prior sponsor, Abbott)
1. Study Identification
Unique Protocol Identification Number
NCT01620528
Brief Title
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Acronym
ELARIS EM-I
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 2017
Overall Recruitment Status
Completed
Study Start Date
May 22, 2012 (undefined)
Primary Completion Date
November 14, 2014 (Actual)
Study Completion Date
September 28, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)
4. Oversight
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 participants.
Detailed Description
This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of two doses of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Gonadotropin-Releasing Hormone Antagonist, Endometriosis associated pain, Dysmenorrhea (DYS), Non-Menstrual Pelvic Pain (NMPP), Elagolix
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
872 (Actual)
8. Arms, Groups, and Interventions
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 twice daily (BID) for the 6-month Treatment Period
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo BID for the 6-month Treatment Period
Intervention Type
Drug
Intervention Name(s)
elagolix
Other Intervention Name(s)
ABT-620, elagolix sodium
Intervention Description
oral tablet
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
oral tablet
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). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
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). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
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 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 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 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 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 rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Time Frame
Baseline, Month 3 of Treatment Period
Title
Percentage of Responders at Month 1 Based on Daily Assessment of DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
At Month 1 of the Treatment Period
Title
Percentage of Responders at Month 2 Based on Daily Assessment of DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
At Month 2 of the Treatment Period
Title
Percentage of Responders at Month 4 Based on Daily Assessment of DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
At Month 4 of the Treatment Period
Title
Percentage of Responders at Month 5 Based on Daily Assessment of DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
At Month 5 of the Treatment Period
Title
Percentage of Responders at Month 6 Based on Daily Assessment of DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
At Month 6 of the Treatment Period
Title
Percentage of Responders at Month 1 Based on Daily Assessment of NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
At Month 1 of Treatment Period
Title
Percentage of Responders at Month 2 Based on Daily Assessment of NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
At Month 2 of Treatment Period
Title
Percentage of Responders at Month 4 Based on Daily Assessment of NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
At Month 4 of Treatment Period
Title
Percentage of Responders at Month 5 Based on Daily Assessment of NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
At Month 5 of Treatment Period
Title
Percentage of Responders at Month 6 Based on Daily Assessment of NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
At Month 6 of Treatment Period
Title
Percentage of Responders at Month 1 for DYSP
Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
At Month 1 of the Treatment Period
Title
Percentage of Responders at Month 2 for DYSP
Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
At Month 2 of the Treatment Period
Title
Percentage of Responders at Month 4 for DYSP
Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
At Month 4 of the Treatment Period
Title
Percentage of Responders at Month 5 for DYSP
Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
At Month 5 of the Treatment Period
Title
Percentage of Responders at Month 6 for DYSP
Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
At Month 6 of the Treatment Period
Title
Change From Baseline to Month 1 in Mean Pain Score for DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 1 of Treatment Period
Title
Change From Baseline to Month 2 in Mean Pain Score for DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 2 of Treatment Period
Title
Change From Baseline to Month 3 in Mean Pain Score for DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 3 of Treatment Period
Title
Change From Baseline to Month 4 in Mean Pain Score for DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 4 of Treatment Period
Title
Change From Baseline to Month 5 in Mean Pain Score for DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 5 of Treatment Period
Title
Percent Change From Baseline to Month 1 in Mean Pain Score for DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 1 of Treatment Period
Title
Percent Change From Baseline to Month 2 in Mean Pain Score for DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 2 of Treatment Period
Title
Percent Change From Baseline to Month 3 in Mean Pain Score for DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 3 of Treatment Period
Title
Percent Change From Baseline to Month 4 in Mean Pain Score for DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 4 of Treatment Period
Title
Percent Change From Baseline to Month 5 in Mean Pain Score for DYS
Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 5 of Treatment Period
Title
Percent Change From Baseline to Month 6 in Mean Pain Score for 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 1 in Mean Pain Score for NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 1 of Treatment Period
Title
Change From Baseline to Month 2 in Mean Pain Score for NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 2 of Treatment Period
Title
Change From Baseline to Month 3 in Mean Pain Score for NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 3 of Treatment Period
Title
Change From Baseline to Month 4 in Mean Pain Score for NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 4 of Treatment Period
Title
Change From Baseline to Month 5 in Mean Pain Score for NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 5 of Treatment Period
Title
Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 1 of Treatment Period
Title
Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 2 of Treatment Period
Title
Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 3 of Treatment Period
Title
Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 4 of Treatment Period
Title
Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP
Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame
Baseline, Month 5 of Treatment Period
Title
Percent Change From Baseline to Month 6 in Mean Pain Score for 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 1 in Mean Pain Score of DYSP
Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Time Frame
Baseline, Month 1 of Treatment Period
Title
Change From Baseline to Month 2 in Mean Pain Score of DYSP
Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Time Frame
Baseline, Month 2 of Treatment Period
Title
Change From Baseline to Month 4 in Mean Pain Score of DYSP
Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Time Frame
Baseline, Month 4 of Treatment Period
Title
Change From Baseline to Month 5 in Mean Pain Score of DYSP
Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Time Frame
Baseline, Month 5 of Treatment Period
Title
Change From Baseline to Month 6 in Mean Pain Score of DYSP
Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Time Frame
Baseline, Month 6 of Treatment Period
Title
Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics
Description
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Time Frame
Baseline, Month 1 of Treatment Period
Title
Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics
Description
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Time Frame
Baseline, Month 2 of Treatment Period
Title
Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics
Description
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Time Frame
Baseline, Month 4 of Treatment Period
Title
Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics
Description
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Time Frame
Baseline, Month 5 of Treatment Period
Title
Response to Patient Global Impression of Change (PGIC) at Month 1
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
Month 1 of Treatment Period
Title
Response to PGIC at Month 2
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
Month 2 of Treatment Period
Title
Response to PGIC at Month 3
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
Month 3 of Treatment Period
Title
Response to PGIC at Month 4
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
Month 4 of Treatment Period
Title
Response to PGIC at Month 5
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
Month 5 of Treatment Period
Title
Response to PGIC at Month 6
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
Month 6 of Treatment Period
Title
Change From Baseline to Month 1 in NRS Scores
Description
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Time Frame
Baseline, Month 1 of Treatment Period
Title
Change From Baseline to Month 2 in NRS Scores
Description
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Time Frame
Baseline, Month 2 of Treatment Period
Title
Change From Baseline to Month 4 in NRS Scores
Description
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Time Frame
Baseline, Month 4 of Treatment Period
Title
Change From Baseline to Month 5 in NRS Scores
Description
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Time Frame
Baseline, Month 5 of Treatment Period
Title
Change From Baseline to Month 6 in NRS Scores
Description
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Time Frame
Baseline, Month 6 of Treatment Period
Title
Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30)
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, Month 1 of Treatment Period
Title
Change From Baseline to Month 3 in the Pain Domain of the EHP-30
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, Month 3 of Treatment Period
Title
Change From Baseline to Month 6 in the Pain Domain of the EHP-30
Description
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame
Baseline, Month 6 of Treatment Period
Title
Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30
Description
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame
Baseline, Month 1 of Treatment Period
Title
Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30
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, Month 3 of Treatment Period
Title
Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30
Description
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame
Baseline, Month 6 of Treatment Period
Title
Change From Baseline to Month 1 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, Month 1 of Treatment Period
Title
Change From Baseline to Month 2 in 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, Month 2 of Treatment Period
Title
Change From Baseline to Month 3 in 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, Month 3 of Treatment Period
Title
Change From Baseline to Month 4 in 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, Month 4 of Treatment Period
Title
Change From Baseline to Month 5 in 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, Month 5 of Treatment Period
Title
Change From Baseline to Month 6 in 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, Month 6 of Treatment Period
Title
Change From Baseline to Month 1 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, Month 1 of Treatment Period
Title
Change From Baseline to Month 2 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, Month 2 of Treatment Period
Title
Change From Baseline to Month 3 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, Month 3 of Treatment Period
Title
Change From Baseline to Month 4 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, Month 4 of Treatment Period
Title
Change From Baseline to Month 5 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, Month 5 of Treatment Period
Title
Change From Baseline to Month 6 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, Month 6 of Treatment Period
Title
Change From Baseline to Month 1 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, Month 1 of Treatment Period
Title
Change From Baseline to Month 2 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, Month 2 of Treatment Period
Title
Change From Baseline to Month 3 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, Month 3 of Treatment Period
Title
Change From Baseline to Month 4 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, Month 4 of Treatment Period
Title
Change From Baseline to Month 5 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, Month 5 of Treatment Period
Title
Change From Baseline to Month 6 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, Month 6 of Treatment Period
Title
Change From Baseline to Month 1 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, Month 1 of Treatment Period
Title
Change From Baseline to Month 2 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, Month 2 of Treatment Period
Title
Change From Baseline to Month 3 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, Month 3 of Treatment Period
Title
Change From Baseline to Month 4 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, Month 4 of Treatment Period
Title
Change From Baseline to Month 5 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, Month 5 of Treatment Period
Title
Change From Baseline to Month 6 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, Month 6 of Treatment Period
Title
Change From Baseline to Month 1 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, Month 1 of Treatment Period
Title
Change From Baseline to Month 2 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, Month 2 of Treatment Period
Title
Change From Baseline to Month 3 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, Month 3 of Treatment Period
Title
Change From Baseline to Month 4 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, Month 4 of Treatment Period
Title
Change From Baseline to Month 5 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, Month 5 of Treatment Period
Title
Change From Baseline to Month 6 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, Month 6 of Treatment Period
Title
Change From Baseline to Month 1 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, Month 1 of Treatment Period
Title
Change From Baseline to Month 2 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, Month 2 of Treatment Period
Title
Change From Baseline to Month 3 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, Month 3 of Treatment Period
Title
Change From Baseline to Month 4 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, Month 4 of Treatment Period
Title
Change From Baseline to Month 5 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, Month 5 of Treatment Period
Title
Change From Baseline to Month 6 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, Month 6 of Treatment Period
Title
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period
Time Frame
Up to Month 6 of Treatment Period
Title
Number of Days of Hospitalization
Time Frame
Up to Month 6 of Treatment Period
Title
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type
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 Washout (if applicable) or Screening.
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 at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain. 5. Subjects must have at least two menstrual cycles 24 to 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 report of partial response to or side effects from these agents is not exclusionary).
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 genital bleeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Duan, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
28525302
Citation
Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotarski J, Archer DF, Diamond MP, Surrey E, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Rowan JP, Duan WR, Ng J, Schwefel B, Thomas JW, Jain RI, Chwalisz K. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19.
Results Reference
result
PubMed Identifier
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.
Results Reference
derived
PubMed Identifier
34134684
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.
Results Reference
derived
PubMed Identifier
33963686
Citation
Stodtmann S, Nader A, Polepally AR, Suleiman AA, Winzenborg I, Noertersheuser P, Ng J, Mostafa NM, Shebley M. Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis. Clin Transl Sci. 2021 Jul;14(4):1611-1619. doi: 10.1111/cts.13040. Epub 2021 May 7.
Results Reference
derived
PubMed Identifier
33650259
Citation
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.
Results Reference
derived
PubMed Identifier
33564263
Citation
Agarwal SK, Singh SS, Archer DF, Mai Y, Chwalisz K, Gordon K, Surrey E. Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix. J Pain Res. 2021 Feb 2;14:263-271. doi: 10.2147/JPR.S284703. eCollection 2021.
Results Reference
derived
PubMed Identifier
33066973
Citation
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.
Results Reference
derived
PubMed Identifier
32945631
Citation
Abbas Suleiman A, Nader A, Winzenborg I, Beck D, Polepally AR, Ng J, Noertersheuser P, Mostafa NM. Exposure-Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis-Associated Pain. CPT Pharmacometrics Syst Pharmacol. 2020 Nov;9(11):639-648. doi: 10.1002/psp4.12560. Epub 2020 Oct 8.
Results Reference
derived
PubMed Identifier
32769633
Citation
Taylor HS, Soliman AM, Johns B, Pokrzywinski RM, Snabes M, Coyne KS. Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix. Obstet Gynecol. 2020 Sep;136(3):501-509. doi: 10.1097/AOG.0000000000003917.
Results Reference
derived
PubMed Identifier
32621325
Citation
Winzenborg I, Polepally AR, Nader A, Mostafa NM, Noertersheuser P, Ng J. Effect of Elagolix Exposure on Clinical Efficacy End Points in Phase III Trials in Women With Endometriosis-Associated Pain: An Application of Markov Model. CPT Pharmacometrics Syst Pharmacol. 2020 Aug;9(8):466-475. doi: 10.1002/psp4.12545. Epub 2020 Jul 31.
Results Reference
derived
PubMed Identifier
31654294
Citation
Surrey ES, Soliman AM, Palac HL, Agarwal SK. Impact of Elagolix on Workplace and Household Productivity Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials. Patient. 2019 Dec;12(6):651-660. doi: 10.1007/s40271-019-00394-7.
Results Reference
derived
PubMed Identifier
31227284
Citation
Pokrzywinski RM, Soliman AM, Chen J, Snabes M, Diamond MP, Surrey E, Coyne KS. Impact of elagolix on work loss due to endometriosis-associated pain: estimates based on the results of two phase III clinical trials. Fertil Steril. 2019 Sep;112(3):545-551. doi: 10.1016/j.fertnstert.2019.04.031. Epub 2019 Jun 18. Erratum In: Fertil Steril. 2020 Jan;113(1):237.
Results Reference
derived
PubMed Identifier
30992150
Citation
Surrey ES, Soliman AM, Agarwal SK, Snabes MC, Diamond MP. Impact of elagolix treatment on fatigue experienced by women with moderate to severe pain associated with endometriosis. Fertil Steril. 2019 Aug;112(2):298-304.e3. doi: 10.1016/j.fertnstert.2019.02.031. Epub 2019 Apr 13.
Results Reference
derived
PubMed Identifier
30724096
Citation
Wang ST, Johnson SJ, Mitchell D, Soliman AM, Vora JB, Agarwal SK. Cost-effectiveness of elagolix versus leuprolide acetate for treating moderate-to-severe endometriosis pain in the USA. J Comp Eff Res. 2019 Apr;8(5):337-355. doi: 10.2217/cer-2018-0124. Epub 2019 Feb 6.
Results Reference
derived
PubMed Identifier
29476499
Citation
Winzenborg I, Nader A, Polepally AR, Liu M, Degner J, Klein CE, Mostafa NM, Noertersheuser P, Ng J. Population Pharmacokinetics of Elagolix in Healthy Women and Women with Endometriosis. Clin Pharmacokinet. 2018 Oct;57(10):1295-1306. doi: 10.1007/s40262-018-0629-6.
Results Reference
derived
Learn more about this trial
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
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