Endometriosis
Conditions
Keywords
Gonadotropin-Releasing Hormone Antagonist, Endometriosis associated pain, Dysmenorrhea (DYS), Non-Menstrual Pelvic Pain (NMPP), Elagolix
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.
Interventions
DRUGelagolix
oral tablet
OTHERplacebo
oral tablet
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
1. Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent. 2. Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Washout (if applicable) or Screening. 3. Agrees to use required birth control methods during the entire length of participation in the study. 4. 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
1. 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. 2. 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). 3. 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. 4. Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy. 5. Subject has a history of osteoporosis or other metabolic bone disease. 6. Subject has a current history of undiagnosed abnormal genital bleeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) | At Month 3 of the Treatment Period | 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) | At Month 3 of Treatment Period | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Month 6 in NMPP | Baseline, Month 6 of Treatment Period | 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 | Baseline, Month 3 of Treatment Period | 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 | Baseline, Month 6 of Treatment Period | 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) | Baseline, Month 3 of Treatment Period | 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) | Baseline, Month 3 of Treatment Period | 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 | At Month 1 of the Treatment Period | 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 | At Month 2 of the Treatment Period | 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 | At Month 4 of the Treatment Period | 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 | At Month 5 of the Treatment Period | 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 | At Month 6 of the Treatment Period | 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 | At Month 1 of Treatment Period | 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 | At Month 2 of Treatment Period | 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 | At Month 4 of Treatment Period | 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 | At Month 5 of Treatment Period | 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 | At Month 6 of Treatment Period | 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 | At Month 1 of the Treatment Period | 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 | At Month 2 of the Treatment Period | 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 | At Month 4 of the Treatment Period | 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 | At Month 5 of the Treatment Period | 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 | At Month 6 of the Treatment Period | 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 | Baseline, Month 1 of Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Change From Baseline to Month 2 in Mean Pain Score for DYS | Baseline, Month 2 of Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Change From Baseline to Month 3 in Mean Pain Score for DYS | Baseline, Month 3 of Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Change From Baseline to Month 4 in Mean Pain Score for DYS | Baseline, Month 4 of Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Change From Baseline to Month 5 in Mean Pain Score for DYS | Baseline, Month 5 of Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Percent Change From Baseline to Month 1 in Mean Pain Score for DYS | Baseline, Month 1 of Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Percent Change From Baseline to Month 2 in Mean Pain Score for DYS | Baseline, Month 2 of Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Percent Change From Baseline to Month 3 in Mean Pain Score for DYS | Baseline, Month 3 of Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Percent Change From Baseline to Month 4 in Mean Pain Score for DYS | Baseline, Month 4 of Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Percent Change From Baseline to Month 5 in Mean Pain Score for DYS | Baseline, Month 5 of Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Percent Change From Baseline to Month 6 in Mean Pain Score for DYS | Baseline, Month 6 of Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Change From Baseline to Month 1 in Mean Pain Score for NMPP | Baseline, Month 1 of Treatment Period | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Change From Baseline to Month 5 in Mean Pain Score for NMPP | Baseline, Month 5 of Treatment Period | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP | Baseline, Month 1 of Treatment Period | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP | Baseline, Month 2 of Treatment Period | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Change From Baseline to Month 2 in Mean Pain Score for NMPP | Baseline, Month 2 of Treatment Period | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Change From Baseline to Month 3 in Mean Pain Score for NMPP | Baseline, Month 3 of Treatment Period | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Change From Baseline to Month 4 in Mean Pain Score for NMPP | Baseline, Month 4 of Treatment Period | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP | Baseline, Month 3 of Treatment Period | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP | Baseline, Month 4 of Treatment Period | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP | Baseline, Month 5 of Treatment Period | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP | Baseline, Month 6 of Treatment Period | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Change From Baseline to Month 1 in Mean Pain Score of DYSP | Baseline, Month 1 of Treatment Period | The DYSP pain scale ranged from 0 (absent) to 3 (severe). |
| Change From Baseline to Month 2 in Mean Pain Score of DYSP | Baseline, Month 2 of Treatment Period | The DYSP pain scale ranged from 0 (absent) to 3 (severe). |
| Change From Baseline to Month 4 in Mean Pain Score of DYSP | Baseline, Month 4 of Treatment Period | The DYSP pain scale ranged from 0 (absent) to 3 (severe). |
| Change From Baseline to Month 5 in Mean Pain Score of DYSP | Baseline, Month 5 of Treatment Period | The DYSP pain scale ranged from 0 (absent) to 3 (severe). |
| Change From Baseline to Month 6 in Mean Pain Score of DYSP | Baseline, Month 6 of Treatment Period | 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 | Baseline, Month 1 of Treatment Period | 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 | Baseline, Month 2 of Treatment Period | 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 | Baseline, Month 4 of Treatment Period | 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 | Baseline, Month 5 of Treatment Period | 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 | Month 1 of Treatment Period | 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 | Month 2 of Treatment Period | 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 | Month 3 of Treatment Period | 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 | Month 4 of Treatment Period | 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 | Month 5 of Treatment Period | 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 | Month 6 of Treatment Period | 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 | Baseline, Month 1 of Treatment Period | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). |
| Change From Baseline to Month 2 in NRS Scores | Baseline, Month 2 of Treatment Period | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). |
| Change From Baseline to Month 4 in NRS Scores | Baseline, Month 4 of Treatment Period | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). |
| Change From Baseline to Month 5 in NRS Scores | Baseline, Month 5 of Treatment Period | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). |
| Change From Baseline to Month 6 in NRS Scores | Baseline, Month 6 of Treatment Period | 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) | Baseline, Month 1 of Treatment Period | 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 | Baseline, Month 3 of Treatment Period | 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 | Baseline, Month 6 of Treatment Period | 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 | Baseline, Month 1 of Treatment Period | 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 | Baseline, Month 3 of Treatment Period | 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 | Baseline, Month 6 of Treatment Period | 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 | Baseline, Month 1 of Treatment Period | 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 | Baseline, Month 2 of Treatment Period | 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 | Baseline, Month 3 of Treatment Period | 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 | Baseline, Month 4 of Treatment Period | 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 | Baseline, Month 5 of Treatment Period | 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 | Baseline, Month 6 of Treatment Period | 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 | Baseline, Month 1 of Treatment Period | 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 | Baseline, Month 2 of Treatment Period | 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 | Baseline, Month 3 of Treatment Period | 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 | Baseline, Month 4 of Treatment Period | 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 | Baseline, Month 5 of Treatment Period | 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 | Baseline, Month 6 of Treatment Period | 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 | Baseline, Month 1 of Treatment Period | 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 | Baseline, Month 2 of Treatment Period | 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 | Baseline, Month 3 of Treatment Period | 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 | Baseline, Month 4 of Treatment Period | 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 | Baseline, Month 5 of Treatment Period | 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 | Baseline, Month 6 of Treatment Period | 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 | Baseline, Month 1 of Treatment Period | 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 | Baseline, Month 2 of Treatment Period | 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 | Baseline, Month 3 of Treatment Period | 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 | Baseline, Month 4 of Treatment Period | 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 | Baseline, Month 5 of Treatment Period | 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 | Baseline, Month 6 of Treatment Period | 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 | Baseline, Month 1 of Treatment Period | 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 | Baseline, Month 2 of Treatment Period | 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 | Baseline, Month 3 of Treatment Period | 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 Numeric Rating Scale (NRS) Scores | Baseline, Month 3 of the Treatment Period | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). |
| Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Baseline, Month 5 of Treatment Period | 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 | Baseline, Month 6 of Treatment Period | 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 | Baseline, Month 1 of Treatment Period | 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 | Baseline, Month 2 of Treatment Period | 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 | Baseline, Month 3 of Treatment Period | 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 | Baseline, Month 4 of Treatment Period | 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 | Baseline, Month 5 of Treatment Period | 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 | Baseline, Month 6 of Treatment Period | 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 | Up to Month 6 of Treatment Period | — |
| Number of Days of Hospitalization | Up to Month 6 of Treatment Period | — |
| Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Up to Month 6 of Treatment Period | — |
| Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Baseline, Month 4 of Treatment Period | 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 DYS | Baseline, Month 6 of Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe). |
Participant flow
Recruitment details
After completing the Treatment Period, participants (who were eligible and provided consent) entered a separate continuous-use extension study (Study M12-667, NCT01760954).
Pre-assignment details
Participants who prematurely discontinued from study drug and those who declined to participate in or who did not qualify for the continuous-use extension study, except for those who became pregnant, could elect to enter the Post-Treatment Follow-Up (PTFU) Period within this study for up to 12 additional months.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo BID for the 6-month Treatment Period | 374 |
| Elagolix 150 mg QD Elagolix 150 mg QD for the 6-month Treatment Period | 249 |
| Elagolix 200 mg BID Elagolix 200 mg BID for the 6-month Treatment Period | 248 |
| Total | 871 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Post-Treatment Follow-Up Period | Exclusionary Medication Received | 0 | 1 | 1 |
| Post-Treatment Follow-Up Period | Lost to Follow-up | 3 | 2 | 4 |
| Post-Treatment Follow-Up Period | Other | 6 | 4 | 2 |
| Post-Treatment Follow-Up Period | Surgery/Invasive Intervention | 8 | 3 | 4 |
| Post-Treatment Follow-Up Period | Withdrawal by Subject | 3 | 7 | 3 |
| Treatment Period | Adverse Event | 17 | 13 | 21 |
| Treatment Period | Did Not Receive Study Drug | 0 | 0 | 1 |
| Treatment Period | Exclusionary Medication Received | 0 | 1 | 0 |
| Treatment Period | Lost to Follow-up | 16 | 8 | 14 |
| Treatment Period | Other | 9 | 5 | 7 |
| Treatment Period | Pregnancy | 7 | 2 | 2 |
| Treatment Period | Subject Noncompliant | 11 | 2 | 2 |
| Treatment Period | Surgery/Invasive Intervention | 5 | 1 | 3 |
| Treatment Period | Withdrawal by Subject | 35 | 21 | 16 |
Baseline characteristics
| Characteristic | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID | Total |
|---|---|---|---|---|
| Age, Continuous | 31.7 years STANDARD_DEVIATION 6.35 | 31.5 years STANDARD_DEVIATION 5.99 | 31.2 years STANDARD_DEVIATION 6.33 | 31.5 years STANDARD_DEVIATION 6.24 |
| Sex: Female, Male Female | 374 Participants | 249 Participants | 248 Participants | 871 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 180 / 374 | 147 / 249 | 159 / 248 |
| serious Total, serious adverse events | 12 / 374 | 2 / 249 | 7 / 248 |
Outcome results
Primary
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.
Time frame: At Month 3 of the Treatment Period
Population: The modified intent-to-treat (mITT) analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) | 19.6 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) | 46.4 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) | 75.8 percentage of participants |
p-value: <0.001Regression, Logistic
p-value: <0.001Regression, Logistic
Primary
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.
Time frame: At Month 3 of Treatment Period
Population: The mITT analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP) | 36.5 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP) | 50.4 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP) | 54.5 percentage of participants |
p-value: <0.001Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
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.
Time frame: Baseline, Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.20 pills | Standard Error 0.028 |
| Elagolix 150 mg QD | Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.25 pills | Standard Error 0.034 |
| Elagolix 200 mg BID | Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.32 pills | Standard Error 0.034 |
p-value: 0.31397.5% CI: [-0.14, 0.05]mixed-effects model
p-value: 0.00697.5% CI: [-0.22, -0.02]mixed-effects model
Secondary
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.
Time frame: Baseline, Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | -1.32 hours | Standard Error 0.236 |
| Elagolix 150 mg QD | Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | -1.20 hours | Standard Error 0.286 |
| Elagolix 200 mg BID | Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | -2.49 hours | Standard Error 0.294 |
p-value: 0.74195% CI: [-0.61, 0.85]ANCOVA
p-value: 0.00295% CI: [-1.9, -0.42]ANCOVA
Secondary
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.
Time frame: Baseline, Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -1.27 hours | Standard Error 0.229 |
| Elagolix 150 mg QD | Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -2.19 hours | Standard Error 0.289 |
| Elagolix 200 mg BID | Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -2.89 hours | Standard Error 0.288 |
p-value: 0.01395% CI: [-1.65, -0.2]ANCOVA
p-value: <0.00195% CI: [-2.35, -0.9]ANCOVA
Secondary
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.
Time frame: Baseline, Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -0.46 hours | Standard Error 0.224 |
| Elagolix 150 mg QD | Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -1.64 hours | Standard Error 0.281 |
| Elagolix 200 mg BID | Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -1.51 hours | Standard Error 0.282 |
p-value: 0.00195% CI: [-1.9, -0.48]ANCOVA
p-value: 0.00495% CI: [-1.76, -0.34]ANCOVA
Secondary
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.
Time frame: Baseline, Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -4.07 hours | Standard Error 0.555 |
| Elagolix 150 mg QD | Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -4.93 hours | Standard Error 0.668 |
| Elagolix 200 mg BID | Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -6.00 hours | Standard Error 0.694 |
p-value: 0.32695% CI: [-2.57, 0.85]ANCOVA
p-value: 0.03195% CI: [-3.67, -0.18]ANCOVA
Secondary
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.
Time frame: Baseline, Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -1.76 hours | Standard Error 0.352 |
| Elagolix 150 mg QD | Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -3.88 hours | Standard Error 0.445 |
| Elagolix 200 mg BID | Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -4.36 hours | Standard Error 0.443 |
p-value: <0.00195% CI: [-3.24, -1.01]ANCOVA
p-value: <0.00195% CI: [-3.71, -1.49]ANCOVA
Secondary
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.
Time frame: Baseline, Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -5.46 hours | Standard Error 0.615 |
| Elagolix 150 mg QD | Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -6.17 hours | Standard Error 0.745 |
| Elagolix 200 mg BID | Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -8.69 hours | Standard Error 0.764 |
p-value: 0.46295% CI: [-2.61, 1.19]ANCOVA
p-value: 0.00195% CI: [-5.16, -1.3]ANCOVA
Secondary
Change From Baseline to Month 1 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 1 in Mean Pain Score for DYS | -0.33 units on a scale | Standard Error 0.044 |
| Elagolix 150 mg QD | Change From Baseline to Month 1 in Mean Pain Score for DYS | -0.83 units on a scale | Standard Error 0.054 |
| Elagolix 200 mg BID | Change From Baseline to Month 1 in Mean Pain Score for DYS | -0.98 units on a scale | Standard Error 0.054 |
p-value: <0.00197.5% CI: [-0.65, -0.34]mixed-effects model
p-value: <0.00197.5% CI: [-0.81, -0.49]mixed-effects model
Secondary
Change From Baseline to Month 1 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 1 in Mean Pain Score for NMPP | -0.16 units on a scale | Standard Error 0.023 |
| Elagolix 150 mg QD | Change From Baseline to Month 1 in Mean Pain Score for NMPP | -0.22 units on a scale | Standard Error 0.028 |
| Elagolix 200 mg BID | Change From Baseline to Month 1 in Mean Pain Score for NMPP | -0.26 units on a scale | Standard Error 0.028 |
p-value: 0.11197.5% CI: [-0.14, 0.02]mixed-effects model
p-value: 0.00897.5% CI: [-0.18, -0.01]mixed-effects model
Secondary
Change From Baseline to Month 1 in Mean Pain Score of DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Time frame: Baseline, Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded not applicable for the entire time point and at Baseline are excluded from the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 1 in Mean Pain Score of DYSP | -0.18 units on a scale | Standard Error 0.032 |
| Elagolix 150 mg QD | Change From Baseline to Month 1 in Mean Pain Score of DYSP | -0.29 units on a scale | Standard Error 0.04 |
| Elagolix 200 mg BID | Change From Baseline to Month 1 in Mean Pain Score of DYSP | -0.22 units on a scale | Standard Error 0.042 |
p-value: 0.03897.5% CI: [-0.22, 0.01]mixed-effects model
p-value: 0.48897.5% CI: [-0.16, 0.08]mixed-effects model
Secondary
Change From Baseline to Month 1 in NRS Scores
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Time frame: Baseline, Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 1 in NRS Scores | -0.72 units on a scale | Standard Error 0.069 |
| Elagolix 150 mg QD | Change From Baseline to Month 1 in NRS Scores | -1.00 units on a scale | Standard Error 0.085 |
| Elagolix 200 mg BID | Change From Baseline to Month 1 in NRS Scores | -1.12 units on a scale | Standard Error 0.085 |
p-value: 0.01195% CI: [-0.52, -0.03]mixed-effects model
p-value: <0.00197.5% CI: [-0.65, -0.16]mixed-effects model
Secondary
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.
Time frame: Baseline, Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30) | -14.47 units on a scale | Standard Error 0.997 |
| Elagolix 150 mg QD | Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30) | -20.76 units on a scale | Standard Error 1.213 |
| Elagolix 200 mg BID | Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30) | -24.23 units on a scale | Standard Error 1.257 |
p-value: <0.00195% CI: [-9.37, -3.21]ANCOVA
p-value: <0.00195% CI: [-12.91, -6.61]ANCOVA
Secondary
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.
Time frame: Baseline, Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30 | -10.47 units on a scale | Standard Error 1.239 |
| Elagolix 150 mg QD | Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30 | -11.26 units on a scale | Standard Error 1.488 |
| Elagolix 200 mg BID | Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30 | -15.52 units on a scale | Standard Error 1.614 |
p-value: 0.68595% CI: [-4.59, 3.02]ANCOVA
p-value: 0.01395% CI: [-9.04, -1.05]ANCOVA
Secondary
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.
Time frame: Baseline, Month 2 of Treatment Period
Population: The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.24 pills | Standard Error 0.029 |
| Elagolix 150 mg QD | Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.27 pills | Standard Error 0.036 |
| Elagolix 200 mg BID | Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.46 pills | Standard Error 0.037 |
p-value: 0.51997.5% CI: [-0.13, 0.07]mixed-effects model
p-value: <0.00197.5% CI: [-0.32, -0.11]mixed-effects model
Secondary
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.
Time frame: Baseline, Month 2 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -1.43 hours | Standard Error 0.295 |
| Elagolix 150 mg QD | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -2.75 hours | Standard Error 0.36 |
| Elagolix 200 mg BID | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -3.06 hours | Standard Error 0.369 |
p-value: 0.00595% CI: [-2.24, -0.41]ANCOVA
p-value: <0.00195% CI: [-2.56, -0.71]ANCOVA
Secondary
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.
Time frame: Baseline, Month 2 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -1.17 hours | Standard Error 0.238 |
| Elagolix 150 mg QD | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -1.93 hours | Standard Error 0.291 |
| Elagolix 200 mg BID | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -2.23 hours | Standard Error 0.299 |
p-value: 0.04595% CI: [-1.49, -0.02]mixed-effects model
p-value: 0.00695% CI: [-1.81, -0.31]ANCOVA
Secondary
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.
Time frame: Baseline, Month 2 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | -1.29 hours | Standard Error 0.222 |
| Elagolix 150 mg QD | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | -1.77 hours | Standard Error 0.266 |
| Elagolix 200 mg BID | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | -2.56 hours | Standard Error 0.278 |
p-value: 0.17295% CI: [-1.16, 0.21]ANCOVA
p-value: <0.00195% CI: [-1.97, -0.57]ANCOVA
Secondary
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.
Time frame: Baseline, Month 2 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -5.42 hours | Standard Error 0.56 |
| Elagolix 150 mg QD | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -6.83 hours | Standard Error 0.671 |
| Elagolix 200 mg BID | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -8.94 hours | Standard Error 0.701 |
p-value: 0.10795% CI: [-3.13, 0.31]ANCOVA
p-value: <0.00195% CI: [-5.28, -1.75]ANCOVA
Secondary
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.
Time frame: Baseline, Month 2 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -2.60 hours | Standard Error 0.423 |
| Elagolix 150 mg QD | Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -4.69 hours | Standard Error 0.517 |
| Elagolix 200 mg BID | Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -5.25 hours | Standard Error 0.529 |
p-value: 0.00295% CI: [-3.4, -0.78]ANCOVA
p-value: <0.00195% CI: [-3.98, -1.32]ANCOVA
Secondary
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.
Time frame: Baseline, Month 2 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -6.70 hours | Standard Error 0.621 |
| Elagolix 150 mg QD | Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -8.72 hours | Standard Error 0.746 |
| Elagolix 200 mg BID | Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -11.56 hours | Standard Error 0.778 |
p-value: 0.03995% CI: [-3.93, -0.11]ANCOVA
p-value: <0.00195% CI: [-6.82, -2.9]ANCOVA
Secondary
Change From Baseline to Month 2 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 2 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 2 in Mean Pain Score for DYS | -0.32 units on a scale | Standard Error 0.042 |
| Elagolix 150 mg QD | Change From Baseline to Month 2 in Mean Pain Score for DYS | -0.96 units on a scale | Standard Error 0.052 |
| Elagolix 200 mg BID | Change From Baseline to Month 2 in Mean Pain Score for DYS | -1.68 units on a scale | Standard Error 0.053 |
p-value: <0.00197.5% CI: [-0.79, -0.49]mixed-effects model
p-value: <0.00197.5% CI: [-1.51, -1.2]mixed-effects model
Secondary
Change From Baseline to Month 2 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 2 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 2 in Mean Pain Score for NMPP | -0.26 units on a scale | Standard Error 0.028 |
| Elagolix 150 mg QD | Change From Baseline to Month 2 in Mean Pain Score for NMPP | -0.33 units on a scale | Standard Error 0.035 |
| Elagolix 200 mg BID | Change From Baseline to Month 2 in Mean Pain Score for NMPP | -0.44 units on a scale | Standard Error 0.035 |
p-value: 0.09297.5% CI: [-0.18, 0.02]mixed-effects model
p-value: <0.00197.5% CI: [-0.28, -0.08]mixed-effects model
Secondary
Change From Baseline to Month 2 in Mean Pain Score of DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Time frame: Baseline, Month 2 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded not applicable for the entire time point and at Baseline are excluded from the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 2 in Mean Pain Score of DYSP | -0.26 units on a scale | Standard Error 0.038 |
| Elagolix 150 mg QD | Change From Baseline to Month 2 in Mean Pain Score of DYSP | -0.33 units on a scale | Standard Error 0.046 |
| Elagolix 200 mg BID | Change From Baseline to Month 2 in Mean Pain Score of DYSP | -0.38 units on a scale | Standard Error 0.048 |
p-value: 0.25297.5% CI: [-0.2, 0.07]mixed-effects model
p-value: 0.05897.5% CI: [-0.25, 0.02]mixed-effects model
Secondary
Change From Baseline to Month 2 in NRS Scores
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Time frame: Baseline, Month 2 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 2 in NRS Scores | -0.91 units on a scale | Standard Error 0.086 |
| Elagolix 150 mg QD | Change From Baseline to Month 2 in NRS Scores | -1.38 units on a scale | Standard Error 0.106 |
| Elagolix 200 mg BID | Change From Baseline to Month 2 in NRS Scores | -1.87 units on a scale | Standard Error 0.107 |
p-value: <0.00197.5% CI: [-0.77, -0.16]mixed-effects model
p-value: -0.9697.5% CI: [-1.27, -0.65]mixed-effects model
Secondary
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.
Time frame: Baseline, Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.29 pills | Standard Error 0.032 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.29 pills | Standard Error 0.039 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.55 pills | Standard Error 0.04 |
Comparison: Ranked secondary efficacy endpoint 4 of 7.p-value: 0.91mixed-effects model
Comparison: Ranked secondary efficacy endpoint 4 of 7.p-value: <0.001mixed-effects model
Secondary
Change From Baseline to Month 3 in Dyspareunia (DYSP)
The DYSP pain scale ranges from 0 (absent) to 3 (severe).
Time frame: Baseline, Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded not applicable for the entire time point and at Baseline are excluded from the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 3 in Dyspareunia (DYSP) | -0.29 units on a scale | Standard Error 0.041 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in Dyspareunia (DYSP) | -0.39 units on a scale | Standard Error 0.05 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in Dyspareunia (DYSP) | -0.49 units on a scale | Standard Error 0.052 |
Comparison: Ranked secondary efficacy endpoint 6 of 7.p-value: 0.144mixed-effects model
Comparison: Ranked secondary efficacy endpoint 6 of 7.p-value: 0.003mixed-effects model
Secondary
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.
Time frame: Baseline, Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -1.37 hours | Standard Error 0.292 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -3.00 hours | Standard Error 0.358 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -3.47 hours | Standard Error 0.363 |
p-value: <0.00195% CI: [-2.53, -0.72]ANCOVA
p-value: <0.00195% CI: [-3.02, -1.19]ANCOVA
Secondary
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.
Time frame: Baseline, Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -1.35 hours | Standard Error 0.21 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -1.89 hours | Standard Error 0.256 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -2.33 hours | Standard Error 0.261 |
p-value: 0.10395% CI: [-1.19, 0.11]ANCOVA
p-value: 0.00395% CI: [-1.64, -0.32]ANCOVA
Secondary
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.
Time frame: Baseline, Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | -0.87 hours | Standard Error 0.277 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | -1.92 hours | Standard Error 0.333 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | -2.65 hours | Standard Error 0.343 |
p-value: 0.01695% CI: [-1.9, -0.19]ANCOVA
p-value: <0.00195% CI: [-2.65, -0.91]ANCOVA
Secondary
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.
Time frame: Baseline, Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -6.23 hours | Standard Error 0.526 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -7.24 hours | Standard Error 0.632 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -9.16 hours | Standard Error 0.657 |
p-value: 0.21995% CI: [-2.63, 0.6]ANCOVA
p-value: <0.00195% CI: [-4.59, -1.28]ANCOVA
Secondary
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.
Time frame: Baseline, Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -2.73 hours | Standard Error 0.394 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -4.90 hours | Standard Error 0.483 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -5.73 hours | Standard Error 0.492 |
p-value: <0.00195% CI: [-3.39, -0.95]ANCOVA
p-value: <0.00195% CI: [-4.23, -1.76]ANCOVA
Secondary
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.
Time frame: Baseline, Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -7.00 hours | Standard Error 0.654 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -9.20 hours | Standard Error 0.787 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -11.90 hours | Standard Error 0.808 |
p-value: 0.03295% CI: [-4.21, -0.18]ANCOVA
p-value: <0.00195% CI: [-6.95, -2.86]ANCOVA
Secondary
Change From Baseline to Month 3 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 3 in Mean Pain Score for DYS | -0.35 units on a scale | Standard Error 0.043 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in Mean Pain Score for DYS | -1.03 units on a scale | Standard Error 0.052 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in Mean Pain Score for DYS | -1.73 units on a scale | Standard Error 0.054 |
p-value: <0.00197.5% CI: [-0.83, -0.53]mixed-effects model
p-value: <0.00197.5% CI: [-1.54, -1.23]mixed-effects model
Secondary
Change From Baseline to Month 3 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 3 in Mean Pain Score for NMPP | -0.32 units on a scale | Standard Error 0.032 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in Mean Pain Score for NMPP | -0.44 units on a scale | Standard Error 0.039 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in Mean Pain Score for NMPP | -0.61 units on a scale | Standard Error 0.039 |
p-value: 0.01797.5% CI: [-0.23, -0.01]mixed-effects model
p-value: <0.00197.5% CI: [-0.41, -0.18]mixed-effects model
Secondary
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).
Time frame: Baseline, Month 3 of the Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores | -1.09 units on a scale | Standard Error 0.098 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores | -1.74 units on a scale | Standard Error 0.12 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores | -2.39 units on a scale | Standard Error 0.122 |
Comparison: Ranked secondary efficacy endpoint 1 of 7.p-value: <0.001mixed-effects model
Comparison: Ranked secondary efficacy endpoint 1 of 7.p-value: <0.001mixed-effects model
Secondary
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.
Time frame: Baseline, Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 3 in the Pain Domain of the EHP-30 | -17.71 units on a scale | Standard Error 1.101 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in the Pain Domain of the EHP-30 | -26.99 units on a scale | Standard Error 1.321 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in the Pain Domain of the EHP-30 | -36.46 units on a scale | Standard Error 1.386 |
p-value: <0.00195% CI: [-12.66, -5.91]ANCOVA
p-value: <0.00195% CI: [-22.22, -15.27]ANCOVA
Secondary
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.
Time frame: Baseline, Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30 | -12.57 units on a scale | Standard Error 1.551 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30 | -17.32 units on a scale | Standard Error 1.813 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30 | -26.44 units on a scale | Standard Error 2.032 |
p-value: 0.04795% CI: [-9.43, -0.05]ANCOVA
p-value: <0.00195% CI: [-18.89, -8.84]ANCOVA
Secondary
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.
Time frame: Baseline, Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids) | -0.10 pills | Standard Error 0.024 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids) | -0.07 pills | Standard Error 0.029 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids) | -0.22 pills | Standard Error 0.029 |
Comparison: Ranked secondary efficacy endpoint 7 of 7.p-value: 0.424mixed-effects model
Comparison: Ranked secondary efficacy endpoint 7 of 7.p-value: 0.002mixed-effects model
Secondary
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.
Time frame: Baseline, Month 4 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.28 pills | Standard Error 0.033 |
| Elagolix 150 mg QD | Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.39 pills | Standard Error 0.041 |
| Elagolix 200 mg BID | Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.57 pills | Standard Error 0.042 |
p-value: 0.03797.5% CI: [-0.23, 0.01]mixed-effects model
p-value: <0.00197.5% CI: [-0.41, -0.17]mixed-effects model
Secondary
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.
Time frame: Baseline, Month 4 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -1.38 hours | Standard Error 0.265 |
| Elagolix 150 mg QD | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -2.59 hours | Standard Error 0.331 |
| Elagolix 200 mg BID | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -3.61 hours | Standard Error 0.33 |
p-value: 0.00495% CI: [-2.05, -0.38]ANCOVA
p-value: <0.00195% CI: [-3.06, -1.4]ANCOVA
Secondary
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.
Time frame: Baseline, Month 4 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -1.51 hours | Standard Error 0.224 |
| Elagolix 150 mg QD | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -1.81 hours | Standard Error 0.28 |
| Elagolix 200 mg BID | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -2.55 hours | Standard Error 0.278 |
p-value: 0.3995% CI: [-1.01, 0.4]ANCOVA
p-value: 0.00395% CI: [-1.75, -0.35]ANCOVA
Secondary
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.
Time frame: Baseline, Month 4 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | -1.08 hours | Standard Error 0.284 |
| Elagolix 150 mg QD | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | -1.85 hours | Standard Error 0.334 |
| Elagolix 200 mg BID | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | -2.44 hours | Standard Error 0.351 |
p-value: 0.0895% CI: [-1.63, 0.09]ANCOVA
p-value: 0.00395% CI: [-2.25, -0.48]ANCOVA
Secondary
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.
Time frame: Baseline, Month 4 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -6.81 hours | Standard Error 0.465 |
| Elagolix 150 mg QD | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -8.41 hours | Standard Error 0.546 |
| Elagolix 200 mg BID | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -10.70 hours | Standard Error 0.573 |
p-value: 0.02695% CI: [-3.01, -0.19]ANCOVA
p-value: <0.00195% CI: [-5.34, -2.43]ANCOVA
Secondary
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.
Time frame: Baseline, Month 4 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -2.89 hours | Standard Error 0.403 |
| Elagolix 150 mg QD | Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -4.43 hours | Standard Error 0.502 |
| Elagolix 200 mg BID | Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -6.13 hours | Standard Error 0.501 |
p-value: 0.01795% CI: [-2.8, -0.27]ANCOVA
p-value: <0.00195% CI: [-4.5, -1.98]ANCOVA
Secondary
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.
Time frame: Baseline, Month 4 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -7.84 hours | Standard Error 0.605 |
| Elagolix 150 mg QD | Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -10.26 hours | Standard Error 0.712 |
| Elagolix 200 mg BID | Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -13.09 hours | Standard Error 0.747 |
p-value: 0.0195% CI: [-4.26, -0.58]ANCOVA
p-value: <0.00195% CI: [-7.14, -3.36]ANCOVA
Secondary
Change From Baseline to Month 4 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 4 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 4 in Mean Pain Score for DYS | -0.40 units on a scale | Standard Error 0.045 |
| Elagolix 150 mg QD | Change From Baseline to Month 4 in Mean Pain Score for DYS | -1.05 units on a scale | Standard Error 0.054 |
| Elagolix 200 mg BID | Change From Baseline to Month 4 in Mean Pain Score for DYS | -1.72 units on a scale | Standard Error 0.057 |
p-value: <0.00197.5% CI: [-0.81, -0.49]mixed-effects model
p-value: <0.00197.5% CI: [-1.49, -1.16]mixed-effects model
Secondary
Change From Baseline to Month 4 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 4 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 4 in Mean Pain Score for NMPP | -0.33 units on a scale | Standard Error 0.034 |
| Elagolix 150 mg QD | Change From Baseline to Month 4 in Mean Pain Score for NMPP | -0.51 units on a scale | Standard Error 0.041 |
| Elagolix 200 mg BID | Change From Baseline to Month 4 in Mean Pain Score for NMPP | -0.72 units on a scale | Standard Error 0.042 |
p-value: <0.00197.5% CI: [-0.31, -0.07]mixed-effects model
p-value: <0.00197.5% CI: [-0.51, -0.27]mixed-effects model
Secondary
Change From Baseline to Month 4 in Mean Pain Score of DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Time frame: Baseline, Month 4 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded not applicable for the entire time point and at Baseline are excluded from the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 4 in Mean Pain Score of DYSP | -0.27 units on a scale | Standard Error 0.044 |
| Elagolix 150 mg QD | Change From Baseline to Month 4 in Mean Pain Score of DYSP | -0.45 units on a scale | Standard Error 0.053 |
| Elagolix 200 mg BID | Change From Baseline to Month 4 in Mean Pain Score of DYSP | -0.61 units on a scale | Standard Error 0.056 |
p-value: 0.00997.5% CI: [-0.34, -0.03]mixed-effects model
p-value: <0.00197.5% CI: [-0.5, -0.18]mixed-effects model
Secondary
Change From Baseline to Month 4 in NRS Scores
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Time frame: Baseline, Month 4 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 4 in NRS Scores | -1.15 units on a scale | Standard Error 0.103 |
| Elagolix 150 mg QD | Change From Baseline to Month 4 in NRS Scores | -1.95 units on a scale | Standard Error 0.126 |
| Elagolix 200 mg BID | Change From Baseline to Month 4 in NRS Scores | -2.76 units on a scale | Standard Error 0.129 |
p-value: <0.00197.5% CI: [-1.17, -0.44]mixed-effects model
p-value: <0.00197.5% CI: [-1.98, -1.24]mixed-effects model
Secondary
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.
Time frame: Baseline, Month 5 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.29 pills | Standard Error 0.034 |
| Elagolix 150 mg QD | Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.36 pills | Standard Error 0.041 |
| Elagolix 200 mg BID | Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.60 pills | Standard Error 0.042 |
p-value: 0.297.5% CI: [-0.19, 0.05]mixed-effects model
p-value: <0.00197.5% CI: [-0.42, -0.18]mixed-effects model
Secondary
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.
Time frame: Baseline, Month 5 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -2.13 hours | Standard Error 0.25 |
| Elagolix 150 mg QD | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -3.10 hours | Standard Error 0.302 |
| Elagolix 200 mg BID | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -3.94 hours | Standard Error 0.304 |
p-value: 0.01395% CI: [-1.74, -0.2]ANCOVA
p-value: <0.00195% CI: [-2.58, -1.04]ANCOVA
Secondary
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.
Time frame: Baseline, Month 5 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -1.67 hours | Standard Error 0.169 |
| Elagolix 150 mg QD | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -1.86 hours | Standard Error 0.205 |
| Elagolix 200 mg BID | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -2.71 hours | Standard Error 0.206 |
p-value: 0.4695% CI: [-0.72, 0.32]ANCOVA
p-value: <0.00195% CI: [-1.57, -0.52]ANCOVA
Secondary
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.
Time frame: Baseline, Month 5 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | -1.10 hours | Standard Error 0.258 |
| Elagolix 150 mg QD | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | -1.75 hours | Standard Error 0.308 |
| Elagolix 200 mg BID | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | -2.94 hours | Standard Error 0.33 |
p-value: 0.10695% CI: [-1.44, 0.14]ANCOVA
p-value: <0.00195% CI: [-2.67, -1.02]ANCOVA
Secondary
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.
Time frame: Baseline, Month 5 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -7.80 hours | Standard Error 0.488 |
| Elagolix 150 mg QD | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -8.31 hours | Standard Error 0.577 |
| Elagolix 200 mg BID | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -10.93 hours | Standard Error 0.631 |
p-value: 0.50295% CI: [-2, 0.98]ANCOVA
p-value: <0.00195% CI: [-4.7, -1.56]ANCOVA
Secondary
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.
Time frame: Baseline, Month 5 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -3.80 hours | Standard Error 0.349 |
| Elagolix 150 mg QD | Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -4.94 hours | Standard Error 0.423 |
| Elagolix 200 mg BID | Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -6.62 hours | Standard Error 0.425 |
p-value: 0.03895% CI: [-2.22, -0.07]ANCOVA
p-value: <0.00195% CI: [-3.91, -1.74]ANCOVA
Secondary
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.
Time frame: Baseline, Month 5 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -8.87 hours | Standard Error 0.604 |
| Elagolix 150 mg QD | Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -10.04 hours | Standard Error 0.719 |
| Elagolix 200 mg BID | Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -14.00 hours | Standard Error 0.771 |
p-value: 0.21595% CI: [-3.02, 0.68]ANCOVA
p-value: <0.00195% CI: [-7.06, -3.2]ANCOVA
Secondary
Change From Baseline to Month 5 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 5 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 5 in Mean Pain Score for DYS | -0.43 units on a scale | Standard Error 0.045 |
| Elagolix 150 mg QD | Change From Baseline to Month 5 in Mean Pain Score for DYS | -1.02 units on a scale | Standard Error 0.054 |
| Elagolix 200 mg BID | Change From Baseline to Month 5 in Mean Pain Score for DYS | -1.84 units on a scale | Standard Error 0.056 |
p-value: <0.00197.5% CI: [-0.75, -0.43]mixed-effects model
p-value: <0.00197.5% CI: [-1.58, -1.25]mixed-effects model
Secondary
Change From Baseline to Month 5 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 5 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 5 in Mean Pain Score for NMPP | -0.34 units on a scale | Standard Error 0.034 |
| Elagolix 150 mg QD | Change From Baseline to Month 5 in Mean Pain Score for NMPP | -0.49 units on a scale | Standard Error 0.041 |
| Elagolix 200 mg BID | Change From Baseline to Month 5 in Mean Pain Score for NMPP | -0.74 units on a scale | Standard Error 0.042 |
p-value: 0.00497.5% CI: [-0.27, -0.03]mixed-effects model
p-value: <0.00197.5% CI: [-0.52, -0.27]mixed-effects model
Secondary
Change From Baseline to Month 5 in Mean Pain Score of DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Time frame: Baseline, Month 5 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded not applicable for the entire time point and at Baseline are excluded from the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 5 in Mean Pain Score of DYSP | -0.30 units on a scale | Standard Error 0.047 |
| Elagolix 150 mg QD | Change From Baseline to Month 5 in Mean Pain Score of DYSP | -0.44 units on a scale | Standard Error 0.056 |
| Elagolix 200 mg BID | Change From Baseline to Month 5 in Mean Pain Score of DYSP | -0.57 units on a scale | Standard Error 0.06 |
p-value: 0.0697.5% CI: [-0.3, 0.03]mixed-effects model
p-value: <0.00197.5% CI: [-0.44, -0.1]mixed-effects model
Secondary
Change From Baseline to Month 5 in NRS Scores
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Time frame: Baseline, Month 5 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 5 in NRS Scores | -1.24 units on a scale | Standard Error 0.106 |
| Elagolix 150 mg QD | Change From Baseline to Month 5 in NRS Scores | -1.92 units on a scale | Standard Error 0.129 |
| Elagolix 200 mg BID | Change From Baseline to Month 5 in NRS Scores | -2.85 units on a scale | Standard Error 0.132 |
p-value: <0.00197.5% CI: [-1.05, -0.3]mixed-effects model
p-value: <0.00197.5% CI: [-1.99, -1.23]mixed-effects model
Secondary
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.
Time frame: Baseline, Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.27 pills | Standard Error 0.036 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.35 pills | Standard Error 0.043 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.56 pills | Standard Error 0.045 |
Comparison: Ranked secondary efficacy endpoint 5 of 7.p-value: 0.185mixed-effects model
Comparison: Ranked secondary efficacy endpoint 5 of 7.p-value: <0.001mixed-effects model
Secondary
Change From Baseline to Month 6 in DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 6 in DYS | -0.44 units on a scale | Standard Error 0.047 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in DYS | -0.89 units on a scale | Standard Error 0.057 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in DYS | -1.75 units on a scale | Standard Error 0.059 |
Comparison: Ranked secondary efficacy endpoint 2 of 7.p-value: <0.001mixed-effects model
Comparison: Ranked secondary efficacy endpoint 2 of 7.p-value: <0.001mixed-effects model
Secondary
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.
Time frame: Baseline, Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -1.45 hours | Standard Error 0.313 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -2.73 hours | Standard Error 0.359 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | -3.94 hours | Standard Error 0.367 |
p-value: 0.00795% CI: [-2.22, -0.34]ANCOVA
p-value: <0.00195% CI: [-3.44, -1.54]ANCOVA
Secondary
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.
Time frame: Baseline, Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -1.48 hours | Standard Error 0.232 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -2.07 hours | Standard Error 0.265 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | -2.78 hours | Standard Error 0.275 |
p-value: 0.09595% CI: [-1.28, 0.1]ANCOVA
p-value: <0.00195% CI: [-2.01, -0.59]ANCOVA
Secondary
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.
Time frame: Baseline, Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | -0.27 hours | Standard Error 0.409 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | -1.02 hours | Standard Error 0.471 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | -2.48 hours | Standard Error 0.503 |
p-value: 0.23295% CI: [-1.97, 0.48]ANCOVA
p-value: <0.00195% CI: [-3.48, -0.93]ANCOVA
Secondary
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.
Time frame: Baseline, Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -6.75 hours | Standard Error 0.554 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -8.11 hours | Standard Error 0.637 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | -11.21 hours | Standard Error 0.679 |
p-value: 0.10895% CI: [-3.02, 0.3]ANCOVA
p-value: <0.00195% CI: [-6.19, -2.74]ANCOVA
Secondary
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.
Time frame: Baseline, Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -2.94 hours | Standard Error 0.433 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -4.78 hours | Standard Error 0.496 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | -6.69 hours | Standard Error 0.507 |
p-value: 0.00695% CI: [-3.13, -0.54]ANCOVA
p-value: <0.00195% CI: [-5.06, -2.44]ANCOVA
Secondary
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.
Time frame: Baseline, Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -6.88 hours | Standard Error 0.761 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -9.14 hours | Standard Error 0.874 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | -13.67 hours | Standard Error 0.936 |
p-value: 0.05395% CI: [-4.53, 0.03]ANCOVA
p-value: <0.00195% CI: [-9.17, -4.41]ANCOVA
Secondary
Change From Baseline to Month 6 in Mean Pain Score of DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Time frame: Baseline, Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded not applicable for the entire time point and at Baseline are excluded from the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 6 in Mean Pain Score of DYSP | -0.29 units on a scale | Standard Error 0.048 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in Mean Pain Score of DYSP | -0.41 units on a scale | Standard Error 0.057 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in Mean Pain Score of DYSP | -0.60 units on a scale | Standard Error 0.062 |
p-value: 0.11897.5% CI: [-0.28, 0.05]mixed-effects model
p-value: <0.00197.5% CI: [-0.48, -0.13]mixed-effects model
Secondary
Change From Baseline to Month 6 in NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 6 in NMPP | -0.31 units on a scale | Standard Error 0.035 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in NMPP | -0.48 units on a scale | Standard Error 0.043 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in NMPP | -0.72 units on a scale | Standard Error 0.044 |
Comparison: Ranked secondary efficacy endpoint 3 of 7.p-value: 0.004mixed-effects model
Comparison: Ranked secondary efficacy endpoint 3 of 7.p-value: <0.001mixed-effects model
Secondary
Change From Baseline to Month 6 in NRS Scores
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Time frame: Baseline, Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 6 in NRS Scores | -1.15 units on a scale | Standard Error 0.112 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in NRS Scores | -1.80 units on a scale | Standard Error 0.136 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in NRS Scores | -2.75 units on a scale | Standard Error 0.14 |
p-value: <0.00197.5% CI: [-1.04, -0.25]mixed-effects model
p-value: <0.00197.5% CI: [-2, -1.2]mixed-effects model
Secondary
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.
Time frame: Baseline, Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 6 in the Pain Domain of the EHP-30 | -15.42 units on a scale | Standard Error 1.283 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in the Pain Domain of the EHP-30 | -27.99 units on a scale | Standard Error 1.522 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in the Pain Domain of the EHP-30 | -40.52 units on a scale | Standard Error 1.591 |
p-value: <0.00195% CI: [-16.48, -8.66]ANCOVA
p-value: <0.00195% CI: [-29.12, -21.09]ANCOVA
Secondary
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.
Time frame: Baseline, Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30 | -11.56 units on a scale | Standard Error 1.909 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30 | -16.27 units on a scale | Standard Error 2.203 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30 | -29.07 units on a scale | Standard Error 2.384 |
p-value: 0.10795% CI: [-10.43, 1.02]ANCOVA
p-value: <0.00195% CI: [-23.52, -11.5]ANCOVA
Secondary
Number of Days of Hospitalization
Time frame: Up to Month 6 of Treatment Period
Population: The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Includes participants who were hospitalized during the Treatment Period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Days of Hospitalization | 2.9 days | Standard Deviation 2.45 |
| Elagolix 150 mg QD | Number of Days of Hospitalization | 2.0 days | Standard Deviation 1 |
| Elagolix 200 mg BID | Number of Days of Hospitalization | 2.0 days | Standard Deviation 1.68 |
Secondary
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type
Time frame: Up to Month 6 of Treatment Period
Population: The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Electrocardiogram | 3 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Arthroscopy | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Oophorectomy | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Endometrial Ablation | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Transfusion | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Magnetic Resonance Imaging | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Histological Exam | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Abdominal Hysterectomy | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Laparotomy | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Intrauterine Insemination | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Urine Test | 26 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Laparoscopic Hysterectomy | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | In Vitro Fertilization | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Biopsy | 1 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | All Categories | 62 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Ultrasound | 14 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Blood Draw | 27 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | X-Ray | 14 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Therapeutic Laparoscopy | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Consultation | 6 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Angiography | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Surgery for Adhesions | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | CT Scan | 21 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Other (Not Specified) | 16 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Physical Examination | 32 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Diagnostic Laparoscopy | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Vaginal Hysterectomy | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Pelvic Exam | 5 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Endometrial Ablation | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | All Categories | 21 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Abdominal Hysterectomy | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Angiography | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Arthroscopy | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Biopsy | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Blood Draw | 7 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Consultation | 3 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | CT Scan | 3 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Diagnostic Laparoscopy | 1 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Electrocardiogram | 1 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Histological Exam | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Intrauterine Insemination | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | In Vitro Fertilization | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Laparoscopic Hysterectomy | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Laparotomy | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Magnetic Resonance Imaging | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Oophorectomy | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Pelvic Exam | 1 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Physical Examination | 10 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Surgery for Adhesions | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Therapeutic Laparoscopy | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Transfusion | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Ultrasound | 3 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Urine Test | 8 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Vaginal Hysterectomy | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | X-Ray | 2 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Other (Not Specified) | 10 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Urine Test | 11 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Pelvic Exam | 2 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | CT Scan | 6 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Angiography | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Physical Examination | 15 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Consultation | 3 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | All Categories | 32 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Surgery for Adhesions | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Blood Draw | 16 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Vaginal Hysterectomy | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Therapeutic Laparoscopy | 1 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Abdominal Hysterectomy | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Transfusion | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Biopsy | 1 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | In Vitro Fertilization | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Intrauterine Insemination | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Other (Not Specified) | 10 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Laparoscopic Hysterectomy | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Histological Exam | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Ultrasound | 6 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Laparotomy | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Endometrial Ablation | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Arthroscopy | 1 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Magnetic Resonance Imaging | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Electrocardiogram | 3 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | X-Ray | 5 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Oophorectomy | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Diagnostic Laparoscopy | 0 Participants |
Secondary
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period
Time frame: Up to Month 6 of Treatment Period
Population: The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Baseline | 69 Participants |
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 1 | 70 Participants |
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 2 | 59 Participants |
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 3 | 66 Participants |
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 4 | 54 Participants |
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 5 | 43 Participants |
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 6 | 38 Participants |
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Overall | 189 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 2 | 38 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 6 | 26 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 3 | 37 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 4 | 35 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 5 | 32 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Baseline | 54 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 1 | 50 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Overall | 126 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 2 | 33 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 1 | 47 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Baseline | 51 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 3 | 48 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 6 | 21 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 5 | 22 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 4 | 42 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Overall | 113 Participants |
Secondary
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.
Time frame: At Month 1 of the Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 1 Based on Daily Assessment of DYS | 14.5 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 1 Based on Daily Assessment of DYS | 35.1 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 1 Based on Daily Assessment of DYS | 44.1 percentage of participants |
p-value: <0.001Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
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.
Time frame: At Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 1 Based on Daily Assessment of NMPP | 25.8 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 1 Based on Daily Assessment of NMPP | 32.3 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 1 Based on Daily Assessment of NMPP | 33.9 percentage of participants |
p-value: 0.103Regression, Logistic
p-value: 0.023Regression, Logistic
Secondary
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.
Time frame: At Month 1 of the Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 1 for DYSP | 26.3 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 1 for DYSP | 30.4 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 1 for DYSP | 31.8 percentage of participants |
p-value: 0.306Regression, Logistic
p-value: 0.239Regression, Logistic
Secondary
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.
Time frame: At Month 2 of the Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 2 Based on Daily Assessment of DYS | 17.2 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 2 Based on Daily Assessment of DYS | 44.8 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 2 Based on Daily Assessment of DYS | 71.3 percentage of participants |
p-value: <0.001Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
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.
Time frame: At Month 2 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 2 Based on Daily Assessment of NMPP | 32.2 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 2 Based on Daily Assessment of NMPP | 41.1 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 2 Based on Daily Assessment of NMPP | 46.3 percentage of participants |
p-value: 0.031Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
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.
Time frame: At Month 2 of the Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 2 for DYSP | 33.1 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 2 for DYSP | 33.7 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 2 for DYSP | 44.7 percentage of participants |
p-value: 0.855Regression, Logistic
p-value: 0.012Regression, Logistic
Secondary
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.
Time frame: At Month 4 of the Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 4 Based on Daily Assessment of DYS | 21.7 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 4 Based on Daily Assessment of DYS | 47.6 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 4 Based on Daily Assessment of DYS | 75.3 percentage of participants |
p-value: <0.001Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
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.
Time frame: At Month 4 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 4 Based on Daily Assessment of NMPP | 35.4 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 4 Based on Daily Assessment of NMPP | 53.2 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 4 Based on Daily Assessment of NMPP | 63.8 percentage of participants |
p-value: <0.001Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
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.
Time frame: At Month 4 of the Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 4 for DYSP | 33.1 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 4 for DYSP | 44.3 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 4 for DYSP | 54.2 percentage of participants |
p-value: 0.01Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
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.
Time frame: At Month 5 of the Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward..
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 5 Based on Daily Assessment of DYS | 24.3 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 5 Based on Daily Assessment of DYS | 45.7 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 5 Based on Daily Assessment of DYS | 79.0 percentage of participants |
p-value: <0.001Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
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.
Time frame: At Month 5 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 5 Based on Daily Assessment of NMPP | 38.3 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 5 Based on Daily Assessment of NMPP | 49.8 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 5 Based on Daily Assessment of NMPP | 62.1 percentage of participants |
p-value: 0.005Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
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.
Time frame: At Month 5 of the Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 5 for DYSP | 35.3 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 5 for DYSP | 43.7 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 5 for DYSP | 54.8 percentage of participants |
p-value: 0.061Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
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.
Time frame: At Month 6 of the Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 6 Based on Daily Assessment of DYS | 23.1 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 6 Based on Daily Assessment of DYS | 42.1 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 6 Based on Daily Assessment of DYS | 75.3 percentage of participants |
p-value: <0.001Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
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.
Time frame: At Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 6 Based on Daily Assessment of NMPP | 34.9 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 6 Based on Daily Assessment of NMPP | 45.7 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 6 Based on Daily Assessment of NMPP | 62.1 percentage of participants |
p-value: 0.008Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
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.
Time frame: At Month 6 of the Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders at Month 6 for DYSP | 33.3 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 6 for DYSP | 39.6 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 6 for DYSP | 50.3 percentage of participants |
p-value: 0.126Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
Percent Change From Baseline to Month 1 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline to Month 1 in Mean Pain Score for DYS | -14.35 percentage change | Standard Error 2.079 |
| Elagolix 150 mg QD | Percent Change From Baseline to Month 1 in Mean Pain Score for DYS | -38.42 percentage change | Standard Error 2.547 |
| Elagolix 200 mg BID | Percent Change From Baseline to Month 1 in Mean Pain Score for DYS | -45.35 percentage change | Standard Error 2.562 |
p-value: <0.00197.5% CI: [-31.45, -16.69]mixed-effects model
p-value: <0.00197.5% CI: [-38.41, -23.6]mixed-effects model
Secondary
Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP | -7.51 percentage change | Standard Error 1.736 |
| Elagolix 150 mg QD | Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP | -13.74 percentage change | Standard Error 2.131 |
| Elagolix 200 mg BID | Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP | -15.23 percentage change | Standard Error 2.139 |
p-value: 0.02497.5% CI: [-12.4, -0.06]mixed-effects model
p-value: 0.00597.5% CI: [-13.9, -1.53]mixed-effects model
Secondary
Percent Change From Baseline to Month 2 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 2 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline to Month 2 in Mean Pain Score for DYS | -13.44 percentage change | Standard Error 1.965 |
| Elagolix 150 mg QD | Percent Change From Baseline to Month 2 in Mean Pain Score for DYS | -44.23 percentage change | Standard Error 2.407 |
| Elagolix 200 mg BID | Percent Change From Baseline to Month 2 in Mean Pain Score for DYS | -77.22 percentage change | Standard Error 2.46 |
p-value: -30.7997.5% CI: [-37.77, -23.82]mixed-effects model
p-value: <0.00197.5% CI: [-70.85, -56.71]mixed-effects model
Secondary
Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 2 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP | -13.81 percentage change | Standard Error 2.039 |
| Elagolix 150 mg QD | Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP | -19.50 percentage change | Standard Error 2.501 |
| Elagolix 200 mg BID | Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP | -27.53 percentage change | Standard Error 2.529 |
p-value: 0.07897.5% CI: [-12.93, 1.56]mixed-effects model
p-value: <0.00197.5% CI: [-21.01, -6.42]mixed-effects model
Secondary
Percent Change From Baseline to Month 3 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline to Month 3 in Mean Pain Score for DYS | -14.80 percentage change | Standard Error 2.022 |
| Elagolix 150 mg QD | Percent Change From Baseline to Month 3 in Mean Pain Score for DYS | -47.01 percentage change | Standard Error 2.451 |
| Elagolix 200 mg BID | Percent Change From Baseline to Month 3 in Mean Pain Score for DYS | -79.74 percentage change | Standard Error 2.519 |
p-value: <0.00197.5% CI: [-39.35, -25.08]mixed-effects model
p-value: <0.00197.5% CI: [-72.19, -57.68]mixed-effects model
Secondary
Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP | -17.64 percentage change | Standard Error 2.204 |
| Elagolix 150 mg QD | Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP | -26.10 percentage change | Standard Error 2.688 |
| Elagolix 200 mg BID | Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP | -40.13 percentage change | Standard Error 2.737 |
p-value: 0.01597.5% CI: [-16.27, -0.66]mixed-effects model
p-value: <0.00197.5% CI: [-30.38, -14.6]mixed-effects model
Secondary
Percent Change From Baseline to Month 4 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 4 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline to Month 4 in Mean Pain Score for DYS | -18.08 percentage change | Standard Error 2.088 |
| Elagolix 150 mg QD | Percent Change From Baseline to Month 4 in Mean Pain Score for DYS | -48.02 percentage change | Standard Error 2.519 |
| Elagolix 200 mg BID | Percent Change From Baseline to Month 4 in Mean Pain Score for DYS | -79.98 percentage change | Standard Error 2.627 |
p-value: <0.00197.5% CI: [-37.28, -22.59]mixed-effects model
p-value: <0.00197.5% CI: [-69.44, -54.36]mixed-effects model
Secondary
Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 4 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP | -17.94 percentage change | Standard Error 2.333 |
| Elagolix 150 mg QD | Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP | -32.05 percentage change | Standard Error 2.837 |
| Elagolix 200 mg BID | Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP | -48.35 percentage change | Standard Error 2.909 |
p-value: <0.00197.5% CI: [-22.36, -5.87]mixed-effects model
p-value: <0.00197.5% CI: [-38.78, -22.04]mixed-effects model
Secondary
Percent Change From Baseline to Month 5 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 5 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline to Month 5 in Mean Pain Score for DYS | -18.09 percentage change | Standard Error 2.072 |
| Elagolix 150 mg QD | Percent Change From Baseline to Month 5 in Mean Pain Score for DYS | -46.72 percentage change | Standard Error 2.517 |
| Elagolix 200 mg BID | Percent Change From Baseline to Month 5 in Mean Pain Score for DYS | -84.58 percentage change | Standard Error 2.595 |
p-value: <0.00197.5% CI: [-35.96, -21.31]mixed-effects model
p-value: <0.00197.5% CI: [-73.95, -59.04]mixed-effects model
Secondary
Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 5 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP | -19.60 percentage change | Standard Error 2.371 |
| Elagolix 150 mg QD | Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP | -31.15 percentage change | Standard Error 2.888 |
| Elagolix 200 mg BID | Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP | -49.28 percentage change | Standard Error 2.954 |
p-value: 0.00297.5% CI: [-19.94, -3.16]mixed-effects model
p-value: <0.00197.5% CI: [-38.19, -21.18]mixed-effects model
Secondary
Percent Change From Baseline to Month 6 in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline to Month 6 in Mean Pain Score for DYS | -19.21 percentage change | Standard Error 2.217 |
| Elagolix 150 mg QD | Percent Change From Baseline to Month 6 in Mean Pain Score for DYS | -40.60 percentage change | Standard Error 2.681 |
| Elagolix 200 mg BID | Percent Change From Baseline to Month 6 in Mean Pain Score for DYS | -79.99 percentage change | Standard Error 2.782 |
p-value: <0.00197.5% CI: [-29.2, -13.57]mixed-effects model
p-value: <0.00197.5% CI: [-68.77, -52.79]mixed-effects model
Secondary
Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP | -18.17 percentage change | Standard Error 2.418 |
| Elagolix 150 mg QD | Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP | -30.55 percentage change | Standard Error 2.939 |
| Elagolix 200 mg BID | Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP | -48.14 percentage change | Standard Error 3.019 |
p-value: 0.00197.5% CI: [-20.92, -3.83]mixed-effects model
p-value: <0.00197.5% CI: [-38.66, -21.28]mixed-effects model
Secondary
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.
Time frame: Month 1 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Response to Patient Global Impression of Change (PGIC) at Month 1 | 3.50 units on a scale | Standard Error 0.06 |
| Elagolix 150 mg QD | Response to Patient Global Impression of Change (PGIC) at Month 1 | 2.97 units on a scale | Standard Error 0.073 |
| Elagolix 200 mg BID | Response to Patient Global Impression of Change (PGIC) at Month 1 | 2.76 units on a scale | Standard Error 0.075 |
p-value: <0.00195% CI: [-0.72, -0.34]ANOVA
p-value: <0.00195% CI: [-0.93, -0.56]ANOVA
Secondary
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.
Time frame: Month 2 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Response to PGIC at Month 2 | 3.13 units on a scale | Standard Error 0.062 |
| Elagolix 150 mg QD | Response to PGIC at Month 2 | 2.74 units on a scale | Standard Error 0.076 |
| Elagolix 200 mg BID | Response to PGIC at Month 2 | 2.11 units on a scale | Standard Error 0.077 |
p-value: <0.00195% CI: [-0.58, -0.19]ANOVA
p-value: <0.00195% CI: [-1.21, -0.82]ANOVA
Secondary
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.
Time frame: Month 3 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Response to PGIC at Month 3 | 3.14 units on a scale | Standard Error 0.064 |
| Elagolix 150 mg QD | Response to PGIC at Month 3 | 2.53 units on a scale | Standard Error 0.079 |
| Elagolix 200 mg BID | Response to PGIC at Month 3 | 2.01 units on a scale | Standard Error 0.079 |
p-value: <0.00195% CI: [-0.81, -0.41]ANOVA
p-value: <0.00195% CI: [-1.32, -0.92]ANOVA
Secondary
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.
Time frame: Month 4 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Response to PGIC at Month 4 | 3.16 units on a scale | Standard Error 0.067 |
| Elagolix 150 mg QD | Response to PGIC at Month 4 | 2.54 units on a scale | Standard Error 0.082 |
| Elagolix 200 mg BID | Response to PGIC at Month 4 | 1.91 units on a scale | Standard Error 0.084 |
p-value: <0.00195% CI: [-0.83, -0.42]ANOVA
p-value: <0.00195% CI: [-1.47, -1.05]ANOVA
Secondary
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.
Time frame: Month 5 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Response to PGIC at Month 5 | 3.19 units on a scale | Standard Error 0.07 |
| Elagolix 150 mg QD | Response to PGIC at Month 5 | 2.50 units on a scale | Standard Error 0.086 |
| Elagolix 200 mg BID | Response to PGIC at Month 5 | 1.87 units on a scale | Standard Error 0.088 |
p-value: <0.00195% CI: [-0.91, -0.48]ANOVA
p-value: <0.00195% CI: [-1.54, -1.1]ANOVA
Secondary
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.
Time frame: Month 6 of Treatment Period
Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Response to PGIC at Month 6 | 3.27 units on a scale | Standard Error 0.077 |
| Elagolix 150 mg QD | Response to PGIC at Month 6 | 2.56 units on a scale | Standard Error 0.094 |
| Elagolix 200 mg BID | Response to PGIC at Month 6 | 1.92 units on a scale | Standard Error 0.096 |
p-value: <0.00195% CI: [-0.96, -0.48]ANOVA
p-value: <0.00195% CI: [-1.59, -1.11]ANOVA