Endometriosis
Conditions
Keywords
Non-Menstrual Pelvic Pain (NMPP), Dysmenorrhea (DYS), Elagolix, Endometriosis Associated Pain, Gonadotropin-Releasing Hormone Antagonist
Brief summary
A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female subjects.
Detailed description
The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study. Subjects will be required to use nonhormonal dual contraception during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.
Interventions
OTHERplacebo
DRUGElagolix
Sponsors
AbbVie
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 the Washout Period. 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 or greater 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 regular menstrual cycles with an interval of 24-38 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. 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 uterine 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) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain. |
| Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP) | At Month 3 of Treatment Period | The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain. |
Secondary
| 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 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts. |
| Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics | Baseline, Month 6 of Treatment Period | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts. |
| Change From Baseline to Month 3 in Dyspareunia (DYSP) | 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 country-specific rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen. Assessment was based on average pill counts. |
| Percentage of Responders for Each Month, Except Month 3, in DYS | Months 1, 2, 4, 5, 6 of the Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain. |
| Percentage of Responders for Each Month, Except Month 3, in NMPP | Months 1, 2, 4, 5, 6 of the Treatment Period | The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain. |
| Percentage of Responders at Each Month for DYSP | Months 1, 2, 3, 4, 5, 6 of Treatment Period | The DYSP pain scale ranged from 0 (absent) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.29 or greater from Baseline in DYSP as well as no increased rescue analgesic use for endometriosis-associated pain. |
| Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Baseline (Prior to administering study drug), Months 1, 2, 3, 4, 5 of Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Baseline, Months 1, 2, 3, 4, 5 of Treatment Period | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Baseline, Months 1, 2, 4, 5, 6 of Treatment Period | The DYSP pain scale ranged from 0 (absent) to 3 (severe). |
| 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). |
| Patient Global Impression of Change (PGIC) Questionnaire | Months 1, 2, 3, 4, 5, 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 Each Month, Except Month 3, in NRS Scores | Baseline, Months 1, 2, 4, 5, 6 of Treatment Period | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). |
| Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores | Baseline, Months 1, 3, 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 domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. |
| Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores | Baseline, Months 1, 3, 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 domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. |
| Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Baseline, Months 1, 2, 3, 4, 5, 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 Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Baseline, Months 1, 2, 3, 4, 5, 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 Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Baseline, Months 1, 2, 3, 4, 5, 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 Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Baseline, Months 1, 2, 3, 4, 5, 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 Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Baseline, Months 1, 2, 3, 4, 5, 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 Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Baseline, Months 1, 2, 3, 4, 5, 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 | Months 1, 2, 3, 4, 5, 6 of Treatment Period | This is assessed using Health Resource Utilization Questionnaire (HRUQ). |
| Number of Days of Hospitalization | Up to Month 6 of Treatment Period | This is assessed using HRUQ. |
| Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Up to Month 6 of Treatment Period | This is assessed using HRUQ. |
| Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics | Baseline, Months 1, 2, 4, 5 | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts. |
| Change From Baseline to Month 6 in DYS | Baseline, Month 6 of Treatment Period | The DYS pain scale ranges from 0 (none) to 3 (severe). |
Participant flow
Recruitment details
Participants were randomized at 187 sites in Argentina, Austria, Australia, Brazil, Czech Republic, Hungary, Italy, New Zealand, Poland, South Africa, Spain, the United States, and the United Kingdom.
Pre-assignment details
The study consisted of 4 periods: a Washout Period (if applicable); a Screening Period of ≤ 100 days prior to first dose; a 6-month Treatment Period; and a Post-Treatment Follow-up Period of ≤ 12 months (if applicable). Participants were randomized into the study in a 3:2:2 ratio to placebo, elagolix 150 mg QD, or elagolix 200 mg BID, respectively.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo BID for the 6-month Treatment Period | 360 |
| Elagolix 150 mg QD Elagolix 150 mg QD for the 6-month Treatment Period | 226 |
| Elagolix 200 mg BID Elagolix 200 mg BID for the 6-month Treatment Period | 229 |
| Total | 815 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Post-Treatment Follow-Up (PTFU) Period | Adverse Event | 0 | 2 | 1 |
| Post-Treatment Follow-Up (PTFU) Period | Consent Withdrawn by Subject | 6 | 3 | 13 |
| Post-Treatment Follow-Up (PTFU) Period | Exclusionary Medication Received | 3 | 0 | 0 |
| Post-Treatment Follow-Up (PTFU) Period | Lost to Follow-up | 0 | 0 | 2 |
| Post-Treatment Follow-Up (PTFU) Period | Other | 6 | 3 | 3 |
| Post-Treatment Follow-Up (PTFU) Period | Surgery/Invasive Intervention | 4 | 4 | 2 |
| Treatment Period | Adverse Event | 19 | 8 | 21 |
| Treatment Period | Consent Withdrawn by Subject | 17 | 12 | 7 |
| Treatment Period | Exclusionary Medication Received | 1 | 1 | 1 |
| Treatment Period | Lack of Efficacy | 11 | 2 | 2 |
| Treatment Period | Lost to Follow-up | 19 | 5 | 7 |
| Treatment Period | Other | 8 | 7 | 2 |
| Treatment Period | Pregnancy | 7 | 2 | 0 |
| Treatment Period | Subject Noncompliant | 4 | 9 | 5 |
| Treatment Period | Surgery/Invasive Intervention | 4 | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID | Total |
|---|---|---|---|---|
| Age, Continuous | 33.1 years STANDARD_DEVIATION 6.69 | 33.1 years STANDARD_DEVIATION 6.8 | 33.4 years STANDARD_DEVIATION 6.67 | 33.2 years STANDARD_DEVIATION 6.71 |
| Sex: Female, Male Female | 360 Participants | 226 Participants | 229 Participants | 815 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 | 0 / 360 | 1 / 226 | 0 / 229 |
| other Total, other adverse events | 158 / 360 | 128 / 226 | 162 / 229 |
| serious Total, serious adverse events | 12 / 360 | 12 / 226 | 5 / 229 |
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) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.
Time frame: At Month 3 of the Treatment Period
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) | 22.7 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) | 43.4 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) | 72.4 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) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.
Time frame: At Month 3 of Treatment Period
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) | 49.8 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP) | 57.8 percentage of participants |
p-value: 0.003Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
Change From Baseline to Each Month, Except Month 3, in NRS Scores
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Time frame: Baseline, Months 1, 2, 4, 5, 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 with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Month, Except Month 3, in NRS Scores | Month 5 | -1.58 units on a scale | Standard Error 0.105 |
| Placebo | Change From Baseline to Each Month, Except Month 3, in NRS Scores | Month 4 | -1.49 units on a scale | Standard Error 0.102 |
| Placebo | Change From Baseline to Each Month, Except Month 3, in NRS Scores | Month 1 | -0.78 units on a scale | Standard Error 0.074 |
| Placebo | Change From Baseline to Each Month, Except Month 3, in NRS Scores | Month 2 | -1.08 units on a scale | Standard Error 0.085 |
| Placebo | Change From Baseline to Each Month, Except Month 3, in NRS Scores | Month 6 | -1.60 units on a scale | Standard Error 0.11 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 3, in NRS Scores | Month 4 | -2.06 units on a scale | Standard Error 0.128 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 3, in NRS Scores | Month 1 | -1.06 units on a scale | Standard Error 0.094 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 3, in NRS Scores | Month 2 | -1.62 units on a scale | Standard Error 0.108 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 3, in NRS Scores | Month 5 | -2.19 units on a scale | Standard Error 0.131 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 3, in NRS Scores | Month 6 | -2.28 units on a scale | Standard Error 0.137 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 3, in NRS Scores | Month 6 | -2.87 units on a scale | Standard Error 0.136 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 3, in NRS Scores | Month 5 | -2.95 units on a scale | Standard Error 0.131 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 3, in NRS Scores | Month 1 | -1.23 units on a scale | Standard Error 0.093 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 3, in NRS Scores | Month 4 | -2.84 units on a scale | Standard Error 0.128 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 3, in NRS Scores | Month 2 | -2.04 units on a scale | Standard Error 0.107 |
Comparison: Month 1p-value: 0.0297.5% CI: [-0.55, -0.01]mixed-effects model
Comparison: Month 1p-value: <0.00197.5% CI: [-0.72, -0.18]mixed-effects model
Comparison: Month 2p-value: <0.00197.5% CI: [-0.85, -0.23]mixed-effects model
Comparison: Month 2p-value: <0.00197.5% CI: [-1.27, -0.65]mixed-effects model
Comparison: Month 4p-value: <0.00197.5% CI: [-0.95, -0.21]mixed-effects model
Comparison: Month 4p-value: <0.00197.5% CI: [-1.72, -0.99]mixed-effects model
Comparison: Month 5p-value: <0.00197.5% CI: [-0.99, -0.23]mixed-effects model
Comparison: Month 5p-value: <0.00197.5% CI: [-1.75, -1]mixed-effects model
Comparison: Month 6p-value: <0.00197.5% CI: [-1.08, -0.3]mixed-effects model
Comparison: Month 6p-value: <0.00197.5% CI: [-1.67, -0.89]mixed-effects model
Secondary
Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Time frame: Baseline, Months 1, 2, 4, 5, 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. Participants with an assessment at given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Month 5 | -0.39 units on a scale | Standard Error 0.046 |
| Placebo | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Month 4 | -0.35 units on a scale | Standard Error 0.045 |
| Placebo | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Month 1 | -0.21 units on a scale | Standard Error 0.037 |
| Placebo | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Month 2 | -0.25 units on a scale | Standard Error 0.038 |
| Placebo | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Month 6 | -0.36 units on a scale | Standard Error 0.049 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Month 4 | -0.40 units on a scale | Standard Error 0.055 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Month 1 | -0.19 units on a scale | Standard Error 0.046 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Month 2 | -0.32 units on a scale | Standard Error 0.047 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Month 5 | -0.41 units on a scale | Standard Error 0.056 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Month 6 | -0.42 units on a scale | Standard Error 0.058 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Month 6 | -0.69 units on a scale | Standard Error 0.058 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Month 5 | -0.70 units on a scale | Standard Error 0.056 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Month 1 | -0.26 units on a scale | Standard Error 0.045 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Month 4 | -0.63 units on a scale | Standard Error 0.055 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | Month 2 | -0.49 units on a scale | Standard Error 0.047 |
Comparison: Month 1p-value: 0.68897.5% CI: [-0.11, 0.16]mixed-effects model
Comparison: Month 1p-value: 0.43197.5% CI: [-0.18, 0.08]mixed-effects model
Comparison: Month 2p-value: 0.27797.5% CI: [-0.2, 0.07]mixed-effects model
Comparison: Month 2p-value: <0.00197.5% CI: [-0.37, -0.1]mixed-effects model
Comparison: Month 4p-value: 0.49497.5% CI: [-0.21, 0.11]mixed-effects model
Comparison: Month 4p-value: <0.00197.5% CI: [-0.43, -0.11]mixed-effects model
Comparison: Month 5p-value: 0.76597.5% CI: [-0.18, 0.14]mixed-effects model
Comparison: Month 5p-value: <0.00197.5% CI: [-0.47, -0.15]mixed-effects model
Comparison: Month 6p-value: 0.46897.5% CI: [-0.23, 0.12]mixed-effects model
Comparison: Month 6p-value: <0.00197.5% CI: [-0.5, -0.16]mixed-effects model
Secondary
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline (Prior to administering study drug), Months 1, 2, 3, 4, 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 with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Month 4 | -0.47 units on a scale | Standard Error 0.044 |
| Placebo | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Month 3 | -0.45 units on a scale | Standard Error 0.042 |
| Placebo | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Month 1 | -0.33 units on a scale | Standard Error 0.044 |
| Placebo | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Month 2 | -0.39 units on a scale | Standard Error 0.042 |
| Placebo | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Month 5 | -0.50 units on a scale | Standard Error 0.045 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Month 3 | -0.97 units on a scale | Standard Error 0.053 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Month 1 | -0.86 units on a scale | Standard Error 0.056 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Month 2 | -0.84 units on a scale | Standard Error 0.053 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Month 4 | -1.05 units on a scale | Standard Error 0.054 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Month 5 | -0.99 units on a scale | Standard Error 0.055 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Month 5 | -1.76 units on a scale | Standard Error 0.055 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Month 4 | -1.74 units on a scale | Standard Error 0.054 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Month 1 | -1.11 units on a scale | Standard Error 0.056 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Month 3 | -1.70 units on a scale | Standard Error 0.052 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | Month 2 | -1.67 units on a scale | Standard Error 0.053 |
Comparison: Month 1p-value: <0.00197.5% CI: [-0.69, -0.37]mixed-effects model
Comparison: Month 1p-value: <0.00197.5% CI: [-0.94, -0.62]mixed-effects model
Comparison: Month 2p-value: <0.00197.5% CI: [-0.6, -0.29]mixed-effects model
Comparison: Month 2p-value: <0.00197.5% CI: [-1.43, -1.12]mixed-effects model
Comparison: Month 3p-value: <0.00197.5% CI: [-0.68, -0.37]mixed-effects model
Comparison: Month 3p-value: <0.00197.5% CI: [-1.4, -1.09]mixed-effects model
Comparison: Month 4p-value: <0.00197.5% CI: [-0.73, -0.42]mixed-effects model
Comparison: Month 4p-value: <0.00197.5% CI: [-1.42, -1.11]mixed-effects model
Comparison: Month 5p-value: <0.00197.5% CI: [-0.65, -0.33]mixed-effects model
Comparison: Month 5p-value: <0.00197.5% CI: [-1.42, -1.1]mixed-effects model
Secondary
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Months 1, 2, 3, 4, 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 with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Month 4 | -0.45 units on a scale | Standard Error 0.033 |
| Placebo | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Month 3 | -0.39 units on a scale | Standard Error 0.031 |
| Placebo | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Month 1 | -0.22 units on a scale | Standard Error 0.025 |
| Placebo | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Month 2 | -0.34 units on a scale | Standard Error 0.027 |
| Placebo | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Month 5 | -0.48 units on a scale | Standard Error 0.034 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Month 3 | -0.50 units on a scale | Standard Error 0.039 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Month 1 | -0.24 units on a scale | Standard Error 0.031 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Month 2 | -0.41 units on a scale | Standard Error 0.034 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Month 4 | -0.54 units on a scale | Standard Error 0.041 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Month 5 | -0.58 units on a scale | Standard Error 0.042 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Month 5 | -0.81 units on a scale | Standard Error 0.042 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Month 4 | -0.78 units on a scale | Standard Error 0.041 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Month 1 | -0.31 units on a scale | Standard Error 0.031 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Month 3 | -0.69 units on a scale | Standard Error 0.039 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | Month 2 | -0.54 units on a scale | Standard Error 0.034 |
Comparison: Month 1p-value: 0.54997.5% CI: [-0.11, 0.07]mixed-effects model
Comparison: Month 1p-value: 0.0297.5% CI: [-0.18, 0]mixed-effects model
Comparison: Month 2p-value: 0.1197.5% CI: [-0.17, 0.03]mixed-effects model
Comparison: Month 2p-value: <0.00197.5% CI: [-0.3, -0.11]mixed-effects model
Comparison: Month 3p-value: 0.04197.5% CI: [-0.22, 0.01]mixed-effects model
Comparison: Month 3p-value: <0.00197.5% CI: [-0.41, -0.18]mixed-effects model
Comparison: Month 4p-value: 0.08197.5% CI: [-0.21, 0.03]mixed-effects model
Comparison: Month 4p-value: <0.00197.5% CI: [-0.45, -0.22]mixed-effects model
Comparison: Month 5p-value: 0.06297.5% CI: [-0.22, 0.02]mixed-effects model
Comparison: Month 5p-value: <0.00197.5% CI: [-0.46, -0.22]mixed-effects model
Secondary
Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
Time frame: Baseline, Months 1, 2, 4, 5
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 | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics | Month 1 | -0.20 number of pills | Standard Error 0.024 |
| Placebo | Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics | Month 2 | -0.25 number of pills | Standard Error 0.026 |
| Placebo | Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics | Month 4 | -0.29 number of pills | Standard Error 0.028 |
| Placebo | Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics | Month 5 | -0.32 number of pills | Standard Error 0.03 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics | Month 5 | -0.37 number of pills | Standard Error 0.038 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics | Month 1 | -0.29 number of pills | Standard Error 0.031 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics | Month 4 | -0.38 number of pills | Standard Error 0.035 |
| Elagolix 150 mg QD | Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics | Month 2 | -0.32 number of pills | Standard Error 0.033 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics | Month 5 | -0.54 number of pills | Standard Error 0.038 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics | Month 2 | -0.44 number of pills | Standard Error 0.033 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics | Month 4 | -0.51 number of pills | Standard Error 0.035 |
| Elagolix 200 mg BID | Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics | Month 1 | -0.32 number of pills | Standard Error 0.031 |
Comparison: Month 1p-value: 0.02997.5% CI: [-0.18, 0]mixed-effects model
Comparison: Month 1p-value: 0.00497.5% CI: [-0.2, -0.03]mixed-effects model
Comparison: Month 2p-value: 0.07697.5% CI: [-0.17, 0.02]mixed-effects model
Comparison: Month 2p-value: <0.00197.5% CI: [-0.28, -0.09]mixed-effects model
Comparison: Month 4p-value: 0.05897.5% CI: [-0.19, 0.02]mixed-effects model
Comparison: Month 4p-value: <0.00197.5% CI: [-0.32, -0.12]mixed-effects model
Comparison: Month 5p-value: 0.28497.5% CI: [-0.16, 0.06]mixed-effects model
Comparison: Month 5p-value: <0.00197.5% CI: [-0.33, -0.11]mixed-effects model
Secondary
Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 1 | -0.61 hours | Standard Error 0.267 |
| Placebo | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 2 | -0.82 hours | Standard Error 0.246 |
| Placebo | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 3 | -0.76 hours | Standard Error 0.268 |
| Placebo | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 4 | -0.55 hours | Standard Error 0.355 |
| Placebo | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 5 | -0.85 hours | Standard Error 0.209 |
| Placebo | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 6 | -0.76 hours | Standard Error 0.246 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 6 | -1.34 hours | Standard Error 0.303 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 1 | -1.62 hours | Standard Error 0.336 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 4 | -1.81 hours | Standard Error 0.434 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 5 | -1.58 hours | Standard Error 0.251 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 2 | -1.80 hours | Standard Error 0.312 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 3 | -1.43 hours | Standard Error 0.338 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 2 | -2.25 hours | Standard Error 0.312 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 3 | -2.17 hours | Standard Error 0.336 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 6 | -1.67 hours | Standard Error 0.296 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 4 | -2.03 hours | Standard Error 0.426 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 1 | -1.56 hours | Standard Error 0.341 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | Month 5 | -1.96 hours | Standard Error 0.251 |
Comparison: Month 1p-value: 0.01995% CI: [-1.86, -0.17]ANCOVA
Comparison: Month 1p-value: 0.02895% CI: [-1.8, -0.1]ANCOVA
Comparison: Month 2p-value: 0.01495% CI: [-1.76, -0.2]ANCOVA
Comparison: Month 2p-value: <0.00195% CI: [-2.22, -0.65]ANCOVA
Comparison: Month 3p-value: 0.12195% CI: [-1.52, 0.18]ANCOVA
Comparison: Month 3p-value: 0.00195% CI: [-2.25, -0.56]ANCOVA
Comparison: Month 4p-value: 0.02695% CI: [-2.35, -0.15]ANCOVA
Comparison: Month 4p-value: 0.00895% CI: [-2.57, -0.39]ANCOVA
Comparison: Month 5p-value: 0.02795% CI: [-1.37, -0.08]ANCOVA
Comparison: Month 5p-value: <0.00195% CI: [-1.75, -0.47]ANCOVA
Comparison: Month 6p-value: 0.14395% CI: [-1.34, 0.2]ANCOVA
Comparison: Month 6p-value: 0.01995% CI: [-1.67, -0.15]ANCOVA
Secondary
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 1 | -1.45 hours | Standard Error 0.261 |
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 2 | -1.63 hours | Standard Error 0.269 |
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 3 | -2.03 hours | Standard Error 0.274 |
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 4 | -2.21 hours | Standard Error 0.285 |
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 5 | -1.87 hours | Standard Error 0.284 |
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 6 | -1.89 hours | Standard Error 0.306 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 6 | -2.61 hours | Standard Error 0.368 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 1 | -2.08 hours | Standard Error 0.322 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 4 | -2.55 hours | Standard Error 0.353 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 5 | -2.99 hours | Standard Error 0.34 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 2 | -2.75 hours | Standard Error 0.327 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 3 | -2.95 hours | Standard Error 0.336 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 2 | -3.06 hours | Standard Error 0.33 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 3 | -2.94 hours | Standard Error 0.333 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 6 | -3.34 hours | Standard Error 0.336 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 4 | -3.54 hours | Standard Error 0.324 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 1 | -2.30 hours | Standard Error 0.315 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | Month 5 | -3.51 hours | Standard Error 0.334 |
Comparison: Month 1p-value: 0.13195% CI: [-1.44, 0.19]ANCOVA
Comparison: Month 1p-value: 0.03795% CI: [-1.65, -0.05]ANCOVA
Comparison: Month 2p-value: 0.00895% CI: [-1.96, -0.29]ANCOVA
Comparison: Month 2p-value: <0.00195% CI: [-2.27, -0.6]ANCOVA
Comparison: Month 3p-value: 0.03695% CI: [-1.76, -0.06]ANCOVA
Comparison: Month 3p-value: 0.03595% CI: [-1.76, -0.06]ANCOVA
Comparison: Month 4p-value: 0.45295% CI: [-1.23, 0.55]ANCOVA
Comparison: Month 4p-value: 0.00295% CI: [-2.18, -0.48]ANCOVA
Comparison: Month 5p-value: 0.01295% CI: [-1.99, -0.25]ANCOVA
Comparison: Month 5p-value: <0.00195% CI: [-2.5, -0.78]ANCOVA
Comparison: Month 6p-value: 0.1395% CI: [-1.67, 0.21]ANCOVA
Comparison: Month 6p-value: 0.00195% CI: [-2.34, -0.56]ANCOVA
Secondary
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 1 | -0.71 hours | Standard Error 0.266 |
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 2 | -1.06 hours | Standard Error 0.247 |
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 3 | -1.31 hours | Standard Error 0.318 |
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 4 | -1.26 hours | Standard Error 0.308 |
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 5 | -0.78 hours | Standard Error 0.406 |
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 6 | -1.44 hours | Standard Error 0.318 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 6 | -2.27 hours | Standard Error 0.383 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 1 | -0.69 hours | Standard Error 0.327 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 4 | -1.19 hours | Standard Error 0.383 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 5 | -1.68 hours | Standard Error 0.488 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 2 | -1.28 hours | Standard Error 0.301 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 3 | -0.88 hours | Standard Error 0.392 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 2 | -1.46 hours | Standard Error 0.305 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 3 | -1.46 hours | Standard Error 0.392 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 6 | -2.29 hours | Standard Error 0.351 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 4 | -2.19 hours | Standard Error 0.353 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 1 | -0.72 hours | Standard Error 0.319 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | Month 5 | -1.69 hours | Standard Error 0.482 |
Comparison: Month 1p-value: 0.97595% CI: [-0.81, 0.84]ANCOVA
Comparison: Month 1p-value: 0.96995% CI: [-0.83, 0.8]ANCOVA
Comparison: Month 2p-value: 0.56995% CI: [-0.99, 0.54]ANCOVA
Comparison: Month 2p-value: 0.31195% CI: [-1.17, 0.37]ANCOVA
Comparison: Month 3p-value: 0.39895% CI: [-0.56, 1.42]ANCOVA
Comparison: Month 3p-value: 0.76195% CI: [-1.15, 0.84]ANCOVA
Comparison: Month 4p-value: 0.87495% CI: [-0.89, 1.04]ANCOVA
Comparison: Month 4p-value: 0.04895% CI: [-1.85, -0.01]ANCOVA
Comparison: Month 5p-value: 0.1695% CI: [-2.14, 0.35]ANCOVA
Comparison: Month 5p-value: 0.15295% CI: [-2.14, 0.33]ANCOVA
Comparison: Month 6p-value: 0.09595% CI: [-1.81, 0.15]ANCOVA
Comparison: Month 6p-value: 0.07195% CI: [-1.79, 0.07]ANCOVA
Secondary
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 1 | -1.60 hours | Standard Error 0.623 |
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 2 | -3.43 hours | Standard Error 0.621 |
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 3 | -4.07 hours | Standard Error 0.633 |
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 4 | -4.58 hours | Standard Error 0.629 |
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 5 | -4.37 hours | Standard Error 0.618 |
| Placebo | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 6 | -6.11 hours | Standard Error 0.692 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 6 | -7.08 hours | Standard Error 0.869 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 1 | -2.94 hours | Standard Error 0.793 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 4 | -6.21 hours | Standard Error 0.774 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 5 | -6.66 hours | Standard Error 0.747 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 2 | -4.74 hours | Standard Error 0.79 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 3 | -6.10 hours | Standard Error 0.799 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 2 | -7.08 hours | Standard Error 0.792 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 3 | -7.27 hours | Standard Error 0.801 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 6 | -9.13 hours | Standard Error 0.845 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 4 | -9.35 hours | Standard Error 0.764 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 1 | -4.69 hours | Standard Error 0.798 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | Month 5 | -9.51 hours | Standard Error 0.753 |
Comparison: Month 1p-value: 0.18695% CI: [-3.32, 0.65]ANCOVA
Comparison: Month 1p-value: 0.00295% CI: [-5.08, -1.1]ANCOVA
Comparison: Month 2p-value: 0.19595% CI: [-3.28, 0.67]ANCOVA
Comparison: Month 2p-value: <0.00195% CI: [-5.63, -1.67]ANCOVA
Comparison: Month 3p-value: 0.04795% CI: [-4.03, -0.02]ANCOVA
Comparison: Month 3p-value: 0.00295% CI: [-5.21, -1.19]ANCOVA
Comparison: Month 4p-value: 0.10395% CI: [-3.59, 0.33]ANCOVA
Comparison: Month 4p-value: <0.00195% CI: [-6.72, -2.83]ANCOVA
Comparison: Month 5p-value: 0.01995% CI: [-4.2, -0.38]ANCOVA
Comparison: Month 5p-value: <0.00195% CI: [-7.06, -3.22]ANCOVA
Comparison: Month 6p-value: 0.38395% CI: [-3.16, 1.22]ANCOVA
Comparison: Month 6p-value: 0.00695% CI: [-5.17, -0.87]ANCOVA
Secondary
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 1 | -2.18 hours | Standard Error 0.39 |
| Placebo | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 2 | -2.71 hours | Standard Error 0.415 |
| Placebo | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 3 | -3.37 hours | Standard Error 0.448 |
| Placebo | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 4 | -3.46 hours | Standard Error 0.463 |
| Placebo | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 5 | -2.62 hours | Standard Error 0.549 |
| Placebo | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 6 | -3.30 hours | Standard Error 0.497 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 6 | -4.89 hours | Standard Error 0.598 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 1 | -2.78 hours | Standard Error 0.482 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 4 | -3.77 hours | Standard Error 0.574 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 5 | -4.67 hours | Standard Error 0.657 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 2 | -4.04 hours | Standard Error 0.503 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 3 | -3.84 hours | Standard Error 0.551 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 2 | -4.48 hours | Standard Error 0.508 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 3 | -4.34 hours | Standard Error 0.546 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 6 | -5.58 hours | Standard Error 0.546 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 4 | -5.64 hours | Standard Error 0.528 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 1 | -2.89 hours | Standard Error 0.47 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | Month 5 | -5.16 hours | Standard Error 0.646 |
Comparison: Month 1p-value: 0.33595% CI: [-1.81, 0.62]ANCOVA
Comparison: Month 1p-value: 0.24295% CI: [-1.91, 0.48]ANCOVA
Comparison: Month 2p-value: 0.04295% CI: [-2.61, -0.05]ANCOVA
Comparison: Month 2p-value: 0.00795% CI: [-3.06, -0.48]ANCOVA
Comparison: Month 3p-value: 0.50395% CI: [-1.87, 0.92]ANCOVA
Comparison: Month 3p-value: 0.16995% CI: [-2.36, 0.41]ANCOVA
Comparison: Month 4p-value: 0.67595% CI: [-1.76, 1.14]ANCOVA
Comparison: Month 4p-value: 0.00295% CI: [-3.55, -0.79]ANCOVA
Comparison: Month 5p-value: 0.01795% CI: [-3.72, -0.36]ANCOVA
Comparison: Month 5p-value: 0.00395% CI: [-4.21, -0.87]ANCOVA
Comparison: Month 6p-value: 0.04295% CI: [-3.12, -0.06]ANCOVA
Comparison: Month 6p-value: 0.00295% CI: [-3.73, -0.83]ANCOVA
Secondary
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 2 | -4.25 hours | Standard Error 0.674 |
| Placebo | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 5 | -5.32 hours | Standard Error 0.701 |
| Placebo | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 4 | -4.87 hours | Standard Error 0.721 |
| Placebo | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 1 | -2.19 hours | Standard Error 0.686 |
| Placebo | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 6 | -6.73 hours | Standard Error 0.793 |
| Placebo | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 3 | -4.66 hours | Standard Error 0.708 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 4 | -7.58 hours | Standard Error 0.879 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 2 | -6.27 hours | Standard Error 0.856 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 3 | -7.31 hours | Standard Error 0.891 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 1 | -4.02 hours | Standard Error 0.865 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 5 | -7.81 hours | Standard Error 0.839 |
| Elagolix 150 mg QD | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 6 | -8.01 hours | Standard Error 0.98 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 6 | -10.70 hours | Standard Error 0.953 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 5 | -11.15 hours | Standard Error 0.839 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 2 | -9.36 hours | Standard Error 0.854 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 1 | -5.91 hours | Standard Error 0.875 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 4 | -11.14 hours | Standard Error 0.862 |
| Elagolix 200 mg BID | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | Month 3 | -9.30 hours | Standard Error 0.886 |
Comparison: Month 1p-value: 0.09895% CI: [-4.01, 0.34]ANCOVA
Comparison: Month 1p-value: <0.00195% CI: [-5.91, -1.54]ANCOVA
Comparison: Month 2p-value: 0.06595% CI: [-4.16, 0.13]ANCOVA
Comparison: Month 2p-value: <0.00195% CI: [-7.24, -2.96]ANCOVA
Comparison: Month 3p-value: 0.0295% CI: [-4.89, -0.41]ANCOVA
Comparison: Month 3p-value: <0.00195% CI: [-6.87, -2.41]ANCOVA
Comparison: Month 4p-value: 0.01795% CI: [-4.95, -0.48]ANCOVA
Comparison: Month 4p-value: <0.00195% CI: [-8.48, -4.06]ANCOVA
Comparison: Month 5p-value: 0.02395% CI: [-4.64, -0.34]ANCOVA
Comparison: Month 5p-value: <0.00195% CI: [-7.98, -3.68]ANCOVA
Comparison: Month 6p-value: 0.31195% CI: [-3.77, 1.2]ANCOVA
Comparison: Month 6p-value: 0.00195% CI: [-6.42, -1.53]ANCOVA
Secondary
Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time frame: Baseline, Months 1, 3, 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 with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores | Month 3 | -19.29 units on a scale | Standard Error 1.103 |
| Placebo | Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores | Month 1 | -15.20 units on a scale | Standard Error 0.971 |
| Placebo | Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores | Month 6 | -19.53 units on a scale | Standard Error 1.34 |
| Elagolix 150 mg QD | Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores | Month 3 | -26.62 units on a scale | Standard Error 1.349 |
| Elagolix 150 mg QD | Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores | Month 1 | -19.40 units on a scale | Standard Error 1.21 |
| Elagolix 150 mg QD | Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores | Month 6 | -28.23 units on a scale | Standard Error 1.601 |
| Elagolix 200 mg BID | Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores | Month 1 | -22.75 units on a scale | Standard Error 1.211 |
| Elagolix 200 mg BID | Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores | Month 6 | -36.44 units on a scale | Standard Error 1.572 |
| Elagolix 200 mg BID | Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores | Month 3 | -34.72 units on a scale | Standard Error 1.36 |
Comparison: Month 1p-value: 0.00795% CI: [-7.25, -1.16]ANCOVA
Comparison: Month 1p-value: <0.00195% CI: [-10.6, -4.5]ANCOVA
Comparison: Month 3p-value: <0.00195% CI: [-10.75, -3.91]ANCOVA
Comparison: Month 3p-value: <0.00195% CI: [-18.87, -11.99]ANCOVA
Comparison: Month 6p-value: <0.00195% CI: [-12.81, -4.6]ANCOVA
Comparison: Month 6p-value: <0.00195% CI: [-20.98, -12.86]ANCOVA
Secondary
Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time frame: Baseline, Months 1, 3, 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 with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores | Month 3 | -14.51 units on a scale | Standard Error 1.502 |
| Placebo | Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores | Month 1 | -9.89 units on a scale | Standard Error 1.229 |
| Placebo | Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores | Month 6 | -14.14 units on a scale | Standard Error 1.891 |
| Elagolix 150 mg QD | Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores | Month 3 | -17.26 units on a scale | Standard Error 1.895 |
| Elagolix 150 mg QD | Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores | Month 1 | -10.46 units on a scale | Standard Error 1.51 |
| Elagolix 150 mg QD | Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores | Month 6 | -17.07 units on a scale | Standard Error 2.215 |
| Elagolix 200 mg BID | Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores | Month 1 | -14.29 units on a scale | Standard Error 1.484 |
| Elagolix 200 mg BID | Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores | Month 6 | -28.24 units on a scale | Standard Error 2.095 |
| Elagolix 200 mg BID | Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores | Month 3 | -25.20 units on a scale | Standard Error 1.848 |
Comparison: Month 1p-value: 0.7795% CI: [-4.4, 3.26]ANCOVA
Comparison: Month 1p-value: 0.02395% CI: [-8.19, -0.61]ANCOVA
Comparison: Month 3p-value: 0.25795% CI: [-7.5, 2.01]ANCOVA
Comparison: Month 3p-value: <0.00195% CI: [-15.37, -6.01]ANCOVA
Comparison: Month 6p-value: 0.31595% CI: [-8.66, 2.8]ANCOVA
Comparison: Month 6p-value: <0.00195% CI: [-19.64, -8.55]ANCOVA
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 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
Time frame: Baseline, Month 3 of Treatment Period
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 | -0.31 number of pills | Standard Error 0.028 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.36 number of pills | Standard Error 0.035 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.49 number of pills | Standard Error 0.034 |
Comparison: Ranked secondary efficacy endpoint 4 of 7.p-value: 0.26mixed-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) | -0.30 units on a scale | Standard Error 0.042 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in Dyspareunia (DYSP) | -0.39 units on a scale | Standard Error 0.052 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in Dyspareunia (DYSP) | -0.60 units on a scale | Standard Error 0.052 |
Comparison: Ranked secondary efficacy endpoint 6 of 7.p-value: 0.172mixed-effects model
Comparison: Ranked secondary efficacy endpoint 6 of 7.p-value: <0.001mixed-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 | -1.33 units on a scale | Standard Error 0.097 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores | -1.90 units on a scale | Standard Error 0.122 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores | -2.55 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 Use of Narcotic Class of Medication (Opioids)
Permitted country-specific rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen. Assessment was based on average pill counts.
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) | -0.12 number of pills | Standard Error 0.019 |
| Elagolix 150 mg QD | Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids) | -0.12 number of pills | Standard Error 0.024 |
| Elagolix 200 mg BID | Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids) | -0.21 number of pills | Standard Error 0.023 |
Comparison: Ranked secondary efficacy endpoint 7 of 7.p-value: 0.968mixed-effects model
Comparison: Ranked secondary efficacy endpoint 7 of 7.p-value: 0.007mixed-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 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
Time frame: Baseline, Month 6 of Treatment Period
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 | -0.32 number of pills | Standard Error 0.03 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.40 number of pills | Standard Error 0.038 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics | -0.52 number of pills | Standard Error 0.037 |
Comparison: Ranked secondary efficacy endpoint 5 of 7.p-value: 0.088mixed-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 | -0.52 units on a scale | Standard Error 0.047 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in DYS | -1.06 units on a scale | Standard Error 0.057 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in DYS | -1.65 units on a scale | Standard Error 0.057 |
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 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 | -0.48 units on a scale | Standard Error 0.035 |
| Elagolix 150 mg QD | Change From Baseline to Month 6 in NMPP | -0.63 units on a scale | Standard Error 0.044 |
| Elagolix 200 mg BID | Change From Baseline to Month 6 in NMPP | -0.80 units on a scale | Standard Error 0.044 |
Comparison: Ranked secondary efficacy endpoint 3 of 7.p-value: 0.009mixed-effects model
Comparison: Ranked secondary efficacy endpoint 3 of 7.p-value: <0.001mixed-effects model
Secondary
Number of Days of Hospitalization
This is assessed using HRUQ.
Time frame: Up to 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. Includes participants who were hospitalized during the Treatment Period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Days of Hospitalization | 3.2 days | Standard Deviation 2.18 |
| Elagolix 150 mg QD | Number of Days of Hospitalization | 3.3 days | Standard Deviation 3.52 |
| Elagolix 200 mg BID | Number of Days of Hospitalization | 2.2 days | Standard Deviation 1.27 |
Secondary
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type
This is assessed using HRUQ.
Time frame: Up to 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Physical Examination | 18 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Electrocardiogram | 4 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | All Categories | 37 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Pelvic Exam | 3 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 | Biopsy | 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 | Histological Exam | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | X-Ray | 12 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 | Intrauterine Insemination | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Urine Test | 8 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 | In Vitro Fertilization | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Blood Draw | 12 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 | Angiography | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Ultrasound | 9 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Colposcopy | 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 | Transfusion | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Consultation | 1 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 | Therapeutic Laparoscopy | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | CT Scan | 7 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 | Surgery for Adhesions | 0 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 | Other (Not Specified) | 13 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Urine Test | 7 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | All Categories | 28 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 | 1 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 | 1 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Blood Draw | 13 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Colposcopy | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Consultation | 5 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | CT Scan | 10 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Diagnostic Laparoscopy | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Electrocardiogram | 2 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 | 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 | 2 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 | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Physical Examination | 16 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 | Vaginal Hysterectomy | 0 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | X-Ray | 11 Participants |
| Elagolix 150 mg QD | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Other (Not Specified) | 4 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 | Pelvic Exam | 2 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Diagnostic Laparoscopy | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | All Categories | 22 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Physical Examination | 14 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | CT Scan | 5 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 | Surgery for Adhesions | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Consultation | 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 | Therapeutic Laparoscopy | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Colposcopy | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Other (Not Specified) | 4 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 | Blood Draw | 4 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | X-Ray | 7 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 | Ultrasound | 2 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 | Intrauterine Insemination | 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 | Laparotomy | 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 | 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 | Endometrial Ablation | 0 Participants |
| Elagolix 200 mg BID | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Urine Test | 6 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 | Electrocardiogram | 0 Participants |
Secondary
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period
This is assessed using Health Resource Utilization Questionnaire (HRUQ).
Time frame: Months 1, 2, 3, 4, 5, 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Baseline | 99 Participants |
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 1 | 93 Participants |
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 2 | 72 Participants |
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 3 | 54 Participants |
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 4 | 62 Participants |
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 5 | 56 Participants |
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 6 | 39 Participants |
| Placebo | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Overall | 201 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 2 | 42 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 6 | 27 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 3 | 46 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 4 | 39 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 5 | 31 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Baseline | 53 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 1 | 47 Participants |
| Elagolix 150 mg QD | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Overall | 124 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 2 | 43 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 1 | 54 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Baseline | 57 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 3 | 40 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 6 | 25 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 5 | 30 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Month 4 | 43 Participants |
| Elagolix 200 mg BID | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Overall | 131 Participants |
Secondary
Patient Global Impression of Change (PGIC) Questionnaire
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Time frame: Months 1, 2, 3, 4, 5, 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. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Patient Global Impression of Change (PGIC) Questionnaire | Month 1 | 3.49 units on a scale | Standard Error 0.062 |
| Placebo | Patient Global Impression of Change (PGIC) Questionnaire | Month 2 | 3.24 units on a scale | Standard Error 0.063 |
| Placebo | Patient Global Impression of Change (PGIC) Questionnaire | Month 3 | 3.16 units on a scale | Standard Error 0.066 |
| Placebo | Patient Global Impression of Change (PGIC) Questionnaire | Month 4 | 3.19 units on a scale | Standard Error 0.068 |
| Placebo | Patient Global Impression of Change (PGIC) Questionnaire | Month 5 | 3.23 units on a scale | Standard Error 0.07 |
| Placebo | Patient Global Impression of Change (PGIC) Questionnaire | Month 6 | 3.22 units on a scale | Standard Error 0.073 |
| Elagolix 150 mg QD | Patient Global Impression of Change (PGIC) Questionnaire | Month 6 | 2.50 units on a scale | Standard Error 0.09 |
| Elagolix 150 mg QD | Patient Global Impression of Change (PGIC) Questionnaire | Month 1 | 3.12 units on a scale | Standard Error 0.078 |
| Elagolix 150 mg QD | Patient Global Impression of Change (PGIC) Questionnaire | Month 4 | 2.56 units on a scale | Standard Error 0.085 |
| Elagolix 150 mg QD | Patient Global Impression of Change (PGIC) Questionnaire | Month 5 | 2.43 units on a scale | Standard Error 0.088 |
| Elagolix 150 mg QD | Patient Global Impression of Change (PGIC) Questionnaire | Month 2 | 2.62 units on a scale | Standard Error 0.079 |
| Elagolix 150 mg QD | Patient Global Impression of Change (PGIC) Questionnaire | Month 3 | 2.53 units on a scale | Standard Error 0.083 |
| Elagolix 200 mg BID | Patient Global Impression of Change (PGIC) Questionnaire | Month 2 | 2.15 units on a scale | Standard Error 0.079 |
| Elagolix 200 mg BID | Patient Global Impression of Change (PGIC) Questionnaire | Month 3 | 2.02 units on a scale | Standard Error 0.083 |
| Elagolix 200 mg BID | Patient Global Impression of Change (PGIC) Questionnaire | Month 6 | 1.95 units on a scale | Standard Error 0.091 |
| Elagolix 200 mg BID | Patient Global Impression of Change (PGIC) Questionnaire | Month 4 | 1.97 units on a scale | Standard Error 0.085 |
| Elagolix 200 mg BID | Patient Global Impression of Change (PGIC) Questionnaire | Month 1 | 2.84 units on a scale | Standard Error 0.077 |
| Elagolix 200 mg BID | Patient Global Impression of Change (PGIC) Questionnaire | Month 5 | 1.98 units on a scale | Standard Error 0.088 |
Comparison: Month 1p-value: <0.00195% CI: [-0.56, -0.18]ANOVA
Comparison: Month 1p-value: <0.00195% CI: [-0.84, -0.46]ANOVA
Comparison: Month 2p-value: <0.00195% CI: [-0.82, -0.42]ANOVA
Comparison: Month 2p-value: <0.00195% CI: [-1.29, -0.89]ANOVA
Comparison: Month 3p-value: <0.00195% CI: [-0.84, -0.42]ANOVA
Comparison: Month 3p-value: <0.00195% CI: [-1.35, -0.93]ANOVA
Comparison: Month 4p-value: <0.00195% CI: [-0.84, -0.41]ANOVA
Comparison: Month 4p-value: <0.00195% CI: [-1.43, -1]ANOVA
Comparison: Month 5p-value: <0.00195% CI: [-1.01, -0.57]ANOVA
Comparison: Month 5p-value: <0.00195% CI: [-1.47, -1.02]ANOVA
Comparison: Month 6p-value: <0.00195% CI: [-0.95, -0.49]ANOVA
Comparison: Month 6p-value: <0.00195% CI: [-1.5, -1.04]ANOVA
Secondary
Percentage of Responders at Each Month for DYSP
The DYSP pain scale ranged from 0 (absent) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.29 or greater from Baseline in DYSP as well as no increased rescue analgesic use for endometriosis-associated pain.
Time frame: Months 1, 2, 3, 4, 5, 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. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Responders at Each Month for DYSP | Month 1 | 33.3 percentage of participants |
| Placebo | Percentage of Responders at Each Month for DYSP | Month 2 | 33.2 percentage of participants |
| Placebo | Percentage of Responders at Each Month for DYSP | Month 3 | 39.5 percentage of participants |
| Placebo | Percentage of Responders at Each Month for DYSP | Month 4 | 38.5 percentage of participants |
| Placebo | Percentage of Responders at Each Month for DYSP | Month 5 | 37.4 percentage of participants |
| Placebo | Percentage of Responders at Each Month for DYSP | Month 6 | 39.4 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Each Month for DYSP | Month 6 | 39.9 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Each Month for DYSP | Month 1 | 33.8 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Each Month for DYSP | Month 4 | 41.3 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Each Month for DYSP | Month 5 | 42.8 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Each Month for DYSP | Month 2 | 39.9 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders at Each Month for DYSP | Month 3 | 44.0 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Each Month for DYSP | Month 2 | 47.4 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Each Month for DYSP | Month 3 | 53.7 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Each Month for DYSP | Month 6 | 55.8 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Each Month for DYSP | Month 4 | 59.8 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Each Month for DYSP | Month 1 | 35.1 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders at Each Month for DYSP | Month 5 | 58.1 percentage of participants |
Comparison: Month 1p-value: 0.90197.5% CI: [0.624, 1.693]Regression, Logistic
Comparison: Month 1p-value: 0.6597.5% CI: [0.68, 1.789]Regression, Logistic
Comparison: Month 2p-value: 0.15497.5% CI: [0.841, 2.17]Regression, Logistic
Comparison: Month 2p-value: 0.00397.5% CI: [1.175, 2.979]Regression, Logistic
Comparison: Month 3p-value: 0.29497.5% CI: [0.776, 2.013]Regression, Logistic
Comparison: Month 3p-value: 0.00397.5% CI: [1.163, 2.989]Regression, Logistic
Comparison: Month 4p-value: 0.52197.5% CI: [0.713, 1.839]Regression, Logistic
Comparison: Month 4p-value: <0.00197.5% CI: [1.544, 3.963]Regression, Logistic
Comparison: Month 5p-value: 0.2797.5% CI: [0.787, 2.023]Regression, Logistic
Comparison: Month 5p-value: <0.00197.5% CI: [1.5, 3.891]Regression, Logistic
Comparison: Month 6p-value: 0.95397.5% CI: [0.631, 1.624]Regression, Logistic
Comparison: Month 6p-value: <0.00197.5% CI: [1.253, 3.183]Regression, Logistic
Secondary
Percentage of Responders for Each Month, Except Month 3, in DYS
The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.
Time frame: Months 1, 2, 4, 5, 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. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Responders for Each Month, Except Month 3, in DYS | Month 5 | 23.7 percentage of participants |
| Placebo | Percentage of Responders for Each Month, Except Month 3, in DYS | Month 4 | 21.2 percentage of participants |
| Placebo | Percentage of Responders for Each Month, Except Month 3, in DYS | Month 1 | 17.3 percentage of participants |
| Placebo | Percentage of Responders for Each Month, Except Month 3, in DYS | Month 2 | 19.0 percentage of participants |
| Placebo | Percentage of Responders for Each Month, Except Month 3, in DYS | Month 6 | 25.4 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders for Each Month, Except Month 3, in DYS | Month 4 | 45.9 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders for Each Month, Except Month 3, in DYS | Month 1 | 33.0 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders for Each Month, Except Month 3, in DYS | Month 2 | 39.4 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders for Each Month, Except Month 3, in DYS | Month 5 | 44.1 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders for Each Month, Except Month 3, in DYS | Month 6 | 46.2 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders for Each Month, Except Month 3, in DYS | Month 6 | 76.9 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders for Each Month, Except Month 3, in DYS | Month 5 | 80.7 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders for Each Month, Except Month 3, in DYS | Month 1 | 46.2 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders for Each Month, Except Month 3, in DYS | Month 4 | 79.8 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders for Each Month, Except Month 3, in DYS | Month 2 | 69.8 percentage of participants |
Comparison: Month 1p-value: <0.00197.5% CI: [1.507, 3.697]Regression, Logistic
Comparison: Month 1p-value: <0.00197.5% CI: [2.707, 6.469]Regression, Logistic
Comparison: Month 2p-value: <0.00197.5% CI: [1.811, 4.312]Regression, Logistic
Comparison: Month 2p-value: <0.00197.5% CI: [6.615, 16.282]Regression, Logistic
Comparison: Month 4p-value: <0.00197.5% CI: [2.084, 4.845]Regression, Logistic
Comparison: Month 4p-value: <0.00197.5% CI: [9.429, 24.554]Regression, Logistic
Comparison: Month 5p-value: <0.00197.5% CI: [1.683, 3.859]Regression, Logistic
Comparison: Month 5p-value: <0.00197.5% CI: [8.716, 22.664]Regression, Logistic
Comparison: Month 6p-value: <0.00197.5% CI: [1.685, 3.816]Regression, Logistic
Comparison: Month 6p-value: <0.00197.5% CI: [6.434, 15.874]Regression, Logistic
Secondary
Percentage of Responders for Each Month, Except Month 3, in NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.
Time frame: Months 1, 2, 4, 5, 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. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Responders for Each Month, Except Month 3, in NMPP | Month 2 | 32.1 percentage of participants |
| Placebo | Percentage of Responders for Each Month, Except Month 3, in NMPP | Month 1 | 23.5 percentage of participants |
| Placebo | Percentage of Responders for Each Month, Except Month 3, in NMPP | Month 5 | 39.8 percentage of participants |
| Placebo | Percentage of Responders for Each Month, Except Month 3, in NMPP | Month 6 | 40.6 percentage of participants |
| Placebo | Percentage of Responders for Each Month, Except Month 3, in NMPP | Month 4 | 38.7 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders for Each Month, Except Month 3, in NMPP | Month 1 | 27.6 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders for Each Month, Except Month 3, in NMPP | Month 5 | 50.5 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders for Each Month, Except Month 3, in NMPP | Month 6 | 51.6 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders for Each Month, Except Month 3, in NMPP | Month 2 | 39.8 percentage of participants |
| Elagolix 150 mg QD | Percentage of Responders for Each Month, Except Month 3, in NMPP | Month 4 | 51.4 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders for Each Month, Except Month 3, in NMPP | Month 4 | 63.2 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders for Each Month, Except Month 3, in NMPP | Month 2 | 50.7 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders for Each Month, Except Month 3, in NMPP | Month 5 | 63.2 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders for Each Month, Except Month 3, in NMPP | Month 1 | 29.3 percentage of participants |
| Elagolix 200 mg BID | Percentage of Responders for Each Month, Except Month 3, in NMPP | Month 6 | 62.2 percentage of participants |
Comparison: Month 1p-value: 0.37697.5% CI: [0.765, 1.855]Regression, Logistic
Comparison: Month 1p-value: 0.10197.5% CI: [0.89, 2.127]Regression, Logistic
Comparison: Month 2p-value: 0.08897.5% CI: [0.909, 2.029]Regression, Logistic
Comparison: Month 2p-value: <0.00197.5% CI: [1.488, 3.278]Regression, Logistic
Comparison: Month 4p-value: 0.00397.5% CI: [1.136, 2.477]Regression, Logistic
Comparison: Month 4p-value: <0.00197.5% CI: [1.832, 4.044]Regression, Logistic
Comparison: Month 5p-value: 0.01397.5% CI: [1.042, 2.267]Regression, Logistic
Comparison: Month 5p-value: <0.00197.5% CI: [1.75, 3.857]Regression, Logistic
Comparison: Month 6p-value: 0.0197.5% CI: [1.062, 2.306]Regression, Logistic
Comparison: Month 6p-value: <0.00197.5% CI: [1.63, 3.57]Regression, Logistic
Secondary
Percent Change From Baseline to Each Month in Mean Pain Score for DYS
The DYS pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 1 | -14.36 percentage change | Standard Error 2.268 |
| Placebo | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 2 | -17.36 percentage change | Standard Error 2.087 |
| Placebo | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 3 | -20.58 percentage change | Standard Error 2.031 |
| Placebo | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 4 | -21.55 percentage change | Standard Error 2.104 |
| Placebo | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 5 | -22.63 percentage change | Standard Error 2.159 |
| Placebo | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 6 | -23.81 percentage change | Standard Error 2.225 |
| Elagolix 150 mg QD | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 6 | -49.70 percentage change | Standard Error 2.738 |
| Elagolix 150 mg QD | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 1 | -39.67 percentage change | Standard Error 2.886 |
| Elagolix 150 mg QD | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 4 | -48.52 percentage change | Standard Error 2.601 |
| Elagolix 150 mg QD | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 5 | -45.99 percentage change | Standard Error 2.664 |
| Elagolix 150 mg QD | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 2 | -39.26 percentage change | Standard Error 2.629 |
| Elagolix 150 mg QD | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 3 | -45.73 percentage change | Standard Error 2.528 |
| Elagolix 200 mg BID | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 2 | -80.68 percentage change | Standard Error 2.638 |
| Elagolix 200 mg BID | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 3 | -82.52 percentage change | Standard Error 2.513 |
| Elagolix 200 mg BID | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 6 | -80.43 percentage change | Standard Error 2.727 |
| Elagolix 200 mg BID | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 4 | -83.92 percentage change | Standard Error 2.599 |
| Elagolix 200 mg BID | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 1 | -53.68 percentage change | Standard Error 2.867 |
| Elagolix 200 mg BID | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | Month 5 | -85.53 percentage change | Standard Error 2.65 |
Comparison: Month 1p-value: <0.00197.5% CI: [-33.55, -17.07]mixed-effects model
Comparison: Month 1p-value: <0.00197.5% CI: [-47.53, -31.11]mixed-effects model
Comparison: Month 2p-value: <0.00197.5% CI: [-29.44, -14.36]mixed-effects model
Comparison: Month 2p-value: <0.00197.5% CI: [-70.87, -55.76]mixed-effects model
Comparison: Month 3p-value: <0.00197.5% CI: [-32.43, -17.88]mixed-effects model
Comparison: Month 3p-value: <0.00197.5% CI: [-69.2, -54.68]mixed-effects model
Comparison: Month 4p-value: <0.00197.5% CI: [-34.48, -19.46]mixed-effects model
Comparison: Month 4p-value: <0.00197.5% CI: [-69.89, -54.86]mixed-effects model
Comparison: Month 5p-value: <0.00197.5% CI: [-31.06, -15.66]mixed-effects model
Comparison: Month 5p-value: <0.00197.5% CI: [-70.58, -55.22]mixed-effects model
Comparison: Month 6p-value: <0.00197.5% CI: [-33.81, -17.97]mixed-effects model
Comparison: Month 6p-value: <0.00197.5% CI: [-64.53, -48.7]mixed-effects model
Secondary
Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time frame: Baseline, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 1 | -12.43 percentage change | Standard Deviation 1.814 |
| Placebo | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 2 | -21.13 percentage change | Standard Deviation 1.836 |
| Placebo | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 3 | -25.78 percentage change | Standard Deviation 2.104 |
| Placebo | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 4 | -29.94 percentage change | Standard Deviation 2.17 |
| Placebo | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 5 | -31.96 percentage change | Standard Deviation 2.214 |
| Placebo | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 6 | -31.25 percentage change | Standard Deviation 2.349 |
| Elagolix 150 mg QD | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 6 | -42.09 percentage change | Standard Deviation 2.914 |
| Elagolix 150 mg QD | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 1 | -15.47 percentage change | Standard Deviation 2.313 |
| Elagolix 150 mg QD | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 4 | -36.19 percentage change | Standard Deviation 2.711 |
| Elagolix 150 mg QD | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 5 | -38.17 percentage change | Standard Deviation 2.756 |
| Elagolix 150 mg QD | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 2 | -26.30 percentage change | Standard Deviation 2.326 |
| Elagolix 150 mg QD | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 3 | -32.63 percentage change | Standard Deviation 2.643 |
| Elagolix 200 mg BID | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 2 | -34.32 percentage change | Standard Deviation 2.316 |
| Elagolix 200 mg BID | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 3 | -44.83 percentage change | Standard Deviation 2.625 |
| Elagolix 200 mg BID | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 6 | -52.42 percentage change | Standard Deviation 2.897 |
| Elagolix 200 mg BID | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 4 | -51.52 percentage change | Standard Deviation 2.696 |
| Elagolix 200 mg BID | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 1 | -18.86 percentage change | Standard Deviation 2.288 |
| Elagolix 200 mg BID | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | Month 5 | -53.61 percentage change | Standard Deviation 2.737 |
Comparison: Month 6p-value: 0.00497.5% CI: [-19.24, -2.43]mixed-effects model
Comparison: Month 6p-value: <0.00197.5% CI: [-29.54, -12.79]mixed-effects model
Comparison: Month 1p-value: 0.30197.5% CI: [-9.64, 3.56]mixed-effects model
Comparison: Month 1p-value: 0.02897.5% CI: [-12.99, 0.13]mixed-effects model
Comparison: Month 2p-value: 0.08297.5% CI: [-11.82, 1.49]mixed-effects model
Comparison: Month 2p-value: <0.00197.5% CI: [-19.83, -6.55]mixed-effects model
Comparison: Month 3p-value: 0.04397.5% CI: [-14.43, 0.75]mixed-effects model
Comparison: Month 3p-value: <0.00197.5% CI: [-26.61, -11.49]mixed-effects model
Comparison: Month 4p-value: 0.07297.5% CI: [-14.05, 1.55]mixed-effects model
Comparison: Month 4p-value: <0.00197.5% CI: [-29.35, -13.81]mixed-effects model
Comparison: Month 5p-value: 0.0897.5% CI: [-14.15, 1.73]mixed-effects model
Comparison: Month 5p-value: <0.00197.5% CI: [-29.56, -13.75]mixed-effects model