Trial Outcomes & Findings for A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain (NCT NCT01620528)

Results Overview

The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

872 participants

Primary outcome timeframe

At Month 3 of the Treatment Period

Results posted on

2018-09-18

Participant Flow

After completing the Treatment Period, participants (who were eligible and provided consent) entered a separate continuous-use extension study (Study M12-667, NCT01760954).

Participants who prematurely discontinued from study drug and those who declined to participate in or who did not qualify for the continuous-use extension study, except for those who became pregnant, could elect to enter the Post-Treatment Follow-Up (PTFU) Period within this study for up to 12 additional months.

Participant milestones

Participant milestones
Measure	Placebo Placebo twice daily (BID) for the 6-month Treatment Period	Elagolix 150 mg QD Elagolix 150 mg once daily (QD) for the 6-month Treatment Period	Elagolix 200 mg BID Elagolix 200 mg BID for the 6-month Treatment Period
Treatment Period STARTED	374	249	249
Treatment Period COMPLETED	274	196	183
Treatment Period NOT COMPLETED	100	53	66
Post-Treatment Follow-Up Period STARTED	68	48	51
Post-Treatment Follow-Up Period Completed PTFU Month 6	46	26	18
Post-Treatment Follow-Up Period Completed PTFU Month 12	2	5	19
Post-Treatment Follow-Up Period COMPLETED	48	31	37
Post-Treatment Follow-Up Period NOT COMPLETED	20	17	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo twice daily (BID) for the 6-month Treatment Period	Elagolix 150 mg QD Elagolix 150 mg once daily (QD) for the 6-month Treatment Period	Elagolix 200 mg BID Elagolix 200 mg BID for the 6-month Treatment Period
Treatment Period Did Not Receive Study Drug	0	0	1
Treatment Period Withdrawal by Subject	35	21	16
Treatment Period Adverse Event	17	13	21
Treatment Period Lost to Follow-up	16	8	14
Treatment Period Other	9	5	7
Treatment Period Subject Noncompliant	11	2	2
Treatment Period Pregnancy	7	2	2
Treatment Period Surgery/Invasive Intervention	5	1	3
Treatment Period Exclusionary Medication Received	0	1	0
Post-Treatment Follow-Up Period Withdrawal by Subject	3	7	3
Post-Treatment Follow-Up Period Lost to Follow-up	3	2	4
Post-Treatment Follow-Up Period Exclusionary Medication Received	0	1	1
Post-Treatment Follow-Up Period Surgery/Invasive Intervention	8	3	4
Post-Treatment Follow-Up Period Other	6	4	2

Baseline Characteristics

A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=374 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=249 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=248 Participants Elagolix 200 mg BID for the 6-month Treatment Period	Total n=871 Participants Total of all reporting groups
Age, Continuous	31.7 years STANDARD_DEVIATION 6.35 • n=5 Participants	31.5 years STANDARD_DEVIATION 5.99 • n=7 Participants	31.2 years STANDARD_DEVIATION 6.33 • n=5 Participants	31.5 years STANDARD_DEVIATION 6.24 • n=4 Participants
Sex: Female, Male Female	374 Participants n=5 Participants	249 Participants n=7 Participants	248 Participants n=5 Participants	871 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=373 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=248 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=244 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)	19.6 percentage of participants	46.4 percentage of participants	75.8 percentage of participants

PRIMARY outcome

Timeframe: 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.

The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=373 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=248 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=244 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)	36.5 percentage of participants	50.4 percentage of participants	54.5 percentage of participants

SECONDARY outcome

Timeframe: 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.

The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).

Outcome measures

Outcome measures
Measure	Placebo n=329 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=226 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=213 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores	-1.09 units on a scale Standard Error 0.098	-1.74 units on a scale Standard Error 0.120	-2.39 units on a scale Standard Error 0.122

SECONDARY outcome

Timeframe: 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.

The DYS pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=288 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=198 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=182 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in DYS	-0.44 units on a scale Standard Error 0.047	-0.89 units on a scale Standard Error 0.057	-1.75 units on a scale Standard Error 0.059

SECONDARY outcome

Timeframe: 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.

The NMPP pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=288 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=198 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=182 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in NMPP	-0.31 units on a scale Standard Error 0.035	-0.48 units on a scale Standard Error 0.043	-0.72 units on a scale Standard Error 0.044

SECONDARY outcome

Timeframe: 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.

Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.

Outcome measures

Outcome measures
Measure	Placebo n=329 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=226 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=213 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics	-0.29 pills Standard Error 0.032	-0.29 pills Standard Error 0.039	-0.55 pills Standard Error 0.040

SECONDARY outcome

Timeframe: 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.

Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.

Outcome measures

Outcome measures
Measure	Placebo n=288 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=198 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=182 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics	-0.27 pills Standard Error 0.036	-0.35 pills Standard Error 0.043	-0.56 pills Standard Error 0.045

SECONDARY outcome

Timeframe: 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.

The DYSP pain scale ranges from 0 (absent) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=246 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=171 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=153 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in Dyspareunia (DYSP)	-0.29 units on a scale Standard Error 0.041	-0.39 units on a scale Standard Error 0.050	-0.49 units on a scale Standard Error 0.052

SECONDARY outcome

Timeframe: 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.

Permitted rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.

Outcome measures

Outcome measures
Measure	Placebo n=329 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=226 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=213 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)	-0.10 pills Standard Error 0.024	-0.07 pills Standard Error 0.029	-0.22 pills Standard Error 0.029

SECONDARY outcome

Timeframe: At Month 1 of the Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=372 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=248 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=245 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 1 Based on Daily Assessment of DYS	14.5 percentage of participants	35.1 percentage of participants	44.1 percentage of participants

SECONDARY outcome

Timeframe: At Month 2 of the Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=373 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=248 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=244 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 2 Based on Daily Assessment of DYS	17.2 percentage of participants	44.8 percentage of participants	71.3 percentage of participants

SECONDARY outcome

Timeframe: At Month 4 of the Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=373 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=248 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=243 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 4 Based on Daily Assessment of DYS	21.7 percentage of participants	47.6 percentage of participants	75.3 percentage of participants

SECONDARY outcome

Timeframe: At Month 5 of the Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward..

The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=371 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=247 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=243 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 5 Based on Daily Assessment of DYS	24.3 percentage of participants	45.7 percentage of participants	79.0 percentage of participants

SECONDARY outcome

Timeframe: At Month 6 of the Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=372 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=247 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=243 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 6 Based on Daily Assessment of DYS	23.1 percentage of participants	42.1 percentage of participants	75.3 percentage of participants

SECONDARY outcome

Timeframe: At Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=372 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=248 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=245 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 1 Based on Daily Assessment of NMPP	25.8 percentage of participants	32.3 percentage of participants	33.9 percentage of participants

SECONDARY outcome

Timeframe: At Month 2 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=373 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=248 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=244 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 2 Based on Daily Assessment of NMPP	32.2 percentage of participants	41.1 percentage of participants	46.3 percentage of participants

SECONDARY outcome

Timeframe: At Month 4 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=373 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=248 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=243 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 4 Based on Daily Assessment of NMPP	35.4 percentage of participants	53.2 percentage of participants	63.8 percentage of participants

SECONDARY outcome

Timeframe: At Month 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=371 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=247 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=243 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 5 Based on Daily Assessment of NMPP	38.3 percentage of participants	49.8 percentage of participants	62.1 percentage of participants

SECONDARY outcome

Timeframe: At Month 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=372 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=247 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=243 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 6 Based on Daily Assessment of NMPP	34.9 percentage of participants	45.7 percentage of participants	62.1 percentage of participants

SECONDARY outcome

Timeframe: At Month 1 of the Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=293 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=191 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=176 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 1 for DYSP	26.3 percentage of participants	30.4 percentage of participants	31.8 percentage of participants

SECONDARY outcome

Timeframe: At Month 2 of the Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=287 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=190 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=179 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 2 for DYSP	33.1 percentage of participants	33.7 percentage of participants	44.7 percentage of participants

SECONDARY outcome

Timeframe: At Month 4 of the Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=278 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=185 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=168 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 4 for DYSP	33.1 percentage of participants	44.3 percentage of participants	54.2 percentage of participants

SECONDARY outcome

Timeframe: At Month 5 of the Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=275 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=183 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=166 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 5 for DYSP	35.3 percentage of participants	43.7 percentage of participants	54.8 percentage of participants

SECONDARY outcome

Timeframe: At Month 6 of the Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Outcome measures

Outcome measures
Measure	Placebo n=270 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=187 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=161 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 6 for DYSP	33.3 percentage of participants	39.6 percentage of participants	50.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The DYS pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=372 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=248 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=245 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 1 in Mean Pain Score for DYS	-0.33 units on a scale Standard Error 0.044	-0.83 units on a scale Standard Error 0.054	-0.98 units on a scale Standard Error 0.054

SECONDARY outcome

Timeframe: Baseline, Month 2 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The DYS pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=348 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=232 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=221 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 2 in Mean Pain Score for DYS	-0.32 units on a scale Standard Error 0.042	-0.96 units on a scale Standard Error 0.052	-1.68 units on a scale Standard Error 0.053

SECONDARY outcome

Timeframe: 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.

The DYS pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=329 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=226 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=213 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in Mean Pain Score for DYS	-0.35 units on a scale Standard Error 0.043	-1.03 units on a scale Standard Error 0.052	-1.73 units on a scale Standard Error 0.054

SECONDARY outcome

Timeframe: Baseline, Month 4 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The DYS pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=316 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=219 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=198 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 4 in Mean Pain Score for DYS	-0.40 units on a scale Standard Error 0.045	-1.05 units on a scale Standard Error 0.054	-1.72 units on a scale Standard Error 0.057

SECONDARY outcome

Timeframe: Baseline, Month 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The DYS pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=299 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=202 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=191 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 5 in Mean Pain Score for DYS	-0.43 units on a scale Standard Error 0.045	-1.02 units on a scale Standard Error 0.054	-1.84 units on a scale Standard Error 0.056

SECONDARY outcome

Timeframe: Baseline, Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The DYS pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=372 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=248 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=245 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percent Change From Baseline to Month 1 in Mean Pain Score for DYS	-14.35 percentage change Standard Error 2.079	-38.42 percentage change Standard Error 2.547	-45.35 percentage change Standard Error 2.562

SECONDARY outcome

Timeframe: Baseline, Month 2 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The DYS pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=348 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=232 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=221 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percent Change From Baseline to Month 2 in Mean Pain Score for DYS	-13.44 percentage change Standard Error 1.965	-44.23 percentage change Standard Error 2.407	-77.22 percentage change Standard Error 2.460

SECONDARY outcome

Timeframe: 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.

The DYS pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=329 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=226 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=213 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percent Change From Baseline to Month 3 in Mean Pain Score for DYS	-14.80 percentage change Standard Error 2.022	-47.01 percentage change Standard Error 2.451	-79.74 percentage change Standard Error 2.519

SECONDARY outcome

Timeframe: Baseline, Month 4 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The DYS pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=316 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=219 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=198 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percent Change From Baseline to Month 4 in Mean Pain Score for DYS	-18.08 percentage change Standard Error 2.088	-48.02 percentage change Standard Error 2.519	-79.98 percentage change Standard Error 2.627

SECONDARY outcome

Timeframe: Baseline, Month 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The DYS pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=299 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=202 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=191 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percent Change From Baseline to Month 5 in Mean Pain Score for DYS	-18.09 percentage change Standard Error 2.072	-46.72 percentage change Standard Error 2.517	-84.58 percentage change Standard Error 2.595

SECONDARY outcome

Timeframe: 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.

The DYS pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=288 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=198 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=182 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percent Change From Baseline to Month 6 in Mean Pain Score for DYS	-19.21 percentage change Standard Error 2.217	-40.60 percentage change Standard Error 2.681	-79.99 percentage change Standard Error 2.782

SECONDARY outcome

Timeframe: Baseline, Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases

The NMPP pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=372 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=248 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=245 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 1 in Mean Pain Score for NMPP	-0.16 units on a scale Standard Error 0.023	-0.22 units on a scale Standard Error 0.028	-0.26 units on a scale Standard Error 0.028

SECONDARY outcome

Timeframe: Baseline, Month 2 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases

The NMPP pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=348 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=232 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=221 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 2 in Mean Pain Score for NMPP	-0.26 units on a scale Standard Error 0.028	-0.33 units on a scale Standard Error 0.035	-0.44 units on a scale Standard Error 0.035

SECONDARY outcome

Timeframe: 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

The NMPP pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=329 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=226 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=213 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in Mean Pain Score for NMPP	-0.32 units on a scale Standard Error 0.032	-0.44 units on a scale Standard Error 0.039	-0.61 units on a scale Standard Error 0.039

SECONDARY outcome

Timeframe: Baseline, Month 4 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases

The NMPP pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=316 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=219 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=198 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 4 in Mean Pain Score for NMPP	-0.33 units on a scale Standard Error 0.034	-0.51 units on a scale Standard Error 0.041	-0.72 units on a scale Standard Error 0.042

SECONDARY outcome

Timeframe: Baseline, Month 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases

The NMPP pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=299 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=202 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=191 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 5 in Mean Pain Score for NMPP	-0.34 units on a scale Standard Error 0.034	-0.49 units on a scale Standard Error 0.041	-0.74 units on a scale Standard Error 0.042

SECONDARY outcome

Timeframe: Baseline, Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The NMPP pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=372 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=248 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=245 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP	-7.51 percentage change Standard Error 1.736	-13.74 percentage change Standard Error 2.131	-15.23 percentage change Standard Error 2.139

SECONDARY outcome

Timeframe: Baseline, Month 2 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The NMPP pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=348 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=232 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=221 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP	-13.81 percentage change Standard Error 2.039	-19.50 percentage change Standard Error 2.501	-27.53 percentage change Standard Error 2.529

SECONDARY outcome

Timeframe: 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.

The NMPP pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=329 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=226 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=213 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP	-17.64 percentage change Standard Error 2.204	-26.10 percentage change Standard Error 2.688	-40.13 percentage change Standard Error 2.737

SECONDARY outcome

Timeframe: Baseline, Month 4 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The NMPP pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=316 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=219 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=198 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP	-17.94 percentage change Standard Error 2.333	-32.05 percentage change Standard Error 2.837	-48.35 percentage change Standard Error 2.909

SECONDARY outcome

Timeframe: Baseline, Month 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The NMPP pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=299 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=202 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=191 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP	-19.60 percentage change Standard Error 2.371	-31.15 percentage change Standard Error 2.888	-49.28 percentage change Standard Error 2.954

SECONDARY outcome

Timeframe: 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.

The NMPP pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=288 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=198 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=182 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP	-18.17 percentage change Standard Error 2.418	-30.55 percentage change Standard Error 2.939	-48.14 percentage change Standard Error 3.019

SECONDARY outcome

Timeframe: Baseline, Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis.

The DYSP pain scale ranged from 0 (absent) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=293 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=191 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=176 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 1 in Mean Pain Score of DYSP	-0.18 units on a scale Standard Error 0.032	-0.29 units on a scale Standard Error 0.040	-0.22 units on a scale Standard Error 0.042

SECONDARY outcome

Timeframe: Baseline, Month 2 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis.

The DYSP pain scale ranged from 0 (absent) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=267 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=178 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=165 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 2 in Mean Pain Score of DYSP	-0.26 units on a scale Standard Error 0.038	-0.33 units on a scale Standard Error 0.046	-0.38 units on a scale Standard Error 0.048

SECONDARY outcome

Timeframe: Baseline, Month 4 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis.

The DYSP pain scale ranged from 0 (absent) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=231 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=164 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=139 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 4 in Mean Pain Score of DYSP	-0.27 units on a scale Standard Error 0.044	-0.45 units on a scale Standard Error 0.053	-0.61 units on a scale Standard Error 0.056

SECONDARY outcome

Timeframe: Baseline, Month 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis.

The DYSP pain scale ranged from 0 (absent) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=217 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=149 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=131 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 5 in Mean Pain Score of DYSP	-0.30 units on a scale Standard Error 0.047	-0.44 units on a scale Standard Error 0.056	-0.57 units on a scale Standard Error 0.060

SECONDARY outcome

Timeframe: Baseline, Month 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis.

The DYSP pain scale ranged from 0 (absent) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=203 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=149 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=120 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in Mean Pain Score of DYSP	-0.29 units on a scale Standard Error 0.048	-0.41 units on a scale Standard Error 0.057	-0.60 units on a scale Standard Error 0.062

SECONDARY outcome

Timeframe: Baseline, Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.

Outcome measures

Outcome measures
Measure	Placebo n=372 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=248 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=245 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics	-0.20 pills Standard Error 0.028	-0.25 pills Standard Error 0.034	-0.32 pills Standard Error 0.034

SECONDARY outcome

Timeframe: Baseline, Month 2 of Treatment Period

Population: The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.

Outcome measures

Outcome measures
Measure	Placebo n=348 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=232 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=221 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics	-0.24 pills Standard Error 0.029	-0.27 pills Standard Error 0.036	-0.46 pills Standard Error 0.037

SECONDARY outcome

Timeframe: Baseline, Month 4 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.

Outcome measures

Outcome measures
Measure	Placebo n=316 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=219 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=198 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics	-0.28 pills Standard Error 0.033	-0.39 pills Standard Error 0.041	-0.57 pills Standard Error 0.042

SECONDARY outcome

Timeframe: Baseline, Month 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.

Outcome measures

Outcome measures
Measure	Placebo n=299 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=202 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=191 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics	-0.29 pills Standard Error 0.034	-0.36 pills Standard Error 0.041	-0.60 pills Standard Error 0.042

SECONDARY outcome

Timeframe: Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

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.

Outcome measures

Outcome measures
Measure	Placebo n=353 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=234 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=226 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Response to Patient Global Impression of Change (PGIC) at Month 1	3.50 units on a scale Standard Error 0.060	2.97 units on a scale Standard Error 0.073	2.76 units on a scale Standard Error 0.075

SECONDARY outcome

Timeframe: Month 2 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

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.

Outcome measures

Outcome measures
Measure	Placebo n=353 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=231 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=225 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Response to PGIC at Month 2	3.13 units on a scale Standard Error 0.062	2.74 units on a scale Standard Error 0.076	2.11 units on a scale Standard Error 0.077

SECONDARY outcome

Timeframe: Month 3 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

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.

Outcome measures

Outcome measures
Measure	Placebo n=346 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=229 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=227 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Response to PGIC at Month 3	3.14 units on a scale Standard Error 0.064	2.53 units on a scale Standard Error 0.079	2.01 units on a scale Standard Error 0.079

SECONDARY outcome

Timeframe: Month 4 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

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.

Outcome measures

Outcome measures
Measure	Placebo n=352 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=230 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=222 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Response to PGIC at Month 4	3.16 units on a scale Standard Error 0.067	2.54 units on a scale Standard Error 0.082	1.91 units on a scale Standard Error 0.084

SECONDARY outcome

Timeframe: Month 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

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.

Outcome measures

Outcome measures
Measure	Placebo n=350 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=233 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=223 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Response to PGIC at Month 5	3.19 units on a scale Standard Error 0.070	2.50 units on a scale Standard Error 0.086	1.87 units on a scale Standard Error 0.088

SECONDARY outcome

Timeframe: Month 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.

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.

Outcome measures

Outcome measures
Measure	Placebo n=308 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=207 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=200 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Response to PGIC at Month 6	3.27 units on a scale Standard Error 0.077	2.56 units on a scale Standard Error 0.094	1.92 units on a scale Standard Error 0.096

SECONDARY outcome

Timeframe: Baseline, Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).

Outcome measures

Outcome measures
Measure	Placebo n=372 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=248 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=244 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 1 in NRS Scores	-0.72 units on a scale Standard Error 0.069	-1.00 units on a scale Standard Error 0.085	-1.12 units on a scale Standard Error 0.085

SECONDARY outcome

Timeframe: Baseline, Month 2 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).

Outcome measures

Outcome measures
Measure	Placebo n=348 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=232 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=221 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 2 in NRS Scores	-0.91 units on a scale Standard Error 0.086	-1.38 units on a scale Standard Error 0.106	-1.87 units on a scale Standard Error 0.107

SECONDARY outcome

Timeframe: Baseline, Month 4 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).

Outcome measures

Outcome measures
Measure	Placebo n=316 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=219 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=198 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 4 in NRS Scores	-1.15 units on a scale Standard Error 0.103	-1.95 units on a scale Standard Error 0.126	-2.76 units on a scale Standard Error 0.129

SECONDARY outcome

Timeframe: Baseline, Month 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).

Outcome measures

Outcome measures
Measure	Placebo n=299 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=202 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=191 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 5 in NRS Scores	-1.24 units on a scale Standard Error 0.106	-1.92 units on a scale Standard Error 0.129	-2.85 units on a scale Standard Error 0.132

SECONDARY outcome

Timeframe: 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.

The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).

Outcome measures

Outcome measures
Measure	Placebo n=288 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=198 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=182 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in NRS Scores	-1.15 units on a scale Standard Error 0.112	-1.80 units on a scale Standard Error 0.136	-2.75 units on a scale Standard Error 0.140

SECONDARY outcome

Timeframe: Baseline, Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=345 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=233 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=217 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30)	-14.47 units on a scale Standard Error 0.997	-20.76 units on a scale Standard Error 1.213	-24.23 units on a scale Standard Error 1.257

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=312 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=217 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=197 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in the Pain Domain of the EHP-30	-17.71 units on a scale Standard Error 1.101	-26.99 units on a scale Standard Error 1.321	-36.46 units on a scale Standard Error 1.386

SECONDARY outcome

Timeframe: 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.

The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.

Outcome measures

Outcome measures
Measure	Placebo n=249 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=177 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=162 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in the Pain Domain of the EHP-30	-15.42 units on a scale Standard Error 1.283	-27.99 units on a scale Standard Error 1.522	-40.52 units on a scale Standard Error 1.591

SECONDARY outcome

Timeframe: Baseline, Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.

Outcome measures

Outcome measures
Measure	Placebo n=248 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=172 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=146 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30	-10.47 units on a scale Standard Error 1.239	-11.26 units on a scale Standard Error 1.488	-15.52 units on a scale Standard Error 1.614

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=228 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=167 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=133 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30	-12.57 units on a scale Standard Error 1.551	-17.32 units on a scale Standard Error 1.813	-26.44 units on a scale Standard Error 2.032

SECONDARY outcome

Timeframe: 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.

The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.

Outcome measures

Outcome measures
Measure	Placebo n=170 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=128 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=110 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30	-11.56 units on a scale Standard Error 1.909	-16.27 units on a scale Standard Error 2.203	-29.07 units on a scale Standard Error 2.384

SECONDARY outcome

Timeframe: Baseline, Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=171 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=162 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism	-1.32 hours Standard Error 0.236	-1.20 hours Standard Error 0.286	-2.49 hours Standard Error 0.294

SECONDARY outcome

Timeframe: Baseline, Month 2 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=232 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=160 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=147 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism	-1.29 hours Standard Error 0.222	-1.77 hours Standard Error 0.266	-2.56 hours Standard Error 0.278

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=215 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=148 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=140 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism	-0.87 hours Standard Error 0.277	-1.92 hours Standard Error 0.333	-2.65 hours Standard Error 0.343

SECONDARY outcome

Timeframe: Baseline, Month 4 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=205 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=148 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=134 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism	-1.08 hours Standard Error 0.284	-1.85 hours Standard Error 0.334	-2.44 hours Standard Error 0.351

SECONDARY outcome

Timeframe: Baseline, Month 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=209 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=147 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=128 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism	-1.10 hours Standard Error 0.258	-1.75 hours Standard Error 0.308	-2.94 hours Standard Error 0.330

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=159 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=120 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=105 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism	-0.27 hours Standard Error 0.409	-1.02 hours Standard Error 0.471	-2.48 hours Standard Error 0.503

SECONDARY outcome

Timeframe: Baseline, Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=319 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=200 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=202 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism	-1.27 hours Standard Error 0.229	-2.19 hours Standard Error 0.289	-2.89 hours Standard Error 0.288

SECONDARY outcome

Timeframe: Baseline, Month 2 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=287 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=192 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=183 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism	-1.43 hours Standard Error 0.295	-2.75 hours Standard Error 0.360	-3.06 hours Standard Error 0.369

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=278 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=185 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=179 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism	-1.37 hours Standard Error 0.292	-3.00 hours Standard Error 0.358	-3.47 hours Standard Error 0.363

SECONDARY outcome

Timeframe: Baseline, Month 4 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=264 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=170 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=171 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism	-1.38 hours Standard Error 0.265	-2.59 hours Standard Error 0.331	-3.61 hours Standard Error 0.330

SECONDARY outcome

Timeframe: Baseline, Month 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=253 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=173 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=171 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism	-2.13 hours Standard Error 0.250	-3.10 hours Standard Error 0.302	-3.94 hours Standard Error 0.304

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=191 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=145 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=139 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism	-1.45 hours Standard Error 0.313	-2.73 hours Standard Error 0.359	-3.94 hours Standard Error 0.367

SECONDARY outcome

Timeframe: Baseline, Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=246 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=170 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=157 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism	-4.07 hours Standard Error 0.555	-4.93 hours Standard Error 0.668	-6.00 hours Standard Error 0.694

SECONDARY outcome

Timeframe: Baseline, Month 2 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=228 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=158 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=145 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism	-5.42 hours Standard Error 0.560	-6.83 hours Standard Error 0.671	-8.94 hours Standard Error 0.701

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=213 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=147 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=136 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism	-6.23 hours Standard Error 0.526	-7.24 hours Standard Error 0.632	-9.16 hours Standard Error 0.657

SECONDARY outcome

Timeframe: Baseline, Month 4 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=201 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=146 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=132 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism	-6.81 hours Standard Error 0.465	-8.41 hours Standard Error 0.546	-10.70 hours Standard Error 0.573

SECONDARY outcome

Timeframe: Baseline, Month 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=206 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=147 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=123 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism	-7.80 hours Standard Error 0.488	-8.31 hours Standard Error 0.577	-10.93 hours Standard Error 0.631

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=157 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=118 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=104 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism	-6.75 hours Standard Error 0.554	-8.11 hours Standard Error 0.637	-11.21 hours Standard Error 0.679

SECONDARY outcome

Timeframe: Baseline, Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=314 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=200 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=199 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism	-0.46 hours Standard Error 0.224	-1.64 hours Standard Error 0.281	-1.51 hours Standard Error 0.282

SECONDARY outcome

Timeframe: Baseline, Month 2 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=285 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=190 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=181 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism	-1.17 hours Standard Error 0.238	-1.93 hours Standard Error 0.291	-2.23 hours Standard Error 0.299

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=275 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=185 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=178 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism	-1.35 hours Standard Error 0.210	-1.89 hours Standard Error 0.256	-2.33 hours Standard Error 0.261

SECONDARY outcome

Timeframe: Baseline, Month 4 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=263 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=168 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=170 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism	-1.51 hours Standard Error 0.224	-1.81 hours Standard Error 0.280	-2.55 hours Standard Error 0.278

SECONDARY outcome

Timeframe: Baseline, Month 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=253 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=172 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=169 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism	-1.67 hours Standard Error 0.169	-1.86 hours Standard Error 0.205	-2.71 hours Standard Error 0.206

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=191 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=145 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=135 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism	-1.48 hours Standard Error 0.232	-2.07 hours Standard Error 0.265	-2.78 hours Standard Error 0.275

SECONDARY outcome

Timeframe: Baseline, Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=171 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=162 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace	-5.46 hours Standard Error 0.615	-6.17 hours Standard Error 0.745	-8.69 hours Standard Error 0.764

SECONDARY outcome

Timeframe: Baseline, Month 2 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=232 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=160 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=147 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace	-6.70 hours Standard Error 0.621	-8.72 hours Standard Error 0.746	-11.56 hours Standard Error 0.778

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=215 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=148 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=140 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace	-7.00 hours Standard Error 0.654	-9.20 hours Standard Error 0.787	-11.90 hours Standard Error 0.808

SECONDARY outcome

Timeframe: Baseline, Month 4 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=205 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=148 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=134 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace	-7.84 hours Standard Error 0.605	-10.26 hours Standard Error 0.712	-13.09 hours Standard Error 0.747

SECONDARY outcome

Timeframe: Baseline, Month 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=209 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=147 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=128 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace	-8.87 hours Standard Error 0.604	-10.04 hours Standard Error 0.719	-14.00 hours Standard Error 0.771

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=159 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=120 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=105 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace	-6.88 hours Standard Error 0.761	-9.14 hours Standard Error 0.874	-13.67 hours Standard Error 0.936

SECONDARY outcome

Timeframe: Baseline, Month 1 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=319 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=200 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=202 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household	-1.76 hours Standard Error 0.352	-3.88 hours Standard Error 0.445	-4.36 hours Standard Error 0.443

SECONDARY outcome

Timeframe: Baseline, Month 2 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=287 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=192 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=183 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household	-2.60 hours Standard Error 0.423	-4.69 hours Standard Error 0.517	-5.25 hours Standard Error 0.529

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=278 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=185 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=179 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household	-2.73 hours Standard Error 0.394	-4.90 hours Standard Error 0.483	-5.73 hours Standard Error 0.492

SECONDARY outcome

Timeframe: Baseline, Month 4 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=264 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=170 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=171 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household	-2.89 hours Standard Error 0.403	-4.43 hours Standard Error 0.502	-6.13 hours Standard Error 0.501

SECONDARY outcome

Timeframe: Baseline, Month 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=253 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=173 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=171 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household	-3.80 hours Standard Error 0.349	-4.94 hours Standard Error 0.423	-6.62 hours Standard Error 0.425

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=191 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=145 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=139 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household	-2.94 hours Standard Error 0.433	-4.78 hours Standard Error 0.496	-6.69 hours Standard Error 0.507

SECONDARY outcome

Timeframe: Up to Month 6 of Treatment Period

Population: The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug.

Outcome measures

Outcome measures
Measure	Placebo n=374 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=249 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=248 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Baseline	69 Participants	54 Participants	51 Participants
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Month 1	70 Participants	50 Participants	47 Participants
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Month 2	59 Participants	38 Participants	33 Participants
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Month 3	66 Participants	37 Participants	48 Participants
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Month 4	54 Participants	35 Participants	42 Participants
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Month 5	43 Participants	32 Participants	22 Participants
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Month 6	38 Participants	26 Participants	21 Participants
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Overall	189 Participants	126 Participants	113 Participants

SECONDARY outcome

Timeframe: Up to Month 6 of Treatment Period

Population: The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Includes participants who were hospitalized during the Treatment Period.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=3 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=13 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Number of Days of Hospitalization	2.9 days Standard Deviation 2.45	2.0 days Standard Deviation 1.00	2.0 days Standard Deviation 1.68

SECONDARY outcome

Timeframe: Up to Month 6 of Treatment Period

Population: The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug.

Outcome measures

Outcome measures
Measure	Placebo n=374 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=249 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=248 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type X-Ray	14 Participants	2 Participants	5 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type All Categories	62 Participants	21 Participants	32 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Abdominal Hysterectomy	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Angiography	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Arthroscopy	0 Participants	0 Participants	1 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Biopsy	1 Participants	0 Participants	1 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Blood Draw	27 Participants	7 Participants	16 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Consultation	6 Participants	3 Participants	3 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type CT Scan	21 Participants	3 Participants	6 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Diagnostic Laparoscopy	0 Participants	1 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Electrocardiogram	3 Participants	1 Participants	3 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Endometrial Ablation	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Histological Exam	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Intrauterine Insemination	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type In Vitro Fertilization	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Laparoscopic Hysterectomy	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Laparotomy	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Magnetic Resonance Imaging	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Oophorectomy	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Pelvic Exam	5 Participants	1 Participants	2 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Physical Examination	32 Participants	10 Participants	15 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Surgery for Adhesions	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Therapeutic Laparoscopy	0 Participants	0 Participants	1 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Transfusion	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Ultrasound	14 Participants	3 Participants	6 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Urine Test	26 Participants	8 Participants	11 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Vaginal Hysterectomy	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Other (Not Specified)	16 Participants	10 Participants	10 Participants

Adverse Events

Placebo

Serious events: 12 serious events

Other events: 180 other events

Deaths: 0 deaths

Elagolix 150 MG QD

Serious events: 2 serious events

Other events: 147 other events

Deaths: 0 deaths

Elagolix 200 MG BID

Serious events: 7 serious events

Other events: 159 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Global Medical Services

AbbVie (prior sponsor Abbott)

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER