Trial Outcomes & Findings for An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis (NCT NCT00619866)

NCT ID: NCT00619866

Last Updated: 2018-09-07

Results Overview

The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 155 participants
• Primary outcome timeframe: Baseline and week 12
• Results posted on: 2018-09-07

Participant Flow

The study was conducted at 50 centers in the United States from February 2008 to August 2009.

Patients were randomized equally to oral elagolix 150 mg or 250 mg once daily, or placebo for 12 weeks. Thereafter, patients originally randomized to placebo were re-randomized to one of the two elagolix doses and patients originally randomized to elagolix continued their assigned dose for an additional 12 weeks.

Participant milestones

Measure	Placebo Participants received placebo tablets once a day (QD) for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 150 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 150 mg for 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Weeks 1 - 12 STARTED	52	51	52	0	0
Weeks 1 - 12 COMPLETED	38	45	42	0	0
Weeks 1 - 12 NOT COMPLETED	14	6	10	0	0
Weeks 13 - 24 STARTED	0	45	42	18	20
Weeks 13 - 24 COMPLETED	0	38	37	14	18
Weeks 13 - 24 NOT COMPLETED	0	7	5	4	2

Reasons for withdrawal

Measure	Placebo Participants received placebo tablets once a day (QD) for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 150 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 150 mg for 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Weeks 1 - 12 Lost to Follow-up	4	0	2	0	0
Weeks 1 - 12 Sponsor Decision	0	1	0	0	0
Weeks 13 - 24 Adverse Event	0	0	2	1	0
Weeks 13 - 24 Protocol Deviation	0	0	0	1	0
Weeks 1 - 12 Adverse Event	0	1	2	0	0
Weeks 1 - 12 Non-compliance	0	0	1	0	0
Weeks 1 - 12 Withdrawal by Subject	7	2	4	0	0
Weeks 1 - 12 Lack of Efficacy	3	2	1	0	0
Weeks 13 - 24 Withdrawal by Subject	0	3	2	2	2
Weeks 13 - 24 Non-compliance	0	1	1	0	0
Weeks 13 - 24 Lost to Follow-up	0	3	0	0	0

Baseline Characteristics

An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis

Baseline characteristics by cohort

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=52 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Total n=155 Participants Total of all reporting groups
Age, Continuous	31.2 years STANDARD_DEVIATION 1.0 • n=5 Participants	30.9 years STANDARD_DEVIATION 1.0 • n=7 Participants	31.0 years STANDARD_DEVIATION 1.0 • n=5 Participants	31.0 years STANDARD_DEVIATION 0.5 • n=4 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	51 Participants n=7 Participants	52 Participants n=5 Participants	155 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
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Black	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized White	43 Participants n=5 Participants	42 Participants n=7 Participants	41 Participants n=5 Participants	126 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	13 Participants n=4 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and week 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.

The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit.

Outcome measures

Measure	Placebo n=38 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=44 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=45 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12	-0.88 units on a scale Standard Error 0.18	-1.19 units on a scale Standard Error 0.18	-1.25 units on a scale Standard Error 0.18	—

SECONDARY outcome

Timeframe: Baseline and weeks 4 and 8

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.

The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit.

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain Week 4	-0.60 units on a scale Standard Error 0.17	-0.90 units on a scale Standard Error 0.17	-0.83 units on a scale Standard Error 0.17	—
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain Week 8	-0.71 units on a scale Standard Error 0.18	-1.23 units on a scale Standard Error 0.17	-0.94 units on a scale Standard Error 0.17	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.

The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit.

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain Week 12	-1.30 units on a scale Standard Error 0.36	-2.45 units on a scale Standard Error 0.34	-2.74 units on a scale Standard Error 0.34	—
Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain Week 4	-1.27 units on a scale Standard Error 0.32	-1.39 units on a scale Standard Error 0.32	-1.58 units on a scale Standard Error 0.32	—
Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain Week 8	-1.25 units on a scale Standard Error 0.34	-1.94 units on a scale Standard Error 0.33	-2.41 units on a scale Standard Error 0.33	—

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8, and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time every day in an e-Diary according to the following response options:

• 0 = No pelvic pain
• 1 = Mild pelvic pain; subject could not do some of the things she usually does
• 2 = Moderate pelvic pain; subject could not do many of the things she usually does
• 3 = Severe pelvic pain; subject could not do most or all of the things she usually does.

The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each visit.

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score Week 4	-0.14 units on a scale Standard Error 0.05	-0.18 units on a scale Standard Error 0.05	-0.16 units on a scale Standard Error 0.05	—
Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score Week 8	-0.12 units on a scale Standard Error 0.05	-0.30 units on a scale Standard Error 0.05	-0.17 units on a scale Standard Error 0.05	—
Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score Week 12	-0.22 units on a scale Standard Error 0.06	-0.27 units on a scale Standard Error 0.05	-0.25 units on a scale Standard Error 0.05	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day in an e-Diary according to the following response options:

• Subject is not having her period
• 0 = No pain related to period
• 1 = Mild pain related to period; subject could not do some of the things she usually does
• 2 = Moderate pain related to period; subject could not do many of the things she usually does
• 3 = Severe pain related to period; subject could not do most of or all of the things she usually does.

The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit.

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Change From Baseline in the Monthly Mean Dysmenorrhea Score Week 4	-0.20 units on a scale Standard Error 0.09	-0.49 units on a scale Standard Error 0.09	-0.40 units on a scale Standard Error 0.09	—
Change From Baseline in the Monthly Mean Dysmenorrhea Score Week 8	-0.29 units on a scale Standard Error 0.10	-0.71 units on a scale Standard Error 0.09	-0.79 units on a scale Standard Error 0.09	—
Change From Baseline in the Monthly Mean Dysmenorrhea Score Week 12	-0.24 units on a scale Standard Error 0.10	-0.68 units on a scale Standard Error 0.10	-0.76 units on a scale Standard Error 0.10	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

Participants assessed dysmenorrhea and pelvic pain not related to menses and their impact on daily activities at approximately the same time every day on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe) in an e-Diary.

The sum of the dysmenorrhea and non-menstrual pelvic pain scores on each day were calculated to create a daily total score. On days the participant was not having her period, the dysmenorrhea score was not defined; hence, the total score was equal to the non-menstrual pelvic pain score (range 0 to 3). On days where the participant recorded menstruation the total score ranged from 0 to 6, where higher scores indicate more severe pain. The monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores is the average of the daily values reported during the 4 weeks prior to each visit.

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Change From Baseline in the Monthly Mean Total of Dysmenorrhea and Non-menstrual Pelvic Pain Scores Week 4	-0.18 units on a scale Standard Error 0.06	-0.34 units on a scale Standard Error 0.06	-0.29 units on a scale Standard Error 0.06	—
Change From Baseline in the Monthly Mean Total of Dysmenorrhea and Non-menstrual Pelvic Pain Scores Week 8	-0.18 units on a scale Standard Error 0.06	-0.48 units on a scale Standard Error 0.06	-0.33 units on a scale Standard Error 0.06	—
Change From Baseline in the Monthly Mean Total of Dysmenorrhea and Non-menstrual Pelvic Pain Scores Week 12	-0.27 units on a scale Standard Error 0.07	-0.44 units on a scale Standard Error 0.06	-0.41 units on a scale Standard Error 0.06	—

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.

The percentage of days a participant reported a value of zero (or "no pain") for the NRS was calculated for the 4 weeks prior to each visit.

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Percentage of Days With No Pain Based on NRS Week 12	47.431 percentage of days Standard Error 4.955	44.841 percentage of days Standard Error 5.857	41.760 percentage of days Standard Error 5.796	—
Percentage of Days With No Pain Based on NRS Baseline	27.600 percentage of days Standard Error 3.588	25.380 percentage of days Standard Error 3.564	25.515 percentage of days Standard Error 3.493	—
Percentage of Days With No Pain Based on NRS Week 4	35.252 percentage of days Standard Error 4.118	36.401 percentage of days Standard Error 4.606	32.355 percentage of days Standard Error 4.604	—
Percentage of Days With No Pain Based on NRS Week 8	40.861 percentage of days Standard Error 4.671	43.780 percentage of days Standard Error 5.114	36.737 percentage of days Standard Error 5.467	—

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time every day in an e-Diary according to the following response options:

• 0 = No pelvic pain
• 1 = Mild pelvic pain; subject could not do some of the things she usually does
• 2 = Moderate pelvic pain; subject could not do many of the things she usually does
• 3 = Severe pelvic pain; subject could not do most or all of the things she usually does.

The percentage of days a participant reported a value of zero ("no pain") for non-menstrual pelvic pain was calculated for the 4 weeks prior to each visit.

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Percentage of Days With No Pain Based Based on Non-menstrual Pelvic Pain Daily Assessment Baseline	34.939 percentage of days Standard Error 3.831	36.821 percentage of days Standard Error 4.041	38.530 percentage of days Standard Error 4.065	—
Percentage of Days With No Pain Based Based on Non-menstrual Pelvic Pain Daily Assessment Week 4	42.986 percentage of days Standard Error 4.229	45.469 percentage of days Standard Error 4.968	44.443 percentage of days Standard Error 4.905	—
Percentage of Days With No Pain Based Based on Non-menstrual Pelvic Pain Daily Assessment Week 8	46.228 percentage of days Standard Error 4.777	54.967 percentage of days Standard Error 5.291	47.524 percentage of days Standard Error 5.367	—
Percentage of Days With No Pain Based Based on Non-menstrual Pelvic Pain Daily Assessment Week 12	54.270 percentage of days Standard Error 4.768	53.836 percentage of days Standard Error 6.077	50.061 percentage of days Standard Error 5.496	—

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day in an e-Diary according to the following response options:

• Subject is not having her period
• 0 = No pain related to period
• 1 = Mild pain related to period; subject could not do some of the things she usually does
• 2 = Moderate pain related to period; subject could not do many of the things she usually does
• = Severe pain related to period; subject could not do most of or all of the things she usually does.

The percentage of days a participant reported a value of zero ("no pain") for dysmenorrhea was calculated for the 4 weeks prior to each visit.

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Percentage of Days With No Pain Based Based on Dysmenorrhea Daily Assessment Week 4	30.513 percentage of days Standard Error 4.435	43.411 percentage of days Standard Error 5.775	39.475 percentage of days Standard Error 5.509	—
Percentage of Days With No Pain Based Based on Dysmenorrhea Daily Assessment Week 8	35.057 percentage of days Standard Error 5.135	56.952 percentage of days Standard Error 6.016	67.411 percentage of days Standard Error 6.190	—
Percentage of Days With No Pain Based Based on Dysmenorrhea Daily Assessment Week 12	34.439 percentage of days Standard Error 5.000	61.658 percentage of days Standard Error 6.717	66.186 percentage of days Standard Error 6.336	—
Percentage of Days With No Pain Based Based on Dysmenorrhea Daily Assessment Baseline	26.350 percentage of days Standard Error 3.710	14.340 percentage of days Standard Error 2.154	21.086 percentage of days Standard Error 3.210	—

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

Participants assessed dysmenorrhea and pelvic pain not related to menses and their impact on daily activities at approximately the same time every day in an e-Diary on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The sum of the dysmenorrhea and non-menstrual pelvic pain scores on each day were calculated to create a daily total score. On days the participant was not having her period, the dysmenorrhea score was not defined; hence, the total score was equal to the non-menstrual pelvic pain score (range 0 to 3). On days where the participant recorded menstruation the total score ranged from 0 to 6, where higher scores indicate more severe pain.

The percentage of days a participant reported a value of zero ("no pain") for the non-menstrual pelvic pain and dysmenorrhea total score was calculated for the 4 weeks prior to each visit.

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Percentage of Days With No Pain Based Based on Total Score of Non-menstrual Pelvic Pain and Dysmenorrhea Daily Assessment Week 4	39.586 percentage of days Standard Error 4.058	44.020 percentage of days Standard Error 4.825	43.230 percentage of days Standard Error 4.844	—
Percentage of Days With No Pain Based Based on Total Score of Non-menstrual Pelvic Pain and Dysmenorrhea Daily Assessment Week 8	43.961 percentage of days Standard Error 4.607	53.526 percentage of days Standard Error 5.200	47.108 percentage of days Standard Error 5.380	—
Percentage of Days With No Pain Based Based on Total Score of Non-menstrual Pelvic Pain and Dysmenorrhea Daily Assessment Week 12	50.340 percentage of days Standard Error 4.552	52.584 percentage of days Standard Error 5.999	49.409 percentage of days Standard Error 5.494	—
Percentage of Days With No Pain Based Based on Total Score of Non-menstrual Pelvic Pain and Dysmenorrhea Daily Assessment Baseline	33.009 percentage of days Standard Error 3.690	32.940 percentage of days Standard Error 3.649	35.967 percentage of days Standard Error 3.815	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.

The percentage of days of any analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of an analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of "none").

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Change From Baseline in the Percentage of Days of Any Analgesic Use Week 4	-4.8 percentage of days Standard Error 2.3	-8.7 percentage of days Standard Error 2.3	-6.8 percentage of days Standard Error 2.3	—
Change From Baseline in the Percentage of Days of Any Analgesic Use Week 8	-5.8 percentage of days Standard Error 2.4	-12.6 percentage of days Standard Error 2.4	-10.4 percentage of days Standard Error 2.4	—
Change From Baseline in the Percentage of Days of Any Analgesic Use Week 12	-6.1 percentage of days Standard Error 2.5	-10.5 percentage of days Standard Error 2.4	-13.9 percentage of days Standard Error 2.4	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.

The percentage of days of prescription analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a prescription analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of "none").

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Change From Baseline in the Percentage of Days of Prescription Analgesic Use Week 4	-1.0 percentage of days Standard Error 1.2	-4.0 percentage of days Standard Error 1.2	-2.3 percentage of days Standard Error 1.2	—
Change From Baseline in the Percentage of Days of Prescription Analgesic Use Week 8	-0.8 percentage of days Standard Error 1.4	-3.2 percentage of days Standard Error 1.3	-3.2 percentage of days Standard Error 1.4	—
Change From Baseline in the Percentage of Days of Prescription Analgesic Use Week 12	-2.1 percentage of days Standard Error 1.6	-2.6 percentage of days Standard Error 1.6	-3.3 percentage of days Standard Error 1.6	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.

The percentage of days of narcotic analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a narcotic analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of "none").

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Change From Baseline in the Percentage of Days of Narcotic Analgesic Use Week 4	-0.8 percentage of days Standard Error 1.1	-2.5 percentage of days Standard Error 1.2	-2.1 percentage of days Standard Error 1.2	—
Change From Baseline in the Percentage of Days of Narcotic Analgesic Use Week 8	-0.8 percentage of days Standard Error 1.2	-1.8 percentage of days Standard Error 1.2	-3.0 percentage of days Standard Error 1.2	—
Change From Baseline in the Percentage of Days of Narcotic Analgesic Use Week 12	-1.7 percentage of days Standard Error 1.3	-1.3 percentage of days Standard Error 1.3	-3.6 percentage of days Standard Error 1.3	—

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.

The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit.

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Percentage of Participants With 30% Decrease From Baseline in Monthly Mean NRS Week 4	38.5 percentage of participants Interval 25.2 to 51.7	43.1 percentage of participants Interval 29.5 to 56.7	47.1 percentage of participants Interval 33.4 to 60.8	—
Percentage of Participants With 30% Decrease From Baseline in Monthly Mean NRS Week 12	60.5 percentage of participants Interval 45.0 to 76.1	63.6 percentage of participants Interval 49.4 to 77.9	60.0 percentage of participants Interval 45.7 to 74.3	—
Percentage of Participants With 30% Decrease From Baseline in Monthly Mean NRS Week 8	54.5 percentage of participants Interval 39.8 to 69.3	60.4 percentage of participants Interval 46.6 to 74.3	51.1 percentage of participants Interval 36.8 to 65.4	—

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.

The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit.

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Percentage of Participants With 30% Decrease From Baseline in Monthly Peak NRS Week 4	30.8 percentage of participants Interval 18.2 to 43.3	35.3 percentage of participants Interval 22.2 to 48.4	31.4 percentage of participants Interval 18.6 to 44.1	—
Percentage of Participants With 30% Decrease From Baseline in Monthly Peak NRS Week 8	38.6 percentage of participants Interval 24.2 to 53.0	43.8 percentage of participants Interval 29.7 to 57.8	48.9 percentage of participants Interval 34.6 to 63.2	—
Percentage of Participants With 30% Decrease From Baseline in Monthly Peak NRS Week 12	36.8 percentage of participants Interval 21.5 to 52.2	47.7 percentage of participants Interval 33.3 to 62.5	57.8 percentage of participants Interval 43.3 to 72.2	—

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.

The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit.

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Percentage of Participants With 50% Decrease From Baseline in Monthly Mean NRS Week 4	21.2 percentage of participants Interval 10.1 to 32.3	37.3 percentage of participants Interval 24.0 to 50.5	25.5 percentage of participants Interval 13.5 to 37.5	—
Percentage of Participants With 50% Decrease From Baseline in Monthly Mean NRS Week 8	36.4 percentage of participants Interval 22.1 to 50.6	45.8 percentage of participants Interval 31.7 to 59.9	38.3 percentage of participants Interval 24.4 to 52.2	—
Percentage of Participants With 50% Decrease From Baseline in Monthly Mean NRS Week 12	36.8 percentage of participants Interval 21.5 to 52.2	45.5 percentage of participants Interval 30.7 to 60.2	44.4 percentage of participants Interval 29.9 to 59.0	—

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.

The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit.

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Percentage of Participants With 50% Decrease From Baseline in Monthly Peak NRS Week 4	11.5 percentage of participants Interval 2.9 to 20.2	17.6 percentage of participants Interval 7.2 to 28.1	19.6 percentage of participants Interval 8.7 to 30.5	—
Percentage of Participants With 50% Decrease From Baseline in Monthly Peak NRS Week 8	11.4 percentage of participants Interval 2.0 to 20.7	25.0 percentage of participants Interval 12.8 to 37.2	36.2 percentage of participants Interval 22.4 to 49.9	—
Percentage of Participants With 50% Decrease From Baseline in Monthly Peak NRS Week 12	23.7 percentage of participants Interval 10.2 to 37.2	34.1 percentage of participants Interval 20.1 to 48.1	42.2 percentage of participants Interval 27.8 to 56.7	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. To assess dyspareunia (painful intercourse) participants were asked to select the best description of pain during sexual intercourse over the past 28 days using the following response categories:

• 0 = Absent; No discomfort during sexual intercourse.
• 1 = Mild; I can tolerate the discomfort during sexual intercourse.
• 2 = Moderate; Intercourse is sometime interrupted due to pain.
• 3 = Severe; I prefer to avoid intercourse because of pain.
• Not applicable. I am not sexually active for reasons other than my endometriosis symptoms.

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS) Week 4	-0.19 units on a scale Standard Error 0.12	-0.21 units on a scale Standard Error 0.12	-0.56 units on a scale Standard Error 0.13	—
Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS) Week 8	-0.15 units on a scale Standard Error 0.12	-0.68 units on a scale Standard Error 0.12	-0.66 units on a scale Standard Error 0.14	—
Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS) Week 12	-0.29 units on a scale Standard Error 0.13	-0.67 units on a scale Standard Error 0.12	-0.49 units on a scale Standard Error 0.14	—

SECONDARY outcome

Timeframe: Weeks 4, 8, and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:

1. Very Much Improved

2. Much Improved

3. Minimally Improved

4. Not Changed

5. Minimally Worse

6. Much Worse

7. Very Much Worse

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Patient Global Impression of Change at Weeks 4, 8 and 12 Week 4	3.4 units on a scale Standard Error 0.2	3.0 units on a scale Standard Error 0.2	2.8 units on a scale Standard Error 0.2	—
Patient Global Impression of Change at Weeks 4, 8 and 12 Week 8	3.0 units on a scale Standard Error 0.2	2.3 units on a scale Standard Error 0.1	2.4 units on a scale Standard Error 0.2	—
Patient Global Impression of Change at Weeks 4, 8 and 12 Week 12	3.2 units on a scale Standard Error 0.2	2.2 units on a scale Standard Error 0.2	2.2 units on a scale Standard Error 0.2	—

SECONDARY outcome

Timeframe: Weeks 4, 8, and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:

1. Very Much Improved

2. Much Improved

3. Minimally Improved

4. Not Changed

5. Minimally Worse

6. Much Worse

7. Very Much Worse

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Percentage of Participants With a PGIC Response of Minimally Improved, Much Improved, or Very Much Improved Week 4	54.2 percentage of participants Interval 40.1 to 68.3	62.0 percentage of participants Interval 48.5 to 75.5	80.0 percentage of participants Interval 68.9 to 91.1	—
Percentage of Participants With a PGIC Response of Minimally Improved, Much Improved, or Very Much Improved Week 8	67.4 percentage of participants Interval 53.8 to 80.9	91.7 percentage of participants Interval 83.8 to 99.5	84.4 percentage of participants Interval 73.9 to 95.0	—
Percentage of Participants With a PGIC Response of Minimally Improved, Much Improved, or Very Much Improved Week 12	60.0 percentage of participants Interval 44.8 to 75.2	88.9 percentage of participants Interval 79.7 to 98.1	82.2 percentage of participants Interval 71.1 to 93.4	—

SECONDARY outcome

Timeframe: Weeks 4, 8, and 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:

1. Very Much Improved

2. Much Improved

3. Minimally Improved

4. Not Changed

5. Minimally Worse

6. Much Worse

7. Very Much Worse

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved Week 12	32.5 percentage of participants Interval 18.0 to 47.0	66.7 percentage of participants Interval 52.9 to 80.4	62.2 percentage of participants Interval 48.1 to 76.4	—
Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved Week 4	12.5 percentage of participants Interval 3.1 to 21.9	34.0 percentage of participants Interval 20.9 to 47.1	38.0 percentage of participants Interval 24.5 to 51.5	—
Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved Week 8	37.0 percentage of participants Interval 23.0 to 50.9	58.3 percentage of participants Interval 44.4 to 72.3	60.0 percentage of participants Interval 45.7 to 74.3	—

SECONDARY outcome

Timeframe: Baseline and week 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:

• A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image with five response categories for each item (Never, Rarely, Sometimes, Often, Always)
• A supplemental questionnaire consisting of six additional questions which assess the areas of work, relationship with children, sexual intercourse, feelings about the medical profession, treatment, and infertility with the same five response categories plus an additional response category of Not Relevant which was not scored.

The scores associated with each possible outcome category are as follows: never (0), rarely (25), sometimes (50), often (75), and always (100). A negative change from baseline score indicates improvement in quality of life.

Outcome measures

Measure	Placebo n=52 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=51 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=51 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12 Pain	-11.8 units on a scale Standard Error 3.6	-25.0 units on a scale Standard Error 3.3	-17.3 units on a scale Standard Error 4.0	—
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12 Emotional Wellbeing	-6.6 units on a scale Standard Error 4.0	-17.2 units on a scale Standard Error 3.5	-9.5 units on a scale Standard Error 4.8	—
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12 Self-image	-9.9 units on a scale Standard Error 3.1	-18.9 units on a scale Standard Error 3.7	-10.7 units on a scale Standard Error 4.0	—
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12 Sexual Intercourse	-9.8 units on a scale Standard Error 4.6	-23.1 units on a scale Standard Error 3.9	-19.6 units on a scale Standard Error 5.5	—
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12 Medical Profession	0.0 units on a scale Standard Error 3.7	-17.5 units on a scale Standard Error 3.9	-14.0 units on a scale Standard Error 4.2	—
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12 Frustration with Treatment	-8.6 units on a scale Standard Error 4.7	-26.2 units on a scale Standard Error 4.2	-23.2 units on a scale Standard Error 5.4	—
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12 Concerns with Infertility	-9.8 units on a scale Standard Error 4.1	-5.1 units on a scale Standard Error 4.1	-9.1 units on a scale Standard Error 4.0	—
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12 Control and Powerlessness	-10.5 units on a scale Standard Error 4.7	-25.6 units on a scale Standard Error 3.4	-22.6 units on a scale Standard Error 4.8	—
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12 Social Support	-18.4 units on a scale Standard Error 4.2	-25.0 units on a scale Standard Error 4.1	-15.5 units on a scale Standard Error 4.8	—
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12 Work	-6.9 units on a scale Standard Error 4.2	-28.8 units on a scale Standard Error 3.9	-22.1 units on a scale Standard Error 3.2	—
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12 Relationship with Children	-7.0 units on a scale Standard Error 5.3	-25.0 units on a scale Standard Error 4.4	-20.3 units on a scale Standard Error 5.2	—

SECONDARY outcome

Timeframe: Baseline and week 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and with available BMD data at baseline and week 12.

Bone mineral density (BMD) of the femur (total hip) was measured by dual-energy X-ray absorptiometry (DXA).

Outcome measures

Measure	Placebo n=37 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=42 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=43 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Percent Change From Baseline in Bone Mineral Density of the Femur at Week 12	-0.283 percent change Standard Deviation 1.851	-0.294 percent change Standard Deviation 1.762	-0.382 percent change Standard Deviation 1.338	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and with available BMD data at baseline and week 24.

Bone mineral density (BMD) of the femur (total hip) was measured by dual-energy X-ray absorptiometry (DXA).

Outcome measures

Measure	Placebo n=37 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=37 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=13 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg n=17 Participants Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24	-0.743 percent change Standard Deviation 1.877	-1.024 percent change Standard Deviation 1.759	-0.924 percent change Standard Deviation 1.198	-0.076 percent change Standard Deviation 2.362

SECONDARY outcome

Timeframe: Baseline and week 12

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and with available BMD data at baseline and week 12.

Bone mineral density (BMD) of the spine was measured by dual-energy X-ray absorptiometry (DXA).

Outcome measures

Measure	Placebo n=36 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=43 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=42 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Percent Change From Baseline in Bone Mineral Density of the Spine at Week 12	0.375 percent change Standard Deviation 2.091	-0.045 percent change Standard Deviation 2.088	-0.937 percent change Standard Deviation 2.747	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: All randomized participants who received at least one dose of randomized, double-blind study drug and with available BMD data at baseline and week 24.

Bone mineral density (BMD) of the spine was measured by dual-energy X-ray absorptiometry (DXA).

Outcome measures

Measure	Placebo n=38 Participants Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.	Elagolix 150 mg n=37 Participants Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.	Elagolix 250 mg n=14 Participants Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.	Placebo / Elagolix 250 mg n=15 Participants Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24	-1.032 percent change Standard Deviation 1.983	-1.631 percent change Standard Deviation 2.874	-0.692 percent change Standard Deviation 1.724	0.681 percent change Standard Deviation 2.720

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Elagolix 150 mg

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Elagolix 250 mg

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=52 participants at risk Participants received elagolix 150 mg tablets once a day for 12 weeks.	Elagolix 150 mg n=69 participants at risk Participants initially randomized to elagolix 150 mg received elagolix 150 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg for an additional 12 weeks. Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 150 mg for 12 weeks.	Elagolix 250 mg n=72 participants at risk Participants initially randomized to elagolix 250 mg received elagolix 250 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks. Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS	0.00% 0/52 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	0.00% 0/69 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	1.4% 1/72 • Number of events 1 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.

Other adverse events

Measure	Placebo n=52 participants at risk Participants received elagolix 150 mg tablets once a day for 12 weeks.	Elagolix 150 mg n=69 participants at risk Participants initially randomized to elagolix 150 mg received elagolix 150 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg for an additional 12 weeks. Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 150 mg for 12 weeks.	Elagolix 250 mg n=72 participants at risk Participants initially randomized to elagolix 250 mg received elagolix 250 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks. Participants initially randomized to placebo were re-randomized at week 12 to receive elagolix 250 mg for 12 weeks.
Gastrointestinal disorders NAUSEA	1.9% 1/52 • Number of events 1 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	8.7% 6/69 • Number of events 7 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	8.3% 6/72 • Number of events 6 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.
Infections and infestations NASOPHARYNGITIS	5.8% 3/52 • Number of events 3 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	2.9% 2/69 • Number of events 4 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	4.2% 3/72 • Number of events 4 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.
Infections and infestations SINUSITIS	3.8% 2/52 • Number of events 2 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	8.7% 6/69 • Number of events 6 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	2.8% 2/72 • Number of events 2 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	5.8% 3/52 • Number of events 3 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	8.7% 6/69 • Number of events 6 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	5.6% 4/72 • Number of events 4 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.
Infections and infestations URINARY TRACT INFECTION	3.8% 2/52 • Number of events 2 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	7.2% 5/69 • Number of events 5 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	5.6% 4/72 • Number of events 4 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.
Infections and infestations VAGINAL MYCOSIS	5.8% 3/52 • Number of events 3 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	1.4% 1/69 • Number of events 1 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	8.3% 6/72 • Number of events 8 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.
Investigations BLOOD CHOLESTEROL INCREASED	0.00% 0/52 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	5.8% 4/69 • Number of events 4 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	0.00% 0/72 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.
Musculoskeletal and connective tissue disorders ARTHRALGIA	7.7% 4/52 • Number of events 5 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	4.3% 3/69 • Number of events 3 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	6.9% 5/72 • Number of events 5 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.
Musculoskeletal and connective tissue disorders BACK PAIN	3.8% 2/52 • Number of events 2 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	5.8% 4/69 • Number of events 4 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	2.8% 2/72 • Number of events 2 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.
Nervous system disorders HEADACHE	1.9% 1/52 • Number of events 1 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	8.7% 6/69 • Number of events 9 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	5.6% 4/72 • Number of events 12 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.
Nervous system disorders MIGRAINE	0.00% 0/52 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	4.3% 3/69 • Number of events 3 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	5.6% 4/72 • Number of events 4 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.
Skin and subcutaneous tissue disorders ACNE	1.9% 1/52 • Number of events 1 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	0.00% 0/69 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.	8.3% 6/72 • Number of events 6 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.

Additional Information

Global Medical Services

AbbVie

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