Trial Outcomes & Findings for Efficacy and Safety Study of Elagolix in Women With Endometriosis (NCT NCT00973973)

NCT ID: NCT00973973

Last Updated: 2018-09-26

Results Overview

Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day of their period in an electronic diary (e-Diary) according to the following response options: * 0 = No discomfort * 1 = Mild discomfort but I was easily able to do the things I usually do * 2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3 = Severe pain that made it difficult to do the things I usually do. The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 137 participants
• Primary outcome timeframe: Baseline and Weeks 4 and 8
• Results posted on: 2018-09-26

Participant Flow

Participants were enrolled at 37 centers in the United States.

The study consisted of up to 8 weeks of screening with data collection to establish baseline pain, an 8-week double-blind placebo-controlled treatment period, a 16-week open-label treatment period with all patients receiving elagolix 150 mg once per day, and a 6-week posttreatment follow-up period.

Participant milestones

Measure	Placebo Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Double-blind Treatment Phase (Weeks 1-8) STARTED	69	68
Double-blind Treatment Phase (Weeks 1-8) Received Study Drug	69	68
Double-blind Treatment Phase (Weeks 1-8) COMPLETED	63	60
Double-blind Treatment Phase (Weeks 1-8) NOT COMPLETED	6	8
Open-label Treatment Phase (Weeks 8-24) STARTED	63	60
Open-label Treatment Phase (Weeks 8-24) COMPLETED	57	55
Open-label Treatment Phase (Weeks 8-24) NOT COMPLETED	6	5

Reasons for withdrawal

Measure	Placebo Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Double-blind Treatment Phase (Weeks 1-8) Adverse Event	1	3
Double-blind Treatment Phase (Weeks 1-8) Protocol Deviation	1	0
Double-blind Treatment Phase (Weeks 1-8) Withdrawal by Subject	1	3
Double-blind Treatment Phase (Weeks 1-8) Lack of Efficacy	1	0
Double-blind Treatment Phase (Weeks 1-8) Lost to Follow-up	1	1
Double-blind Treatment Phase (Weeks 1-8) Sponsor/Investigator Decision	1	1
Open-label Treatment Phase (Weeks 8-24) Adverse Event	1	2
Open-label Treatment Phase (Weeks 8-24) Protocol Deviation	1	0
Open-label Treatment Phase (Weeks 8-24) Noncompliance	1	0
Open-label Treatment Phase (Weeks 8-24) Withdrawal by Subject	1	3
Open-label Treatment Phase (Weeks 8-24) Lost to Follow-up	1	0
Open-label Treatment Phase (Weeks 8-24) Sponsor/Investigator Decision	1	0

Baseline Characteristics

Efficacy and Safety Study of Elagolix in Women With Endometriosis

Baseline characteristics by cohort

Measure	Placebo n=69 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=68 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.	Total n=137 Participants Total of all reporting groups
Age, Continuous	33.0 years STANDARD_DEVIATION 0.9 • n=5 Participants	32.8 years STANDARD_DEVIATION 0.7 • n=7 Participants	32.9 years STANDARD_DEVIATION 0.6 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	68 Participants n=7 Participants	137 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized White	57 Participants n=5 Participants	55 Participants n=7 Participants	112 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Weeks 4 and 8

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). 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 of their period in an electronic diary (e-Diary) according to the following response options:

• 0 = No discomfort
• 1 = Mild discomfort but I was easily able to do the things I usually do
• 2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do
• 3 = Severe pain that made it difficult to do the things I usually do.

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=66 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=66 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Double-blind Treatment Phase Week 4	-0.24 units on a scale Standard Error 0.076	-0.49 units on a scale Standard Error 0.076
Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Double-blind Treatment Phase Week 8	-0.37 units on a scale Standard Error 0.107	-1.13 units on a scale Standard Error 0.107

PRIMARY outcome

Timeframe: Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. 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 of their period in an electronic diary (e-Diary) according to the following response options:

• 0 = No discomfort
• 1 = Mild discomfort but I was easily able to do the things I usually do
• 2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do
• 3 = Severe pain that made it difficult to do the things I usually do.

The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit, except for the week 30 value which is based on 6 weeks of data.

Outcome measures

Measure	Placebo n=61 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=60 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases Week 12	-0.768 units on a scale Standard Error 0.118	-1.060 units on a scale Standard Error 0.130
Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases Week 16	-1.325 units on a scale Standard Error 0.112	-1.022 units on a scale Standard Error 0.137
Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases Week 20	-1.026 units on a scale Standard Error 0.119	-0.991 units on a scale Standard Error 0.121
Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases Week 24	-1.282 units on a scale Standard Error 0.118	-1.372 units on a scale Standard Error 0.132
Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases Week 30	-0.547 units on a scale Standard Error 0.104	-0.534 units on a scale Standard Error 0.102

PRIMARY outcome

Timeframe: Baseline and weeks 4 and 8

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). 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 each day they were not having their period in an e-Diary according to the following response options:

• 0 = No discomfort
• 1 = Mild discomfort but I was easily able to do the things I usually do
• 2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do
• 3 = Severe pain that made it difficult to do the things I usually do.

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=66 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=66 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Double-Blind Treatment Phase Week 4	-0.05 units on a scale Standard Error 0.061	-0.26 units on a scale Standard Error 0.061
Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Double-Blind Treatment Phase Week 8	-0.19 units on a scale Standard Error 0.071	-0.47 units on a scale Standard Error 0.071

PRIMARY outcome

Timeframe: Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. 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 each day they were not having their period in an e-Diary according to the following response options:

• 0 = No discomfort
• 1 = Mild discomfort but I was easily able to do the things I usually do
• 2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do
• 3 = Severe pain that made it difficult to do the things I usually do.

The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each visit, except for the week 30 value which is based on 6 weeks of data.

Outcome measures

Measure	Placebo n=61 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=60 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Open-label and Posttreatment Phases Week 12	-0.355 units on a scale Standard Error 0.087	-0.727 units on a scale Standard Error 0.072
Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Open-label and Posttreatment Phases Week 16	-0.422 units on a scale Standard Error 0.078	-0.763 units on a scale Standard Error 0.079
Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Open-label and Posttreatment Phases Week 20	-0.524 units on a scale Standard Error 0.090	-0.759 units on a scale Standard Error 0.082
Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Open-label and Posttreatment Phases Week 24	-0.543 units on a scale Standard Error 0.092	-0.801 units on a scale Standard Error 0.082
Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Open-label and Posttreatment Phases Week 30	-0.326 units on a scale Standard Error 0.104	-0.689 units on a scale Standard Error 0.085

PRIMARY outcome

Timeframe: Baseline and weeks 4 and 8

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at each time point.

Participants assessed dysmenorrhea or non-menstrual pelvic pain at approximately the same time each day in an e-Diary according to the following:

• 0 = No discomfort
• 1 = Mild discomfort but I was easily able to do the things I usually do
• 2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do
• 3 = Severe pain that made it difficult to do the things I usually do.

The monthly mean cumulative pain score is the average of the daily values for all days (menstrual and non-menstrual) reported during the 4 weeks prior to each visit.

Outcome measures

Measure	Placebo n=66 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=66 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline in the Monthly Mean Cumulative Pain Score During the Double-Blind Treatment Phase Week 4	-0.11 units on a scale Standard Error 0.058	-0.32 units on a scale Standard Error 0.058
Change From Baseline in the Monthly Mean Cumulative Pain Score During the Double-Blind Treatment Phase Week 8	-0.21 units on a scale Standard Error 0.070	-0.55 units on a scale Standard Error 0.070

PRIMARY outcome

Timeframe: Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. The analysis includes participants with non-missing data at each time point.

Participants assessed dysmenorrhea or non-menstrual pelvic pain at approximately the same time each day in an e-Diary according to the following:

• 0: No discomfort
• 1: Mild discomfort, I was easily able to do the things I usually do
• 2: Moderate discomfort or pain making it difficult to do some of the things I usually do
• 3: Severe pain making it difficult to do the things I usually do

The monthly mean cumulative pain score is the average of the daily values for all days (menstrual and non-menstrual) reported during the 4 weeks prior to each visit, except for the week 30 value which is based on 6 weeks of data.

Outcome measures

Measure	Placebo n=61 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=60 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline in the Monthly Mean Cumulative Pain Score During the Open-label and Posttreatment Phases Week 12	-0.433 units on a scale Standard Error 0.082	-0.781 units on a scale Standard Error 0.070
Change From Baseline in the Monthly Mean Cumulative Pain Score During the Open-label and Posttreatment Phases Week 16	-0.530 units on a scale Standard Error 0.072	-0.793 units on a scale Standard Error 0.083
Change From Baseline in the Monthly Mean Cumulative Pain Score During the Open-label and Posttreatment Phases Week 20	-0.615 units on a scale Standard Error 0.085	-0.798 units on a scale Standard Error 0.081
Change From Baseline in the Monthly Mean Cumulative Pain Score During the Open-label and Posttreatment Phases Week 24	-0.655 units on a scale Standard Error 0.088	-0.878 units on a scale Standard Error 0.082
Change From Baseline in the Monthly Mean Cumulative Pain Score During the Open-label and Posttreatment Phases Week 30	-0.374 units on a scale Standard Error 0.095	-0.666 units on a scale Standard Error 0.085

PRIMARY outcome

Timeframe: Baseline and weeks 4 and 8

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with non-missing data at each time point. If a participant's responses were all "does not apply" for that month the score was treated as missing.

Participants assessed their dyspareunia (pain during sexual intercourse) at approximately the same time every day in an e-Diary according to the following response options:

• 0 = Absent; No discomfort during sexual intercourse
• 1 = Mild; I was able to tolerate the discomfort during sexual intercourse
• 2 = Moderate; Intercourse was interrupted due to pain
• 3 = Severe; I avoided intercourse because of pain
• Does not apply; I was not sexually active for reasons other than my endometriosis or did not have sexual intercourse

The monthly mean dyspareunia score is the average of the daily values reported during the 4 weeks prior to each visit. Responses of "does not apply" were not included in the calculations.

Outcome measures

Measure	Placebo n=59 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=53 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline in the Monthly Mean Dyspareunia Score During the Double-Blind Treatment Phase Week 4	-0.07 units on a scale Standard Error 0.087	-0.34 units on a scale Standard Error 0.091
Change From Baseline in the Monthly Mean Dyspareunia Score During the Double-Blind Treatment Phase Week 8	-0.23 units on a scale Standard Error 0.095	-0.61 units on a scale Standard Error 0.098

PRIMARY outcome

Timeframe: Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)

Population: Randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12 and non-missing data at each time point. If a participant's responses were all "does not apply" for that month the score was treated as missing.

Participants assessed their dyspareunia (pain during sexual intercourse) at approximately the same time every day in an e-Diary according to the following response options:

• 0: Absent; No discomfort during sexual intercourse
• 1: Mild; I was able to tolerate the discomfort during sexual intercourse
• 2: Moderate; Intercourse was interrupted due to pain
• 3: Severe; I avoided intercourse because of pain
• Does not apply; I was not sexually active for reasons other than my endometriosis or did not have sexual intercourse

The monthly mean dyspareunia score is the average of the daily values reported during the 4 weeks prior to each visit, except for week 30 which is based on 6 weeks of data. Responses of "does not apply" were not included in the calculations.

Outcome measures

Measure	Placebo n=53 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=47 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline in the Monthly Mean Dyspareunia Score During the Open-label and Posttreatment Phases Week 12	-0.334 units on a scale Standard Error 0.125	-0.696 units on a scale Standard Error 0.112
Change From Baseline in the Monthly Mean Dyspareunia Score During the Open-label and Posttreatment Phases Week 16	-0.453 units on a scale Standard Error 0.114	-0.738 units on a scale Standard Error 0.124
Change From Baseline in the Monthly Mean Dyspareunia Score During the Open-label and Posttreatment Phases Week 20	-0.492 units on a scale Standard Error 0.135	-0.778 units on a scale Standard Error 0.121
Change From Baseline in the Monthly Mean Dyspareunia Score During the Open-label and Posttreatment Phases Week 24	-0.633 units on a scale Standard Error 0.155	-0.789 units on a scale Standard Error 0.115
Change From Baseline in the Monthly Mean Dyspareunia Score During the Open-label and Posttreatment Phases Week 30	-0.300 units on a scale Standard Error 0.118	-0.730 units on a scale Standard Error 0.118

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with non-missing data at baseline and week 8.

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

• 0: No discomfort
• 1: Mild discomfort but I was easily able to do the things I usually do
• 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
• 3: Severe pain that made it difficult to do the things I usually do.

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

Response was defined as the percentage of participants with a percent decrease from baseline in the week 8 monthly mean score that was greater than or equal to each specified threshold value (10% through 90% in steps of 10%).

Outcome measures

Measure	Placebo n=64 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=64 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Percentage of Participants With a Response in Monthly Mean Dysmenorrhea Score at Week 8 10% Reduction	56.3 percentage of participants	68.8 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dysmenorrhea Score at Week 8 20% Reduction	43.8 percentage of participants	68.8 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dysmenorrhea Score at Week 8 30% Reduction	32.8 percentage of participants	62.5 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dysmenorrhea Score at Week 8 40% Reduction	25.0 percentage of participants	59.4 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dysmenorrhea Score at Week 8 50% Reduction	15.6 percentage of participants	54.7 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dysmenorrhea Score at Week 8 60% Reduction	9.4 percentage of participants	51.6 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dysmenorrhea Score at Week 8 70% Reduction	4.7 percentage of participants	46.9 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dysmenorrhea Score at Week 8 80% Reduction	3.1 percentage of participants	43.8 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dysmenorrhea Score at Week 8 90% Reduction	3.1 percentage of participants	43.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with non-missing data at baseline and week 8.

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

• 0 = No discomfort
• 1 = Mild discomfort but I was easily able to do the things I usually do
• 2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do
• 3 = Severe pain that made it difficult to do the things I usually do.

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

Response is defined as the percentage of participants with a percent decrease from baseline in the week 8 monthly mean score that was greater than or equal to each specified threshold value (10% through 90% in steps of 10%).

Outcome measures

Measure	Placebo n=64 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=64 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Percentage of Participants With a Response in Monthly Mean Non-menstrual Pelvic Pain Score at Week 8 10% Reduction	51.6 percentage of participants	79.7 percentage of participants
Percentage of Participants With a Response in Monthly Mean Non-menstrual Pelvic Pain Score at Week 8 20% Reduction	40.6 percentage of participants	68.8 percentage of participants
Percentage of Participants With a Response in Monthly Mean Non-menstrual Pelvic Pain Score at Week 8 30% Reduction	32.8 percentage of participants	62.5 percentage of participants
Percentage of Participants With a Response in Monthly Mean Non-menstrual Pelvic Pain Score at Week 8 40% Reduction	25.0 percentage of participants	51.6 percentage of participants
Percentage of Participants With a Response in Monthly Mean Non-menstrual Pelvic Pain Score at Week 8 50% Reduction	25.0 percentage of participants	32.8 percentage of participants
Percentage of Participants With a Response in Monthly Mean Non-menstrual Pelvic Pain Score at Week 8 60% Reduction	20.3 percentage of participants	26.6 percentage of participants
Percentage of Participants With a Response in Monthly Mean Non-menstrual Pelvic Pain Score at Week 8 70% Reduction	14.1 percentage of participants	21.9 percentage of participants
Percentage of Participants With a Response in Monthly Mean Non-menstrual Pelvic Pain Score at Week 8 80% Reduction	9.4 percentage of participants	10.9 percentage of participants
Percentage of Participants With a Response in Monthly Mean Non-menstrual Pelvic Pain Score at Week 8 90% Reduction	4.7 percentage of participants	7.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with non-missing data at baseline and week 8.

Participants assessed dysmenorrhea or non-menstrual pelvic pain at approximately the same time every day in an e-Diary according to the following:

• 0 = No discomfort
• 1 = Mild discomfort
• 2 = Moderate discomfort or pain
• 3 = Severe pain

The monthly mean cumulative pain score is the average of the daily values for all days (menstrual and non-menstrual) in the 4 weeks prior to each time point.

Response is the percentage of participants with a percent decrease from baseline in the week 8 monthly mean score that was greater than or equal to each specified threshold value (10% through 90% in steps of 10%).

Outcome measures

Measure	Placebo n=64 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=64 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Percentage of Participants With a Response in Monthly Mean Cumulative Pain Score at Week 8 50% Reduction	20.3 percentage of participants	37.5 percentage of participants
Percentage of Participants With a Response in Monthly Mean Cumulative Pain Score at Week 8 60% Reduction	15.6 percentage of participants	26.6 percentage of participants
Percentage of Participants With a Response in Monthly Mean Cumulative Pain Score at Week 8 70% Reduction	7.8 percentage of participants	18.8 percentage of participants
Percentage of Participants With a Response in Monthly Mean Cumulative Pain Score at Week 8 80% Reduction	3.1 percentage of participants	9.4 percentage of participants
Percentage of Participants With a Response in Monthly Mean Cumulative Pain Score at Week 8 90% Reduction	0.0 percentage of participants	9.4 percentage of participants
Percentage of Participants With a Response in Monthly Mean Cumulative Pain Score at Week 8 10% Reduction	51.6 percentage of participants	76.6 percentage of participants
Percentage of Participants With a Response in Monthly Mean Cumulative Pain Score at Week 8 20% Reduction	40.6 percentage of participants	70.3 percentage of participants
Percentage of Participants With a Response in Monthly Mean Cumulative Pain Score at Week 8 30% Reduction	37.5 percentage of participants	59.4 percentage of participants
Percentage of Participants With a Response in Monthly Mean Cumulative Pain Score at Week 8 40% Reduction	23.4 percentage of participants	46.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with non-missing data at baseline and week 8. If a participant's responses were all "does not apply" for that month the score was treated as missing.

Participants assessed their dyspareunia (pain during sexual intercourse) at approximately the same time every day in an e-Diary according to the following response options:

• 0 = Absent; No discomfort during sexual intercourse
• 1 = Mild; I was able to tolerate the discomfort during sexual intercourse
• 2 = Moderate; Intercourse was interrupted due to pain
• 3 = Severe; I avoided intercourse because of pain
• Does not apply; I was not sexually active for reasons other than my endometriosis or did not have sexual intercourse

The monthly mean dyspareunia score is the average of the daily values reported during the 4 weeks prior to each time point.

Response is defined as the percentage of participants with a percent decrease from baseline in the week 8 monthly mean score that was greater than or equal to each specified threshold value (10% through 90% in steps of 10%).

Outcome measures

Measure	Placebo n=47 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=45 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Percentage of Participants With a Response in Monthly Mean Dyspareunia Score at Week 8 10% Reduction	44.7 percentage of participants	73.3 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dyspareunia Score at Week 8 20% Reduction	38.3 percentage of participants	64.4 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dyspareunia Score at Week 8 30% Reduction	34.0 percentage of participants	57.8 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dyspareunia Score at Week 8 40% Reduction	27.7 percentage of participants	53.3 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dyspareunia Score at Week 8 50% Reduction	23.4 percentage of participants	48.9 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dyspareunia Score at Week 8 60% Reduction	19.1 percentage of participants	37.8 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dyspareunia Score at Week 8 70% Reduction	19.1 percentage of participants	31.1 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dyspareunia Score at Week 8 80% Reduction	17.0 percentage of participants	22.2 percentage of participants
Percentage of Participants With a Response in Monthly Mean Dyspareunia Score at Week 8 90% Reduction	12.8 percentage of participants	20.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4 and 8

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). 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=66 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=66 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline in the Percentage of Days of Any Analgesic Use During the Double-Blind Treatment Phase Week 4	-5.78 percentage of days Standard Error 2.782	-15.62 percentage of days Standard Error 2.782
Change From Baseline in the Percentage of Days of Any Analgesic Use During the Double-Blind Treatment Phase Week 8	-9.19 percentage of days Standard Error 2.763	-21.63 percentage of days Standard Error 2.763

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. 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 (except for week 30 which is based on 6 weeks of data) 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=61 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=60 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline in the Percentage of Days of Any Analgesic Use During the Open-Label and Posttreatment Phases Week 12	-14.91 percentage of days Standard Error 3.76	-27.70 percentage of days Standard Error 3.49
Change From Baseline in the Percentage of Days of Any Analgesic Use During the Open-Label and Posttreatment Phases Week 16	-18.34 percentage of days Standard Error 3.33	-26.27 percentage of days Standard Error 3.71
Change From Baseline in the Percentage of Days of Any Analgesic Use During the Open-Label and Posttreatment Phases Week 20	-19.82 percentage of days Standard Error 4.05	-26.35 percentage of days Standard Error 4.27
Change From Baseline in the Percentage of Days of Any Analgesic Use During the Open-Label and Posttreatment Phases Week 24	-20.63 percentage of days Standard Error 4.17	-29.21 percentage of days Standard Error 4.23
Change From Baseline in the Percentage of Days of Any Analgesic Use During the Open-Label and Posttreatment Phases Week 30	-11.64 percentage of days Standard Error 4.18	-21.83 percentage of days Standard Error 4.30

SECONDARY outcome

Timeframe: Baseline and Weeks 4 and 8

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). 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=66 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=66 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline in the Percentage of Days of Prescription Analgesic Use During the Double-Blind Treatment Phase Week 4	0.92 percentage of days Standard Error 1.929	-5.29 percentage of days Standard Error 1.929
Change From Baseline in the Percentage of Days of Prescription Analgesic Use During the Double-Blind Treatment Phase Week 8	-0.82 percentage of days Standard Error 1.802	-7.16 percentage of days Standard Error 1.802

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. 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 (except for week 30 which is based on 6 weeks of data) 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=61 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=60 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline in the Percentage of Days of Prescription Analgesic Use During the Open-Label and Posttreatment Phases Week 12	-2.34 percentage of days Standard Error 2.70	-8.53 percentage of days Standard Error 1.66
Change From Baseline in the Percentage of Days of Prescription Analgesic Use During the Open-Label and Posttreatment Phases Week 16	-5.52 percentage of days Standard Error 2.26	-7.52 percentage of days Standard Error 1.67
Change From Baseline in the Percentage of Days of Prescription Analgesic Use During the Open-Label and Posttreatment Phases Week 20	-5.21 percentage of days Standard Error 2.78	-6.06 percentage of days Standard Error 2.31
Change From Baseline in the Percentage of Days of Prescription Analgesic Use During the Open-Label and Posttreatment Phases Week 24	-5.89 percentage of days Standard Error 2.56	-7.83 percentage of days Standard Error 1.89
Change From Baseline in the Percentage of Days of Prescription Analgesic Use During the Open-Label and Posttreatment Phases Week 30	-0.72 percentage of days Standard Error 3.07	-6.06 percentage of days Standard Error 2.26

SECONDARY outcome

Timeframe: Baseline and Weeks 4 and 8

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). 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=66 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=66 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline in the Percentage of Days of Narcotic Analgesic Use During the Double-Blind Treatment Phase Week 4	-0.51 percentage of days Standard Error 1.287	-3.63 percentage of days Standard Error 1.287
Change From Baseline in the Percentage of Days of Narcotic Analgesic Use During the Double-Blind Treatment Phase Week 8	-1.19 percentage of days Standard Error 1.369	-4.71 percentage of days Standard Error 1.369

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. 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 (except for week 30 which is based on 6 weeks of data) 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=61 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=60 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline in the Percentage of Days of Narcotic Analgesic Use During the Open-Label and Posttreatment Phases Week 12	-1.91 percentage of days Standard Error 2.16	-4.79 percentage of days Standard Error 1.25
Change From Baseline in the Percentage of Days of Narcotic Analgesic Use During the Open-Label and Posttreatment Phases Week 16	-4.03 percentage of days Standard Error 1.76	-3.64 percentage of days Standard Error 1.27
Change From Baseline in the Percentage of Days of Narcotic Analgesic Use During the Open-Label and Posttreatment Phases Week 20	-2.79 percentage of days Standard Error 2.24	-5.41 percentage of days Standard Error 1.64
Change From Baseline in the Percentage of Days of Narcotic Analgesic Use During the Open-Label and Posttreatment Phases Week 24	-3.12 percentage of days Standard Error 2.20	-3.92 percentage of days Standard Error 1.68
Change From Baseline in the Percentage of Days of Narcotic Analgesic Use During the Open-Label and Posttreatment Phases Week 30	0.75 percentage of days Standard Error 2.73	-3.56 percentage of days Standard Error 1.69

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at baseline and week 8.

The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).

Dysmenorrhea, dyspareunia, and non-menstrual pelvic pain scores are based on the participant's assessment of symptoms during the past 28 days; pelvic tenderness and induration were assessed by the investigator based on findings associated with a pelvic examination.

The total CPSSS has a maximum possible value of 15 (total score range: 0 to 15, where a lower score indicates less signs and symptoms of endometriosis or better functioning). Individual component scores range from 0 (absent) to 3 (severe).

Outcome measures

Measure	Placebo n=66 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=66 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline to the End of the Double-blind Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores Total Score	-2.19 units on a scale Standard Error 0.359	-4.45 units on a scale Standard Error 0.356
Change From Baseline to the End of the Double-blind Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores Dysmenorrhea Component	-0.39 units on a scale Standard Error 0.127	-1.44 units on a scale Standard Error 0.127
Change From Baseline to the End of the Double-blind Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores Non-menstrual Pelvic Pain Component	-0.54 units on a scale Standard Error 0.101	-0.90 units on a scale Standard Error 0.101
Change From Baseline to the End of the Double-blind Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores Dyspareunia Component	-0.46 units on a scale Standard Error 0.123	-0.74 units on a scale Standard Error 0.121
Change From Baseline to the End of the Double-blind Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores Pelvic Tenderness Component	-0.41 units on a scale Standard Error 0.102	-0.80 units on a scale Standard Error 0.101
Change From Baseline to the End of the Double-blind Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores Pelvic Induration Component	-0.38 units on a scale Standard Error 0.089	-0.66 units on a scale Standard Error 0.088

SECONDARY outcome

Timeframe: Baseline and week 24

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 24. The analysis includes participants with non-missing data for each component at baseline and week 24.

The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).

Dysmenorrhea, dyspareunia, and non-menstrual pelvic pain scores are based on the participant's assessment of symptoms during the past 28 days; pelvic tenderness and induration were assessed by the investigator based on findings associated with a pelvic examination.

The total CPSSS has a maximum possible value of 15 (total score range: 0 to 15, where a lower score indicates less signs and symptoms of endometriosis or better functioning). Individual component scores range from 0 (absent) to 3 (severe).

Outcome measures

Measure	Placebo n=57 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=57 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline to the End of the Open-label Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores Total Score	-5.571 units on a scale Standard Error 0.451	-5.404 units on a scale Standard Error 0.384
Change From Baseline to the End of the Open-label Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores Dysmenorrhea Component	-1.544 units on a scale Standard Error 0.175	-1.386 units on a scale Standard Error 0.175
Change From Baseline to the End of the Open-label Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores Non-menstrual Pelvic Pain Component	-1.000 units on a scale Standard Error 0.128	-1.211 units on a scale Standard Error 0.127
Change From Baseline to the End of the Open-label Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores Dyspareunia Component	-1.12 units on a scale Standard Error 0.17	-0.77 units on a scale Standard Error 0.16
Change From Baseline to the End of the Open-label Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores Pelvic Tenderness Component	-1.000 units on a scale Standard Error 0.120	-1.175 units on a scale Standard Error 0.112
Change From Baseline to the End of the Open-label Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores Pelvic Induration Component	-0.964 units on a scale Standard Error 0.142	-0.807 units on a scale Standard Error 0.121

SECONDARY outcome

Timeframe: Weeks 4 and 8

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). 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=66 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=66 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Patient Global Impression of Change During the Double-blind Treatment Phase Week 4	3.6 units on a scale Standard Error 0.16	2.8 units on a scale Standard Error 0.16
Patient Global Impression of Change During the Double-blind Treatment Phase Week 8	3.4 units on a scale Standard Error 0.18	2.4 units on a scale Standard Error 0.18

SECONDARY outcome

Timeframe: Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. 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=61 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=60 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Patient Global Impression of Change During the Open-Label and Posttreatment Phases Week 12	2.5 units on a scale Standard Error 0.2	2.0 units on a scale Standard Error 0.1
Patient Global Impression of Change During the Open-Label and Posttreatment Phases Week 16	2.4 units on a scale Standard Error 0.2	1.8 units on a scale Standard Error 0.1
Patient Global Impression of Change During the Open-Label and Posttreatment Phases Week 20	2.2 units on a scale Standard Error 0.2	2.0 units on a scale Standard Error 0.1
Patient Global Impression of Change During the Open-Label and Posttreatment Phases Week 24	2.0 units on a scale Standard Error 0.2	1.8 units on a scale Standard Error 0.1
Patient Global Impression of Change During the Open-Label and Posttreatment Phases Week 30	2.4 units on a scale Standard Error 0.2	2.2 units on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: Weeks 4 and 8

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). 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=66 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=66 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved During the Double-blind Treatment Phase Week 4	18.5 percentage of participants Interval 9.0 to 27.9	37.9 percentage of participants Interval 26.2 to 49.6
Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved During the Double-blind Treatment Phase Week 8	30.2 percentage of participants Interval 18.8 to 41.5	60.3 percentage of participants Interval 48.2 to 72.4

SECONDARY outcome

Timeframe: Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. 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=61 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=60 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved During the Open-label Treatment Phase Week 20	71.9 percentage of participants	71.9 percentage of participants
Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved During the Open-label Treatment Phase Week 12	59.0 percentage of participants	76.3 percentage of participants
Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved During the Open-label Treatment Phase Week 16	61.7 percentage of participants	76.3 percentage of participants
Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved During the Open-label Treatment Phase Week 24	73.7 percentage of participants	86.0 percentage of participants
Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved During the Open-label Treatment Phase Week 30	69.1 percentage of participants	73.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline and week 8

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at baseline and week 8 for each question.

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 impact of endometriosis in 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 impact of endometriosis on 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=63 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=63 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline to the End of the Double-blind Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Pain	-12.3 units on a scale Standard Error 3.2	-29.0 units on a scale Standard Error 3.0
Change From Baseline to the End of the Double-blind Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Control and Powerlessness	-12.7 units on a scale Standard Error 3.2	-35.3 units on a scale Standard Error 3.7
Change From Baseline to the End of the Double-blind Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Emotional Well-being	-10.3 units on a scale Standard Error 2.9	-17.1 units on a scale Standard Error 3.1
Change From Baseline to the End of the Double-blind Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Social Support	-13.1 units on a scale Standard Error 3.5	-27.8 units on a scale Standard Error 3.9
Change From Baseline to the End of the Double-blind Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Self-image	-7.1 units on a scale Standard Error 3.3	-23.4 units on a scale Standard Error 3.5
Change From Baseline to the End of the Double-blind Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Work	-13.0 units on a scale Standard Error 3.4	-26.4 units on a scale Standard Error 3.4
Change From Baseline to the End of the Double-blind Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Relationship with Children	-19.0 units on a scale Standard Error 4.8	-31.5 units on a scale Standard Error 5.5
Change From Baseline to the End of the Double-blind Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Sexual Intercourse	-14.3 units on a scale Standard Error 2.9	-22.6 units on a scale Standard Error 3.8
Change From Baseline to the End of the Double-blind Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Medical Profession	-9.5 units on a scale Standard Error 2.9	-11.5 units on a scale Standard Error 3.3
Change From Baseline to the End of the Double-blind Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Frustration with Treatment	-20.8 units on a scale Standard Error 5.1	-36.5 units on a scale Standard Error 4.6
Change From Baseline to the End of the Double-blind Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Concerns with Infertility	-10.6 units on a scale Standard Error 3.6	-14.1 units on a scale Standard Error 3.3

SECONDARY outcome

Timeframe: Baseline and week 24

Population: All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. The analysis includes participants with non-missing data at baseline and week 24 for each question.

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 impact of endometriosis on 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 impact of endometriosis on 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=61 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=60 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Change From Baseline to the End of the Open-label Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Pain	-30.3 units on a scale Standard Error 3.9	-36.4 units on a scale Standard Error 2.9
Change From Baseline to the End of the Open-label Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Control and Powerlessness	-35.1 units on a scale Standard Error 4.3	-39.5 units on a scale Standard Error 3.5
Change From Baseline to the End of the Open-label Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Emotional Well-being	-22.8 units on a scale Standard Error 4.0	-23.7 units on a scale Standard Error 3.3
Change From Baseline to the End of the Open-label Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Social Support	-29.8 units on a scale Standard Error 4.5	-37.7 units on a scale Standard Error 4.1
Change From Baseline to the End of the Open-label Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Self-image	-20.6 units on a scale Standard Error 4.3	-25.9 units on a scale Standard Error 3.9
Change From Baseline to the End of the Open-label Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Work	-27.6 units on a scale Standard Error 4.4	-37.0 units on a scale Standard Error 3.1
Change From Baseline to the End of the Open-label Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Relationship with Children	-39.6 units on a scale Standard Error 5.4	-40.0 units on a scale Standard Error 4.2
Change From Baseline to the End of the Open-label Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Sexual Intercourse	-30.1 units on a scale Standard Error 3.9	-27.2 units on a scale Standard Error 4.0
Change From Baseline to the End of the Open-label Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Medical Profession	-16.8 units on a scale Standard Error 4.5	-19.6 units on a scale Standard Error 3.9
Change From Baseline to the End of the Open-label Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Frustration with Treatment	-40.1 units on a scale Standard Error 5.5	-40.6 units on a scale Standard Error 4.4
Change From Baseline to the End of the Open-label Treatment Phase in Endometriosis Health Profile-5 (EHP-5) Concerns with Infertility	-20.8 units on a scale Standard Error 5.0	-22.8 units on a scale Standard Error 3.8

SECONDARY outcome

Timeframe: Screening (8 weeks prior to day 1) and the double-blind treatment phase (Weeks 1-8)

Population: Participants who received at least one dose of randomized, double-blind study drug (safety analysis set) with non-missing data.

Uterine bleeding was reported daily by participants during the study using the e-Diary.

The percentage of days a participant reported any bleeding was calculated as the total number of days the participant reported any bleeding ( light, moderate, or heavy) divided by the total number of days the participant had a non-missing e-Diary report of vaginal bleeding in the phase.

Outcome measures

Measure	Placebo n=69 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=68 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Percentage of Days With Uterine Bleeding During the Double- Blind Treatment Phase Screening	24.29 percentage of days Standard Error 0.96	22.98 percentage of days Standard Error 1.12
Percentage of Days With Uterine Bleeding During the Double- Blind Treatment Phase Double-Blind Treatment Phase (Weeks 1-8)	23.91 percentage of days Standard Error 1.62	14.00 percentage of days Standard Error 1.03

SECONDARY outcome

Timeframe: From last day of study drug up to 6 weeks after the last dose.

Population: Participants who received at least one dose of randomized, double-blind study drug (safety analysis set) with non-missing post-treatment data.

Defined as the number of days from the last dose of study drug until the start date of the first post-treatment menses.

Outcome measures

Measure	Placebo n=56 Participants Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.	Elagolix 150 mg n=58 Participants Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
Number of Days to First Posttreatment Menses	22.0 days Interval 1.0 to 40.0	25.0 days Interval 3.0 to 45.0

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Elagolix

Serious events: 1 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=69 participants at risk Participants received placebo orally once a day for 8 weeks during the double-blind treatment period.	Elagolix n=131 participants at risk Participants initially randomized to elagolix received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period. Participants originally randomized to placebo were switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.
Gastrointestinal disorders ABDOMINAL PAIN LOWER	0.00% 0/69 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.	0.76% 1/131 • Number of events 1 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.
Nervous system disorders CONVULSION	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 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.	0.00% 0/131 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS	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 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.	0.00% 0/131 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.
Psychiatric disorders DEPRESSION SUICIDAL	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 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.	0.00% 0/131 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.

Other adverse events

Measure	Placebo n=69 participants at risk Participants received placebo orally once a day for 8 weeks during the double-blind treatment period.	Elagolix n=131 participants at risk Participants initially randomized to elagolix received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period. Participants originally randomized to placebo were switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.
Gastrointestinal disorders NAUSEA	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 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.	9.9% 13/131 • Number of events 13 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.
Infections and infestations NASOPHARYNGITIS	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 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.	5.3% 7/131 • Number of events 7 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.
Infections and infestations SINUSITIS	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 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.	6.1% 8/131 • Number of events 9 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	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 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.	6.1% 8/131 • Number of events 10 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.
Nervous system disorders HEADACHE	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 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.	9.9% 13/131 • Number of events 20 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.
Vascular disorders HOT FLUSH	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 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.	9.9% 13/131 • Number of events 13 • From the first dose of any study drug through week 24. The Placebo treatment group includes data for the 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.

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