A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain

• Sponsor: AbbVie (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03343067
• Collaborator: (none)
• Enrollment: 11
• Locations: 37
• Arms: 4
• Actual Duration (Months): 9.9
• Patients Per Site: 0.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both elagolix alone and elagolix plus estradiol/norethindrone acetate (E2/NETA) over 24 months in the management of endometriosis with associated moderate to severe pain in premenopausal women.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: elagolix; Drug: estradiol/norethindrone acetate (E2/NETA)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Study to Evaluate Safety and Efficacy of Elagolix Alone or Elagolix With Hormonal Add-Back in Subjects With Endometriosis With Associated Moderate to Severe Pain
• Actual Study Start Date: Dec 27, 2017
• Actual Primary Completion Date: Oct 23, 2018
• Actual Study Completion Date: Oct 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 24 (Double-Blind): Efficacy responders to elagolix 150 mg QD at Month 3 and continue treatment through Month 24	Drug: elagolix; Tablets
Experimental: Arm C Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 24 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group and continue treatment through Month 24.	Drug: elagolix; Tablets; Drug: estradiol/norethindrone acetate (E2/NETA); Capsules
Experimental: Arm D Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 150 mg QD treatment group Month 7 Through Month 24 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 6 and assigned to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group and continue treatment through Month 24.	Drug: elagolix; Tablets; Drug: estradiol/norethindrone acetate (E2/NETA); Capsules
Experimental: Arm B Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 150 mg QD treatment group Month 7 Through Month 24 (Double-Blind): Efficacy responders to elagolix 150 mg QD at Month 6 and continue treatment through Month 24.	Drug: elagolix; Tablets

Outcome Measures

Primary Outcome Measures

1. Proportion of Responders at Month 6 Based on DYS Pain Scale [Month 6]

   Proportion of responders at Month 6 based upon the scale for DYS pain scale (ranging from 0 [none] to 3 [severe]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain.

2. Proportion of Responders at Month 6 Based on NMPP Pain Scale [Month 6]

   Proportion of responders at Month 6 based upon the scale for NMPP pain scale (ranging from 0 [none] to 3 [severe]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain.

Secondary Outcome Measures

1. Change From Baseline in DYS at Month 6 [Month 0 (baseline), Month 6]

   The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.

2. Change From Baseline in NMPP at Month 6 [Month 0 (baseline), Month 6]

   The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.

3. Change From Baseline in Dyspareunia at Month 6 [Month 0 (baseline), Month 6]

   The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.

4. Change From Baseline in Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS) at Month 6 [Month 0 (baseline), Month 6]

   The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.

5. Change From Baseline in Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) at Month 6 [Month 0 (baseline), Month 6]

   Based on average pill counts and assessed using the daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.

6. Percentage of Participants With 30% or More Reduction From Baseline Based on the 35 Day Mean of the Daily Diary Endometriosis-Associated Pain Score Via NRS at Month 6 [Month 6]

   The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window.

7. Proportion of Responders Over Time [Month 0 (baseline), Months 1, 2, 3, 4, 5, 6]

   As assessed by change and percent change from baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively.

8. Proportion of Responders Over Time (Not Taking Into Consideration of Analgesic Use) [Month 0 (baseline), Months 1, 2, 3, 4, 5, 6]

   As assessed by change and percent change from Baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively.

9. Change From Baseline Over Time in Monthly Average DYS Pain Score [Month 0 (baseline), Months 1, 2, 3, 4, 5, 6]

   The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. The analysis was based on a 28-day window. If a participant prematurely discontinued during the open-label period, based on the analysis window, some data might fall into Month 4 analysis.

10. Change From Baseline Over Time in Monthly Average NMPP Pain Score [Month 0 (baseline), Months 1, 2, 3, 4, 5, 6]

    The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.

11. Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score [Month 0 (baseline), Months 1, 2, 3, 4, 5, 6]

    The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.

12. Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS [Month 0 (baseline), Months 1, 2, 3, 4, 5, 6]

    The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.

13. Percent Change From Baseline to Each Month During the Treatment Period for DYS [Month 0 (baseline), Months 1, 2, 3, 4, 5, 6]

    The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.

14. Percent Change From Baseline to Each Month During the Treatment Period for NMPP [Month 0 (baseline), Months 1, 2, 3, 4, 5, 6]

    The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.

15. Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia [Month 0 (baseline), Months 1, 2, 3, 4, 5, 6]

    The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.

16. Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS [Month 0 (baseline), Months 1, 2, 3, 4, 5, 6]

    The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.

17. Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics [Month 0 (baseline), Months 1, 2, 3, 4, 5, 6]

    Based on average pill counts and assessed using a daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.

18. Number of Analgesic Use Responders and Non-Responders Over Time [Months 1, 2, 3, 4, 5, 6]

    Based only on reduction of rescue analgesics used. Responders were defined as: participants with no analgesic use at screening and no analgesic use added participants with NSAID only use at screening and NSAID dose stopped, decreased, or stable (<15% increase) and no opioid use added participants with opioid only use at screening and opioid dose stopped, decreased, or stable (<15% increase), opioid dose stopped and NSAID substituted (any dose), opioid dose decreased and NSAID added (any dose) participants with NSAID + opioid use at screening and any of the following: NSAID dose stopped + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose decreased + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose stable (< 15% increase) + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose increased by >15% + opioid analgesic use stopped; NSAID dose increased by >15% + opioid analgesic dose decreases.

19. Patient Global Impression of Change (PGIC) Scores Over Time [Months 1, 2, 3, 4, 5, 6]

    The PGIC is a 7-point response scale where participants rate their endometriosis related pain as: very much improved (1), much improved (2), minimally improved (3), not changed (4), minimally worse (5), much worse (6), very much worse (7).

20. Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time [Month 0 (baseline), Months 1, 2, 3, 4, 5, 6]

    The endometriosis-associated pain questionnaire is an 11-point NRS assessing overall endometriosis-associated pain over a 7-day recall period. Participants assessed their endometriosis-associated pain on a scale of 0 to 10, with 0 = no pain and 10 = worst pain ever.

21. Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain [Month 0 (baseline), Months 3, 6]

    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.

22. EHP-30 Scores Over Time: Control and Powerlessness [Month 0 (baseline), Months 3, 6]

    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.

23. EHP-30 Scores Over Time: Emotional Well-Being [Month 0 (baseline), Months 3, 6]

    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.

24. EHP-30 Scores Over Time: Social Support [Month 0 (baseline), Months 3, 6]

    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.

25. EHP-30 Scores Over Time: Self-Image [Month 0 (baseline), Months 3, 6]

    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.

26. EHP-30 Scores Over Time: Sexual Intercourse [Month 0 (baseline), Months 3, 6]

    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.

27. EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility [Month 0 (baseline), Months 3, 6]

    The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).

28. EQ-5D-5L Scores Over Time: Self-Care [Month 0 (baseline), Months 3, 6]

    The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).

29. EQ-5D-5L Scores Over Time: Usual Activities [Month 0 (baseline), Months 3, 6]

    The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).

30. EQ-5D-5L Scores Over Time: Pain/Discomfort [Month 0 (baseline), Months 3, 6]

    The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).

31. EQ-5D-5L Scores Over Time: Anxiety/Depression [Month 0 (baseline), Months 3, 6]

    The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).

32. EQ-5D-5L VAS Scores Over Time: Health Today [Month 0 (baseline), Months 3, 6]

    The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate VAS indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).

33. Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Scores Over Time: Percent Work Missed Due to Problem [Month 0 (baseline), Month 6]

    Absenteeism is presented as the mean percentage of work time missed due to health problem (as reported on the WPAI:SHP), and is calculated as: 100*number of hours of work missed due to health problem / (number of hours of work missed due to health problem + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

34. WPAI:SHP Scores Over Time: Percent Impairment While Working Due to Problem [Month 0 (baseline), Month 6]

    Presenteeism (the extent to which health problem decreased productivity) is presented as the mean percentage of impairment while working due to health problem, and is calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

35. WPAI:SHP Scores Over Time: Percent Overall Work Impairment Due to Problem [Month 0 (baseline), Month 6]

    The mean percentage of overall work impairment due to health problem (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which health problem decreased productivity (%)* [number of hours worked / (number of hours of work missed due to health problem + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

36. WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem [Month 0 (baseline), Month 6]

    Activity impairment due to health problem (the extent to which health problem affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

37. Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time [Month 0 (baseline), Months 3, 6]

    The 6-item ETSQ was developed to assess patient-reported satisfaction with effects on endometriosis pain, dysmenorrhea, dyspareunia, amount of bleeding tolerability and overall treatment satisfaction. The ETSQ has a 7 point response scale. The range for this scale is 0 to 36, with lower ETSQ scores reflecting lower levels of satisfaction with endometriosis treatment.

38. PROMIS Fatigue Short Form 6a Scores Over Time [Month 0 (baseline), Month 6]

    The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue. Possible scores range from 6 to 30, 6 = not at all (no fatigue), and 30 = very much (most fatigue).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participant is a premenopausal female 18 to 49 years of age (inclusive) at the time of Screening.

• Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of endometriosis established by visualization or histology within 10 years prior to entry into Washout or Screening,

• Participant must agree to use only those rescue analgesics permitted by the protocol during the Screening and Treatment Periods for her endometriosis-associated pain.

• Participant must have the following documented in the e-Diary during the last 35 days prior to Study Day 1:

1. At least 2 days of "moderate" or "severe" DYS, AND either,

2. At least 2 days of "moderate" or "severe" NMPP and an average NMPP score of at least 1.0, OR

3. At least 4 days of "moderate" or "severe" NMPP and an average NMPP score of at least 0.5.

Exclusion Criteria:

• Participant has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic therapy, which would interfere with the assessment of endometriosis-associated pain.

• Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled or intranasal corticosteroids are allowed.

• Participant has a history of major depression or post-traumatic stress disorder (PTSD) within 2 years prior to screening or other major psychiatric disorder at any time

• Participant has a history of suicide attempts or answered "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening or prior to study drug dosing on Day 1.

• Participant has any condition that would interfere with obtaining adequate dual energy x-ray absorptiometry (DXA) measurements

• Screening DXA results of the lumbar spine (L1 - L4), femoral neck or total hip bone mineral density (BMD) corresponding to less than 2 or more standard deviations below normal (Z-score < -2.0 for participants < 40 years of age, T-score for participants >= 40 years of age).

• Participant has either

1. a newly diagnosed, clinically significant medical condition that requires therapeutic intervention (e.g., new onset hypertension) that has not been stabilized 30 days prior to enrollment on Day 1 OR

2. a clinically significant medical condition that is anticipated to required intervention during the course of study participation (e.g., anticipated major elective surgery) OR

3. an unstable medical condition that makes the participant an unsuitable candidate for the study in the opinion of the Investigator

• Participant has any conditions contraindicated with use of E2/NETA

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pinnacle Research Group /ID# 202016	Anniston	Alabama	United States	36207
2	Noble Clinical Research /ID# 170628	Tucson	Arizona	United States	85704
3	Lynn Institute of the Ozarks /ID# 165052	Little Rock	Arkansas	United States	72205
4	SC Clinical Research /ID# 165049	Garden Grove	California	United States	92844
5	Marvel Clinical Research /ID# 169633	Huntington Beach	California	United States	92647
6	Health care Affiliates Medical Group /ID# 165048	Santa Ana	California	United States	92704
7	Western States Clinical Res /ID# 169809	Wheat Ridge	Colorado	United States	80033-2896
8	Nova Clinical Research, LLC /ID# 202227	Bradenton	Florida	United States	34209-4616
9	Midland Florida Clinical Research Center /ID# 201327	DeLand	Florida	United States	32720-0920
10	Southeastern Integrated Med /ID# 203109	Gainesville	Florida	United States	32607
11	Care Partners Clinical Researc /ID# 168395	Jacksonville	Florida	United States	32277
12	LCC Medical Research Institute /ID# 168888	Miami	Florida	United States	33126
13	A Premier Clinical Research of Florida, LLC /ID# 201887	Orange City	Florida	United States	32763-2833
14	GCP Clinical Research, LLC /ID# 169774	Tampa	Florida	United States	33609-4044
15	Triple O Research Institute /ID# 201128	West Palm Beach	Florida	United States	33407-3100
16	Bingham Memorial Hospital /ID# 170110	Blackfoot	Idaho	United States	83221
17	Leavitt Womens Healthcare /ID# 169495	Idaho Falls	Idaho	United States	83404-8322
18	Quad Clinical Research, LLC /ID# 168294	Chicago	Illinois	United States	60605
19	Quad Clinical Research, LLC /ID# 170629	Chicago	Illinois	United States	60605
20	Women's Health Care, PC /ID# 165033	Newburgh	Indiana	United States	47630-8940
21	Delricht Research /ID# 200219	New Orleans	Louisiana	United States	70115
22	Quad Clinical Research, LLC /ID# 200180	Saint Louis	Missouri	United States	63108-3204
23	Montana Health Research Inst /ID# 170624	Billings	Montana	United States	59102
24	Excel Clinical Research /ID# 170620	Las Vegas	Nevada	United States	89109
25	Northwell health system /ID# 200162	Manhasset	New York	United States	11030-3816
26	Radiant Research, Inc /ID# 200045	Akron	Ohio	United States	44311
27	Central Ohio Clinical Research /ID# 170750	Columbus	Ohio	United States	43213-3399
28	Optimed Research /ID# 167642	Columbus	Ohio	United States	43235
29	VitaLink Research /ID# 168401	Greenville	South Carolina	United States	29601
30	VitaLink Research /ID# 170625	Greenville	South Carolina	United States	29601
31	Fusion Clinical Research of Spartanburg /ID# 200010	Spartanburg	South Carolina	United States	29301-5642
32	Centex Studies, Inc /ID# 169897	Houston	Texas	United States	77058-2705
33	America's Adv. Wellness Center /ID# 170005	Houston	Texas	United States	77080
34	ClinRx Research, LLC /ID# 201189	Plano	Texas	United States	75024-5280
35	Progressive Clinical Research /ID# 205565	San Antonio	Texas	United States	78229
36	Eastern Virginia Med School /ID# 165016	Norfolk	Virginia	United States	23507-1627
37	Seattle Reproductive Medicine /ID# 171079	Seattle	Washington	United States	98109

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: AbbVie Inc., AbbVie

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 29, 2017

More Information

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT03343067
• Other Study ID Numbers: M16-383
• First Posted: Nov 17, 2017
• Last Update Posted: Nov 27, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by AbbVie: Endometriosis associated pain; Elagolix; Non-menstrual pelvic pain (NMPP); Dysmenorrhea (DYS)
• Additional relevant MeSH terms: Endometriosis; Norethindrone; Norethindrone Acetate; Estradiol

Study Results

Participant Flow

Pre-assignment Detail	The study was terminated early for business reasons, not for safety concerns. There are no subject data past Treatment Month 6.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window
Period Title: Open Label Period: Day 1 to Month 3
STARTED	7	3	1
COMPLETED	0	3	1
NOT COMPLETED	7	0	0
Period Title: Open Label Period: Day 1 to Month 3
STARTED	0	3	1
COMPLETED	0	0	0
NOT COMPLETED	0	3	1

Baseline Characteristics

Arm/Group Title	Group A	Group B	Group C	Total
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Total of all reporting groups
Overall Participants	7	3	1	11
Age, Customized (Count of Participants)
20 to < 25 years	1 14.3%	1 33.3%	0 0%	2 18.2%
25 to < 30 years	0 0%	1 33.3%	0 0%	1 9.1%
30 to < 35 years	1 14.3%	0 0%	1 100%	2 18.2%
35 to < 40 years	1 14.3%	0 0%	0 0%	1 9.1%
40 to < 45 years	3 42.9%	1 33.3%	0 0%	4 36.4%
45 to < 50 years	1 14.3%	0 0%	0 0%	1 9.1%
Sex: Female, Male (Count of Participants)
Female	7 100%	3 100%	1 100%	11 100%
Male	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 14.3%	1 33.3%	1 100%	3 27.3%
Not Hispanic or Latino	6 85.7%	2 66.7%	0 0%	8 72.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	2 28.6%	1 33.3%	0 0%	3 27.3%
White	5 71.4%	1 33.3%	0 0%	6 54.5%
More than one race	0 0%	1 33.3%	1 100%	2 18.2%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Dysmenorrhea (DYS) Pain Scale (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	0.641 (0.1689)	0.429 (0.1030)	0.600 (NA)	0.579 (0.1696)
Non-Menstrual Pelvic Pain (NMPP) Pain Scale (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	1.053 (0.4534)	0.914 (0.4721)	2.400 (NA)	1.138 (0.5893)
Dyspareunia Pain Scale (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	0.539 (0.9064)	0.043 (0.0202)	3.000 (NA)	0.686 (1.1187)
Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	5.176 (1.9302)	3.638 (1.5692)	7.371 (NA)	4.956 (1.9663)
Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) (pills/day) [Mean (Standard Deviation) ]
NSAID	2.388 (2.7765)	0.581 (0.9330)	0.743 (NA)	1.745 (2.3655)
Opioid	0.241 (0.3750)	0.057 (0.0990)	0.571 (NA)	0.221 (0.3270)
NSAID + Opioid	2.629 (2.6903)	0.638 (0.8918)	1.314 (NA)	1.966 (2.3196)

Outcome Measures

1. Primary Outcome

Title	Proportion of Responders at Month 6 Based on DYS Pain Scale
Description	Proportion of responders at Month 6 based upon the scale for DYS pain scale (ranging from 0 [none] to 3 [severe]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Analysis was intended to be based on a receiver operating characteristic (ROC) threshold, which could not be calculated, since only 1 participant had a Month 6 assessment for this endpoint at the time of study termination.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	0	0	0

2. Primary Outcome

Title	Proportion of Responders at Month 6 Based on NMPP Pain Scale
Description	Proportion of responders at Month 6 based upon the scale for NMPP pain scale (ranging from 0 [none] to 3 [severe]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Analysis was intended to be based on ROC threshold, which could not be calculated, since only 1 participant had a Month 6 assessment for this endpoint at the time of study termination.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	0	0	0

3. Secondary Outcome

Title	Change From Baseline in DYS at Month 6
Description	The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame	Month 0 (baseline), Month 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at baseline and given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	0	1	0
Mean (Standard Deviation) [score on a scale]	-0.23 (NA)

4. Secondary Outcome

Title	Change From Baseline in NMPP at Month 6
Description	The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame	Month 0 (baseline), Month 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at baseline and given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	0	2	0
Mean (Standard Deviation) [score on a scale]	-0.13 (0.061)

5. Secondary Outcome

Title	Change From Baseline in Dyspareunia at Month 6
Description	The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame	Month 0 (baseline), Month 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at baseline and given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	0	1	0
Mean (Standard Deviation) [score on a scale]	0.29 (NA)

6. Secondary Outcome

Title	Change From Baseline in Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS) at Month 6
Description	The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame	Month 0 (baseline), Month 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at baseline and given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	0	2	0
Mean (Standard Deviation) [score on a scale]	-1.36 (0.020)

7. Secondary Outcome

Title	Change From Baseline in Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) at Month 6
Description	Based on average pill counts and assessed using the daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.
Time Frame	Month 0 (baseline), Month 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at baseline and given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	0	2	0
NSAID: Change at Month 6	0.63 (0.606)
Opioid: Change at Month 6	0.09 (0.121)
NSAID + Opioid: Change at Month 6	0.71 (0.485)

8. Secondary Outcome

Title	Percentage of Participants With 30% or More Reduction From Baseline Based on the 35 Day Mean of the Daily Diary Endometriosis-Associated Pain Score Via NRS at Month 6
Description	The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Participants with both baseline and post-baseline values for Daily Diary Endometriosis-Associated Pain Score via NRS.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	0	2	0
Number [percentage of participants]	50.0 714.3%

9. Secondary Outcome

Title	Proportion of Responders Over Time
Description	As assessed by change and percent change from baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively.
Time Frame	Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description

Analysis was intended to be based on ROC threshold, which could not be calculated for this endpoint due to low enrollment at the time of study termination.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	0	0	0

10. Secondary Outcome

Title	Proportion of Responders Over Time (Not Taking Into Consideration of Analgesic Use)
Description	As assessed by change and percent change from Baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively.
Time Frame	Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description

Analysis was intended to be based on ROC threshold, which could not be calculated for this endpoint due to low enrollment at the time of study termination.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	0	0	0

11. Secondary Outcome

Title	Change From Baseline Over Time in Monthly Average DYS Pain Score
Description	The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. The analysis was based on a 28-day window. If a participant prematurely discontinued during the open-label period, based on the analysis window, some data might fall into Month 4 analysis.
Time Frame	Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at baseline and given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	6	2	0
Change at Month 1	0.05 (0.655)	-0.04 (NA)
Change at Month 2	-0.18 (0.124)	-0.26 (NA)
Change at Month 3	-0.50 (0.263)	-0.34 (NA)
Change at Month 4	-0.69 (NA)	-0.06 (NA)
Change at Month 5	-0.16 (0.141)
Change at Month 6	-0.23 (NA)

12. Secondary Outcome

Title	Change From Baseline Over Time in Monthly Average NMPP Pain Score
Description	The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame	Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at baseline and given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	6	3	1
Change at Month 1	-0.13 (0.252)	-0.07 (0.508)	0.39 (NA)
Change at Month 2	-0.48 (0.394)	-0.30 (0.167)	0.29 (NA)
Change at Month 3	-0.70 (0.828)	-0.30 (0.092)	0.54 (NA)
Change at Month 4	-1.34 (NA)	-0.34 (0.029)	0.46 (NA)
Change at Month 5	-0.27 (0.256)
Change at Month 6	-0.13 (0.061)

13. Secondary Outcome

Title	Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score
Description	The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame	Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at baseline and given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	4	2	1
Change at Month 1	-0.50 (0.741)	0.30 (NA)	-0.29 (NA)
Change at Month 2	-1.44 (1.071)	0.06 (NA)	-0.37 (NA)
Change at Month 3	-2.20 (NA)	0.07 (0.101)	-0.03 (NA)
Change at Month 4	-2.23 (NA)	0.09 (0.040)	-0.03 (NA)
Change at Month 5	0.09 (0.081)
Change at Month 6	0.29 (NA)

14. Secondary Outcome

Title	Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS
Description	The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame	Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at baseline and given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Change at Month 1	-0.86 (1.975)	-0.89 (1.159)	-0.84 (NA)
Change at Month 2	-2.40 (2.106)	-2.02 (0.758)	-1.40 (NA)
Change at Month 3	-3.70 (3.616)	-1.81 (0.430)	-1.34 (NA)
Change at Month 4	-6.43 (NA)	-1.43 (1.078)	-1.06 (NA)
Change at Month 5	-1.40 (0.961)
Change at Month 6	-1.36 (0.020)

15. Secondary Outcome

Title	Percent Change From Baseline to Each Month During the Treatment Period for DYS
Description	The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame	Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at baseline and given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	6	2	0
Percent Change at Month 1	1.67 (109.961)	-7.89 (NA)
Percent Change at Month 2	-27.45 (17.119)	-75.00 (NA)
Percent Change at Month 3	-62.92 (24.159)	-85.71 (NA)
Percent Change at Month 4	-80.00 (NA)	-16.67 (NA)
Percent Change at Month 5	-40.48 (33.672)
Percent Change at Month 6	-57.14 (NA)

16. Secondary Outcome

Title	Percent Change From Baseline to Each Month During the Treatment Period for NMPP
Description	The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame	Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at baseline and given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	6	3	1
Percent Change at Month 1	-11.81 (26.677)	4.22 (53.238)	16.07 (NA)
Percent Change at Month 2	-37.53 (31.150)	-34.21 (18.044)	11.90 (NA)
Percent Change at Month 3	-38.26 (42.319)	-38.03 (20.343)	22.62 (NA)
Percent Change at Month 4	-71.21 (NA)	-44.49 (20.725)	19.05 (NA)
Percent Change at Month 5	-28.40 (33.641)
Percent Change at Month 6	-17.23 (16.044)

17. Secondary Outcome

Title	Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia
Description	The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame	Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at baseline and given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Percent Change at Month 1	0.14 (18.180)	-15.27 (26.791)	-9.52 (NA)
Percent Change at Month 2	6.60 (15.719)	-15.26 (21.840)	-12.38 (NA)
Percent Change at Month 3	60.88 (65.632)	-21.63 (24.719)	-0.95 (NA)
Percent Change at Month 4	106.25 (NA)	-12.67 (20.433)	-0.95 (NA)
Percent Change at Month 5	-14.86 (16.002)
Percent Change at Month 6	-18.08 (25.571)

18. Secondary Outcome

Title	Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS
Description	The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame	Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at baseline and given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Percent Change at Month 1	-14.10 (37.146)	-19.61 (35.468)	-11.34 (NA)
Percent Change at Month 2	-37.82 (18.066)	-56.25 (4.507)	-18.99 (NA)
Percent Change at Month 3	-43.98 (35.509)	-53.05 (13.803)	-18.22 (NA)
Percent Change at Month 4	-70.98 (NA)	-38.00 (31.275)	-14.34 (NA)
Percent Change at Month 5	-35.81 (9.326)
Percent Change at Month 6	-33.56 (11.357)

19. Secondary Outcome

Title	Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics
Description	Based on average pill counts and assessed using a daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.
Time Frame	Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at baseline and given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
NSAID: Change at Month 1	-0.84 (0.796)	0.09 (0.388)	-0.67 (NA)
NSAID: Change at Month 2	-1.15 (0.785)	-0.17 (0.834)	0.63 (NA)
NSAID: Change at Month 3	-0.96 (1.030)	-0.43 (1.091)	-0.71 (NA)
NSAID: Change at Month 4	-1.69 (NA)	0.01 (0.845)	-0.63 (NA)
NSAID: Change at Month 5	0.23 (1.197)
NSAID: Change at Month 6	0.63 (0.606)
Opioid: Change at Month 1	0.12 (0.552)	-0.06 (0.099)	-0.43 (NA)
Opioid: Change at Month 2	-0.17 (0.263)	-0.03 (0.049)	-0.51 (NA)
Opioid: Change at Month 3	-0.17 (0.242)	0.02 (0.016)	-0.49 (NA)
Opioid: Change at Month 4	-0.34 (NA)	-0.01 (0.044)	-0.40 (NA)
Opioid: Change at Month 5	-0.05 (0.082)
Opioid: Change at Month 6	0.09 (0.121)
NSAID + Opioid: Change at Month 1	-0.72 (1.178)	0.03 (0.436)	-1.10 (NA)
NSAID + Opioid: Change at Month 2	-1.33 (0.767)	-0.20 (0.830)	-1.14 (NA)
NSAID + Opioid: Change at Month 3	-1.13 (1.273)	-0.41 (1.107)	-1.20 (NA)
NSAID + Opioid: Change at Month 4	-2.03 (NA)	-0.00 (0.863)	-1.03 (NA)
NSAID + Opioid: Change at Month 5	0.18 (1.217)
NSAID + Opioid: Change at Month 6	0.71 (0.485)

20. Secondary Outcome

Title	Number of Analgesic Use Responders and Non-Responders Over Time
Description	Based only on reduction of rescue analgesics used. Responders were defined as: participants with no analgesic use at screening and no analgesic use added participants with NSAID only use at screening and NSAID dose stopped, decreased, or stable (<15% increase) and no opioid use added participants with opioid only use at screening and opioid dose stopped, decreased, or stable (<15% increase), opioid dose stopped and NSAID substituted (any dose), opioid dose decreased and NSAID added (any dose) participants with NSAID + opioid use at screening and any of the following: NSAID dose stopped + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose decreased + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose stable (< 15% increase) + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose increased by >15% + opioid analgesic use stopped; NSAID dose increased by >15% + opioid analgesic dose decreases.
Time Frame	Months 1, 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Month 1: Responder	5 71.4%	2 66.7%	1 100%
Month 1: Non-Responder	2 28.6%	1 33.3%	0 0%
Month 2: Responder	4 57.1%	2 66.7%	1 100%
Month 2: Non-Responder	1 14.3%	1 33.3%	0 0%
Month 3: Responder	2 28.6%	1 33.3%	1 100%
Month 3: Non-Responder	0 0%	2 66.7%	0 0%
Month 4: Responder	1 14.3%	2 66.7%	1 100%
Month 4: Non-Responder	0 0%	1 33.3%	0 0%
Month 5: Responder	0 0%	2 66.7%	0 0%
Month 5: Non-Responder	0 0%	1 33.3%	0 0%
Month 6: Responder	0 0%	0 0%	0 0%
Month 6: Non-Responder	0 0%	2 66.7%	0 0%

21. Secondary Outcome

Title	Patient Global Impression of Change (PGIC) Scores Over Time
Description	The PGIC is a 7-point response scale where participants rate their endometriosis related pain as: very much improved (1), much improved (2), minimally improved (3), not changed (4), minimally worse (5), much worse (6), very much worse (7).
Time Frame	Months 1, 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Month 1	2.9 (1.35)	2.3 (0.58)	2.0 (NA)
Month 2	2.0 (0.00)	1.3 (0.58)	2.0 (NA)
Month 3	2.0 (NA)	2.0 (1.00)	5.0 (NA)
Month 4	2.0 (1.00)	2.0 (NA)
Month 5	2.5 (0.71)
Month 6	1.0 (NA)

22. Secondary Outcome

Title	Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time
Description	The endometriosis-associated pain questionnaire is an 11-point NRS assessing overall endometriosis-associated pain over a 7-day recall period. Participants assessed their endometriosis-associated pain on a scale of 0 to 10, with 0 = no pain and 10 = worst pain ever.
Time Frame	Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Baseline	8.2 (1.79)	9.0 (1.00)	7.0 (NA)
Month 1	5.7 (3.04)	7.7 (1.15)	8.0 (NA)
Month 2	4.5 (0.71)	2.7 (1.15)	5.0 (NA)
Month 3	9.0 (NA)	5.3 (2.31)	8.0 (NA)
Month 4	3.3 (0.58)	7.0 (NA)
Month 5	8.0 (0.00)
Month 6	4.0 (NA)

23. Secondary Outcome

Title	Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain
Description	The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame	Month 0 (baseline), Months 3, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Baseline	59.42 (11.694)	47.73 (14.193)	59.09 (NA)
Month 3	38.07 (26.529)	17.42 (22.422)	38.64 (NA)
Month 6	27.27 (NA)

24. Secondary Outcome

Title	EHP-30 Scores Over Time: Control and Powerlessness
Description	The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame	Month 0 (baseline), Months 3, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Baseline	71.43 (19.159)	56.94 (19.691)	41.67 (NA)
Month 3	36.46 (32.874)	26.39 (21.382)	25.00 (NA)
Month 6	8.33 (NA)

25. Secondary Outcome

Title	EHP-30 Scores Over Time: Emotional Well-Being
Description	The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame	Month 0 (baseline), Months 3, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Baseline	29.76 (8.815)	50.00 (8.333)	45.83 (NA)
Month 3	18.75 (12.500)	23.61 (17.347)	37.50 (NA)
Month 6	25.00 (NA)

26. Secondary Outcome

Title	EHP-30 Scores Over Time: Social Support
Description	The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame	Month 0 (baseline), Months 3, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Baseline	48.21 (21.565)	45.83 (19.094)	50.00 (NA)
Month 3	17.19 (11.831)	16.67 (28.868)	18.75 (NA)
Month 6	25.00 (NA)

27. Secondary Outcome

Title	EHP-30 Scores Over Time: Self-Image
Description	The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame	Month 0 (baseline), Months 3, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Baseline	50.00 (22.048)	36.11 (31.549)	75.00 (NA)
Month 3	43.75 (41.597)	8.33 (14.434)	8.33 (NA)
Month 6	16.67 (NA)

28. Secondary Outcome

Title	EHP-30 Scores Over Time: Sexual Intercourse
Description	The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame	Month 0 (baseline), Months 3, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	6	2	1
Baseline	70.00 (22.361)	62.50 (31.820)	60.00 (NA)
Month 3	45.00 (23.452)	45.00 (42.426)	60.00 (NA)
Month 6	30.00 (NA)

29. Secondary Outcome

Title	EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility
Description	The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
Time Frame	Month 0 (baseline), Months 3, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Baseline	1.4 (0.53)	1.0 (0.00)	1.0 (NA)
Month 3	1.3 (0.50)	1.0 (0.00)	2.0 (NA)
Month 6	1.0 (NA)

30. Secondary Outcome

Title	EQ-5D-5L Scores Over Time: Self-Care
Description	The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
Time Frame	Month 0 (baseline), Months 3, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Baseline	1.0 (0.00)	1.0 (0.00)	1.0 (NA)
Month 3	1.0 (0.00)	1.0 (0.00)	1.0 (NA)
Month 6	1.0 (NA)

31. Secondary Outcome

Title	EQ-5D-5L Scores Over Time: Usual Activities
Description	The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
Time Frame	Month 0 (baseline), Months 3, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Baseline	2.0 (0.82)	1.3 (0.58)	1.0 (NA)
Month 3	1.5 (0.58)	1.7 (1.15)	2.0 (NA)
Month 6	1.0 (NA)

32. Secondary Outcome

Title	EQ-5D-5L Scores Over Time: Pain/Discomfort
Description	The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
Time Frame	Month 0 (baseline), Months 3, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Baseline	2.7 (0.76)	2.7 (0.58)	4.0 (NA)
Month 3	2.0 (1.15)	1.7 (0.58)	3.0 (NA)
Month 6	1.0 (NA)

33. Secondary Outcome

Title	EQ-5D-5L Scores Over Time: Anxiety/Depression
Description	The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
Time Frame	Month 0 (baseline), Months 3, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Baseline	1.0 (0.00)	1.3 (0.58)	1.0 (NA)
Month 3	1.0 (0.00)	1.0 (0.00)	1.0 (NA)
Month 6	1.0 (NA)

34. Secondary Outcome

Title	EQ-5D-5L VAS Scores Over Time: Health Today
Description	The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate VAS indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
Time Frame	Month 0 (baseline), Months 3, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Baseline	79.7 (15.16)	53.3 (35.12)	72.0 (NA)
Month 3	72.8 (17.63)	85.0 (15.00)	70.0 (NA)
Month 6	94.0 (NA)

35. Secondary Outcome

Title	Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Scores Over Time: Percent Work Missed Due to Problem
Description	Absenteeism is presented as the mean percentage of work time missed due to health problem (as reported on the WPAI:SHP), and is calculated as: 100*number of hours of work missed due to health problem / (number of hours of work missed due to health problem + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
Time Frame	Month 0 (baseline), Month 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	6	3	0
Baseline	0.16 (0.205)	0.08 (0.144)
Month 6	0.00 (0.000)	0.00 (NA)

36. Secondary Outcome

Title	WPAI:SHP Scores Over Time: Percent Impairment While Working Due to Problem
Description	Presenteeism (the extent to which health problem decreased productivity) is presented as the mean percentage of impairment while working due to health problem, and is calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
Time Frame	Month 0 (baseline), Month 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	6	3	0
Baseline	0.57 (0.273)	0.53 (0.153)
Month 6	0.30 (0.265)	0.30 (NA)

37. Secondary Outcome

Title	WPAI:SHP Scores Over Time: Percent Overall Work Impairment Due to Problem
Description	The mean percentage of overall work impairment due to health problem (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which health problem decreased productivity (%)* [number of hours worked / (number of hours of work missed due to health problem + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
Time Frame	Month 0 (baseline), Month 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	6	3	0
Baseline	0.61 (0.307)	0.56 (0.194)
Month 6	0.30 (0.265)	0.30 (NA)

38. Secondary Outcome

Title	WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem
Description	Activity impairment due to health problem (the extent to which health problem affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
Time Frame	Month 0 (baseline), Month 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Baseline	0.66 (0.237)	0.67 (0.058)	0.70 (NA)
Month 6	0.40 (0.346)	0.30 (NA)	0.70 (NA)

39. Secondary Outcome

Title	Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time
Description	The 6-item ETSQ was developed to assess patient-reported satisfaction with effects on endometriosis pain, dysmenorrhea, dyspareunia, amount of bleeding tolerability and overall treatment satisfaction. The ETSQ has a 7 point response scale. The range for this scale is 0 to 36, with lower ETSQ scores reflecting lower levels of satisfaction with endometriosis treatment.
Time Frame	Month 0 (baseline), Months 3, 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Baseline	19.71 (4.536)	18.00 (0.000)	18.00 (NA)
Month 3	22.25 (9.430)	25.47 (6.652)	25.00 (NA)
Month 6	31.00 (NA)

40. Secondary Outcome

Title	PROMIS Fatigue Short Form 6a Scores Over Time
Description	The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue. Possible scores range from 6 to 30, 6 = not at all (no fatigue), and 30 = very much (most fatigue).
Time Frame	Month 0 (baseline), Month 6

Outcome Measure Data

Analysis Population Description

Participants with an assessment at given time point.

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.	Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
Measure Participants	7	3	1
Baseline	22.1 (4.10)	19.3 (6.11)	27.0 (NA)
Month 6	15.3 (7.77)	11.0 (NA)	21.0 (NA)

Adverse Events

Time Frame	From first dose of study drug up to 6 months, plus 30 days.
Arm/Group Title	Group A		Group B		Group C
Arm/Group Description	Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period.		Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.		Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.
All Cause Mortality
	Group A		Group B		Group C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/3 (0%)		0/1 (0%)
Serious Adverse Events
	Group A		Group B		Group C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/3 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Group A		Group B		Group C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/7 (42.9%)		3/3 (100%)		1/1 (100%)
Ear and labyrinth disorders
EAR DISCOMFORT	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0
Gastrointestinal disorders
ABDOMINAL PAIN UPPER	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0
DIARRHOEA	1/7 (14.3%)	1	1/3 (33.3%)	1	0/1 (0%)	0
NAUSEA	2/7 (28.6%)	2	0/3 (0%)	0	0/1 (0%)	0
VOMITING	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0
General disorders
CHILLS	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0
FATIGUE	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0
Immune system disorders
ANAPHYLACTIC REACTION	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	1
DRUG HYPERSENSITIVITY	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	1
Infections and infestations
GARDNERELLA INFECTION	0/7 (0%)	0	1/3 (33.3%)	1	1/1 (100%)	1
ORAL HERPES	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0
URINARY TRACT INFECTION	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0
VAGINAL INFECTION	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0
Metabolism and nutrition disorders
POLYDIPSIA	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0
Nervous system disorders
HEADACHE	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0
Psychiatric disorders
IRRITABILITY	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0
Reproductive system and breast disorders
ADNEXA UTERI PAIN	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0
DYSMENORRHOEA	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0
MENSTRUATION DELAYED	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0
PELVIC PAIN	0/7 (0%)	0	1/3 (33.3%)	1	1/1 (100%)	1
Respiratory, thoracic and mediastinal disorders
THROAT TIGHTNESS	0/7 (0%)	0	0/3 (0%)	0	1/1 (100%)	1
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0
NIGHT SWEATS	1/7 (14.3%)	1	0/3 (0%)	0	0/1 (0%)	0
Vascular disorders
HOT FLUSH	0/7 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0

Limitations/Caveats

Due to early study termination at Treatment Month 6 with low subject enrollment, no clinically or statistically meaningful efficacy conclusions can be made. The study was terminated early for business reasons, not for safety concerns.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.