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

• ClinicalTrials.gov Identifier: NCT01620528
• Recruitment Status: Completed
• First Posted: June 15, 2012
• Results First Posted: September 18, 2018
• Last Update Posted: September 18, 2018
• Sponsor: AbbVie (prior sponsor, Abbott)
• Information provided by (Responsible Party): AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description

Brief Summary:

A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants.

Condition or disease	Intervention/treatment	Phase
Endometriosis	Drug: elagolix; Other: placebo	Phase 3

Detailed Description:

This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of two doses of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 872 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
• Study Start Date: May 22, 2012
• Actual Primary Completion Date: November 14, 2014
• Actual Study Completion Date: September 28, 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Elagolix 150 mg QD; Elagolix 150 mg once daily (QD) for the 6-month Treatment Period	Drug: elagolix; oral tablet; Other Name: ABT-620, elagolix sodium
Experimental: Elagolix 200 mg BID; Elagolix 200 mg twice daily (BID) for the 6-month Treatment Period	Drug: elagolix; oral tablet; Other Name: ABT-620, elagolix sodium
Placebo Comparator: Placebo; Placebo BID for the 6-month Treatment Period	Other: placebo; oral tablet

Outcome Measures

Primary Outcome Measures :

1. Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) [ Time Frame: At Month 3 of the Treatment Period ]
   The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
2. Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP) [ Time Frame: At Month 3 of Treatment Period ]
   The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Secondary Outcome Measures :

1. Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores [ Time Frame: Baseline, Month 3 of the Treatment Period ]
   The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
2. Change From Baseline to Month 6 in DYS [ Time Frame: Baseline, Month 6 of Treatment Period ]
   The DYS pain scale ranges from 0 (none) to 3 (severe).
3. Change From Baseline to Month 6 in NMPP [ Time Frame: Baseline, Month 6 of Treatment Period ]
   The NMPP pain scale ranges from 0 (none) to 3 (severe).
4. Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics [ Time Frame: Baseline, Month 3 of Treatment Period ]
   Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
5. Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics [ Time Frame: Baseline, Month 6 of Treatment Period ]
   Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
6. Change From Baseline to Month 3 in Dyspareunia (DYSP) [ Time Frame: Baseline, Month 3 of Treatment Period ]
   The DYSP pain scale ranges from 0 (absent) to 3 (severe).
7. Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids) [ Time Frame: Baseline, Month 3 of Treatment Period ]
   Permitted rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
8. Percentage of Responders at Month 1 Based on Daily Assessment of DYS [ Time Frame: At Month 1 of the Treatment Period ]
   The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
9. Percentage of Responders at Month 2 Based on Daily Assessment of DYS [ Time Frame: At Month 2 of the Treatment Period ]
   The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
10. Percentage of Responders at Month 4 Based on Daily Assessment of DYS [ Time Frame: At Month 4 of the Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
11. Percentage of Responders at Month 5 Based on Daily Assessment of DYS [ Time Frame: At Month 5 of the Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
12. Percentage of Responders at Month 6 Based on Daily Assessment of DYS [ Time Frame: At Month 6 of the Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
13. Percentage of Responders at Month 1 Based on Daily Assessment of NMPP [ Time Frame: At Month 1 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
14. Percentage of Responders at Month 2 Based on Daily Assessment of NMPP [ Time Frame: At Month 2 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
15. Percentage of Responders at Month 4 Based on Daily Assessment of NMPP [ Time Frame: At Month 4 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
16. Percentage of Responders at Month 5 Based on Daily Assessment of NMPP [ Time Frame: At Month 5 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
17. Percentage of Responders at Month 6 Based on Daily Assessment of NMPP [ Time Frame: At Month 6 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
18. Percentage of Responders at Month 1 for DYSP [ Time Frame: At Month 1 of the Treatment Period ]
    The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
19. Percentage of Responders at Month 2 for DYSP [ Time Frame: At Month 2 of the Treatment Period ]
    The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
20. Percentage of Responders at Month 4 for DYSP [ Time Frame: At Month 4 of the Treatment Period ]
    The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
21. Percentage of Responders at Month 5 for DYSP [ Time Frame: At Month 5 of the Treatment Period ]
    The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
22. Percentage of Responders at Month 6 for DYSP [ Time Frame: At Month 6 of the Treatment Period ]
    The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
23. Change From Baseline to Month 1 in Mean Pain Score for DYS [ Time Frame: Baseline, Month 1 of Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe).
24. Change From Baseline to Month 2 in Mean Pain Score for DYS [ Time Frame: Baseline, Month 2 of Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe).
25. Change From Baseline to Month 3 in Mean Pain Score for DYS [ Time Frame: Baseline, Month 3 of Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe).
26. Change From Baseline to Month 4 in Mean Pain Score for DYS [ Time Frame: Baseline, Month 4 of Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe).
27. Change From Baseline to Month 5 in Mean Pain Score for DYS [ Time Frame: Baseline, Month 5 of Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe).
28. Percent Change From Baseline to Month 1 in Mean Pain Score for DYS [ Time Frame: Baseline, Month 1 of Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe).
29. Percent Change From Baseline to Month 2 in Mean Pain Score for DYS [ Time Frame: Baseline, Month 2 of Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe).
30. Percent Change From Baseline to Month 3 in Mean Pain Score for DYS [ Time Frame: Baseline, Month 3 of Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe).
31. Percent Change From Baseline to Month 4 in Mean Pain Score for DYS [ Time Frame: Baseline, Month 4 of Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe).
32. Percent Change From Baseline to Month 5 in Mean Pain Score for DYS [ Time Frame: Baseline, Month 5 of Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe).
33. Percent Change From Baseline to Month 6 in Mean Pain Score for DYS [ Time Frame: Baseline, Month 6 of Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe).
34. Change From Baseline to Month 1 in Mean Pain Score for NMPP [ Time Frame: Baseline, Month 1 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe).
35. Change From Baseline to Month 2 in Mean Pain Score for NMPP [ Time Frame: Baseline, Month 2 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe).
36. Change From Baseline to Month 3 in Mean Pain Score for NMPP [ Time Frame: Baseline, Month 3 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe).
37. Change From Baseline to Month 4 in Mean Pain Score for NMPP [ Time Frame: Baseline, Month 4 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe).
38. Change From Baseline to Month 5 in Mean Pain Score for NMPP [ Time Frame: Baseline, Month 5 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe).
39. Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP [ Time Frame: Baseline, Month 1 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe).
40. Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP [ Time Frame: Baseline, Month 2 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe).
41. Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP [ Time Frame: Baseline, Month 3 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe).
42. Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP [ Time Frame: Baseline, Month 4 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe).
43. Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP [ Time Frame: Baseline, Month 5 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe).
44. Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP [ Time Frame: Baseline, Month 6 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe).
45. Change From Baseline to Month 1 in Mean Pain Score of DYSP [ Time Frame: Baseline, Month 1 of Treatment Period ]
    The DYSP pain scale ranged from 0 (absent) to 3 (severe).
46. Change From Baseline to Month 2 in Mean Pain Score of DYSP [ Time Frame: Baseline, Month 2 of Treatment Period ]
    The DYSP pain scale ranged from 0 (absent) to 3 (severe).
47. Change From Baseline to Month 4 in Mean Pain Score of DYSP [ Time Frame: Baseline, Month 4 of Treatment Period ]
    The DYSP pain scale ranged from 0 (absent) to 3 (severe).
48. Change From Baseline to Month 5 in Mean Pain Score of DYSP [ Time Frame: Baseline, Month 5 of Treatment Period ]
    The DYSP pain scale ranged from 0 (absent) to 3 (severe).
49. Change From Baseline to Month 6 in Mean Pain Score of DYSP [ Time Frame: Baseline, Month 6 of Treatment Period ]
    The DYSP pain scale ranged from 0 (absent) to 3 (severe).
50. Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics [ Time Frame: Baseline, Month 1 of Treatment Period ]
    Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
51. Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics [ Time Frame: Baseline, Month 2 of Treatment Period ]
    Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
52. Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics [ Time Frame: Baseline, Month 4 of Treatment Period ]
    Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
53. Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics [ Time Frame: Baseline, Month 5 of Treatment Period ]
    Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
54. Response to Patient Global Impression of Change (PGIC) at Month 1 [ Time Frame: Month 1 of Treatment Period ]
    The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
55. Response to PGIC at Month 2 [ Time Frame: Month 2 of Treatment Period ]
    The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
56. Response to PGIC at Month 3 [ Time Frame: Month 3 of Treatment Period ]
    The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
57. Response to PGIC at Month 4 [ Time Frame: Month 4 of Treatment Period ]
    The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
58. Response to PGIC at Month 5 [ Time Frame: Month 5 of Treatment Period ]
    The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
59. Response to PGIC at Month 6 [ Time Frame: Month 6 of Treatment Period ]
    The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
60. Change From Baseline to Month 1 in NRS Scores [ Time Frame: Baseline, Month 1 of Treatment Period ]
    The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
61. Change From Baseline to Month 2 in NRS Scores [ Time Frame: Baseline, Month 2 of Treatment Period ]
    The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
62. Change From Baseline to Month 4 in NRS Scores [ Time Frame: Baseline, Month 4 of Treatment Period ]
    The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
63. Change From Baseline to Month 5 in NRS Scores [ Time Frame: Baseline, Month 5 of Treatment Period ]
    The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
64. Change From Baseline to Month 6 in NRS Scores [ Time Frame: Baseline, Month 6 of Treatment Period ]
    The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
65. Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30) [ Time Frame: Baseline, Month 1 of Treatment Period ]
    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
66. Change From Baseline to Month 3 in the Pain Domain of the EHP-30 [ Time Frame: Baseline, Month 3 of Treatment Period ]
    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
67. Change From Baseline to Month 6 in the Pain Domain of the EHP-30 [ Time Frame: Baseline, Month 6 of Treatment Period ]
    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
68. Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30 [ Time Frame: Baseline, Month 1 of Treatment Period ]
    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
69. Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30 [ Time Frame: Baseline, Month 3 of Treatment Period ]
    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
70. Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30 [ Time Frame: Baseline, Month 6 of Treatment Period ]
    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
71. Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism [ Time Frame: Baseline, Month 1 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
72. Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism [ Time Frame: Baseline, Month 2 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
73. Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism [ Time Frame: Baseline, Month 3 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
74. Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism [ Time Frame: Baseline, Month 4 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
75. Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism [ Time Frame: Baseline, Month 5 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
76. Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism [ Time Frame: Baseline, Month 6 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
77. Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism [ Time Frame: Baseline, Month 1 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
78. Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism [ Time Frame: Baseline, Month 2 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
79. Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism [ Time Frame: Baseline, Month 3 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
80. Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism [ Time Frame: Baseline, Month 4 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
81. Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism [ Time Frame: Baseline, Month 5 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
82. Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism [ Time Frame: Baseline, Month 6 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
83. Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism [ Time Frame: Baseline, Month 1 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
84. Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism [ Time Frame: Baseline, Month 2 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
85. Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism [ Time Frame: Baseline, Month 3 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
86. Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism [ Time Frame: Baseline, Month 4 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
87. Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism [ Time Frame: Baseline, Month 5 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
88. Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism [ Time Frame: Baseline, Month 6 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
89. Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism [ Time Frame: Baseline, Month 1 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
90. Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism [ Time Frame: Baseline, Month 2 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
91. Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism [ Time Frame: Baseline, Month 3 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
92. Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism [ Time Frame: Baseline, Month 4 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
93. Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism [ Time Frame: Baseline, Month 5 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
94. Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism [ Time Frame: Baseline, Month 6 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
95. Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace [ Time Frame: Baseline, Month 1 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
96. Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace [ Time Frame: Baseline, Month 2 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
97. Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace [ Time Frame: Baseline, Month 3 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
98. Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace [ Time Frame: Baseline, Month 4 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
99. Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace [ Time Frame: Baseline, Month 5 of Treatment Period ]
    The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
100. Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace [ Time Frame: Baseline, Month 6 of Treatment Period ]
     The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
101. Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household [ Time Frame: Baseline, Month 1 of Treatment Period ]
     The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
102. Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household [ Time Frame: Baseline, Month 2 of Treatment Period ]
     The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
103. Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household [ Time Frame: Baseline, Month 3 of Treatment Period ]
     The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
104. Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household [ Time Frame: Baseline, Month 4 of Treatment Period ]
     The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
105. Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household [ Time Frame: Baseline, Month 5 of Treatment Period ]
     The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
106. Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household [ Time Frame: Baseline, Month 6 of Treatment Period ]
     The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
107. Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period [ Time Frame: Up to Month 6 of Treatment Period ]
108. Number of Days of Hospitalization [ Time Frame: Up to Month 6 of Treatment Period ]
109. Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type [ Time Frame: Up to Month 6 of Treatment Period ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
2. Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Washout (if applicable) or Screening.
3. Agrees to use required birth control methods during the entire length of participation in the study.
4. Subject has a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain. 5. Subjects must have at least two menstrual cycles 24 to 38 days within the Screening Period, prior to Day 1

Exclusion Criteria:

1. Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.
2. Subject has a history of previous non-response to Gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary).
3. Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.
4. Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
5. Subject has a history of osteoporosis or other metabolic bone disease.
6. Subject has a current history of undiagnosed abnormal genital bleeding.

Contacts and Locations

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Rachel Duan, MD; AbbVie

More Information

Publications of Results:

Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotarski J, Archer DF, Diamond MP, Surrey E, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Rowan JP, Duan WR, Ng J, Schwefel B, Thomas JW, Jain RI, Chwalisz K. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Beck D, Winzenborg I, Liu M, Degner J, Mostafa NM, Noertersheuser P, Shebley M. Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids. Clin Pharmacokinet. 2022 Apr;61(4):577-587. doi: 10.1007/s40262-021-01096-w. Epub 2021 Dec 8.

Abrao MS, Surrey E, Gordon K, Snabes MC, Wang H, Ijacu H, Taylor HS. Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patients. BMC Womens Health. 2021 Jun 16;21(1):246. doi: 10.1186/s12905-021-01385-3.

Stodtmann S, Nader A, Polepally AR, Suleiman AA, Winzenborg I, Noertersheuser P, Ng J, Mostafa NM, Shebley M. Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis. Clin Transl Sci. 2021 Jul;14(4):1611-1619. doi: 10.1111/cts.13040. Epub 2021 May 7.

Beck D, Winzenborg I, Gao W, Mostafa NM, Noertersheuser P, Chiuve SE, Owens C, Shebley M. Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women. Clin Transl Sci. 2021 Jul;14(4):1452-1463. doi: 10.1111/cts.13006. Epub 2021 Apr 8. Erratum In: Clin Transl Sci. 2022 Mar;15(3):799.

Agarwal SK, Singh SS, Archer DF, Mai Y, Chwalisz K, Gordon K, Surrey E. Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix. J Pain Res. 2021 Feb 2;14:263-271. doi: 10.2147/JPR.S284703. eCollection 2021.

Pokrzywinski RM, Soliman AM, Snabes MC, Chen J, Taylor HS, Coyne KS. Responsiveness and thresholds for clinically meaningful changes in worst pain numerical rating scale for dysmenorrhea and nonmenstrual pelvic pain in women with moderate to severe endometriosis. Fertil Steril. 2021 Feb;115(2):423-430. doi: 10.1016/j.fertnstert.2020.07.013. Epub 2020 Oct 14.

Abbas Suleiman A, Nader A, Winzenborg I, Beck D, Polepally AR, Ng J, Noertersheuser P, Mostafa NM. Exposure-Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis-Associated Pain. CPT Pharmacometrics Syst Pharmacol. 2020 Nov;9(11):639-648. doi: 10.1002/psp4.12560. Epub 2020 Oct 8.

Taylor HS, Soliman AM, Johns B, Pokrzywinski RM, Snabes M, Coyne KS. Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix. Obstet Gynecol. 2020 Sep;136(3):501-509. doi: 10.1097/AOG.0000000000003917.

Winzenborg I, Polepally AR, Nader A, Mostafa NM, Noertersheuser P, Ng J. Effect of Elagolix Exposure on Clinical Efficacy End Points in Phase III Trials in Women With Endometriosis-Associated Pain: An Application of Markov Model. CPT Pharmacometrics Syst Pharmacol. 2020 Aug;9(8):466-475. doi: 10.1002/psp4.12545. Epub 2020 Jul 31.

Surrey ES, Soliman AM, Palac HL, Agarwal SK. Impact of Elagolix on Workplace and Household Productivity Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials. Patient. 2019 Dec;12(6):651-660. doi: 10.1007/s40271-019-00394-7.

Pokrzywinski RM, Soliman AM, Chen J, Snabes M, Diamond MP, Surrey E, Coyne KS. Impact of elagolix on work loss due to endometriosis-associated pain: estimates based on the results of two phase III clinical trials. Fertil Steril. 2019 Sep;112(3):545-551. doi: 10.1016/j.fertnstert.2019.04.031. Epub 2019 Jun 18. Erratum In: Fertil Steril. 2020 Jan;113(1):237.

Surrey ES, Soliman AM, Agarwal SK, Snabes MC, Diamond MP. Impact of elagolix treatment on fatigue experienced by women with moderate to severe pain associated with endometriosis. Fertil Steril. 2019 Aug;112(2):298-304.e3. doi: 10.1016/j.fertnstert.2019.02.031. Epub 2019 Apr 13.

Wang ST, Johnson SJ, Mitchell D, Soliman AM, Vora JB, Agarwal SK. Cost-effectiveness of elagolix versus leuprolide acetate for treating moderate-to-severe endometriosis pain in the USA. J Comp Eff Res. 2019 Apr;8(5):337-355. doi: 10.2217/cer-2018-0124. Epub 2019 Feb 6.

Winzenborg I, Nader A, Polepally AR, Liu M, Degner J, Klein CE, Mostafa NM, Noertersheuser P, Ng J. Population Pharmacokinetics of Elagolix in Healthy Women and Women with Endometriosis. Clin Pharmacokinet. 2018 Oct;57(10):1295-1306. doi: 10.1007/s40262-018-0629-6.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01620528
• Other Study ID Numbers: M12-665
• First Posted: June 15, 2012
• Results First Posted: September 18, 2018
• Last Update Posted: September 18, 2018
• Last Verified: March 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Gonadotropin-Releasing Hormone Antagonist; Endometriosis associated pain; Dysmenorrhea (DYS); Non-Menstrual Pelvic Pain (NMPP); Elagolix

Additional relevant MeSH terms:

Endometriosis; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases