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

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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:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620528


Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Rachel Duan, MD AbbVie

Publications of Results:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01620528     History of Changes
Other Study ID Numbers: M12-665
First Posted: June 15, 2012    Key Record Dates
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