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EndometriosisPhase 3ELARIS EM-INCT01620528

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

A Phase 3 study testing elagolix in people with Endometriosis, run by AbbVie (prior sponsor, Abbott).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 years, women only
Conditions the study is for
Endometriosis
What is being tested?
elagolix
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
872 participants
Where
No sites listed yet
Study dates
22 May 2012to 28 Sep 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
  • Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Washout (if applicable) or Screening.
  • Agrees to use required birth control methods during the entire length of participation in the study.
  • 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

Who cannot join

  • 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.
  • 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).
  • 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.
  • Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
  • Subject has a history of osteoporosis or other metabolic bone disease.
  • Subject has a current history of undiagnosed abnormal genital bleeding.

About this study

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

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.

Read the 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.

Conditions
Endometriosis
Being tested
elagolix, placebo
Keywords
Gonadotropin-Releasing Hormone Antagonist, Endometriosis associated pain, Dysmenorrhea (DYS), Non-Menstrual Pelvic Pain (NMPP), Elagolix
Medical subject headings
Endometriosis, Dysmenorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • elagolixDrug

    Also called ABT-620, elagolix sodium

    oral tablet

  • placeboOther

    oral tablet

Study groups in NCT01620528
Study groupRoleWhat they receive
Elagolix 150 mg QDExperimentalElagolix 150 mg once daily (QD) for the 6-month Treatment Period
Receives: Drug: elagolix
Elagolix 200 mg BIDExperimentalElagolix 200 mg twice daily (BID) for the 6-month Treatment Period
Receives: Drug: elagolix
PlaceboPlacebo comparatorPlacebo BID for the 6-month Treatment Period
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)

    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.

    Measured: At Month 3 of the Treatment Period

  2. Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)

    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.

    Measured: At Month 3 of Treatment Period

Secondary outcomes (109)

  1. Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores

    The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).

    Measured: Baseline, Month 3 of the Treatment Period

  2. Change From Baseline to Month 6 in DYS

    The DYS pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 6 of Treatment Period

  3. Change From Baseline to Month 6 in NMPP

    The NMPP pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 6 of Treatment Period

  4. Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics

    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.

    Measured: Baseline, Month 3 of Treatment Period

  5. Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics

    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.

    Measured: Baseline, Month 6 of Treatment Period

  6. Change From Baseline to Month 3 in Dyspareunia (DYSP)

    The DYSP pain scale ranges from 0 (absent) to 3 (severe).

    Measured: Baseline, Month 3 of Treatment Period

  7. Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)

    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.

    Measured: Baseline, Month 3 of Treatment Period

  8. Percentage of Responders at Month 1 Based on Daily Assessment of DYS

    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.

    Measured: At Month 1 of the Treatment Period

  9. Percentage of Responders at Month 2 Based on Daily Assessment of DYS

    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.

    Measured: At Month 2 of the Treatment Period

  10. Percentage of Responders at Month 4 Based on Daily Assessment of DYS

    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.

    Measured: At Month 4 of the Treatment Period

  11. Percentage of Responders at Month 5 Based on Daily Assessment of DYS

    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.

    Measured: At Month 5 of the Treatment Period

  12. Percentage of Responders at Month 6 Based on Daily Assessment of DYS

    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.

    Measured: At Month 6 of the Treatment Period

  13. Percentage of Responders at Month 1 Based on Daily Assessment of NMPP

    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.

    Measured: At Month 1 of Treatment Period

  14. Percentage of Responders at Month 2 Based on Daily Assessment of NMPP

    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.

    Measured: At Month 2 of Treatment Period

  15. Percentage of Responders at Month 4 Based on Daily Assessment of NMPP

    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.

    Measured: At Month 4 of Treatment Period

  16. Percentage of Responders at Month 5 Based on Daily Assessment of NMPP

    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.

    Measured: At Month 5 of Treatment Period

  17. Percentage of Responders at Month 6 Based on Daily Assessment of NMPP

    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.

    Measured: At Month 6 of Treatment Period

  18. Percentage of Responders at Month 1 for DYSP

    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.

    Measured: At Month 1 of the Treatment Period

  19. Percentage of Responders at Month 2 for DYSP

    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.

    Measured: At Month 2 of the Treatment Period

  20. Percentage of Responders at Month 4 for DYSP

    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.

    Measured: At Month 4 of the Treatment Period

  21. Percentage of Responders at Month 5 for DYSP

    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.

    Measured: At Month 5 of the Treatment Period

  22. Percentage of Responders at Month 6 for DYSP

    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.

    Measured: At Month 6 of the Treatment Period

  23. Change From Baseline to Month 1 in Mean Pain Score for DYS

    The DYS pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 1 of Treatment Period

  24. Change From Baseline to Month 2 in Mean Pain Score for DYS

    The DYS pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 2 of Treatment Period

  25. Change From Baseline to Month 3 in Mean Pain Score for DYS

    The DYS pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 3 of Treatment Period

  26. Change From Baseline to Month 4 in Mean Pain Score for DYS

    The DYS pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 4 of Treatment Period

  27. Change From Baseline to Month 5 in Mean Pain Score for DYS

    The DYS pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 5 of Treatment Period

  28. Percent Change From Baseline to Month 1 in Mean Pain Score for DYS

    The DYS pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 1 of Treatment Period

  29. Percent Change From Baseline to Month 2 in Mean Pain Score for DYS

    The DYS pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 2 of Treatment Period

  30. Percent Change From Baseline to Month 3 in Mean Pain Score for DYS

    The DYS pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 3 of Treatment Period

  31. Percent Change From Baseline to Month 4 in Mean Pain Score for DYS

    The DYS pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 4 of Treatment Period

  32. Percent Change From Baseline to Month 5 in Mean Pain Score for DYS

    The DYS pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 5 of Treatment Period

  33. Percent Change From Baseline to Month 6 in Mean Pain Score for DYS

    The DYS pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 6 of Treatment Period

  34. Change From Baseline to Month 1 in Mean Pain Score for NMPP

    The NMPP pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 1 of Treatment Period

  35. Change From Baseline to Month 2 in Mean Pain Score for NMPP

    The NMPP pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 2 of Treatment Period

  36. Change From Baseline to Month 3 in Mean Pain Score for NMPP

    The NMPP pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 3 of Treatment Period

  37. Change From Baseline to Month 4 in Mean Pain Score for NMPP

    The NMPP pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 4 of Treatment Period

  38. Change From Baseline to Month 5 in Mean Pain Score for NMPP

    The NMPP pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 5 of Treatment Period

  39. Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP

    The NMPP pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 1 of Treatment Period

  40. Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP

    The NMPP pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 2 of Treatment Period

  41. Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP

    The NMPP pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 3 of Treatment Period

  42. Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP

    The NMPP pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 4 of Treatment Period

  43. Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP

    The NMPP pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 5 of Treatment Period

  44. Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP

    The NMPP pain scale ranges from 0 (none) to 3 (severe).

    Measured: Baseline, Month 6 of Treatment Period

  45. Change From Baseline to Month 1 in Mean Pain Score of DYSP

    The DYSP pain scale ranged from 0 (absent) to 3 (severe).

    Measured: Baseline, Month 1 of Treatment Period

  46. Change From Baseline to Month 2 in Mean Pain Score of DYSP

    The DYSP pain scale ranged from 0 (absent) to 3 (severe).

    Measured: Baseline, Month 2 of Treatment Period

  47. Change From Baseline to Month 4 in Mean Pain Score of DYSP

    The DYSP pain scale ranged from 0 (absent) to 3 (severe).

    Measured: Baseline, Month 4 of Treatment Period

  48. Change From Baseline to Month 5 in Mean Pain Score of DYSP

    The DYSP pain scale ranged from 0 (absent) to 3 (severe).

    Measured: Baseline, Month 5 of Treatment Period

  49. Change From Baseline to Month 6 in Mean Pain Score of DYSP

    The DYSP pain scale ranged from 0 (absent) to 3 (severe).

    Measured: Baseline, Month 6 of Treatment Period

  50. Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics

    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.

    Measured: Baseline, Month 1 of Treatment Period

  51. Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics

    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.

    Measured: Baseline, Month 2 of Treatment Period

  52. Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics

    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.

    Measured: Baseline, Month 4 of Treatment Period

  53. Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics

    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.

    Measured: Baseline, Month 5 of Treatment Period

  54. Response to Patient Global Impression of Change (PGIC) at Month 1

    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.

    Measured: Month 1 of Treatment Period

  55. Response to PGIC at Month 2

    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.

    Measured: Month 2 of Treatment Period

  56. Response to PGIC at Month 3

    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.

    Measured: Month 3 of Treatment Period

  57. Response to PGIC at Month 4

    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.

    Measured: Month 4 of Treatment Period

  58. Response to PGIC at Month 5

    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.

    Measured: Month 5 of Treatment Period

  59. Response to PGIC at Month 6

    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.

    Measured: Month 6 of Treatment Period

  60. Change From Baseline to Month 1 in NRS Scores

    The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).

    Measured: Baseline, Month 1 of Treatment Period

  61. Change From Baseline to Month 2 in NRS Scores

    The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).

    Measured: Baseline, Month 2 of Treatment Period

  62. Change From Baseline to Month 4 in NRS Scores

    The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).

    Measured: Baseline, Month 4 of Treatment Period

  63. Change From Baseline to Month 5 in NRS Scores

    The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).

    Measured: Baseline, Month 5 of Treatment Period

  64. Change From Baseline to Month 6 in NRS Scores

    The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).

    Measured: Baseline, Month 6 of Treatment Period

  65. Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30)

    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.

    Measured: Baseline, Month 1 of Treatment Period

  66. Change From Baseline to Month 3 in the Pain Domain of the EHP-30

    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.

    Measured: Baseline, Month 3 of Treatment Period

  67. Change From Baseline to Month 6 in the Pain Domain of the EHP-30

    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.

    Measured: Baseline, Month 6 of Treatment Period

  68. Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30

    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.

    Measured: Baseline, Month 1 of Treatment Period

  69. Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30

    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.

    Measured: Baseline, Month 3 of Treatment Period

  70. Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30

    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.

    Measured: Baseline, Month 6 of Treatment Period

  71. Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism

    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.

    Measured: Baseline, Month 1 of Treatment Period

  72. Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism

    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.

    Measured: Baseline, Month 2 of Treatment Period

  73. Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism

    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.

    Measured: Baseline, Month 3 of Treatment Period

  74. Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism

    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.

    Measured: Baseline, Month 4 of Treatment Period

  75. Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism

    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.

    Measured: Baseline, Month 5 of Treatment Period

  76. Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism

    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.

    Measured: Baseline, Month 6 of Treatment Period

  77. Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism

    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.

    Measured: Baseline, Month 1 of Treatment Period

  78. Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism

    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.

    Measured: Baseline, Month 2 of Treatment Period

  79. Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism

    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.

    Measured: Baseline, Month 3 of Treatment Period

  80. Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism

    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.

    Measured: Baseline, Month 4 of Treatment Period

  81. Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism

    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.

    Measured: Baseline, Month 5 of Treatment Period

  82. Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism

    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.

    Measured: Baseline, Month 6 of Treatment Period

  83. Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism

    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.

    Measured: Baseline, Month 1 of Treatment Period

  84. Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism

    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.

    Measured: Baseline, Month 2 of Treatment Period

  85. Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism

    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.

    Measured: Baseline, Month 3 of Treatment Period

  86. Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism

    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.

    Measured: Baseline, Month 4 of Treatment Period

  87. Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism

    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.

    Measured: Baseline, Month 5 of Treatment Period

  88. Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism

    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.

    Measured: Baseline, Month 6 of Treatment Period

  89. Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism

    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.

    Measured: Baseline, Month 1 of Treatment Period

  90. Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism

    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.

    Measured: Baseline, Month 2 of Treatment Period

  91. Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism

    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.

    Measured: Baseline, Month 3 of Treatment Period

  92. Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism

    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.

    Measured: Baseline, Month 4 of Treatment Period

  93. Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism

    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.

    Measured: Baseline, Month 5 of Treatment Period

  94. Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism

    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.

    Measured: Baseline, Month 6 of Treatment Period

  95. Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace

    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.

    Measured: Baseline, Month 1 of Treatment Period

  96. Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace

    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.

    Measured: Baseline, Month 2 of Treatment Period

  97. Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace

    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.

    Measured: Baseline, Month 3 of Treatment Period

  98. Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace

    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.

    Measured: Baseline, Month 4 of Treatment Period

  99. Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace

    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.

    Measured: Baseline, Month 5 of Treatment Period

  100. Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace

    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.

    Measured: Baseline, Month 6 of Treatment Period

  101. Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household

    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.

    Measured: Baseline, Month 1 of Treatment Period

  102. Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household

    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.

    Measured: Baseline, Month 2 of Treatment Period

  103. Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household

    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.

    Measured: Baseline, Month 3 of Treatment Period

  104. Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household

    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.

    Measured: Baseline, Month 4 of Treatment Period

  105. Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household

    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.

    Measured: Baseline, Month 5 of Treatment Period

  106. Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household

    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.

    Measured: Baseline, Month 6 of Treatment Period

  107. Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period

    Measured: Up to Month 6 of Treatment Period

  108. Number of Days of Hospitalization

    Measured: Up to Month 6 of Treatment Period

  109. Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type

    Measured: Up to Month 6 of Treatment Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2012 (estimated)
  2. Study start22 May 2012
  3. Primary completion14 Nov 2014
  4. Study completion28 Sep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
872 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01620528
Sponsor's protocol ID
M12-665
Acronym
ELARIS EM-I
Status last verified
Mar 2017
First submitted
15 May 2012
Last updated
18 Sep 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28525302

  • 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.

    PubMed 34878624

  • 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.

    PubMed 34134684

  • 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.

    PubMed 33963686

  • 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.

    PubMed 33650259

  • 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.

    PubMed 33564263

  • 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.

    PubMed 33066973

  • 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.

    PubMed 32945631

  • 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.

    PubMed 32769633

  • 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.

    PubMed 32621325

  • 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.

    PubMed 31654294

  • 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.

    PubMed 31227284

  • 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.

    PubMed 30992150

  • 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.

    PubMed 30724096

  • 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.

    PubMed 29476499

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing elagolix in people with Endometriosis, run by AbbVie (prior sponsor, Abbott).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) (time frame: At Month 3 of the Treatment Period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01620528, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.

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