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Trial record 1 of 1 for:    NCT01620528
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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) )

Tracking Information
First Submitted Date  ICMJE May 15, 2012
First Posted Date  ICMJE June 15, 2012
Results First Submitted Date  ICMJE August 9, 2018
Results First Posted Date  ICMJE September 18, 2018
Last Update Posted Date September 18, 2018
Study Start Date  ICMJE May 22, 2012
Actual Primary Completion Date November 14, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2012)
  • Endometriosis Associated Pain [ Time Frame: Baseline ]
  • Endometriosis Associated Pain [ Time Frame: Month 3 of Treatment Period ]
    Proportion of responders based reduction from baseline.
  • Endometriosis Associated Pain [ Time Frame: Month 6 of Treatment Period ]
    Proportion of responders based reduction from baseline.
  • Bone Mineral Density (DXA Scan) [ Time Frame: Baseline ]
  • Bone Mineral Density (DXA Scan) [ Time Frame: Month 6 of Treatment Period ]
    Change from baseline
  • Bone Mineral Density (DXA Scan) [ Time Frame: Month 6 of Follow-Up Period ]
    Change from Baseline
  • Bone Mineral Density (DXA Scan) [ Time Frame: Month 12 of Follow-Up Period ]
    Change from Baseline
  • Endometrial Biopsy; Assessment of significant endometrial biopsy findings at baseline [ Time Frame: Baseline ]
    Assessment of significant endometrial biopsy findings (e.g., endometrial thickness, etc)
  • Endometrial Biopsy; Changes from baseline to final treatment in biopsy findings [ Time Frame: Month 6 of Treatment Period ]
    Percent of subjects in each diagnostic category of biopsy result
  • Transvaginal Ultrasound (TVU); Assessment of significant TVU findings at baseline [ Time Frame: Baseline ]
    Assessment of significant TVU finding (e.g., ovarian cyst, etc)
  • Transvaginal Ultrasound (TVU); Changes from baseline to final treatment in TVU findings [ Time Frame: Month 6 of Treatment Period ]
    Change from baseline in endometrial thickness; percent of subjects with ovarian cyst
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period [ Time Frame: Up to Month 6 of Treatment Period ]
  • Number of Days of Hospitalization [ Time Frame: Up to Month 6 of Treatment Period ]
  • Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type [ Time Frame: Up to Month 6 of Treatment Period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2012)
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Baseline ]
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 1 of Treatment Period ]
    Change from Baseline
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 2 of Treatment Period ]
    Change from Baseline
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 3 of Treatment Period ]
    Change from Baseline
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 4 of Treatment Period ]
    Change from Baseline
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 5 of Treatment Period ]
    Change from Baseline
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 6 of Treatment Period ]
    Change from Baseline
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 1 of Follow-up Period ]
    Change from Baseline
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 3 of Follow-up Period ]
    Change from Baseline
  • Number of study subjects with Adverse Events [ Time Frame: Up to Month 18 ]
    Proportion of subjects reporting adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • Drug: elagolix
    oral tablet
    Other Name: ABT-620, elagolix sodium
  • Other: placebo
    oral tablet
Study Arms  ICMJE
  • Experimental: Elagolix 150 mg QD
    Elagolix 150 mg once daily (QD) for the 6-month Treatment Period
    Intervention: Drug: elagolix
  • Experimental: Elagolix 200 mg BID
    Elagolix 200 mg twice daily (BID) for the 6-month Treatment Period
    Intervention: Drug: elagolix
  • Placebo Comparator: Placebo
    Placebo BID for the 6-month Treatment Period
    Intervention: Other: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2015)
872
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2012)
875
Actual Study Completion Date  ICMJE September 28, 2015
Actual Primary Completion Date November 14, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   Puerto Rico,   United States
 
Administrative Information
NCT Number  ICMJE NCT01620528
Other Study ID Numbers  ICMJE M12-665
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie ( AbbVie (prior sponsor, Abbott) )
Study Sponsor  ICMJE AbbVie (prior sponsor, Abbott)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rachel Duan, MD AbbVie
PRS Account AbbVie
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP