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A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain (ELARIS EM-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01931670
Recruitment Status : Completed
First Posted : August 29, 2013
Results First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE August 27, 2013
First Posted Date  ICMJE August 29, 2013
Results First Submitted Date  ICMJE August 9, 2018
Results First Posted Date  ICMJE September 7, 2018
Last Update Posted Date September 7, 2018
Actual Study Start Date  ICMJE September 9, 2013
Actual Primary Completion Date January 6, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 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) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.
  • 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) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2013)
  • Proportion of responders with Endometriosis Associated Pain assessed using modified Biberoglu and Behrman (B&B) scale [ Time Frame: Up to Month 3 ]
    Proportion of responders based on reduction from Baseline
  • Change in Bone Mineral Density as assessed by the Dual-energy X-Ray Absorptiometry (DXA) Scan [ Time Frame: From Month 0 to Month 18 ]
    Change from Baseline in Bone Mineral Density
  • Change in Endometrial Thickness assessed by Transvaginal Ultrasound (TVU) [ Time Frame: From Month 0 to Month 6 ]
    Change from Baseline in endometrial thickness
  • Change in percentage of subjects with significant Transvaginal Ultrasound (TVU) findings [ Time Frame: From Month 0 to Month 6 ]
    Percent of subjects with ovarian cyst
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 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 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 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 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 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 country-specific rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen. Assessment was based on average pill counts.
  • Percentage of Responders for Each Month, Except Month 3, in DYS [ Time Frame: Months 1, 2, 4, 5, 6 of the Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.
  • Percentage of Responders for Each Month, Except Month 3, in NMPP [ Time Frame: Months 1, 2, 4, 5, 6 of the Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.
  • Percentage of Responders at Each Month for DYSP [ Time Frame: Months 1, 2, 3, 4, 5, 6 of Treatment Period ]
    The DYSP pain scale ranged from 0 (absent) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.29 or greater from Baseline in DYSP as well as no increased rescue analgesic use for endometriosis-associated pain.
  • Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS [ Time Frame: Baseline (Prior to administering study drug), Months 1, 2, 3, 4, 5 of Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe).
  • Percent Change From Baseline to Each Month in Mean Pain Score for DYS [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period ]
    The DYS pain scale ranges from 0 (none) to 3 (severe).
  • Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP [ Time Frame: Baseline, Months 1, 2, 3, 4, 5 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe).
  • Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period ]
    The NMPP pain scale ranges from 0 (none) to 3 (severe).
  • Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP [ Time Frame: Baseline, Months 1, 2, 4, 5, 6 of Treatment Period ]
    The DYSP pain scale ranged from 0 (absent) to 3 (severe).
  • Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics [ Time Frame: Baseline, Months 1, 2, 4, 5 ]
    Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
  • Patient Global Impression of Change (PGIC) Questionnaire [ Time Frame: Months 1, 2, 3, 4, 5, 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 Each Month, Except Month 3, in NRS Scores [ Time Frame: Baseline, Months 1, 2, 4, 5, 6 of Treatment Period ]
    The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
  • Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores [ Time Frame: Baseline, Months 1, 3, 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 domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
  • Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores [ Time Frame: Baseline, Months 1, 3, 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 domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
  • Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 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 Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 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 Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 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 Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 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 Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 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 Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 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: Months 1, 2, 3, 4, 5, 6 of Treatment Period ]
    This is assessed using Health Resource Utilization Questionnaire (HRUQ).
  • Number of Days of Hospitalization [ Time Frame: Up to Month 6 of Treatment Period ]
    This is assessed using HRUQ.
  • Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type [ Time Frame: Up to Month 6 of Treatment Period ]
    This is assessed using HRUQ.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2013)
  • Change in Clinical Laboratory Tests [ Time Frame: From Month 0 to Month 9 ]
    Mean change from Baseline (hematology, chemistry, urinalysis and endocrine testing)
  • Proportion of subjects with Adverse Events [ Time Frame: Up to Month 18 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Global Phase 3 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 subjects.
Detailed Description 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. Subjects will be required to use nonhormonal dual contraception during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.
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
  • Other: placebo
  • Drug: Elagolix
    Other Names:
    • ABT-620
    • elagolix sodium
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo twice daily (BID) for the 6-month Treatment Period
    Intervention: Other: placebo
  • 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 BID for the 6-month Treatment Period
    Intervention: Drug: Elagolix
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: August 9, 2018)
815
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2013)
788
Actual Study Completion Date  ICMJE December 19, 2016
Actual Primary Completion Date January 6, 2016   (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 the Washout Period.
  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 or greater 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 regular menstrual cycles with an interval of 24-38 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.
  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 uterine 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 Argentina,   Australia,   Austria,   Brazil,   Czech Republic,   Hungary,   Italy,   New Zealand,   Poland,   Russian Federation,   South Africa,   Spain,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT01931670
Other Study ID Numbers  ICMJE M12-671
2011-004295-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date March 2018

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