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A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain

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: NCT03343067
Recruitment Status : Terminated (The study was terminated early for business reasons, not for safety concerns.)
First Posted : November 17, 2017
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE November 13, 2017
First Posted Date  ICMJE November 17, 2017
Results First Submitted Date  ICMJE October 22, 2019
Results First Posted Date  ICMJE November 27, 2019
Last Update Posted Date November 27, 2019
Actual Study Start Date  ICMJE December 27, 2017
Actual Primary Completion Date October 23, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
  • Proportion of Responders at Month 6 Based on DYS Pain Scale [ Time Frame: Month 6 ]
    Proportion of responders at Month 6 based upon the scale for DYS pain scale (ranging from 0 [none] to 3 [severe]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain.
  • Proportion of Responders at Month 6 Based on NMPP Pain Scale [ Time Frame: Month 6 ]
    Proportion of responders at Month 6 based upon the scale for NMPP pain scale (ranging from 0 [none] to 3 [severe]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain.
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • Proportion of responders based on Dysmenorrhea (DYS) [ Time Frame: At Month 6 ]
    It is measured by the Endometriosis Daily Pain Impact scale in the e-Diary.
  • Proportion of responders based on Non-menstrual pelvic pain (NMPP) [ Time Frame: At Month 6 ]
    It is measured by the Endometriosis Daily Pain Impact scale in the e-Diary.
  • Bone Mineral Density (BMD) evaluation [ Time Frame: Up to Month 24 ]
    This is measured using dual energy x-ray absorptiometry (DXA).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
  • Change From Baseline in DYS at Month 6 [ Time Frame: Month 0 (baseline), Month 6 ]
    The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
  • Change From Baseline in NMPP at Month 6 [ Time Frame: Month 0 (baseline), Month 6 ]
    The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
  • Change From Baseline in Dyspareunia at Month 6 [ Time Frame: Month 0 (baseline), Month 6 ]
    The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
  • Change From Baseline in Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS) at Month 6 [ Time Frame: Month 0 (baseline), Month 6 ]
    The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
  • Change From Baseline in Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) at Month 6 [ Time Frame: Month 0 (baseline), Month 6 ]
    Based on average pill counts and assessed using the daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.
  • Percentage of Participants With 30% or More Reduction From Baseline Based on the 35 Day Mean of the Daily Diary Endometriosis-Associated Pain Score Via NRS at Month 6 [ Time Frame: Month 6 ]
    The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window.
  • Proportion of Responders Over Time [ Time Frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 ]
    As assessed by change and percent change from baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively.
  • Proportion of Responders Over Time (Not Taking Into Consideration of Analgesic Use) [ Time Frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 ]
    As assessed by change and percent change from Baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively.
  • Change From Baseline Over Time in Monthly Average DYS Pain Score [ Time Frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 ]
    The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. The analysis was based on a 28-day window. If a participant prematurely discontinued during the open-label period, based on the analysis window, some data might fall into Month 4 analysis.
  • Change From Baseline Over Time in Monthly Average NMPP Pain Score [ Time Frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 ]
    The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
  • Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score [ Time Frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 ]
    The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
  • Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS [ Time Frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 ]
    The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
  • Percent Change From Baseline to Each Month During the Treatment Period for DYS [ Time Frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 ]
    The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
  • Percent Change From Baseline to Each Month During the Treatment Period for NMPP [ Time Frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 ]
    The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
  • Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia [ Time Frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 ]
    The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
  • Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS [ Time Frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 ]
    The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
  • Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics [ Time Frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 ]
    Based on average pill counts and assessed using a daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.
  • Number of Analgesic Use Responders and Non-Responders Over Time [ Time Frame: Months 1, 2, 3, 4, 5, 6 ]
    Based only on reduction of rescue analgesics used. Responders were defined as:
    • participants with no analgesic use at screening and no analgesic use added
    • participants with NSAID only use at screening and NSAID dose stopped, decreased, or stable (<15% increase) and no opioid use added
    • participants with opioid only use at screening and opioid dose stopped, decreased, or stable (<15% increase), opioid dose stopped and NSAID substituted (any dose), opioid dose decreased and NSAID added (any dose)
    • participants with NSAID + opioid use at screening and any of the following: NSAID dose stopped + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose decreased + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose stable (< 15% increase) + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose increased by >15% + opioid analgesic use stopped; NSAID dose increased by >15% + opioid analgesic dose decreases.
  • Patient Global Impression of Change (PGIC) Scores Over Time [ Time Frame: Months 1, 2, 3, 4, 5, 6 ]
    The PGIC is a 7-point response scale where participants rate their endometriosis related pain as: very much improved (1), much improved (2), minimally improved (3), not changed (4), minimally worse (5), much worse (6), very much worse (7).
  • Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time [ Time Frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 ]
    The endometriosis-associated pain questionnaire is an 11-point NRS assessing overall endometriosis-associated pain over a 7-day recall period. Participants assessed their endometriosis-associated pain on a scale of 0 to 10, with 0 = no pain and 10 = worst pain ever.
  • Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain [ Time Frame: Month 0 (baseline), Months 3, 6 ]
    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
  • EHP-30 Scores Over Time: Control and Powerlessness [ Time Frame: Month 0 (baseline), Months 3, 6 ]
    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
  • EHP-30 Scores Over Time: Emotional Well-Being [ Time Frame: Month 0 (baseline), Months 3, 6 ]
    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
  • EHP-30 Scores Over Time: Social Support [ Time Frame: Month 0 (baseline), Months 3, 6 ]
    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
  • EHP-30 Scores Over Time: Self-Image [ Time Frame: Month 0 (baseline), Months 3, 6 ]
    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
  • EHP-30 Scores Over Time: Sexual Intercourse [ Time Frame: Month 0 (baseline), Months 3, 6 ]
    The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
  • EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility [ Time Frame: Month 0 (baseline), Months 3, 6 ]
    The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
  • EQ-5D-5L Scores Over Time: Self-Care [ Time Frame: Month 0 (baseline), Months 3, 6 ]
    The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
  • EQ-5D-5L Scores Over Time: Usual Activities [ Time Frame: Month 0 (baseline), Months 3, 6 ]
    The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
  • EQ-5D-5L Scores Over Time: Pain/Discomfort [ Time Frame: Month 0 (baseline), Months 3, 6 ]
    The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
  • EQ-5D-5L Scores Over Time: Anxiety/Depression [ Time Frame: Month 0 (baseline), Months 3, 6 ]
    The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
  • EQ-5D-5L VAS Scores Over Time: Health Today [ Time Frame: Month 0 (baseline), Months 3, 6 ]
    The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate VAS indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
  • Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Scores Over Time: Percent Work Missed Due to Problem [ Time Frame: Month 0 (baseline), Month 6 ]
    Absenteeism is presented as the mean percentage of work time missed due to health problem (as reported on the WPAI:SHP), and is calculated as: 100*number of hours of work missed due to health problem / (number of hours of work missed due to health problem + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
  • WPAI:SHP Scores Over Time: Percent Impairment While Working Due to Problem [ Time Frame: Month 0 (baseline), Month 6 ]
    Presenteeism (the extent to which health problem decreased productivity) is presented as the mean percentage of impairment while working due to health problem, and is calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
  • WPAI:SHP Scores Over Time: Percent Overall Work Impairment Due to Problem [ Time Frame: Month 0 (baseline), Month 6 ]
    The mean percentage of overall work impairment due to health problem (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which health problem decreased productivity (%)* [number of hours worked / (number of hours of work missed due to health problem + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
  • WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem [ Time Frame: Month 0 (baseline), Month 6 ]
    Activity impairment due to health problem (the extent to which health problem affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
  • Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time [ Time Frame: Month 0 (baseline), Months 3, 6 ]
    The 6-item ETSQ was developed to assess patient-reported satisfaction with effects on endometriosis pain, dysmenorrhea, dyspareunia, amount of bleeding tolerability and overall treatment satisfaction. The ETSQ has a 7 point response scale. The range for this scale is 0 to 36, with lower ETSQ scores reflecting lower levels of satisfaction with endometriosis treatment.
  • PROMIS Fatigue Short Form 6a Scores Over Time [ Time Frame: Month 0 (baseline), Month 6 ]
    The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue. Possible scores range from 6 to 30, 6 = not at all (no fatigue), and 30 = very much (most fatigue).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • Change from baseline in Dysmenorrhea (DYS) [ Time Frame: From Month 0 (baseline) to Month 6 ]
    It is measured by the Endometriosis Daily Pain Impact scale in the eDiary.
  • Change from baseline in Non-menstrual pelvic pain (NMPP) [ Time Frame: From Month 0 (baseline) to Month 6 ]
    It is measured by the Endometriosis Daily Pain Impact scale in the eDiary.
  • Change from baseline in dyspareunia [ Time Frame: From Month 0 (baseline) to Month 6 ]
    This will be assessed using e-Diary.
  • Change from baseline in Daily Diary endometriosis-associated pain score [ Time Frame: From Month 0 (baseline) to Month 6 ]
    This is assessed using 11-point Numeric Rating Scale (NRS) in the eDiary.
  • Change from baseline in rescue analgesic use across both classes of rescue analgesics based on average pill counts [ Time Frame: From Month 0 (baseline) to Month 6 ]
    This will be assessed using e-Diary.
  • Percentage of participants with reduction from baseline in endometriosis-associated pain score [ Time Frame: Up to Month 6 ]
    This is assessed using Numeric Rating Scale (NRS) in the eDiary.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
Official Title  ICMJE A Study to Evaluate Safety and Efficacy of Elagolix Alone or Elagolix With Hormonal Add-Back in Subjects With Endometriosis With Associated Moderate to Severe Pain
Brief Summary This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both elagolix alone and elagolix plus estradiol/norethindrone acetate (E2/NETA) over 24 months in the management of endometriosis with associated moderate to severe pain in premenopausal women.
Detailed Description Not Provided
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
    Tablets
  • Drug: estradiol/norethindrone acetate (E2/NETA)
    Capsules
Study Arms  ICMJE
  • Experimental: Arm A

    Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

    Month 4 Through Month 24 (Double-Blind): Efficacy responders to elagolix 150 mg QD at Month 3 and continue treatment through Month 24

    Intervention: Drug: elagolix
  • Experimental: Arm C

    Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

    Month 4 Through Month 24 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group and continue treatment through Month 24.

    Interventions:
    • Drug: elagolix
    • Drug: estradiol/norethindrone acetate (E2/NETA)
  • Experimental: Arm D

    Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

    Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 150 mg QD treatment group

    Month 7 Through Month 24 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 6 and assigned to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group and continue treatment through Month 24.

    Interventions:
    • Drug: elagolix
    • Drug: estradiol/norethindrone acetate (E2/NETA)
  • Experimental: Arm B

    Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

    Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 150 mg QD treatment group

    Month 7 Through Month 24 (Double-Blind): Efficacy responders to elagolix 150 mg QD at Month 6 and continue treatment through Month 24.

    Intervention: Drug: elagolix
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: October 4, 2018)
11
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2017)
890
Actual Study Completion Date  ICMJE October 23, 2018
Actual Primary Completion Date October 23, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant is a premenopausal female 18 to 49 years of age (inclusive) at the time of Screening.
  • Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of endometriosis established by visualization or histology within 10 years prior to entry into Washout or Screening,
  • Participant must agree to use only those rescue analgesics permitted by the protocol during the Screening and Treatment Periods for her endometriosis-associated pain.
  • Participant must have the following documented in the e-Diary during the last 35 days prior to Study Day 1:

    1. At least 2 days of "moderate" or "severe" DYS, AND either,
    2. At least 2 days of "moderate" or "severe" NMPP and an average NMPP score of at least 1.0, OR
    3. At least 4 days of "moderate" or "severe" NMPP and an average NMPP score of at least 0.5.

Exclusion Criteria:

  • Participant has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic therapy, which would interfere with the assessment of endometriosis-associated pain.
  • Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled or intranasal corticosteroids are allowed.
  • Participant has a history of major depression or post-traumatic stress disorder (PTSD) within 2 years prior to screening or other major psychiatric disorder at any time
  • Participant has a history of suicide attempts or answered "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening or prior to study drug dosing on Day 1.
  • Participant has any condition that would interfere with obtaining adequate dual energy x-ray absorptiometry (DXA) measurements
  • Screening DXA results of the lumbar spine (L1 - L4), femoral neck or total hip bone mineral density (BMD) corresponding to less than 2 or more standard deviations below normal (Z-score < -2.0 for participants < 40 years of age, T-score for participants >= 40 years of age).
  • Participant has either

    1. a newly diagnosed, clinically significant medical condition that requires therapeutic intervention (e.g., new onset hypertension) that has not been stabilized 30 days prior to enrollment on Day 1 OR
    2. a clinically significant medical condition that is anticipated to required intervention during the course of study participation (e.g., anticipated major elective surgery) OR
    3. an unstable medical condition that makes the participant an unsuitable candidate for the study in the opinion of the Investigator
  • Participant has any conditions contraindicated with use of E2/NETA
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 United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT03343067
Other Study ID Numbers  ICMJE M16-383
Has Data Monitoring Committee No
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: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date July 2019

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