Back to resultsA Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
Primary Purpose
Endometriosis
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
elagolix
estradiol/norethindrone acetate (E2/NETA)
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis associated pain, Elagolix, Non-menstrual pelvic pain (NMPP), Dysmenorrhea (DYS)
Eligibility Criteria
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:
- At least 2 days of "moderate" or "severe" DYS, AND either,
- At least 2 days of "moderate" or "severe" NMPP and an average NMPP score of at least 1.0, OR
- 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
- 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
- a clinically significant medical condition that is anticipated to required intervention during the course of study participation (e.g., anticipated major elective surgery) OR
- 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
Sites / Locations
- Pinnacle Research Group /ID# 202016
- Noble Clinical Research /ID# 170628
- Lynn Institute of the Ozarks /ID# 165052
- SC Clinical Research /ID# 165049
- Marvel Clinical Research /ID# 169633
- Health care Affiliates Medical Group /ID# 165048
- Western States Clinical Res /ID# 169809
- Nova Clinical Research, LLC /ID# 202227
- Midland Florida Clinical Research Center /ID# 201327
- Southeastern Integrated Med /ID# 203109
- Care Partners Clinical Researc /ID# 168395
- LCC Medical Research Institute /ID# 168888
- A Premier Clinical Research of Florida, LLC /ID# 201887
- GCP Clinical Research, LLC /ID# 169774
- Triple O Research Institute /ID# 201128
- Bingham Memorial Hospital /ID# 170110
- Leavitt Womens Healthcare /ID# 169495
- Quad Clinical Research, LLC /ID# 168294
- Quad Clinical Research, LLC /ID# 170629
- Women's Health Care, PC /ID# 165033
- Delricht Research /ID# 200219
- Quad Clinical Research, LLC /ID# 200180
- Montana Health Research Inst /ID# 170624
- Excel Clinical Research /ID# 170620
- Northwell health system /ID# 200162
- Radiant Research, Inc /ID# 200045
- Central Ohio Clinical Research /ID# 170750
- Optimed Research /ID# 167642
- VitaLink Research /ID# 168401
- VitaLink Research /ID# 170625
- Fusion Clinical Research of Spartanburg /ID# 200010
- Centex Studies, Inc /ID# 169897
- America's Adv. Wellness Center /ID# 170005
- ClinRx Research, LLC /ID# 201189
- Progressive Clinical Research /ID# 205565
- Eastern Virginia Med School /ID# 165016
- Seattle Reproductive Medicine /ID# 171079
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Arm A
Arm C
Arm D
Arm B
Arm Description
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
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.
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.
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.
Outcomes
Primary Outcome Measures
Proportion of Responders at Month 6 Based on DYS Pain Scale
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
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.
Secondary Outcome Measures
Change From Baseline in DYS at 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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03343067
Brief Title
A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early for business reasons, not for safety concerns.
Study Start Date
December 27, 2017 (Actual)
Primary Completion Date
October 23, 2018 (Actual)
Study Completion Date
October 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis associated pain, Elagolix, Non-menstrual pelvic pain (NMPP), Dysmenorrhea (DYS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
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
Arm Title
Arm C
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm D
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
elagolix
Intervention Description
Tablets
Intervention Type
Drug
Intervention Name(s)
estradiol/norethindrone acetate (E2/NETA)
Intervention Description
Capsules
Primary Outcome Measure Information:
Title
Proportion of Responders at Month 6 Based on DYS Pain Scale
Description
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.
Time Frame
Month 6
Title
Proportion of Responders at Month 6 Based on NMPP Pain Scale
Description
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.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Change From Baseline in DYS at Month 6
Description
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.
Time Frame
Month 0 (baseline), Month 6
Title
Change From Baseline in NMPP at Month 6
Description
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.
Time Frame
Month 0 (baseline), Month 6
Title
Change From Baseline in Dyspareunia at Month 6
Description
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.
Time Frame
Month 0 (baseline), Month 6
Title
Change From Baseline in Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS) at Month 6
Description
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.
Time Frame
Month 0 (baseline), Month 6
Title
Change From Baseline in Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) at Month 6
Description
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.
Time Frame
Month 0 (baseline), Month 6
Title
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
Description
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.
Time Frame
Month 6
Title
Proportion of Responders Over Time
Description
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.
Time Frame
Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Title
Proportion of Responders Over Time (Not Taking Into Consideration of Analgesic Use)
Description
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.
Time Frame
Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Title
Change From Baseline Over Time in Monthly Average DYS Pain Score
Description
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.
Time Frame
Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Title
Change From Baseline Over Time in Monthly Average NMPP Pain Score
Description
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.
Time Frame
Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Title
Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score
Description
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.
Time Frame
Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Title
Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS
Description
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.
Time Frame
Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Title
Percent Change From Baseline to Each Month During the Treatment Period for DYS
Description
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.
Time Frame
Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Title
Percent Change From Baseline to Each Month During the Treatment Period for NMPP
Description
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.
Time Frame
Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Title
Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia
Description
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.
Time Frame
Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Title
Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS
Description
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.
Time Frame
Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Title
Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics
Description
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.
Time Frame
Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Title
Number of Analgesic Use Responders and Non-Responders Over Time
Description
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.
Time Frame
Months 1, 2, 3, 4, 5, 6
Title
Patient Global Impression of Change (PGIC) Scores Over Time
Description
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).
Time Frame
Months 1, 2, 3, 4, 5, 6
Title
Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time
Description
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.
Time Frame
Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Title
Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain
Description
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.
Time Frame
Month 0 (baseline), Months 3, 6
Title
EHP-30 Scores Over Time: Control and Powerlessness
Description
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.
Time Frame
Month 0 (baseline), Months 3, 6
Title
EHP-30 Scores Over Time: Emotional Well-Being
Description
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.
Time Frame
Month 0 (baseline), Months 3, 6
Title
EHP-30 Scores Over Time: Social Support
Description
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.
Time Frame
Month 0 (baseline), Months 3, 6
Title
EHP-30 Scores Over Time: Self-Image
Description
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.
Time Frame
Month 0 (baseline), Months 3, 6
Title
EHP-30 Scores Over Time: Sexual Intercourse
Description
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.
Time Frame
Month 0 (baseline), Months 3, 6
Title
EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility
Description
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).
Time Frame
Month 0 (baseline), Months 3, 6
Title
EQ-5D-5L Scores Over Time: Self-Care
Description
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).
Time Frame
Month 0 (baseline), Months 3, 6
Title
EQ-5D-5L Scores Over Time: Usual Activities
Description
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).
Time Frame
Month 0 (baseline), Months 3, 6
Title
EQ-5D-5L Scores Over Time: Pain/Discomfort
Description
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).
Time Frame
Month 0 (baseline), Months 3, 6
Title
EQ-5D-5L Scores Over Time: Anxiety/Depression
Description
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).
Time Frame
Month 0 (baseline), Months 3, 6
Title
EQ-5D-5L VAS Scores Over Time: Health Today
Description
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).
Time Frame
Month 0 (baseline), Months 3, 6
Title
Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Scores Over Time: Percent Work Missed Due to Problem
Description
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.
Time Frame
Month 0 (baseline), Month 6
Title
WPAI:SHP Scores Over Time: Percent Impairment While Working Due to Problem
Description
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.
Time Frame
Month 0 (baseline), Month 6
Title
WPAI:SHP Scores Over Time: Percent Overall Work Impairment Due to Problem
Description
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.
Time Frame
Month 0 (baseline), Month 6
Title
WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem
Description
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.
Time Frame
Month 0 (baseline), Month 6
Title
Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time
Description
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.
Time Frame
Month 0 (baseline), Months 3, 6
Title
PROMIS Fatigue Short Form 6a Scores Over Time
Description
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).
Time Frame
Month 0 (baseline), Month 6
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
At least 2 days of "moderate" or "severe" DYS, AND either,
At least 2 days of "moderate" or "severe" NMPP and an average NMPP score of at least 1.0, OR
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
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
a clinically significant medical condition that is anticipated to required intervention during the course of study participation (e.g., anticipated major elective surgery) OR
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group /ID# 202016
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Noble Clinical Research /ID# 170628
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Lynn Institute of the Ozarks /ID# 165052
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
SC Clinical Research /ID# 165049
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Facility Name
Marvel Clinical Research /ID# 169633
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Health care Affiliates Medical Group /ID# 165048
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
Western States Clinical Res /ID# 169809
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033-2896
Country
United States
Facility Name
Nova Clinical Research, LLC /ID# 202227
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209-4616
Country
United States
Facility Name
Midland Florida Clinical Research Center /ID# 201327
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720-0920
Country
United States
Facility Name
Southeastern Integrated Med /ID# 203109
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Care Partners Clinical Researc /ID# 168395
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32277
Country
United States
Facility Name
LCC Medical Research Institute /ID# 168888
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
A Premier Clinical Research of Florida, LLC /ID# 201887
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763-2833
Country
United States
Facility Name
GCP Clinical Research, LLC /ID# 169774
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609-4044
Country
United States
Facility Name
Triple O Research Institute /ID# 201128
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407-3100
Country
United States
Facility Name
Bingham Memorial Hospital /ID# 170110
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Leavitt Womens Healthcare /ID# 169495
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404-8322
Country
United States
Facility Name
Quad Clinical Research, LLC /ID# 168294
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60605
Country
United States
Facility Name
Quad Clinical Research, LLC /ID# 170629
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60605
Country
United States
Facility Name
Women's Health Care, PC /ID# 165033
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630-8940
Country
United States
Facility Name
Delricht Research /ID# 200219
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Quad Clinical Research, LLC /ID# 200180
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108-3204
Country
United States
Facility Name
Montana Health Research Inst /ID# 170624
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Excel Clinical Research /ID# 170620
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Northwell health system /ID# 200162
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030-3816
Country
United States
Facility Name
Radiant Research, Inc /ID# 200045
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Central Ohio Clinical Research /ID# 170750
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213-3399
Country
United States
Facility Name
Optimed Research /ID# 167642
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
VitaLink Research /ID# 168401
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
VitaLink Research /ID# 170625
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Fusion Clinical Research of Spartanburg /ID# 200010
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29301-5642
Country
United States
Facility Name
Centex Studies, Inc /ID# 169897
City
Houston
State/Province
Texas
ZIP/Postal Code
77058-2705
Country
United States
Facility Name
America's Adv. Wellness Center /ID# 170005
City
Houston
State/Province
Texas
ZIP/Postal Code
77080
Country
United States
Facility Name
ClinRx Research, LLC /ID# 201189
City
Plano
State/Province
Texas
ZIP/Postal Code
75024-5280
Country
United States
Facility Name
Progressive Clinical Research /ID# 205565
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Eastern Virginia Med School /ID# 165016
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1627
Country
United States
Facility Name
Seattle Reproductive Medicine /ID# 171079
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing 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.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Learn more about this trial
A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
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