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AzTrials

EndometriosisPhase 3NCT03343067

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

A Phase 3 study testing elagolix and estradiol/norethindrone acetate (E2/NETA) in people with Endometriosis, run by AbbVie at 37 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 years, women only
Conditions the study is for
Endometriosis
What is being tested?
elagolix and estradiol/norethindrone acetate (E2/NETA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
37 sitesUnited States
Study dates
27 Dec 2017to 23 Oct 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • 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.

Who cannot join

  • 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).
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  • 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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

United States37 sites

  • Radiant Research, Inc /ID# 200045

    Akron, Ohio, 44311

  • Pinnacle Research Group /ID# 202016

    Anniston, Alabama, 36207

  • Montana Health Research Inst /ID# 170624

    Billings, Montana, 59102

  • Bingham Memorial Hospital /ID# 170110

    Blackfoot, Idaho, 83221

  • Nova Clinical Research, LLC /ID# 202227

    Bradenton, Florida, 34209-4616

  • Quad Clinical Research, LLC /ID# 168294

    Chicago, Illinois, 60605

  • Quad Clinical Research, LLC /ID# 170629

    Chicago, Illinois, 60605

  • Central Ohio Clinical Research /ID# 170750

    Columbus, Ohio, 43213-3399

  • Optimed Research /ID# 167642

    Columbus, Ohio, 43235

  • Midland Florida Clinical Research Center /ID# 201327

    DeLand, Florida, 32720-0920

  • Southeastern Integrated Med /ID# 203109

    Gainesville, Florida, 32607

  • SC Clinical Research /ID# 165049

    Garden Grove, California, 92844

  • VitaLink Research /ID# 168401

    Greenville, South Carolina, 29601

  • VitaLink Research /ID# 170625

    Greenville, South Carolina, 29601

  • Centex Studies, Inc /ID# 169897

    Houston, Texas, 77058-2705

  • America's Adv. Wellness Center /ID# 170005

    Houston, Texas, 77080

  • Marvel Clinical Research /ID# 169633

    Huntington Beach, California, 92647

  • Leavitt Womens Healthcare /ID# 169495

    Idaho Falls, Idaho, 83404-8322

  • Care Partners Clinical Researc /ID# 168395

    Jacksonville, Florida, 32277

  • Excel Clinical Research /ID# 170620

    Las Vegas, Nevada, 89109

  • Lynn Institute of the Ozarks /ID# 165052

    Little Rock, Arkansas, 72205

  • Northwell health system /ID# 200162

    Manhasset, New York, 11030-3816

  • LCC Medical Research Institute /ID# 168888

    Miami, Florida, 33126

  • Delricht Research /ID# 200219

    New Orleans, Louisiana, 70115

  • Women's Health Care, PC /ID# 165033

    Newburgh, Indiana, 47630-8940

  • Eastern Virginia Med School /ID# 165016

    Norfolk, Virginia, 23507-1627

  • A Premier Clinical Research of Florida, LLC /ID# 201887

    Orange City, Florida, 32763-2833

  • ClinRx Research, LLC /ID# 201189

    Plano, Texas, 75024-5280

  • Progressive Clinical Research /ID# 205565

    San Antonio, Texas, 78229

  • Health care Affiliates Medical Group /ID# 165048

    Santa Ana, California, 92704

  • Seattle Reproductive Medicine /ID# 171079

    Seattle, Washington, 98109

  • Fusion Clinical Research of Spartanburg /ID# 200010

    Spartanburg, South Carolina, 29301-5642

  • Quad Clinical Research, LLC /ID# 200180

    St Louis, Missouri, 63108-3204

  • GCP Clinical Research, LLC /ID# 169774

    Tampa, Florida, 33609-4044

  • Noble Clinical Research /ID# 170628

    Tucson, Arizona, 85704

  • Triple O Research Institute /ID# 201128

    West Palm Beach, Florida, 33407-3100

  • Western States Clinical Res /ID# 169809

    Wheat Ridge, Colorado, 80033-2896

Other trials in United States

About this study

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

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.

Conditions
Endometriosis
Being tested
elagolix, estradiol/norethindrone acetate (E2/NETA)
Keywords
Endometriosis associated pain, Elagolix, Non-menstrual pelvic pain (NMPP), Dysmenorrhea (DYS)
Medical subject headings
Endometriosis, Dysmenorrhea

What participants receive

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

  • elagolixDrug

    Tablets

  • estradiol/norethindrone acetate (E2/NETA)Drug

    Capsules

Study groups in NCT03343067
Study groupRoleWhat they receive
Arm AExperimentalDay 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
Receives: Drug: elagolix
Arm CExperimentalDay 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.
Receives: Drug: elagolix; Drug: estradiol/norethindrone acetate (E2/NETA)
Arm DExperimentalDay 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.
Receives: Drug: elagolix; Drug: estradiol/norethindrone acetate (E2/NETA)
Arm BExperimentalDay 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.
Receives: Drug: elagolix

What is being measured

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

  1. 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.

    Measured: Month 6

  2. 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.

    Measured: Month 6

Secondary outcomes (38)

  1. 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.

    Measured: Month 0 (baseline), Month 6

  2. 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.

    Measured: Month 0 (baseline), Month 6

  3. 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.

    Measured: Month 0 (baseline), Month 6

  4. 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.

    Measured: Month 0 (baseline), Month 6

  5. 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.

    Measured: Month 0 (baseline), Month 6

  6. 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.

    Measured: Month 6

  7. 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.

    Measured: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

  8. 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.

    Measured: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

  9. 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.

    Measured: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

  10. 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.

    Measured: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

  11. 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.

    Measured: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

  12. 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.

    Measured: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

  13. 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.

    Measured: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

  14. 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.

    Measured: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

  15. 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.

    Measured: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

  16. 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.

    Measured: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

  17. 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.

    Measured: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

  18. 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.

    Measured: Months 1, 2, 3, 4, 5, 6

  19. 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).

    Measured: Months 1, 2, 3, 4, 5, 6

  20. 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.

    Measured: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

  21. 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.

    Measured: Month 0 (baseline), Months 3, 6

  22. 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.

    Measured: Month 0 (baseline), Months 3, 6

  23. 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.

    Measured: Month 0 (baseline), Months 3, 6

  24. 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.

    Measured: Month 0 (baseline), Months 3, 6

  25. 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.

    Measured: Month 0 (baseline), Months 3, 6

  26. 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.

    Measured: Month 0 (baseline), Months 3, 6

  27. 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).

    Measured: Month 0 (baseline), Months 3, 6

  28. 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).

    Measured: Month 0 (baseline), Months 3, 6

  29. 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).

    Measured: Month 0 (baseline), Months 3, 6

  30. 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).

    Measured: Month 0 (baseline), Months 3, 6

  31. 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).

    Measured: Month 0 (baseline), Months 3, 6

  32. 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).

    Measured: Month 0 (baseline), Months 3, 6

  33. 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.

    Measured: Month 0 (baseline), Month 6

  34. 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.

    Measured: Month 0 (baseline), Month 6

  35. 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.

    Measured: Month 0 (baseline), Month 6

  36. 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.

    Measured: Month 0 (baseline), Month 6

  37. 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.

    Measured: Month 0 (baseline), Months 3, 6

  38. 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).

    Measured: Month 0 (baseline), Month 6

Timeline

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

  1. First posted17 Nov 2017
  2. Study start27 Dec 2017
  3. Primary completion23 Oct 2018
  4. Study completion23 Oct 2018

Why it stopped: The study was terminated early for business reasons, not for safety concerns.

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03343067
Sponsor's protocol ID
M16-383
Status last verified
Jul 2019
First submitted
13 Nov 2017
Last updated
27 Nov 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing elagolix and estradiol/norethindrone acetate (E2/NETA) in people with Endometriosis, run by AbbVie at 37 sites in United States.

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

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Proportion of Responders at Month 6 Based on DYS Pain Scale (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03343067.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.

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