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

December 15, 2023 updated by: AbbVie

A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate in Subjects With Moderate to Severe Endometriosis-Associated Pain

The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.

Study Overview

Status

Completed

Conditions

Endometriosis

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

681

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
    - Strand Clinic /ID# 152582
- Ontario
  - Ottawa, Ontario, Canada, K1H 8L6
    - The Ottawa Hospital /ID# 148927
  - Sudbury, Ontario, Canada, P3E 5M4
    - Medicor Research Inc /ID# 151453
  - Toronto, Ontario, Canada, M5G 1X5
    - Mount Sinai Hosp.-Toronto /ID# 148972
  - Windsor, Ontario, Canada, N8W 5R7
    - Victory Reproductive Care /ID# 149016
Puerto Rico
- - Ponce, Puerto Rico, 00717
    - Puerto Rico Medical Research /ID# 152040
  - San Juan, Puerto Rico, 00909
    - Clinical Research Puerto Rico /ID# 149018
  - San Juan, Puerto Rico, 00917
    - Rodriguez-Ginorio, San Juan /ID# 145545
  - San Juan, Puerto Rico, 00935
    - School of Medicine University of Puerto Rico-Medical Science Campus /ID# 145546
United States
- Alabama
  - Birmingham, Alabama, United States, 35205
    - Central Research Associates /ID# 163087
  - Birmingham, Alabama, United States, 35235-3430
    - Alabama Clinical Therapeutics, LLC /ID# 145503
  - Birmingham, Alabama, United States, 35235-3430
    - Alabama Clinical Therapeutics, LLC /ID# 151468
  - Fairhope, Alabama, United States, 36532-3029
    - Southern Women's Specialists PC /ID# 148750
  - Mobile, Alabama, United States, 36604-1410
    - Women's Health Alliance of Mobile /ID# 150083
  - Mobile, Alabama, United States, 36604-3302
    - University of South Alabama /ID# 148774
  - Mobile, Alabama, United States, 36608
    - Mobile, Ob-Gyn, P.C. /ID# 145364
- Arizona
  - Mesa, Arizona, United States, 85209
    - Mesa Obstetricians and Gynecologists /ID# 147320
  - Tucson, Arizona, United States, 85712
    - Arizona Research Assoc /ID# 161703
  - Tucson, Arizona, United States, 85745
    - Eclipse Clinical Research /ID# 155600
- Arkansas
  - Searcy, Arkansas, United States, 72143-4802
    - Unity Health- Searcy Medical Center /ID# 203674
- California
  - Cerritos, California, United States, 90703
    - Core Healthcare Group /ID# 149321
  - Encino, California, United States, 91436
    - HRC Fertility /ID# 154143
  - Glendale, California, United States, 91206
    - Glendale Adventist Medical Ctr /ID# 160530
  - Huntington Beach, California, United States, 92646
    - HCP Clinical Research LLC /ID# 152045
  - Irvine, California, United States, 92612-1245
    - Alliance Research Centers /ID# 151240
  - Long Beach, California, United States, 90806
    - Long Beach Clinical Trial Serv /ID# 152428
  - Los Angeles, California, United States, 90036-4667
    - Olympia Clinical Trials /ID# 202325
  - Northridge, California, United States, 91324
    - California Medical Research As /ID# 154746
  - Norwalk, California, United States, 90650
    - Futura Research, Org /ID# 145406
  - Pasadena, California, United States, 91105
    - Huntington Medical Foundation /ID# 154750
  - Sacramento, California, United States, 95821-2640
    - Northern California Research /ID# 159753
  - San Diego, California, United States, 92114-3643
    - Precision Research Institute - San Diego /ID# 152557
  - San Diego, California, United States, 92119
    - MD Strategies Research Centers /ID# 152429
  - Simi Valley, California, United States, 93065
    - Alta California Medical Group /ID# 155706
- Colorado
  - Denver, Colorado, United States, 80209
    - Downtown Womens Health Care /ID# 147955
  - Greenwood Village, Colorado, United States, 80111
    - Advanced Women's Health Institute /ID# 145396
  - Lakewood, Colorado, United States, 80228-1810
    - Red Rocks OB/GYN /ID# 145325
  - Thornton, Colorado, United States, 80229-4385
    - The Women's Health Group - Thornton /ID# 203707
- District of Columbia
  - Washington, District of Columbia, United States, 20036
    - James A. Simon, MD, PC /ID# 145480
- Florida
  - Boynton Beach, Florida, United States, 33436-6634
    - Helix Biomedics, LLC /ID# 147108
  - Brandon, Florida, United States, 33510
    - Gulf Coast Research Group /ID# 162895
  - Clearwater, Florida, United States, 33756
    - Olympian Clinical Research /ID# 148167
  - DeBary, Florida, United States, 32713-2260
    - Omega Research Maitland, LLC /ID# 145167
  - Fort Lauderdale, Florida, United States, 33316
    - KO Clinical Research, LLC /ID# 145410
  - Fort Myers, Florida, United States, 33912
    - Clinical Physiology Associates /ID# 145237
  - Jacksonville, Florida, United States, 32256
    - Solutions Through Adv Rch /ID# 148768
  - Kissimmee, Florida, United States, 34741-2345
    - Vida Clinical Research /ID# 150282
  - Loxahatchee Groves, Florida, United States, 33470
    - Axcess Medical Center /ID# 148169
  - Miami, Florida, United States, 33165
    - Genoma Research Group, Inc /ID# 152558
  - Miami, Florida, United States, 33176-1032
    - Vista Health Research LLC - Miami /ID# 151455
  - Miami, Florida, United States, 33186-1309
    - Palmetto Professional Research /ID# 153838
  - Miami Lakes, Florida, United States, 33016-1501
    - Precision Research Organization /ID# 145337
  - Miami Springs, Florida, United States, 33166
    - Ocean Blue Medical Research Center, Inc /ID# 145514
  - Miramar, Florida, United States, 33027
    - Salom Tangir, LLC /ID# 148739
  - New Port Richey, Florida, United States, 34652
    - Suncoast Clinical Research /ID# 145484
  - Saint Cloud, Florida, United States, 34769
    - Oncova Clinical Research, Inc. /ID# 148175
  - Saint Petersburg, Florida, United States, 33709-3113
    - Meridien Research - St Petersburg /ID# 145345
  - Sarasota, Florida, United States, 34239
    - Physician Care Clin. Res., LLC /ID# 145511
  - Stuart, Florida, United States, 34996
    - Treasure Coast Research /ID# 148174
  - Tampa, Florida, United States, 33612
    - University of South Florida /ID# 145424
  - Tampa, Florida, United States, 33613
    - Stedman Clinical Trials /ID# 152554
  - Wellington, Florida, United States, 33414
    - Virtus Research Consultants, LLC /ID# 147101
  - West Palm Beach, Florida, United States, 33409
    - Comprehensive Clinical Trials /ID# 145148
- Georgia
  - Alpharetta, Georgia, United States, 30005
    - Paramount Research Solutions /ID# 145226
  - Alpharetta, Georgia, United States, 30005
    - Paramount Research Solutions /ID# 149320
  - Atlanta, Georgia, United States, 30328-5532
    - Agile Clinical Research Trials /ID# 145494
  - Atlanta, Georgia, United States, 30342
    - Atlanta Women's Research Inst /ID# 145543
  - College Park, Georgia, United States, 30349
    - Apogee Women's Health Inc. /ID# 145149
  - Columbus, Georgia, United States, 31904
    - Columbus Regional Research Ins /ID# 159752
  - Savannah, Georgia, United States, 31406-2675
    - Meridian Clinical Research, LLC /ID# 148176
  - Suwanee, Georgia, United States, 30024-7159
    - Atlanta Gynecology Research Institute /ID# 149322
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Clinical Research Prime /ID# 161724
  - Idaho Falls, Idaho, United States, 83404
    - Womens Healthcare Assoc, DBA /ID# 148744
  - Meridian, Idaho, United States, 83642
    - Advanced Clinical Research /ID# 147086
  - Meridian, Idaho, United States, 83646-1144
    - Sonora Clinical Research /ID# 145541
  - Nampa, Idaho, United States, 83687
    - Asr, Llc /Id# 161680
- Illinois
  - Champaign, Illinois, United States, 61820
    - Women's Health Practice, LLC /ID# 145517
  - Oak Brook, Illinois, United States, 60523
    - Affinity Clinical Research /ID# 151469
  - Palos Heights, Illinois, United States, 60463-1440
    - Center for Women's Research, Inc /ID# 145486
  - Park Ridge, Illinois, United States, 60068
    - The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 151459
- Indiana
  - Avon, Indiana, United States, 46123-7960
    - American Health Network of Ind /ID# 167996
  - Fort Wayne, Indiana, United States, 46825
    - Women's Health Advantage /ID# 145495
- Iowa
  - West Des Moines, Iowa, United States, 50266
    - The Iowa Clinic /ID# 145409
- Kansas
  - Shawnee Mission, Kansas, United States, 66218
    - Womens & Family Care, LLC dba /ID# 145211
  - Wichita, Kansas, United States, 67205
    - PRN Professional Research Network of Kansas, LLC /ID# 151463
  - Wichita, Kansas, United States, 67226
    - Cypress Medical Research Ctr /ID# 147159
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - University of Louisville /ID# 154751
  - Louisville, Kentucky, United States, 40291-1988
    - Bluegrass Clinical Research /ID# 151209
- Louisiana
  - Covington, Louisiana, United States, 70433
    - Clinical Trials Management, LLC - Covington /ID# 145220
  - Covington, Louisiana, United States, 70433
    - Clinical Trials Management, LLC - Covington /ID# 145520
  - Eunice, Louisiana, United States, 70535
    - Horizon Research Group /ID# 148171
  - Marrero, Louisiana, United States, 70072
    - Praetorian Pharmaceutical Res /ID# 145405
  - New Orleans, Louisiana, United States, 70115
    - Ochsner Baptist OB/GYN Clinic /ID# 147144
  - New Orleans, Louisiana, United States, 70125-1923
    - Women Under Study, LLC /ID# 151216
  - Shreveport, Louisiana, United States, 71118-3133
    - Women's Health Clinic /ID# 155707
  - Shreveport, Louisiana, United States, 71118
    - Omni Fertility and Laser Insti /ID# 145532
- Maine
  - Bangor, Maine, United States, 04401
    - Eastern Maine Medical Center /ID# 161681
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Univ Maryland School Medicine /ID# 151739
  - Baltimore, Maryland, United States, 21208
    - Baltimore Suburban Health /ID# 147164
  - Towson, Maryland, United States, 21204
    - Continental Clinical Solutions /ID# 152041
- Massachusetts
  - Fall River, Massachusetts, United States, 02720-2972
    - NECCR Fall River LLC /ID# 145329
  - Fall River, Massachusetts, United States, 02723
    - Genesis Clinical Research - Fall River /ID# 148573
- Michigan
  - Ann Arbor, Michigan, United States, 48105
    - ClinSite, LLC /ID# 145314
  - Bay City, Michigan, United States, 48602
    - Great Lakes Research Group, Inc. /ID# 145308
  - Saginaw, Michigan, United States, 48604
    - Saginaw Valley Med Res Group /ID# 145527
  - Southfield, Michigan, United States, 48034
    - Wayne State University Physician Group - Southfield /ID# 145431
- Minnesota
  - Saint Paul, Minnesota, United States, 55114
    - Prism Research /ID# 159751
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Womens Clinic of Lincoln, P.C. /ID# 145366
- Nevada
  - Las Vegas, Nevada, United States, 89106-4017
    - Accent Clinical Trials /ID# 147109
  - Las Vegas, Nevada, United States, 89113
    - Office of Edmond E. Pack, MD /ID# 148747
  - Las Vegas, Nevada, United States, 89128
    - R. Garn Mabey Jr, MD Chartered /ID# 145361
- New Jersey
  - Neptune, New Jersey, United States, 07753-4859
    - Jersey Shore University Medical Center /ID# 148756
  - New Brunswick, New Jersey, United States, 08901
    - Rutgers Robert Wood Johnson /ID# 152858
  - Totowa, New Jersey, United States, 07512
    - St. Joseph's Regional Medical /ID# 157759
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Albuquerque Clinical Trials, Inc /ID# 154747
  - Albuquerque, New Mexico, United States, 87109
    - Bosque Women's Care /ID# 147084
- New York
  - Brooklyn, New York, United States, 11203
    - SUNY Downstate Medical Center /ID# 148749
  - Laurelton, New York, United States, 11413
    - Scott Research Inc. /ID# 161704
  - New York, New York, United States, 10016-6023
    - Manhattan Medical Research /ID# 145175
  - New York, New York, United States, 10032-3725
    - Columbia Univ Medical Center /ID# 145334
  - Orchard Park, New York, United States, 14127
    - Hamburg Regional Gynecology Gr /ID# 161705
  - West Seneca, New York, United States, 14224
    - OB.GYN Associates of WNY /ID# 161665
- North Carolina
  - Charlotte, North Carolina, United States, 28209
    - PMG Research of Charlotte /ID# 145432
  - Charlotte, North Carolina, United States, 28210-8508
    - DJL Clinical Research, PLLC /ID# 154679
  - Durham, North Carolina, United States, 27713
    - Carolina Women's Research and Wellness Center /ID# 145356
  - Greensboro, North Carolina, United States, 27408
    - Unified Women's Clinical Research-Greensboro /ID# 155543
  - High Point, North Carolina, United States, 27262
    - Pinewest Ob-Gyn, Inc. /ID# 151743
  - New Bern, North Carolina, United States, 28562
    - Eastern Carolina Women's Centr /ID# 145386
  - Raleigh, North Carolina, United States, 27607
    - Unified Women's Clinical Resea /ID# 145353
  - Wilmington, North Carolina, United States, 28401-6638
    - PMG Research of Wilmington /ID# 152555
- North Dakota
  - Minot, North Dakota, United States, 58701
    - Trinity Health Center Town /ID# 147102
- Ohio
  - Beavercreek, Ohio, United States, 45431-2573
    - Clinical Inquest Center Ltd /ID# 147107
  - Cincinnati, Ohio, United States, 45212
    - CTI Clinical Research Center /ID# 145428
  - Cincinnati, Ohio, United States, 45219
    - The Christ Hospital /ID# 149244
  - Cincinnati, Ohio, United States, 45267-0585
    - University of Cincinnati /ID# 145496
  - Cleveland, Ohio, United States, 44106
    - Univ Hosp Cleveland /ID# 148741
  - Columbus, Ohio, United States, 43210-1257
    - The Ohio State University /ID# 145444
  - Columbus, Ohio, United States, 43213
    - Aventiv Research, Inc. /ID# 145492
  - Columbus, Ohio, United States, 43213
    - Aventiv Research, Inc. /ID# 162896
  - Fairborn, Ohio, United States, 45324
    - Wright State University & CTRA /ID# 145512
  - Toledo, Ohio, United States, 43614
    - University of Toledo /ID# 145403
- Oregon
  - Portland, Oregon, United States, 97239
    - Oregon Health and Science University /ID# 155705
- Pennsylvania
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Main Line Fertility Center /ID# 150099
  - Erie, Pennsylvania, United States, 16507-1423
    - OB/GYN Associates of Erie /ID# 157935
  - Hershey, Pennsylvania, United States, 17033
    - Penn State University and Milton S. Hershey Medical Center /ID# 145231
  - Philadelphia, Pennsylvania, United States, 19104-5502
    - University of Pennsylvania /ID# 145470
  - Philadelphia, Pennsylvania, United States, 19129
    - Drexel Univ College of Med /ID# 149789
  - Smithfield, Pennsylvania, United States, 15478
    - Frontier Clinical Research /ID# 162091
- South Carolina
  - Columbia, South Carolina, United States, 29201
    - Vista Clinical Research /ID# 148767
  - Greenville, South Carolina, United States, 29605
    - University Medical Group /ID# 148777
  - Myrtle Beach, South Carolina, United States, 29572
    - Venus Gynecology, LLC /ID# 145336
  - North Charleston, South Carolina, United States, 29406
    - James T. Martin, Jr., MD., Obs /ID# 148755
  - Summerville, South Carolina, United States, 29485-7539
    - Palmetto Clinical Research /ID# 150992
- South Dakota
  - Watertown, South Dakota, United States, 57201
    - Brown Clinic, PLLP /ID# 154372
- Tennessee
  - Bristol, Tennessee, United States, 37620-7346
    - Holston Medical Group /ID# 145449
  - Chattanooga, Tennessee, United States, 37404
    - Chattanooga Medical Research /ID# 145184
  - Chattanooga, Tennessee, United States, 37421-1605
    - WR-ClinSearch /ID# 145205
  - Jackson, Tennessee, United States, 38305
    - The Jackson Clinic, PA /ID# 145303
  - Memphis, Tennessee, United States, 38119-3895
    - Research Memphis Associates, LLC /ID# 150100
  - Nashville, Tennessee, United States, 37203
    - Access Clinical Trials, Inc. /ID# 145224
- Texas
  - Austin, Texas, United States, 78703-1448
    - Lotus Gynecology /ID# 148479
  - Austin, Texas, United States, 78758-5653
    - AA (Austin Area) ObGyn PLLC /ID# 205696
  - Austin, Texas, United States, 78759
    - Sirius Clinical Research, LLC /ID# 154749
  - Beaumont, Texas, United States, 77702-1100
    - Gadolin Research, LLC /ID# 201383
  - Bedford, Texas, United States, 76022
    - Center for Assisted Reprod. /ID# 154748
  - Dallas, Texas, United States, 75231
    - Texas Health Presbyterian Hosp /ID# 150098
  - Dallas, Texas, United States, 75390-7208
    - UT Southwestern Medical Center /ID# 145201
  - Fort Worth, Texas, United States, 76104-4110
    - Baylor Scott & White /ID# 170430
  - Fort Worth, Texas, United States, 76104
    - Signature Gyn Services /ID# 145534
  - Frisco, Texas, United States, 75035
    - Willowbend Health and Wellness - Frisco /ID# 145245
  - Houston, Texas, United States, 77004-6031
    - Next Innovative Clinical Research /ID# 203863
  - Houston, Texas, United States, 77030
    - Advances in Health, Inc. /ID# 145425
  - Houston, Texas, United States, 77030
    - Houston Methodist Hospital /ID# 170586
  - Houston, Texas, United States, 77036
    - Precision Research Institute - Houston /ID# 154370
  - Houston, Texas, United States, 77054
    - The Woman's Hospital of Texas /ID# 145316
  - Houston, Texas, United States, 77058-2705
    - Centex Studies, Inc /ID# 148776
  - Lampasas, Texas, United States, 76550
    - FMC Science /ID# 150981
  - San Antonio, Texas, United States, 78229
    - Clinical Trials of Texas, Inc /ID# 147100
  - San Antonio, Texas, United States, 78230
    - VIP Trials /ID# 151745
  - San Antonio, Texas, United States, 78258
    - Discovery Clinical Trials-San Antonio /ID# 145363
  - Sugar Land, Texas, United States, 77479
    - Houston Ctr for Clin Research /ID# 148799
  - Webster, Texas, United States, 77598
    - Center of Reproductive Medicin /ID# 145467
- Utah
  - Draper, Utah, United States, 84020
    - Corner Canyon Obstetrics and G /ID# 145519
  - Layton, Utah, United States, 84041
    - Tanner Clinic /ID# 148786
  - Pleasant Grove, Utah, United States, 84062
    - Revere Health /ID# 145540
- Virginia
  - Franklin, Virginia, United States, 23851
    - Southampton Women's Health /ID# 151691
  - Newport News, Virginia, United States, 23606
    - Health Research of Hampton Roads, Inc. (HRHR) /ID# 156477
  - North Chesterfield, Virginia, United States, 23235-4722
    - Clinical Research Partners, LL /ID# 145392
  - North Chesterfield, Virginia, United States, 23235-4722
    - Clinical Research Partners, LL /ID# 145416
  - Richmond, Virginia, United States, 23225
    - Clinical Trials Virginia, Inc. /ID# 145430
  - Richmond, Virginia, United States, 23226-1930
    - Alliance Womens Health /ID# 148770
  - Virginia Beach, Virginia, United States, 23456
    - Tidewater Clinical Research /ID# 145397
- Washington
  - Puyallup, Washington, United States, 98372
    - Clinical Research Adv, Inc. /ID# 149257
  - Seattle, Washington, United States, 98101
    - Virginia Mason Medical Center /ID# 145387
  - Seattle, Washington, United States, 98105
    - Seattle Women's Health, Research, Gynecology /ID# 145341
  - Spokane, Washington, United States, 99207
    - North Spokane Women's Health /ID# 145382
  - Tacoma, Washington, United States, 98431
    - Madigan Army Medical Center /ID# 145186

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Description

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 within 10 years prior to entry into Washout or Screening.
Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for 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" dysmenorrhea (DYS) AND either
2. At least 2 days of "moderate" or "severe" non-menstrual pelvic pain (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-related 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 any major depression or post-traumatic stress disorder (PTSD) within 2 years of the screening visit 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) within the last 1 year at Screening or prior to randomization on Day 1.
Participant has any history of osteoporosis or other metabolic bone disease or 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 2.0 or more standard deviations below normal.
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 randomization on Day 1 OR
2. a clinically significant medical condition that is anticipated to require intervention during the course of study participation (e.g., anticipated major elective surgery) OR
3. an unstable medical condition that makes the subject an unsuitable candidate for the study in the opinion of the Investigator, (including, but not limited to, uncontrolled diabetes mellitus, uncontrolled hypertension, epilepsy requiring anti-epileptic medication, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).
Participant has any conditions contraindicated with use of E2/NETA.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Placebo for elagolix administered twice daily (BID) plus placebo for estradiol/norethindrone acetate (E2/NETA) administered once daily (QD) for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.	Drug: Placebo for Elagolix Tablet Drug: Placebo for E2/NETA Tablets
Experimental: Elagolix / Elagolix + E2/NETA Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.	Drug: Estradiol/Norethindrone Acetate Tablets Other Names: Activella E2/NETA Drug: Elagolix Tablet Other Names: ABT-620 Elagolix Sodium ORILISSA
Experimental: Elagolix + E2/NETA Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.	Drug: Estradiol/Norethindrone Acetate Tablets Other Names: Activella E2/NETA Drug: Elagolix Tablet Other Names: ABT-620 Elagolix Sodium ORILISSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment Time Frame: Month 6, Month 12	Participants recorded rescue analgesic use for endometriosis-associated pain daily and DYS (pain during menstruation ) and its impact on daily activities each day of their period in an electronic diary (e-Diary). DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over 35 days prior to each visit. Response was defined as a reduction of -0.92 or more from baseline in DYS as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesic).	Month 6, Month 12
Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment Time Frame: Month 6, Month 12	Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit. Response was defined as a reduction of -0.55 or greater from baseline for NMPP as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesics).	Month 6, Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in DYS at Month 12 Based on Daily Assessment Time Frame: Baseline, Month 12	Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Pain scores were averaged over the 35 days prior to each visit.	Baseline, Month 12
Change From Baseline in DYS at Month 6 Based on Daily Assessment Time Frame: Baseline, Month 6	Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: 0: No discomfort Mild discomfort but I was easily able to do the things I usually do Moderate discomfort or pain that made it difficult to do some of the things I usually do Severe pain that made it difficult to do the things I usually do. Pain scores were averaged over the 35 days prior to each visit.	Baseline, Month 6
Change From Baseline in DYS at Month 3 Based on Daily Assessment Time Frame: Baseline, Month 3	Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: 0: No discomfort Mild discomfort but I was easily able to do the things I usually do Moderate discomfort or pain that made it difficult to do some of the things I usually do Severe pain that made it difficult to do the things I usually do. Pain scores were averaged over the 35 days prior to each visit.	Baseline, Month 3
Change From Baseline in Non-menstrual Pelvic Pain (NMPP) at Month 12 Based on Daily Assessment Time Frame: Baseline, Month 12	Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit.	Baseline, Month 12
Change From Baseline in NMPP at Month 6 Based on Daily Assessment Time Frame: Baseline, Month 6	Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit.	Baseline, Month 6
Change From Baseline in NMPP at Month 3 Based on Daily Assessment Time Frame: Baseline, Month 3	Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit.	Baseline, Month 3
Change From Baseline to Month 6 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score Time Frame: Baseline, Month 6	The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.	Baseline, Month 6
Change From Baseline in Dyspareunia (DYSP) at Month 12 Based on Daily Assessment Time Frame: Baseline, Month 12	Participants assessed DYSP each day in an e-Diary according to the following response options: 0: None; No discomfort during sexual intercourse 1: Mild; Able to tolerate the discomfort during sexual intercourse 2: Moderate; Intercourse was interrupted due to pain 3: Severe; Avoided intercourse because of pain Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse. Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.	Baseline, Month 12
Change From Baseline in DYSP at Month 6 Based on Daily Assessment Time Frame: Baseline, Month 6	Participants assessed DYSP each day in an e-Diary according to the following response options: 0: None; No discomfort during sexual intercourse 1: Mild; Able to tolerate the discomfort during sexual intercourse 2: Moderate; Intercourse was interrupted due to pain 3: Severe; Avoided intercourse because of pain Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse. Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.	Baseline, Month 6
Change From Baseline in DYSP at Month 3 Based on Daily Assessment Time Frame: Baseline, Month 3	Participants assessed DYSP each day in an e-Diary according to the following response options: 0: None; No discomfort during sexual intercourse 1: Mild; Able to tolerate the discomfort during sexual intercourse 2: Moderate; Intercourse was interrupted due to pain 3: Severe; Avoided intercourse because of pain Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse. Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.	Baseline, Month 3
Change From Baseline to Month 12 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score Time Frame: Baseline, Month 12	The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.	Baseline, Month 12
Change From Baseline in Endometriosis-Associated Pain Score at Month 12 Assessed With Numeric Rating Scale (NRS) Time Frame: Baseline, Month 12	The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.	Baseline, Month 12
Change From Baseline in Endometriosis-Associated Pain Score at Month 6 Assessed With NRS Time Frame: Baseline, Month 6	The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.	Baseline, Month 6
Change From Baseline in Endometriosis-Associated Pain Score at Month 3 Assessed With NRS Time Frame: Baseline, Month 3	The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.	Baseline, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Watts NB, Binkley N, Owens CD, Al-Hendy A, Puscheck EE, Shebley M, Schlaff WD, Simon JA. Bone Mineral Density Changes Associated With Pregnancy, Lactation, and Medical Treatments in Premenopausal Women and Effects Later in Life. J Womens Health (Larchmt). 2021 Oct;30(10):1416-1430. doi: 10.1089/jwh.2020.8989. Epub 2021 Aug 25.

Helpful Links

Related info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2017

Primary Completion (Actual)

March 27, 2020

Study Completion (Actual)

December 6, 2023

Study Registration Dates

First Submitted

July 7, 2017

First Submitted That Met QC Criteria

July 7, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

M14-702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

STUDY_PROTOCOL
SAP
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometriosis

Fabio Barra

Completed

Rectal Water-contrast Transvaginal Ultrasonography Versus Sonovaginography for the Diagnosis of Posterior Deep Pelvic Endometriosis

Endometriosis | Endometriosis, Rectum | Endometriosis of Vagina | Endometriosis Rectovaginal Septum | Endometriosis Pelvic | Endometriosis of Colon

Italy
Ospedale Policlinico San Martino

Completed

Fertility in Untreated Rectosigmoid Endometriosis

Endometriosis | Bowel Endometriosis | Endometriosis, Rectum | Endometriosis Colon

Italy
BioGene Pharmaceutical Ltd.

Withdrawn

Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis (ELTA)

Endometriosis | Endometriosis Ovary | Endometriosis, Rectum | Endometriosis Externa

Switzerland
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...

Completed

Thoracic Endometriosis: A Cohort Study (TORENDO)

Endometriosis | Endometriosis-related Pain | Endometriosis Thoracic | Endometriosis of Lung | Endometriosis of Pleura

Italy
Ospedale Policlinico San Martino

Completed

Three-dimensional (3D) Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis

Endometriosis, Rectum | Endometriosis, Sigmoid

Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Unknown

Indocyanine Green and Rectosigmoid Endometriosis (vincendo)

Bowel Endometriosis | Endometriosis, Rectum

Italy
Ospedale Policlinico San Martino

Active, not recruiting

Bidimensional Rectal-water Contrast-transvaginal Ultrasonography (2D-RWC-TVS) Versus 3D-RWC-TVS in the Diagnosis of Rectosigmoid Endometriosis (3Dvs2D-RWC-TVS)

Endometriosis, Rectum | Endometriosis of Colon

Italy
Catholic University of the Sacred Heart

Completed

Prospective Evaluation of Near-infrared Fluorescence Imaging Use as a Supportive Tool in Deep Infiltrating Endometriosis Surgery (GRE-Endo-2)

Pelvic Endometriosis | Endometriosis Outside Pelvis

Italy
Semmelweis University
University of Pecs

Not yet recruiting

The Role of Galectins in the Non-invasive Diagnosis of Endometriosis

Endometriosis | Endometriosis Ovary | Endometriosis Rectovaginal Septum
Catholic University of the Sacred Heart

Completed

Near-infrared Fluorescence Imaging as a Supportive Tool for Localisation of Deep Infiltrating Endometriosis During Laparoscopy

Pelvic Endometriosis | Endometriosis Outside Pelvis

Italy

Clinical Trials on Placebo for Elagolix

Nanjing Chia-tai Tianqing Pharmaceutical

Recruiting

A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-associated Pain

Endometriosis

China
Qilu Pharmaceutical (Hainan) Co., Ltd.

Recruiting

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

Endometriosis

China
AbbVie

Completed

A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Uterine Fibroids

United States, Puerto Rico
Bayer

Terminated

Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb (SCHUMANN)

Endometriosis

Spain, Belgium, United States, Germany, Austria, Japan, Canada, Hungary, Bulgaria, Italy, China, Czechia, Finland, Norway, Poland, Slovakia, Estonia, Greece, Latvia, Lithuania
AbbVie

Active, not recruiting

Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Uterine Fibroids | Heavy Menstrual Bleeding

United States, Puerto Rico
AbbVie (prior sponsor, Abbott)

Completed

A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain (ELARIS EM-I)

Endometriosis
AbbVie

Completed

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

Endometriosis
AbbVie (prior sponsor, Abbott)
Neurocrine Biosciences

Completed

An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females

Folliculogenesis

United States, Puerto Rico
Yale University
National Heart, Lung, and Blood Institute (NHLBI)

Recruiting

Cardiovascular Disease Risk in Women With Endometriosis

Endometriosis

United States
AbbVie

Completed

Efficacy and Safety Study of Elagolix in Women With Endometriosis

Endometriosis, Pain

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

A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate in Subjects With Moderate to Severe Endometriosis-Associated Pain

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Endometriosis

Clinical Trials on Placebo for Elagolix

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations