Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain

April 17, 2024 updated by: AbbVie

A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Combined Oral Contraceptives in Premenopausal Women With Documented Endometriosis and Associated Moderate to Severe Pain

Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain.

Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico.

Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18.

There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Study Overview

Status

Recruiting

Conditions

Endometriosis

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

800

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 Contact

Name: ABBVIE CALL CENTER
Phone Number: 844-663-3742
Email: abbvieclinicaltrials@abbvie.com

Study Locations

Puerto Rico
- - Cidra, Puerto Rico, 00739
    - Recruiting
    - Advanced Medical Concepts. PSC /ID# 221337
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - San Juan, Puerto Rico, 00917-5022
    - Completed
    - Henry A. Rodriguez Ginorio, MD /ID# 217233
  - San Juan, Puerto Rico, 00935
    - Completed
    - School of Medicine University of Puerto Rico-Medical Science Campus /ID# 217235
United States
- Alabama
  - Anniston, Alabama, United States, 36207
    - Completed
    - Pinnacle Research Group /ID# 217062
  - Birmingham, Alabama, United States, 35218
    - Recruiting
    - ACCEL Research Sites /ID# 218044
  - Birmingham, Alabama, United States, 35235-3430
    - Recruiting
    - Alabama Clinical Therapeutics /ID# 222301
  - Birmingham, Alabama, United States, 35294-7333
    - Recruiting
    - University of Alabama at Birmingham - Women's and Infant's Center /ID# 224503
  - Birmingham, Alabama, United States, 35235-3430
    - Completed
    - Alabama Clinical Therapeutics /ID# 217166
  - Dothan, Alabama, United States, 36301
    - Recruiting
    - Trinity Research Group /ID# 246932
  - Fairhope, Alabama, United States, 36532-3029
    - Completed
    - Southern Women's Specialists PC /ID# 217143
  - Mobile, Alabama, United States, 36604-1410
    - Recruiting
    - Women's Health Alliance of Mobile /ID# 222591
  - Mobile, Alabama, United States, 36608
    - Completed
    - Mobile, OBGYN P.C. /ID# 217135
- Arizona
  - Mesa, Arizona, United States, 85209
    - Recruiting
    - Mesa Obstetricians and Gynecologists /ID# 217092
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Phoenix, Arizona, United States, 85251
    - Completed
    - MomDoc Womens Health Research /ID# 221661
- Arkansas
  - Little Rock, Arkansas, United States, 72212-4187
    - Recruiting
    - Applied Research Center of Arkansas /ID# 248494
  - Searcy, Arkansas, United States, 72143-4802
    - Recruiting
    - Unity Health- Searcy Medical Center /ID# 217050
- California
  - Encinitas, California, United States, 92024
    - Recruiting
    - Diagnamics Inc. /ID# 225385
  - La Palma, California, United States, 90623
    - Completed
    - Atella Clinical Research /ID# 224024
  - Northridge, California, United States, 91324-4622
    - Completed
    - Valley Renal Medical Group Research /ID# 228614
  - Norwalk, California, United States, 90650
    - Completed
    - Futura Research, Org /ID# 217361
  - Sacramento, California, United States, 95821-2640
    - Recruiting
    - Northern California Research /ID# 217301
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - San Diego, California, United States, 92119-3434
    - Completed
    - Advanced Clinical Research Center, LLC /ID# 248398
  - San Diego, California, United States, 92103-3363
    - Completed
    - A & B Clinical Research /ID# 224471
- Colorado
  - Aurora, Colorado, United States, 80012-4505
    - Completed
    - Rocky Mountain Internal Medicine - Aurora /ID# 245161
  - Denver, Colorado, United States, 80209-3804
    - Completed
    - Velocity Clinical Research - Denver /ID# 217297
  - Grand Junction, Colorado, United States, 81505-1018
    - Completed
    - Boeson Research - Grand Junction /ID# 248580
  - Greenwood Village, Colorado, United States, 80111
    - Recruiting
    - Advanced Women's Health Institute /ID# 217150
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Lakewood, Colorado, United States, 80228-1810
    - Recruiting
    - Red Rocks OB/GYN /ID# 217103
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
- Delaware
  - Newark, Delaware, United States, 19713
    - Completed
    - Reproductive Assoc of Delaware /ID# 227764
- District of Columbia
  - Washington, District of Columbia, United States, 20036
    - Recruiting
    - James A. Simon, MD, PC /ID# 218116
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Washington, District of Columbia, United States, 20010
    - Completed
    - Medstar Health Research Institute /ID# 244937
- Florida
  - Apopka, Florida, United States, 32703-5835
    - Recruiting
    - Topaz Clinical Research /ID# 218615
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Aventura, Florida, United States, 33180
    - Recruiting
    - Ideal Clinical Research Inc. /ID# 218832
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Boynton Beach, Florida, United States, 33436-6634
    - Recruiting
    - Helix Biomedics, LLC /ID# 218649
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Clearwater, Florida, United States, 33756
    - Recruiting
    - Olympian Clinical Research /ID# 244426
  - Clearwater, Florida, United States, 33759
    - Completed
    - Women's Medical Research Group /ID# 218524
  - Doral, Florida, United States, 33166-6658
    - Recruiting
    - Doral Medical Research, LLC /ID# 225146
  - Doral, Florida, United States, 33166
    - Recruiting
    - Universal Axon Clinical Research /ID# 248553
  - Fort Lauderdale, Florida, United States, 33316
    - Completed
    - KO Clinical Research, LLC /ID# 217173
  - Fort Myers, Florida, United States, 33912
    - Completed
    - Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 217061
  - Jacksonville, Florida, United States, 32256
    - Recruiting
    - Solutions Through Adv Rch /ID# 220973
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Jacksonville, Florida, United States, 32277
    - Completed
    - Care Partners Clinical Research /ID# 217042
  - Kissimmee, Florida, United States, 34741-2358
    - Recruiting
    - Vida Clinical Research /ID# 245325
  - Kissimmee, Florida, United States, 34741
    - Recruiting
    - Kissimmee Clinical Research /ID# 224749
  - Margate, Florida, United States, 33063
    - Recruiting
    - South Florida Wellness & Clinic /ID# 222897
  - Miami, Florida, United States, 33155-1402
    - Recruiting
    - Gold Coast Health Research, LLC /ID# 248624
  - Miami, Florida, United States, 33174
    - Recruiting
    - The Miami Research Group Inc /ID# 246578
  - Miami, Florida, United States, 33173
    - Completed
    - Admed Research LLC /ID# 227679
  - Miami, Florida, United States, 33175-8802
    - Completed
    - Innova Pharma Research /ID# 245354
  - Miami, Florida, United States, 33145-2457
    - Completed
    - GRE Clinical Research, LLC /ID# 246579
  - Miami Springs, Florida, United States, 33166
    - Completed
    - Ocean Blue Medical Research Center, Inc /ID# 217286
  - Miramar, Florida, United States, 33027
    - Completed
    - Salom Tangir, LLC /ID# 217273
  - New Port Richey, Florida, United States, 34653
    - Recruiting
    - Advanced Research Institute, Inc /ID# 217206
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - New Port Richey, Florida, United States, 34652
    - Recruiting
    - Suncoast Clinical Research Pasco County /ID# 217249
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - North Miami, Florida, United States, 33161-5821
    - Completed
    - Segal Institute for Clinical Research /ID# 221518
  - Orange City, Florida, United States, 32763-2833
    - Completed
    - A Premier Medical Research of FL /ID# 216908
  - Orlando, Florida, United States, 32806-5412
    - Recruiting
    - Osceola Gynecology, LLC - Orlando /ID# 227194
  - Orlando, Florida, United States, 32819-8900
    - Recruiting
    - Clinical Associates of Orlando /ID# 218114
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Orlando, Florida, United States, 32808
    - Recruiting
    - Omega Research Group /ID# 216907
  - Palm Harbor, Florida, United States, 34684
    - Completed
    - Suncoast Clinical Research - Palm Harbor /ID# 219133
  - Pembroke Pines, Florida, United States, 33027-1003
    - Recruiting
    - Royal Research,Corp /ID# 221356
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Sarasota, Florida, United States, 34239
    - Recruiting
    - Physician Care Clin. Res., LLC /ID# 217264
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Tampa, Florida, United States, 33609-4044
    - Recruiting
    - GCP Clinical Research, LLC /ID# 217232
  - Tampa, Florida, United States, 33613
    - Completed
    - University of South Florida- Neuroscience Institute /ID# 217146
  - Wellington, Florida, United States, 33414
    - Completed
    - Virtus Research Consultants, LLC /ID# 217052
  - Winter Park, Florida, United States, 32789-4681
    - Completed
    - Florida Premier Research Institute, LLC /ID# 224499
- Georgia
  - Alpharetta, Georgia, United States, 30005
    - Completed
    - Paramount Research Solutions /ID# 218769
  - Atlanta, Georgia, United States, 30328
    - Recruiting
    - Academia of Women's Health & Endoscopic Surgery /ID# 217260
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Atlanta, Georgia, United States, 30342
    - Completed
    - Atlanta Women's Research Institute /ID# 217303
  - Atlanta, Georgia, United States, 30342-1731
    - Completed
    - Gyn & Fertility Specialists /ID# 223015
  - College Park, Georgia, United States, 30349-3103
    - Recruiting
    - Paramount Research Solutions - College Park /ID# 217358
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Columbus, Georgia, United States, 31909-5715
    - Recruiting
    - Midtown OBGYN North /ID# 222300
  - Columbus, Georgia, United States, 31904
    - Completed
    - Columbus Regional Research Ins /ID# 217294
  - Smyrna, Georgia, United States, 30082-5166
    - Recruiting
    - Innovative Women's HealthCare Solutions - Smyrna /ID# 223692
  - Snellville, Georgia, United States, 30078-6191
    - Recruiting
    - Journey Medical Research Institute - Snellville /ID# 229774
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Recruiting
    - Womens Healthcare Assoc, DBA /ID# 222153
  - Idaho Falls, Idaho, United States, 83404
    - Recruiting
    - Leavitt Womens Healthcare /ID# 217118
  - Meridian, Idaho, United States, 83646-1144
    - Recruiting
    - Sonora Clinical Research /ID# 222147
  - Nampa, Idaho, United States, 83687
    - Active, not recruiting
    - Asr, Llc /Id# 217094
- Illinois
  - Chicago, Illinois, United States, 60639-2103
    - Completed
    - Women's Health Care Center Of Chicago /ID# 245164
  - Oak Brook, Illinois, United States, 60523
    - Completed
    - Alliance for Multispecialty Research, LLC /ID# 217226
  - Park Ridge, Illinois, United States, 60068
    - Recruiting
    - The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 245372
- Indiana
  - Avon, Indiana, United States, 46123-7960
    - Completed
    - American Health Network of IN, LLC (Avon) /ID# 218023
  - Brownsburg, Indiana, United States, 46112
    - Recruiting
    - Investigators Research Group, LLC /ID# 222891
  - Fort Wayne, Indiana, United States, 46825
    - Completed
    - Women's Health Advantage /ID# 246580
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Recruiting
    - University of Iowa Hospitals and Clinics /ID# 217144
  - West Des Moines, Iowa, United States, 50266-8216
    - Recruiting
    - The Iowa Clinic, PC /ID# 217351
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
- Kansas
  - Shawnee Mission, Kansas, United States, 66218
    - Recruiting
    - GTC Research /ID# 217051
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Wichita, Kansas, United States, 67205-1138
    - Completed
    - Alliance for Multispecialty Research (AMR) - Wichita West /ID# 218040
  - Wichita, Kansas, United States, 67226
    - Recruiting
    - Cypress Medical Research Ctr /ID# 217093
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
- Louisiana
  - Covington, Louisiana, United States, 70433
    - Recruiting
    - Clinical Trials Management, LLC - Covington /ID# 217291
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Covington, Louisiana, United States, 70433-4966
    - Completed
    - Clinical Trials Management - Metairie /ID# 217054
  - Eunice, Louisiana, United States, 70535
    - Completed
    - Horizon Research Group /ID# 217100
  - Marrero, Louisiana, United States, 70072
    - Recruiting
    - Praetorian Pharmaceutical Research /ID# 217159
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Metairie, Louisiana, United States, 70001
    - Active, not recruiting
    - Southern Clinical Research A /ID# 218028
  - Shreveport, Louisiana, United States, 71118-3133
    - Completed
    - Women's Health Clinic /ID# 217205
- Maryland
  - Frederick, Maryland, United States, 21702-4301
    - Completed
    - SBL Special Services LLC /ID# 224899
  - Rockville, Maryland, United States, 20850-8726
    - Recruiting
    - Congressional OBGYN /ID# 245349
  - Towson, Maryland, United States, 21204
    - Recruiting
    - Continental Clinical Solutions /ID# 217053
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
- Massachusetts
  - Fall River, Massachusetts, United States, 02720-2972
    - Completed
    - NECCR Fall River LLC /ID# 217108
  - Fall River, Massachusetts, United States, 02723
    - Recruiting
    - Exordia Medical Research, Inc /ID# 217116
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
- Michigan
  - Bay City, Michigan, United States, 48706
    - Recruiting
    - Great Lakes Research Group - Bay City /ID# 217099
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Detroit, Michigan, United States, 48201-1406
    - Recruiting
    - Wayne State University, C.S. Mott Center /ID# 248422
  - Saginaw, Michigan, United States, 48604
    - Recruiting
    - Saginaw Valley Med Res Group /ID# 217296
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
- Missouri
  - Saint Louis, Missouri, United States, 63141
    - Completed
    - Center for Reproductive Medicine and Robotic Surgery /ID# 223494
- Montana
  - Great Falls, Montana, United States, 59405-5315
    - Recruiting
    - Boeson Research - Great Falls /ID# 248560
    - Contact:
      
      Site Coordinator
      
      Phone Number: 406-792-5858
  - Missoula, Montana, United States, 59804-7419
    - Recruiting
    - Boeson Research - Missoula /ID# 248559
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Completed
    - Womens Clinic of Lincoln, P.C. /ID# 217136
- Nevada
  - Las Vegas, Nevada, United States, 89128
    - Completed
    - Private practice: Dr. Rex G. Mabey JR /ID# 217134
  - North Las Vegas, Nevada, United States, 89030-7187
    - Completed
    - Dr. Nader and Associates M.D. P.C. /ID# 223571
- New Jersey
  - Camden, New Jersey, United States, 08103
    - Completed
    - Cooper University Hospital /ID# 227208
  - Neptune, New Jersey, United States, 07753-4859
    - Recruiting
    - Jersey Shore University Medical Center /ID# 217138
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - New Brunswick, New Jersey, United States, 08901
    - Completed
    - Rutgers Robert Wood Johnson /ID# 246933
- New York
  - Brooklyn, New York, United States, 11219
    - Recruiting
    - Maimonides Medical Center /ID# 248493
  - Buffalo, New York, United States, 14221-5771
    - Completed
    - Invision Health /ID# 218687
  - East Syracuse, New York, United States, 13057-3072
    - Recruiting
    - Widewaters Gynecology /ID# 225621
  - New York, New York, United States, 10032-3725
    - Recruiting
    - Columbia Univ Medical Center /ID# 217113
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - New York, New York, United States, 10017-4709
    - Completed
    - Parkmed NYC /ID# 224333
  - New York, New York, United States, 10065
    - Completed
    - New York Presbyterian Hospital Weill Cornell Medical Center /ID# 224329
  - Staten Island, New York, United States, 10306
    - Recruiting
    - Richmond OB/GYN Associates PC /ID# 224833
- North Carolina
  - Charlotte, North Carolina, United States, 28211-5055
    - Recruiting
    - Tyron Medical Partners, PLLC /ID# 245286
  - Charlotte, North Carolina, United States, 28209
    - Completed
    - PMG Research of Charlotte /ID# 217224
  - Durham, North Carolina, United States, 27713-7512
    - Recruiting
    - Carolina Women's Research and Wellness Center /ID# 217133
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - New Bern, North Carolina, United States, 28562
    - Completed
    - Eastern Carolina Women's Centr /ID# 222358
  - Wilmington, North Carolina, United States, 28401
    - Recruiting
    - PMG Research of Wilmington LLC /ID# 217097
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Winston-Salem, North Carolina, United States, 27103-4109
    - Recruiting
    - Carolina Medical Trials - Winston-Salem /ID# 223002
  - Winston-Salem, North Carolina, United States, 27103
    - Completed
    - Unified Women's Clinical Resea /ID# 217132
  - Winston-Salem, North Carolina, United States, 27103
    - Completed
    - Unified Women's Clinical Resea /ID# 218339
- Ohio
  - Beavercreek, Ohio, United States, 45431-2573
    - Recruiting
    - Clinical Inquest Center Ltd /ID# 217961
  - Canton, Ohio, United States, 44720
    - Completed
    - Neuro-Behavioral Clinical Research, Inc. /ID# 224026
  - Cincinnati, Ohio, United States, 45267-0585
    - Completed
    - University of Cincinnati /ID# 217349
  - Cincinnati, Ohio, United States, 45255
    - Recruiting
    - Seven Hills Clinical Research Group /ID# 224941
  - Cleveland, Ohio, United States, 44109
    - Recruiting
    - MetroHealth Medical Center /ID# 224392
  - Columbus, Ohio, United States, 43213-3399
    - Completed
    - Central Ohio Clinical Research /ID# 217059
  - Englewood, Ohio, United States, 45322
    - Recruiting
    - HWC Women's Research Center /ID# 246619
  - Fairborn, Ohio, United States, 45324-2640
    - Recruiting
    - Wright State Physicians - Fairborn /ID# 217272
  - Marion, Ohio, United States, 43302-6318
    - Recruiting
    - Marion Ob/Gyn Inc. /ID# 244175
    - Contact:
      
      Site Coordinator
      
      Phone Number: (740) 204-6667
  - Mayfield Heights, Ohio, United States, 44124
    - Completed
    - Univ Hosp Landerbrook /ID# 217065
  - Tiffin, Ohio, United States, 44883
    - Completed
    - AC Clinical Research /ID# 227356
- Pennsylvania
  - Frackville, Pennsylvania, United States, 17931-2105
    - Completed
    - Grube Gynecology /ID# 245132
  - Hershey, Pennsylvania, United States, 17033-2360
    - Recruiting
    - Penn State University and Milton S. Hershey Medical Center /ID# 217057
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Philadelphia, Pennsylvania, United States, 19104-5502
    - Recruiting
    - University of Pennsylvania /ID# 217243
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Wyomissing, Pennsylvania, United States, 19611
    - Completed
    - reading Hospital /ID# 223599
- South Carolina
  - Columbia, South Carolina, United States, 29201
    - Completed
    - Vista Clinical Research /ID# 217151
  - Greenville, South Carolina, United States, 29605
    - Recruiting
    - University Medical Group /ID# 217355
  - Greenville, South Carolina, United States, 29615
    - Completed
    - Vitalink Research - Greenville /ID# 217075
  - Summerville, South Carolina, United States, 29485-7539
    - Completed
    - Duplicate_Palmetto Clinical Research /ID# 217069
  - West Columbia, South Carolina, United States, 29169-3612
    - Recruiting
    - Biocentric Healthcare Research /ID# 248582
- Tennessee
  - Chattanooga, Tennessee, United States, 37412-3964
    - Recruiting
    - Chattanooga Research and Medicine /ID# 217045
  - Memphis, Tennessee, United States, 38119-3895
    - Completed
    - Research Memphis Associates, LLC /ID# 218022
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - Access Clinical Trials, Inc. /ID# 217055
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
- Texas
  - Dallas, Texas, United States, 75230
    - Recruiting
    - DCT - HCWC, LLC dba Discovery Clinical Trials /ID# 217095
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Dallas, Texas, United States, 75251-2202
    - Recruiting
    - Cedar Health Research /ID# 224407
  - Dallas, Texas, United States, 75390-8575
    - Completed
    - Duplicate_The University of Texas Southwestern Medical Center /ID# 217048
  - Fort Worth, Texas, United States, 76104
    - Recruiting
    - Signature Gyn Services /ID# 217299
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Friendswood, Texas, United States, 77546-3988
    - Recruiting
    - Progressive Women's Health /ID# 248402
  - Frisco, Texas, United States, 75035
    - Completed
    - Willowbend Health and Wellness - Frisco /ID# 217354
  - Georgetown, Texas, United States, 78626-8185
    - Completed
    - FMC Science, LLC - OB/GYN - Georgetown /ID# 218654
  - Houston, Texas, United States, 77024-2515
    - Recruiting
    - University of Texas (UT) Health Women's Research Center at Memorial City /ID# 217362
  - Houston, Texas, United States, 77054-2934
    - Recruiting
    - OBGYN Medical Center Associates - Medical Center Office /ID# 245346
  - Houston, Texas, United States, 77058
    - Completed
    - Centex Studies, Inc. - Houston /ID# 217357
  - Lampasas, Texas, United States, 76550
    - Completed
    - FMC Science /ID# 217047
  - League City, Texas, United States, 77573-2681
    - Completed
    - Maximos OB/GYN /ID# 229385
  - Pearland, Texas, United States, 77854
    - Recruiting
    - Advances in Health, Inc. /ID# 217220
  - San Antonio, Texas, United States, 78258
    - Recruiting
    - Discovery Clinical Trials-San Antonio /ID# 218547
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - San Antonio, Texas, United States, 78229
    - Completed
    - Clinical Trials of Texas, Inc /ID# 217039
  - San Antonio, Texas, United States, 78230
    - Completed
    - VIP Trials /ID# 217261
  - Webster, Texas, United States, 77598
    - Recruiting
    - Center of Reproductive Medicine /ID# 217241
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
- Utah
  - Draper, Utah, United States, 84020
    - Recruiting
    - Corner Canyon Obstetrics and G /ID# 217289
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Pleasant Grove, Utah, United States, 84062
    - Recruiting
    - Physicians Research Options /ID# 217302
  - Salt Lake City, Utah, United States, 84124
    - Recruiting
    - Highland Clinical Research /ID# 224052
- Virginia
  - Newport News, Virginia, United States, 23606
    - Completed
    - Health Research of Hampton Roads, Inc. (HRHR) /ID# 217063
  - North Chesterfield, Virginia, United States, 23235
    - Recruiting
    - Clinical Research Partners /ID# 217359
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Reston, Virginia, United States, 20190-3215
    - Recruiting
    - Virginia Women's Health Associates /ID# 227677
  - Richmond, Virginia, United States, 23225
    - Completed
    - Clinical Trials Virginia, Inc. /ID# 217222
  - Richmond, Virginia, United States, 23226-3786
    - Completed
    - Clinical Research Partners LLC - Richmond Forest Ave /ID# 217149
  - Virginia Beach, Virginia, United States, 23456
    - Recruiting
    - Tidewater Clinical Research /ID# 217152
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
- Washington
  - Seattle, Washington, United States, 98105
    - Recruiting
    - Seattle Clinical Research Center /ID# 217117
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Spokane, Washington, United States, 99207
    - Completed
    - North Spokane Women's Health /ID# 217356

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:

Documented surgical confirmation of endometriosis and associated moderate to severe pain.
Participants must agree to use dual non-hormonal methods of contraception consistently during washout (if applicable), screening, and 3-month double-blind placebo-controlled treatment periods of the study.
Participant, in the investigator's opinion must be an appropriate candidate to receive combined oral contraceptives (COCs).

Exclusion Criteria:

Pregnant or breastfeeding or planning a pregnancy until completion of the study.
Surgical history of hysterectomy or bilateral oophorectomy.
Participant has osteoporosis or other metabolic bone disease or clinically significant gynecological findings from Screening.
Participant has any other active chronic pain condition that would interfere with their assessment of endometriosis-related pain.

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: Double-Blind: Placebo Participants will receive double-blind placebo on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.	Drug: Elagolix Tablet:Oral Other Names: ABT-620 Orilissa Drug: Placebo Tablet:Oral Drug: Combined Oral Contraceptive Tablet:Oral
Experimental: Double-Blind: Elagolix Participants will receive double-blind Elagolix on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.	Drug: Elagolix Tablet:Oral Other Names: ABT-620 Orilissa Drug: Combined Oral Contraceptive Tablet:Oral
Experimental: Double-Blind: Elagolix + COC Participants will receive double-blind elagolix in combination with COC (combined oral contraceptive) on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC for 15 months. Participants will be followed-up for up to 12 months.	Drug: Elagolix Tablet:Oral Other Names: ABT-620 Orilissa Drug: Combined Oral Contraceptive Tablet:Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale Time Frame: Month 3	DYS response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use.	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Responders Based on Non-Menstrual Pelvic Pain (NMPP) Pain Scale Time Frame: Month 3	NMPP response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use.	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.

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)

August 10, 2020

Primary Completion (Estimated)

December 5, 2024

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M18-969

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, analyses plans, 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

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

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.

Yes

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 Elagolix

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
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
Yale University
National Heart, Lung, and Blood Institute (NHLBI)

Recruiting

Cardiovascular Disease Risk in Women With Endometriosis

Endometriosis

United States
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

Completed

Efficacy and Safety Study of Elagolix in Women With Endometriosis

Endometriosis, Pain

Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain

A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Combined Oral Contraceptives in Premenopausal Women With Documented Endometriosis and Associated Moderate to Severe Pain

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

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

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

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 Elagolix

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations