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
- Conditions
- Endometriosis
- Interventions
- Registration Number
- NCT04333576
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 800
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double-Blind: Placebo 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. Double-Blind: Placebo Combined Oral Contraceptive 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. Double-Blind: Elagolix + COC Combined Oral Contraceptive 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. Double-Blind: Elagolix Combined Oral Contraceptive 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. Double-Blind: Placebo Elagolix 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. Double-Blind: Elagolix 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. Double-Blind: Elagolix + COC Elagolix 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.
- Primary Outcome Measures
Name Time Method Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale 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.
- Secondary Outcome Measures
Name Time Method Percentage of Responders Based on Non-Menstrual Pelvic Pain (NMPP) Pain Scale 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.
Trial Locations
- Locations (179)
MomDoc Womens Health Research /ID# 221661
🇺🇸Phoenix, Arizona, United States
Pinnacle Research Group /ID# 217062
🇺🇸Anniston, Alabama, United States
ACCEL Research Sites /ID# 218044
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics /ID# 217166
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics /ID# 222301
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham - Women's and Infant's Center /ID# 224503
🇺🇸Birmingham, Alabama, United States
Trinity Research Group /ID# 246932
🇺🇸Dothan, Alabama, United States
Southern Women's Specialists PC /ID# 217143
🇺🇸Fairhope, Alabama, United States
Women's Health Alliance of Mobile /ID# 222591
🇺🇸Mobile, Alabama, United States
Mobile, OBGYN P.C. /ID# 217135
🇺🇸Mobile, Alabama, United States
Mesa Obstetricians and Gynecologists /ID# 217092
🇺🇸Mesa, Arizona, United States
Applied Research Center of Arkansas /ID# 248494
🇺🇸Little Rock, Arkansas, United States
Unity Health- Searcy Medical Center /ID# 217050
🇺🇸Searcy, Arkansas, United States
Diagnamics Inc. /ID# 225385
🇺🇸Encinitas, California, United States
Atella Clinical Research /ID# 224024
🇺🇸La Palma, California, United States
Valley Renal Medical Group Research /ID# 228614
🇺🇸Northridge, California, United States
Futura Research, Org /ID# 217361
🇺🇸Norwalk, California, United States
Northern California Research /ID# 217301
🇺🇸Sacramento, California, United States
A & B Clinical Research /ID# 224471
🇺🇸San Diego, California, United States
Advanced Clinical Research Center, LLC /ID# 248398
🇺🇸San Diego, California, United States
Rocky Mountain Internal Medicine - Aurora /ID# 245161
🇺🇸Aurora, Colorado, United States
Velocity Clinical Research - Denver /ID# 217297
🇺🇸Denver, Colorado, United States
Boeson Research - Grand Junction /ID# 248580
🇺🇸Grand Junction, Colorado, United States
Advanced Women's Health Institute /ID# 217150
🇺🇸Greenwood Village, Colorado, United States
Red Rocks OB/GYN /ID# 217103
🇺🇸Lakewood, Colorado, United States
Reproductive Assoc of Delaware /ID# 227764
🇺🇸Newark, Delaware, United States
Medstar Health Research Institute /ID# 244937
🇺🇸Washington, District of Columbia, United States
James A. Simon, MD, PC /ID# 218116
🇺🇸Washington, District of Columbia, United States
Topaz Clinical Research /ID# 218615
🇺🇸Apopka, Florida, United States
Ideal Clinical Research Inc. /ID# 218832
🇺🇸Aventura, Florida, United States
Helix Biomedics, LLC /ID# 218649
🇺🇸Boynton Beach, Florida, United States
Olympian Clinical Research /ID# 244426
🇺🇸Clearwater, Florida, United States
Women's Medical Research Group /ID# 218524
🇺🇸Clearwater, Florida, United States
Doral Medical Research, LLC /ID# 225146
🇺🇸Doral, Florida, United States
Universal Axon Clinical Research /ID# 248553
🇺🇸Doral, Florida, United States
KO Clinical Research, LLC /ID# 217173
🇺🇸Fort Lauderdale, Florida, United States
Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 217061
🇺🇸Fort Myers, Florida, United States
Solutions Through Adv Rch /ID# 220973
🇺🇸Jacksonville, Florida, United States
Care Partners Clinical Research /ID# 217042
🇺🇸Jacksonville, Florida, United States
Vida Clinical Research /ID# 245325
🇺🇸Kissimmee, Florida, United States
Kissimmee Clinical Research /ID# 224749
🇺🇸Kissimmee, Florida, United States
South Florida Wellness & Clinic /ID# 222897
🇺🇸Margate, Florida, United States
Ocean Blue Medical Research Center, Inc /ID# 217286
🇺🇸Miami Springs, Florida, United States
GRE Clinical Research, LLC /ID# 246579
🇺🇸Miami, Florida, United States
Gold Coast Health Research, LLC /ID# 248624
🇺🇸Miami, Florida, United States
Admed Research LLC /ID# 227679
🇺🇸Miami, Florida, United States
The Miami Research Group Inc /ID# 246578
🇺🇸Miami, Florida, United States
Innova Pharma Research /ID# 245354
🇺🇸Miami, Florida, United States
Salom Tangir, LLC /ID# 217273
🇺🇸Miramar, Florida, United States
Suncoast Clinical Research Pasco County /ID# 217249
🇺🇸New Port Richey, Florida, United States
Advanced Research Institute, Inc /ID# 217206
🇺🇸New Port Richey, Florida, United States
Segal Institute for Clinical Research /ID# 221518
🇺🇸North Miami, Florida, United States
A Premier Medical Research of FL /ID# 216908
🇺🇸Orange City, Florida, United States
Osceola Gynecology, LLC - Orlando /ID# 227194
🇺🇸Orlando, Florida, United States
Omega Research Group /ID# 216907
🇺🇸Orlando, Florida, United States
Clinical Associates of Orlando /ID# 218114
🇺🇸Orlando, Florida, United States
Suncoast Clinical Research - Palm Harbor /ID# 219133
🇺🇸Palm Harbor, Florida, United States
Royal Research,Corp /ID# 221356
🇺🇸Pembroke Pines, Florida, United States
Physician Care Clin. Res., LLC /ID# 217264
🇺🇸Sarasota, Florida, United States
GCP Clinical Research, LLC /ID# 217232
🇺🇸Tampa, Florida, United States
University of South Florida- Neuroscience Institute /ID# 217146
🇺🇸Tampa, Florida, United States
Virtus Research Consultants, LLC /ID# 217052
🇺🇸Wellington, Florida, United States
Florida Premier Research Institute, LLC /ID# 224499
🇺🇸Winter Park, Florida, United States
Paramount Research Solutions /ID# 218769
🇺🇸Alpharetta, Georgia, United States
Academia of Women's Health & Endoscopic Surgery /ID# 217260
🇺🇸Atlanta, Georgia, United States
Gyn & Fertility Specialists /ID# 223015
🇺🇸Atlanta, Georgia, United States
Atlanta Women's Research Institute /ID# 217303
🇺🇸Atlanta, Georgia, United States
Paramount Research Solutions - College Park /ID# 217358
🇺🇸College Park, Georgia, United States
Columbus Regional Research Ins /ID# 217294
🇺🇸Columbus, Georgia, United States
Midtown OBGYN North /ID# 222300
🇺🇸Columbus, Georgia, United States
Innovative Women's HealthCare Solutions - Smyrna /ID# 223692
🇺🇸Smyrna, Georgia, United States
Journey Medical Research Institute - Snellville /ID# 229774
🇺🇸Snellville, Georgia, United States
Leavitt Womens Healthcare /ID# 217118
🇺🇸Idaho Falls, Idaho, United States
Womens Healthcare Assoc, DBA /ID# 222153
🇺🇸Idaho Falls, Idaho, United States
Sonora Clinical Research /ID# 222147
🇺🇸Meridian, Idaho, United States
Asr, Llc /Id# 217094
🇺🇸Nampa, Idaho, United States
Women's Health Care Center Of Chicago /ID# 245164
🇺🇸Chicago, Illinois, United States
Alliance for Multispecialty Research, LLC /ID# 217226
🇺🇸Oak Brook, Illinois, United States
The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 245372
🇺🇸Park Ridge, Illinois, United States
American Health Network of IN, LLC (Avon) /ID# 218023
🇺🇸Avon, Indiana, United States
Investigators Research Group, LLC /ID# 222891
🇺🇸Brownsburg, Indiana, United States
Women's Health Advantage /ID# 246580
🇺🇸Fort Wayne, Indiana, United States
University of Iowa Hospitals and Clinics /ID# 217144
🇺🇸Iowa City, Iowa, United States
The Iowa Clinic, PC /ID# 217351
🇺🇸West Des Moines, Iowa, United States
GTC Research /ID# 217051
🇺🇸Shawnee Mission, Kansas, United States
Alliance for Multispecialty Research (AMR) - Wichita West /ID# 218040
🇺🇸Wichita, Kansas, United States
Cypress Medical Research Ctr /ID# 217093
🇺🇸Wichita, Kansas, United States
Clinical Trials Management - Metairie /ID# 217054
🇺🇸Covington, Louisiana, United States
Clinical Trials Management, LLC - Covington /ID# 217291
🇺🇸Covington, Louisiana, United States
Horizon Research Group /ID# 217100
🇺🇸Eunice, Louisiana, United States
Praetorian Pharmaceutical Research /ID# 217159
🇺🇸Marrero, Louisiana, United States
Southern Clinical Research A /ID# 218028
🇺🇸Metairie, Louisiana, United States
Women's Health Clinic /ID# 217205
🇺🇸Shreveport, Louisiana, United States
SBL Special Services LLC /ID# 224899
🇺🇸Frederick, Maryland, United States
Congressional OBGYN /ID# 245349
🇺🇸Rockville, Maryland, United States
Continental Clinical Solutions /ID# 217053
🇺🇸Towson, Maryland, United States
NECCR Fall River LLC /ID# 217108
🇺🇸Fall River, Massachusetts, United States
Exordia Medical Research, Inc /ID# 217116
🇺🇸Fall River, Massachusetts, United States
Great Lakes Research Group - Bay City /ID# 217099
🇺🇸Bay City, Michigan, United States
Wayne State University, C.S. Mott Center /ID# 248422
🇺🇸Detroit, Michigan, United States
Saginaw Valley Med Res Group /ID# 217296
🇺🇸Saginaw, Michigan, United States
Center for Reproductive Medicine and Robotic Surgery /ID# 223494
🇺🇸Saint Louis, Missouri, United States
Boeson Research - Great Falls /ID# 248560
🇺🇸Great Falls, Montana, United States
Boeson Research - Missoula /ID# 248559
🇺🇸Missoula, Montana, United States
Womens Clinic of Lincoln, P.C. /ID# 217136
🇺🇸Lincoln, Nebraska, United States
Private practice: Dr. Rex G. Mabey JR /ID# 217134
🇺🇸Las Vegas, Nevada, United States
Dr. Nader and Associates M.D. P.C. /ID# 223571
🇺🇸North Las Vegas, Nevada, United States
Cooper University Hospital /ID# 227208
🇺🇸Camden, New Jersey, United States
Jersey Shore University Medical Center /ID# 217138
🇺🇸Neptune, New Jersey, United States
Rutgers Robert Wood Johnson /ID# 246933
🇺🇸New Brunswick, New Jersey, United States
Maimonides Medical Center /ID# 248493
🇺🇸Brooklyn, New York, United States
Invision Health /ID# 218687
🇺🇸Buffalo, New York, United States
Widewaters Gynecology /ID# 225621
🇺🇸East Syracuse, New York, United States
Parkmed NYC /ID# 224333
🇺🇸New York, New York, United States
Columbia Univ Medical Center /ID# 217113
🇺🇸New York, New York, United States
New York Presbyterian Hospital Weill Cornell Medical Center /ID# 224329
🇺🇸New York, New York, United States
Richmond OB/GYN Associates PC /ID# 224833
🇺🇸Staten Island, New York, United States
PMG Research of Charlotte /ID# 217224
🇺🇸Charlotte, North Carolina, United States
Tyron Medical Partners, PLLC /ID# 245286
🇺🇸Charlotte, North Carolina, United States
Carolina Women's Research and Wellness Center /ID# 217133
🇺🇸Durham, North Carolina, United States
Eastern Carolina Women's Centr /ID# 222358
🇺🇸New Bern, North Carolina, United States
PMG Research of Wilmington LLC /ID# 217097
🇺🇸Wilmington, North Carolina, United States
Carolina Medical Trials - Winston-Salem /ID# 223002
🇺🇸Winston-Salem, North Carolina, United States
Unified Women's Clinical Resea /ID# 217132
🇺🇸Winston-Salem, North Carolina, United States
Unified Women's Clinical Resea /ID# 218339
🇺🇸Winston-Salem, North Carolina, United States
Clinical Inquest Center Ltd /ID# 217961
🇺🇸Beavercreek, Ohio, United States
Neuro-Behavioral Clinical Research, Inc. /ID# 224026
🇺🇸Canton, Ohio, United States
Seven Hills Clinical Research Group /ID# 224941
🇺🇸Cincinnati, Ohio, United States
Duplicate_University Of Cincinnati Medical Center /ID# 217349
🇺🇸Cincinnati, Ohio, United States
MetroHealth Medical Center /ID# 224392
🇺🇸Cleveland, Ohio, United States
Central Ohio Clinical Research /ID# 217059
🇺🇸Columbus, Ohio, United States
HWC Women's Research Center /ID# 246619
🇺🇸Englewood, Ohio, United States
Wright State Physicians Health Center /ID# 217272
🇺🇸Fairborn, Ohio, United States
Marion Ob/Gyn Inc. /ID# 244175
🇺🇸Marion, Ohio, United States
Univ Hosp Landerbrook /ID# 217065
🇺🇸Mayfield Heights, Ohio, United States
AC Clinical Research /ID# 227356
🇺🇸Tiffin, Ohio, United States
Grube Gynecology /ID# 245132
🇺🇸Frackville, Pennsylvania, United States
Penn State University and Milton S. Hershey Medical Center /ID# 217057
🇺🇸Hershey, Pennsylvania, United States
University of Pennsylvania /ID# 217243
🇺🇸Philadelphia, Pennsylvania, United States
reading Hospital /ID# 223599
🇺🇸Wyomissing, Pennsylvania, United States
Vista Clinical Research /ID# 217151
🇺🇸Columbia, South Carolina, United States
University Medical Group /ID# 217355
🇺🇸Greenville, South Carolina, United States
Vitalink Research - Greenville /ID# 217075
🇺🇸Greenville, South Carolina, United States
Duplicate_Palmetto Clinical Research /ID# 217069
🇺🇸Summerville, South Carolina, United States
Biocentric Healthcare Research /ID# 248582
🇺🇸West Columbia, South Carolina, United States
Chattanooga Research and Medicine /ID# 217045
🇺🇸Chattanooga, Tennessee, United States
Research Memphis Associates, LLC /ID# 218022
🇺🇸Memphis, Tennessee, United States
Access Clinical Trials, Inc. /ID# 217055
🇺🇸Nashville, Tennessee, United States
DCT - HCWC, LLC dba Discovery Clinical Trials /ID# 217095
🇺🇸Dallas, Texas, United States
Cedar Health Research /ID# 224407
🇺🇸Dallas, Texas, United States
Duplicate_The University of Texas Southwestern Medical Center /ID# 217048
🇺🇸Dallas, Texas, United States
Signature Gyn Services /ID# 217299
🇺🇸Fort Worth, Texas, United States
Progressive Women's Health /ID# 248402
🇺🇸Friendswood, Texas, United States
Willowbend Health and Wellness - Frisco /ID# 217354
🇺🇸Frisco, Texas, United States
FMC Science, LLC - OB/GYN - Georgetown /ID# 218654
🇺🇸Georgetown, Texas, United States
UTHealth Women's Research Program - Memorial City /ID# 217362
🇺🇸Houston, Texas, United States
OBGYN Medical Center Associates - Medical Center Office /ID# 245346
🇺🇸Houston, Texas, United States
Centex Studies, Inc. - Houston /ID# 217357
🇺🇸Houston, Texas, United States
FMC Science /ID# 217047
🇺🇸Lampasas, Texas, United States
Maximos OB/GYN /ID# 229385
🇺🇸League City, Texas, United States
Advances in Health, Inc. /ID# 217220
🇺🇸Pearland, Texas, United States
Clinical Trials of Texas, Inc /ID# 217039
🇺🇸San Antonio, Texas, United States
VIP Trials /ID# 217261
🇺🇸San Antonio, Texas, United States
Discovery Clinical Trials-San Antonio /ID# 218547
🇺🇸San Antonio, Texas, United States
Center of Reproductive Medicine /ID# 217241
🇺🇸Webster, Texas, United States
Corner Canyon Obstetrics and G /ID# 217289
🇺🇸Draper, Utah, United States
Physicians Research Options /ID# 217302
🇺🇸Pleasant Grove, Utah, United States
Highland Clinical Research /ID# 224052
🇺🇸Salt Lake City, Utah, United States
Health Research of Hampton Roads, Inc. (HRHR) /ID# 217063
🇺🇸Newport News, Virginia, United States
Clinical Research Partners /ID# 217359
🇺🇸North Chesterfield, Virginia, United States
Virginia Women's Health Associates /ID# 227677
🇺🇸Reston, Virginia, United States
Clinical Trials Virginia, Inc. /ID# 217222
🇺🇸Richmond, Virginia, United States
Clinical Research Partners LLC - Richmond Forest Ave /ID# 217149
🇺🇸Richmond, Virginia, United States
Tidewater Clinical Research /ID# 217152
🇺🇸Virginia Beach, Virginia, United States
Seattle Clinical Research Center /ID# 217117
🇺🇸Seattle, Washington, United States
North Spokane Women's Health /ID# 217356
🇺🇸Spokane, Washington, United States
Advanced Medical Concepts. PSC /ID# 221337
🇵🇷Cidra, Puerto Rico
Henry A. Rodriguez Ginorio, MD /ID# 217233
🇵🇷San Juan, Puerto Rico
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 217235
🇵🇷San Juan, Puerto Rico