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

Who is this study for? Patients with Endometriosis
What treatments are being studied? Elagolix+Combined Oral Contraceptive (COC)
Status: Active_not_recruiting
Location: See all (179) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: f
View:

• 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).

Locations
United States
Alabama
Pinnacle Research Group /ID# 217062
Anniston
ACCEL Research Sites /ID# 218044
Birmingham
Alabama Clinical Therapeutics /ID# 217166
Birmingham
Alabama Clinical Therapeutics /ID# 222301
Birmingham
University of Alabama at Birmingham - Women's and Infant's Center /ID# 224503
Birmingham
Trinity Research Group /ID# 246932
Dothan
Southern Women's Specialists PC /ID# 217143
Fairhope
Mobile, OBGYN P.C. /ID# 217135
Mobile
Women's Health Alliance of Mobile /ID# 222591
Mobile
Arkansas
Applied Research Center of Arkansas /ID# 248494
Little Rock
Unity Health- Searcy Medical Center /ID# 217050
Searcy
Arizona
North Valley Women's Care /ID# 217092
Glendale
MomDoc Womens Health Research /ID# 221661
Phoenix
California
Diagnamics Inc. /ID# 225385
Encinitas
Atella Clinical Research /ID# 224024
La Palma
Valley Renal Medical Group Research /ID# 228614
Northridge
Futura Research, Org /ID# 217361
Norwalk
Northern California Research /ID# 217301
Sacramento
A & B Clinical Research /ID# 224471
San Diego
Advanced Clinical Research Center, LLC /ID# 248398
San Diego
Colorado
Rocky Mountain Internal Medicine - Aurora /ID# 245161
Aurora
Velocity Clinical Research - Denver /ID# 217297
Denver
Boeson Research - Grand Junction /ID# 248580
Grand Junction
Advanced Women's Health Institute /ID# 217150
Greenwood Village
Red Rocks OB/GYN /ID# 217103
Lakewood
Washington, D.c.
James A. Simon, MD, PC /ID# 218116
Washington D.c.
Medstar Health Research Institute /ID# 244937
Washington D.c.
Delaware
Reproductive Assoc of Delaware /ID# 227764
Newark
Florida
Topaz Clinical Research /ID# 218615
Apopka
Ideal Clinical Research Inc. /ID# 218832
Aventura
Helix Biomedics, LLC /ID# 218649
Boynton Beach
Olympian Clinical Research /ID# 244426
Clearwater
Women's Medical Research Group /ID# 218524
Clearwater
Doral Medical Research, LLC /ID# 225146
Doral
Universal Axon Clinical Research /ID# 248553
Doral
KO Clinical Research, LLC /ID# 217173
Fort Lauderdale
Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 217061
Fort Myers
Care Partners Clinical Research /ID# 217042
Jacksonville
Solutions Through Adv Rch /ID# 220973
Jacksonville
Kissimmee Clinical Research /ID# 224749
Kissimmee
Vida Clinical Research /ID# 245325
Kissimmee
South Florida Wellness & Clinic /ID# 222897
Margate
Admed Research LLC /ID# 227679
Miami
Gold Coast Health Research, LLC /ID# 248624
Miami
GRE Clinical Research, LLC /ID# 246579
Miami
Innova Pharma Research /ID# 245354
Miami
The Miami Research Group Inc /ID# 246578
Miami
Ocean Blue Medical Research Center, Inc /ID# 217286
Miami Springs
Salom Tangir, LLC /ID# 217273
Miramar
Advanced Research Institute, Inc /ID# 217206
New Port Richey
Suncoast Clinical Research Pasco County /ID# 217249
New Port Richey
Segal Institute for Clinical Research /ID# 221518
North Miami
A Premier Medical Research of FL /ID# 216908
Orange City
Clinical Associates of Orlando /ID# 218114
Orlando
Omega Research Group /ID# 216907
Orlando
Osceola Gynecology, LLC - Orlando /ID# 227194
Orlando
Duplicate_Suncoast Clinical Research - Palm Harbor /ID# 219133
Palm Harbor
Royal Research,Corp /ID# 221356
Pembroke Pines
Physician Care Clin. Res., LLC /ID# 217264
Sarasota
GCP Clinical Research, LLC /ID# 217232
Tampa
Tampa General Hospital - Tampa - General Circle /ID# 217146
Tampa
Virtus Research Consultants, LLC /ID# 217052
Wellington
Florida Premier Research Institute, LLC /ID# 224499
Winter Park
Georgia
Paramount Research Solutions /ID# 218769
Alpharetta
Academia of Women's Health & Endoscopic Surgery /ID# 217260
Atlanta
Atlanta Women's Research Institute /ID# 217303
Atlanta
Gyn & Fertility Specialists /ID# 223015
Atlanta
Paramount Research Solutions - College Park /ID# 217358
College Park
Duplicate_Columbus Regional Research Ins /ID# 217294
Columbus
Midtown OBGYN North /ID# 222300
Columbus
Innovative Women's HealthCare Solutions - Smyrna /ID# 223692
Smyrna
Journey Medical Research Institute - Snellville /ID# 229774
Snellville
Iowa
University of Iowa Hospitals and Clinics /ID# 217144
Iowa City
The Iowa Clinic, PC /ID# 217351
West Des Moines
Idaho
Leavitt Womens Healthcare /ID# 217118
Idaho Falls
Womens Healthcare Assoc, DBA /ID# 222153
Idaho Falls
Sonora Clinical Research /ID# 222147
Meridian
Asr, Llc /Id# 217094
Nampa
Illinois
Women's Health Care Center Of Chicago /ID# 245164
Chicago
Alliance for Multispecialty Research, LLC /ID# 217226
Oak Brook
The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 245372
Park Ridge
Indiana
American Health Network of IN, LLC (Avon) /ID# 218023
Avon
Investigators Research Group, LLC /ID# 222891
Brownsburg
Women's Health Advantage /ID# 246580
Fort Wayne
Kansas
GTC Research /ID# 217051
Shawnee Mission
Alliance for Multispecialty Research (AMR) - Wichita West /ID# 218040
Wichita
Cypress Medical Research Ctr /ID# 217093
Wichita
Louisiana
Clinical Trials Management - Metairie /ID# 217054
Covington
Clinical Trials Management, LLC - Covington /ID# 217291
Covington
Horizon Research Group /ID# 217100
Eunice
Praetorian Pharmaceutical Research /ID# 217159
Marrero
Southern Clinical Research A /ID# 218028
Metairie
Women's Health Clinic /ID# 217205
Shreveport
Massachusetts
Exordia Medical Research, Inc /ID# 217116
Fall River
NECCR Fall River LLC /ID# 217108
Fall River
Maryland
SBL Special Services LLC /ID# 224899
Frederick
Congressional OBGYN /ID# 245349
Rockville
Continental Clinical Solutions /ID# 217053
Towson
Michigan
Great Lakes Research Group - Bay City /ID# 217099
Bay City
Wayne State University, C.S. Mott Center /ID# 248422
Detroit
Saginaw Valley Med Res Group /ID# 217296
Saginaw
Missouri
Center for Reproductive Medicine and Robotic Surgery /ID# 223494
St Louis
Montana
Boeson Research - Great Falls /ID# 248560
Great Falls
Boeson Research - Missoula /ID# 248559
Missoula
North Carolina
Duplicate_PMG Research of Charlotte /ID# 217224
Charlotte
Tyron Medical Partners, PLLC /ID# 245286
Charlotte
Carolina Women's Research and Wellness Center /ID# 217133
Durham
Eastern Carolina Women's Centr /ID# 222358
New Bern
Accellacare Wilmington /ID# 217097
Wilmington
Carolina Medical Trials - Winston-Salem /ID# 223002
Winston-salem
Unified Women's Clinical Research /ID# 217132
Winston-salem
Unified Women's Clinical Research /ID# 218339
Winston-salem
Nebraska
Womens Clinic of Lincoln, P.C. /ID# 217136
Lincoln
New Jersey
Cooper University Hospital /ID# 227208
Camden
Jersey Shore University Medical Center /ID# 217138
Neptune City
Rutgers Robert Wood Johnson /ID# 246933
New Brunswick
Nevada
Private practice: Dr. Rex G. Mabey JR /ID# 217134
Las Vegas
Dr. Nader and Associates M.D. P.C. /ID# 223571
North Las Vegas
New York
Maimonides Medical Center /ID# 248493
Brooklyn
Invision Health /ID# 218687
Buffalo
Widewaters Gynecology /ID# 225621
East Syracuse
Columbia Univ Medical Center /ID# 217113
New York
New York Presbyterian Hospital Weill Cornell Medical Center /ID# 224329
New York
Parkmed NYC /ID# 224333
New York
Richmond OB/GYN Associates PC /ID# 224833
Staten Island
Ohio
Clinical Inquest Center Ltd /ID# 217961
Beavercreek
Neuro-Behavioral Clinical Research, Inc. /ID# 224026
Canton
Duplicate_Duplicate_University Of Cincinnati Medical Center /ID# 217349
Cincinnati
Seven Hills Clinical Research Group /ID# 224941
Cincinnati
MetroHealth Medical Center /ID# 224392
Cleveland
Central Ohio Clinical Research /ID# 217059
Columbus
HWC Women's Research Center /ID# 246619
Englewood
Wright State Physicians Health Center /ID# 217272
Fairborn
Marion Ob/Gyn Inc. /ID# 244175
Marion
Univ Hosp Landerbrook /ID# 217065
Mayfield Heights
AC Clinical Research /ID# 227356
Tiffin
Pennsylvania
Grube Gynecology /ID# 245132
Frackville
Penn State University and Milton S. Hershey Medical Center /ID# 217057
Hershey
University of Pennsylvania /ID# 217243
Philadelphia
reading Hospital /ID# 223599
Wyomissing
South Carolina
Vista Clinical Research /ID# 217151
Columbia
University Medical Group /ID# 217355
Greenville
Vitalink Research - Greenville /ID# 217075
Greenville
Duplicate_Palmetto Clinical Research /ID# 217069
Summerville
Biocentric Healthcare Research /ID# 248582
West Columbia
Tennessee
Chattanooga Research and Medicine /ID# 217045
Chattanooga
Research Memphis Associates, LLC /ID# 218022
Memphis
Access Clinical Trials, Inc. /ID# 217055
Nashville
Texas
Cedar Health Research /ID# 224407
Dallas
DCT - HCWC, LLC dba Discovery Clinical Trials /ID# 217095
Dallas
Duplicate_The University of Texas Southwestern Medical Center /ID# 217048
Dallas
Signature Gyn Services /ID# 217299
Fort Worth
Progressive Women's Health /ID# 248402
Friendswood
Willowbend Health and Wellness - Frisco /ID# 217354
Frisco
FMC Science, LLC - OB/GYN - Georgetown /ID# 218654
Georgetown
Centex Studies, Inc. - Houston /ID# 217357
Houston
OBGYN Medical Center Associates - Medical Center Office /ID# 245346
Houston
UTHealth Women's Research Program - Memorial City /ID# 217362
Houston
FMC Science /ID# 217047
Lampasas
Maximos OB/GYN /ID# 229385
League City
Advances in Health, Inc. /ID# 217220
Pearland
Clinical Trials of Texas, Inc /ID# 217039
San Antonio
Discovery Clinical Trials-San Antonio /ID# 218547
San Antonio
VIP Trials /ID# 217261
San Antonio
Center of Reproductive Medicine /ID# 217241
Webster
Utah
Corner Canyon Obstetrics and G /ID# 217289
Draper
Duplicate_Physicians Research Options /ID# 217302
Pleasant Grove
Highland Clinical Research /ID# 224052
Salt Lake City
Virginia
Health Research of Hampton Roads, Inc. (HRHR) /ID# 217063
Newport News
Clinical Research Partners /ID# 217359
North Chesterfield
Virginia Women's Health Associates /ID# 227677
Reston
Clinical Research Partners LLC - Richmond Forest Ave /ID# 217149
Richmond
Clinical Trials Virginia, Inc. /ID# 217222
Richmond
Tidewater Clinical Research /ID# 217152
Virginia Beach
Washington
Seattle Clinical Research Center /ID# 217117
Seattle
North Spokane Women's Health /ID# 217356
Spokane
Other Locations
Puerto Rico
Advanced Medical Concepts. PSC /ID# 221337
Cidra
Henry A. Rodriguez Ginorio, MD /ID# 217233
San Juan
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 217235
San Juan
Time Frame
Start Date: 2020-08-10
Completion Date: 2030-06
Participants
Target number of participants: 800
Treatments
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.
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.
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.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov