Clinical trial NCT04333576: 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
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Endometriosis
Keywords: Endometriosis
Elagolix
Combined oral contraceptives (COC)
Orilissa
Dysmenorrhea
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-04-03
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale
timeFrame: Month 3
Secondary outcomes:
measure: Percentage of Responders Based on Non-Menstrual Pelvic Pain (NMPP) Pain Scale
timeFrame: Month 3
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group /ID# 217062
state: Alabama
city: Birmingham
country: United States
facility: ACCEL Research Sites /ID# 218044
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics /ID# 217166
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics /ID# 222301
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - Women's and Infant's Center /ID# 224503
state: Alabama
city: Dothan
country: United States
facility: Trinity Research Group /ID# 246932
state: Alabama
city: Fairhope
country: United States
facility: Southern Women's Specialists PC /ID# 217143
state: Alabama
city: Mobile
country: United States
facility: Women's Health Alliance of Mobile /ID# 222591
state: Alabama
city: Mobile
country: United States
facility: Mobile, OBGYN P.C. /ID# 217135
state: Alabama
city: Glendale
country: United States
facility: North Valley Women's Care /ID# 217092
state: Arizona
city: Phoenix
country: United States
facility: MomDoc Womens Health Research /ID# 221661
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas /ID# 248494
state: Arkansas
city: Searcy
country: United States
facility: Unity Health- Searcy Medical Center /ID# 217050
state: Arkansas
city: Encinitas
country: United States
facility: Diagnamics Inc. /ID# 225385
state: California
city: La Palma
country: United States
facility: Atella Clinical Research /ID# 224024
state: California
city: Northridge
country: United States
facility: Valley Renal Medical Group Research /ID# 228614
state: California
city: Norwalk
country: United States
facility: Futura Research, Org /ID# 217361
state: California
city: Sacramento
country: United States
facility: Northern California Research /ID# 217301
state: California
city: San Diego
country: United States
facility: A & B Clinical Research /ID# 224471
state: California
city: San Diego
country: United States
facility: Advanced Clinical Research Center, LLC /ID# 248398
state: California
city: Aurora
country: United States
facility: Rocky Mountain Internal Medicine - Aurora /ID# 245161
state: Colorado
city: Denver
country: United States
facility: Velocity Clinical Research - Denver /ID# 217297
state: Colorado
city: Grand Junction
country: United States
facility: Boeson Research - Grand Junction /ID# 248580
state: Colorado
city: Greenwood Village
country: United States
facility: Advanced Women's Health Institute /ID# 217150
state: Colorado
city: Lakewood
country: United States
facility: Red Rocks OB/GYN /ID# 217103
state: Colorado
city: Newark
country: United States
facility: Reproductive Assoc of Delaware /ID# 227764
state: Delaware
city: Washington
country: United States
facility: Medstar Health Research Institute /ID# 244937
state: District of Columbia
city: Washington
country: United States
facility: James A. Simon, MD, PC /ID# 218116
state: District of Columbia
city: Apopka
country: United States
facility: Topaz Clinical Research /ID# 218615
state: Florida
city: Aventura
country: United States
facility: Ideal Clinical Research Inc. /ID# 218832
state: Florida
city: Boynton Beach
country: United States
facility: Helix Biomedics, LLC /ID# 218649
state: Florida
city: Clearwater
country: United States
facility: Olympian Clinical Research /ID# 244426
state: Florida
city: Clearwater
country: United States
facility: Women's Medical Research Group /ID# 218524
state: Florida
city: Doral
country: United States
facility: Doral Medical Research, LLC /ID# 225146
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research /ID# 248553
state: Florida
city: Fort Lauderdale
country: United States
facility: KO Clinical Research, LLC /ID# 217173
state: Florida
city: Fort Myers
country: United States
facility: Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 217061
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Adv Rch /ID# 220973
state: Florida
city: Jacksonville
country: United States
facility: Care Partners Clinical Research /ID# 217042
state: Florida
city: Kissimmee
country: United States
facility: Vida Clinical Research /ID# 245325
state: Florida
city: Kissimmee
country: United States
facility: Kissimmee Clinical Research /ID# 224749
state: Florida
city: Margate
country: United States
facility: South Florida Wellness & Clinic /ID# 222897
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center, Inc /ID# 217286
state: Florida
city: Miami
country: United States
facility: GRE Clinical Research, LLC /ID# 246579
state: Florida
city: Miami
country: United States
facility: Gold Coast Health Research, LLC /ID# 248624
state: Florida
city: Miami
country: United States
facility: Admed Research LLC /ID# 227679
state: Florida
city: Miami
country: United States
facility: The Miami Research Group Inc /ID# 246578
state: Florida
city: Miami
country: United States
facility: Innova Pharma Research /ID# 245354
state: Florida
city: Miramar
country: United States
facility: Salom Tangir, LLC /ID# 217273
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research Pasco County /ID# 217249
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc /ID# 217206
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research /ID# 221518
state: Florida
city: Orange City
country: United States
facility: A Premier Medical Research of FL /ID# 216908
state: Florida
city: Orlando
country: United States
facility: Osceola Gynecology, LLC - Orlando /ID# 227194
state: Florida
city: Orlando
country: United States
facility: Omega Research Group /ID# 216907
state: Florida
city: Orlando
country: United States
facility: Clinical Associates of Orlando /ID# 218114
state: Florida
city: Palm Harbor
country: United States
facility: Suncoast Clinical Research - Palm Harbor /ID# 219133
state: Florida
city: Pembroke Pines
country: United States
facility: Royal Research,Corp /ID# 221356
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clin. Res., LLC /ID# 217264
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research, LLC /ID# 217232
state: Florida
city: Tampa
country: United States
facility: University of South Florida- Neuroscience Institute /ID# 217146
state: Florida
city: Wellington
country: United States
facility: Virtus Research Consultants, LLC /ID# 217052
state: Florida
city: Winter Park
country: United States
facility: Florida Premier Research Institute, LLC /ID# 224499
state: Florida
city: Alpharetta
country: United States
facility: Paramount Research Solutions /ID# 218769
state: Georgia
city: Atlanta
country: United States
facility: Academia of Women's Health & Endoscopic Surgery /ID# 217260
state: Georgia
city: Atlanta
country: United States
facility: Gyn & Fertility Specialists /ID# 223015
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Women's Research Institute /ID# 217303
state: Georgia
city: College Park
country: United States
facility: Paramount Research Solutions - College Park /ID# 217358
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Ins /ID# 217294
state: Georgia
city: Columbus
country: United States
facility: Midtown OBGYN North /ID# 222300
state: Georgia
city: Smyrna
country: United States
facility: Innovative Women's HealthCare Solutions - Smyrna /ID# 223692
state: Georgia
city: Snellville
country: United States
facility: Journey Medical Research Institute - Snellville /ID# 229774
state: Georgia
city: Idaho Falls
country: United States
facility: Leavitt Womens Healthcare /ID# 217118
state: Idaho
city: Idaho Falls
country: United States
facility: Womens Healthcare Assoc, DBA /ID# 222153
state: Idaho
city: Meridian
country: United States
facility: Sonora Clinical Research /ID# 222147
state: Idaho
city: Nampa
country: United States
facility: Asr, Llc /Id# 217094
state: Idaho
city: Chicago
country: United States
facility: Women's Health Care Center Of Chicago /ID# 245164
state: Illinois
city: Oak Brook
country: United States
facility: Alliance for Multispecialty Research, LLC /ID# 217226
state: Illinois
city: Park Ridge
country: United States
facility: The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 245372
state: Illinois
city: Avon
country: United States
facility: American Health Network of IN, LLC (Avon) /ID# 218023
state: Indiana
city: Brownsburg
country: United States
facility: Investigators Research Group, LLC /ID# 222891
state: Indiana
city: Fort Wayne
country: United States
facility: Women's Health Advantage /ID# 246580
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics /ID# 217144
state: Iowa
city: West Des Moines
country: United States
facility: The Iowa Clinic, PC /ID# 217351
state: Iowa
city: Shawnee Mission
country: United States
facility: GTC Research /ID# 217051
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research (AMR) - Wichita West /ID# 218040
state: Kansas
city: Wichita
country: United States
facility: Cypress Medical Research Ctr /ID# 217093
state: Kansas
city: Covington
country: United States
facility: Clinical Trials Management - Metairie /ID# 217054
state: Louisiana
city: Covington
country: United States
facility: Clinical Trials Management, LLC - Covington /ID# 217291
state: Louisiana
city: Eunice
country: United States
facility: Horizon Research Group /ID# 217100
state: Louisiana
city: Marrero
country: United States
facility: Praetorian Pharmaceutical Research /ID# 217159
state: Louisiana
city: Metairie
country: United States
facility: Southern Clinical Research A /ID# 218028
state: Louisiana
city: Shreveport
country: United States
facility: Women's Health Clinic /ID# 217205
state: Louisiana
city: Frederick
country: United States
facility: SBL Special Services LLC /ID# 224899
state: Maryland
city: Rockville
country: United States
facility: Congressional OBGYN /ID# 245349
state: Maryland
city: Towson
country: United States
facility: Continental Clinical Solutions /ID# 217053
state: Maryland
city: Fall River
country: United States
facility: NECCR Fall River LLC /ID# 217108
state: Massachusetts
city: Fall River
country: United States
facility: Exordia Medical Research, Inc /ID# 217116
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group - Bay City /ID# 217099
state: Michigan
city: Detroit
country: United States
facility: Wayne State University, C.S. Mott Center /ID# 248422
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Med Res Group /ID# 217296
state: Michigan
city: Saint Louis
country: United States
facility: Center for Reproductive Medicine and Robotic Surgery /ID# 223494
state: Missouri
city: Great Falls
country: United States
facility: Boeson Research - Great Falls /ID# 248560
state: Montana
city: Missoula
country: United States
facility: Boeson Research - Missoula /ID# 248559
state: Montana
city: Lincoln
country: United States
facility: Womens Clinic of Lincoln, P.C. /ID# 217136
state: Nebraska
city: Las Vegas
country: United States
facility: Private practice: Dr. Rex G. Mabey JR /ID# 217134
state: Nevada
city: North Las Vegas
country: United States
facility: Dr. Nader and Associates M.D. P.C. /ID# 223571
state: Nevada
city: Camden
country: United States
facility: Cooper University Hospital /ID# 227208
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center /ID# 217138
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson /ID# 246933
state: New Jersey
city: Brooklyn
country: United States
facility: Maimonides Medical Center /ID# 248493
state: New York
city: Buffalo
country: United States
facility: Invision Health /ID# 218687
state: New York
city: East Syracuse
country: United States
facility: Widewaters Gynecology /ID# 225621
state: New York
city: New York
country: United States
facility: Parkmed NYC /ID# 224333
state: New York
city: New York
country: United States
facility: Columbia Univ Medical Center /ID# 217113
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital Weill Cornell Medical Center /ID# 224329
state: New York
city: Staten Island
country: United States
facility: Richmond OB/GYN Associates PC /ID# 224833
state: New York
city: Charlotte
country: United States
facility: PMG Research of Charlotte /ID# 217224
state: North Carolina
city: Charlotte
country: United States
facility: Tyron Medical Partners, PLLC /ID# 245286
state: North Carolina
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Center /ID# 217133
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's Centr /ID# 222358
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington LLC /ID# 217097
state: North Carolina
city: Winston-Salem
country: United States
facility: Carolina Medical Trials - Winston-Salem /ID# 223002
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Resea /ID# 217132
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Resea /ID# 218339
state: North Carolina
city: Beavercreek
country: United States
facility: Clinical Inquest Center Ltd /ID# 217961
state: Ohio
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc. /ID# 224026
state: Ohio
city: Cincinnati
country: United States
facility: Seven Hills Clinical Research Group /ID# 224941
state: Ohio
city: Cincinnati
country: United States
facility: Duplicate_University Of Cincinnati Medical Center /ID# 217349
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center /ID# 224392
state: Ohio
city: Columbus
country: United States
facility: Central Ohio Clinical Research /ID# 217059
state: Ohio
city: Englewood
country: United States
facility: HWC Women's Research Center /ID# 246619
state: Ohio
city: Fairborn
country: United States
facility: Wright State Physicians Health Center /ID# 217272
state: Ohio
city: Marion
country: United States
facility: Marion Ob/Gyn Inc. /ID# 244175
state: Ohio
city: Mayfield Heights
country: United States
facility: Univ Hosp Landerbrook /ID# 217065
state: Ohio
city: Tiffin
country: United States
facility: AC Clinical Research /ID# 227356
state: Ohio
city: Frackville
country: United States
facility: Grube Gynecology /ID# 245132
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State University and Milton S. Hershey Medical Center /ID# 217057
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania /ID# 217243
state: Pennsylvania
city: Wyomissing
country: United States
facility: reading Hospital /ID# 223599
state: Pennsylvania
city: Columbia
country: United States
facility: Vista Clinical Research /ID# 217151
state: South Carolina
city: Greenville
country: United States
facility: University Medical Group /ID# 217355
state: South Carolina
city: Greenville
country: United States
facility: Vitalink Research - Greenville /ID# 217075
state: South Carolina
city: Summerville
country: United States
facility: Duplicate_Palmetto Clinical Research /ID# 217069
state: South Carolina
city: West Columbia
country: United States
facility: Biocentric Healthcare Research /ID# 248582
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Research and Medicine /ID# 217045
state: Tennessee
city: Memphis
country: United States
facility: Research Memphis Associates, LLC /ID# 218022
state: Tennessee
city: Nashville
country: United States
facility: Access Clinical Trials, Inc. /ID# 217055
state: Tennessee
city: Dallas
country: United States
facility: DCT - HCWC, LLC dba Discovery Clinical Trials /ID# 217095
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research /ID# 224407
state: Texas
city: Dallas
country: United States
facility: Duplicate_The University of Texas Southwestern Medical Center /ID# 217048
state: Texas
city: Fort Worth
country: United States
facility: Signature Gyn Services /ID# 217299
state: Texas
city: Friendswood
country: United States
facility: Progressive Women's Health /ID# 248402
state: Texas
city: Frisco
country: United States
facility: Willowbend Health and Wellness - Frisco /ID# 217354
state: Texas
city: Georgetown
country: United States
facility: FMC Science, LLC - OB/GYN - Georgetown /ID# 218654
state: Texas
city: Houston
country: United States
facility: UTHealth Women's Research Program - Memorial City /ID# 217362
state: Texas
city: Houston
country: United States
facility: OBGYN Medical Center Associates - Medical Center Office /ID# 245346
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc. - Houston /ID# 217357
state: Texas
city: Lampasas
country: United States
facility: FMC Science /ID# 217047
state: Texas
city: League City
country: United States
facility: Maximos OB/GYN /ID# 229385
state: Texas
city: Pearland
country: United States
facility: Advances in Health, Inc. /ID# 217220
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc /ID# 217039
state: Texas
city: San Antonio
country: United States
facility: VIP Trials /ID# 217261
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials-San Antonio /ID# 218547
state: Texas
city: Webster
country: United States
facility: Center of Reproductive Medicine /ID# 217241
state: Texas
city: Draper
country: United States
facility: Corner Canyon Obstetrics and G /ID# 217289
state: Utah
city: Pleasant Grove
country: United States
facility: Physicians Research Options /ID# 217302
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research /ID# 224052
state: Utah
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc. (HRHR) /ID# 217063
state: Virginia
city: North Chesterfield
country: United States
facility: Clinical Research Partners /ID# 217359
state: Virginia
city: Reston
country: United States
facility: Virginia Women's Health Associates /ID# 227677
state: Virginia
city: Richmond
country: United States
facility: Clinical Trials Virginia, Inc. /ID# 217222
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners LLC - Richmond Forest Ave /ID# 217149
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research /ID# 217152
state: Virginia
city: Seattle
country: United States
facility: Seattle Clinical Research Center /ID# 217117
state: Washington
city: Spokane
country: United States
facility: North Spokane Women's Health /ID# 217356
state: Washington
city: Cidra
country: Puerto Rico
facility: Advanced Medical Concepts. PSC /ID# 221337
city: San Juan
country: Puerto Rico
facility: Henry A. Rodriguez Ginorio, MD /ID# 217233
city: San Juan
country: Puerto Rico
facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 217235
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: