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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT03271489
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Elagolix — DRUG
    Film-coated 300 mg tablets
  • Estradiol /norethindrone acetate (E2/NETA) — DRUG
    Estradiol 1 mg/norethindrone acetate 0.5 mg capsules
  • E2/NETA Placebo — OTHER
    Placebo capsules
  • Elagolix Placebo — OTHER
    Film-coated placebo tablets

Study Details

This randomized multicenter phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study was double-blind (DB) during the first 12 months and open-label (OL) for the next 36 months.

Key Dates

Start date
Sep 13, 2017
Status verified
Jul 2025
Primary completion
Jun 28, 2024
Completion
Jun 28, 2024

Study Design

Enrollment
478 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
  • Placebo Comparator: Placebo

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline to 60 months ]

Locations (155)

FacilityCityStateZIPSite coordinators
Alabama Clinical Therapeutics /ID# 160835BirminghamAlabama35235-3430-
Alabama Clinical Therapeutics /ID# 160927BirminghamAlabama35235-3430-
Choice Research, LLC /ID# 161498DothanAlabama36303-
Southern Women's Specialists PC /ID# 161531FairhopeAlabama36532-3029-
E Squared Research /ID# 163645HuntsvilleAlabama35801-
Mobile, OBGYN P.C. /ID# 161530MobileAlabama36608-
Women's Health Alliance of Mobile /ID# 161443MobileAlabama36604-1410-
Mesa Obstetricians and Gynecologists /ID# 160955MesaArizona85209-
Eclipse Clinical Research /ID# 161516TucsonArizona85745-
Noble Clinical Research /ID# 166949TucsonArizona85704-
Vision's Clinical Research-Tucson /ID# 161508TucsonArizona85712-
Duplicate_Core Healthcare Group /ID# 160858CerritosCalifornia90703-
Diagnamics Inc. /ID# 160950EncinitasCalifornia92024-
HRC Fertility /ID# 161493EncinoCalifornia91436-
SC Clinical Research /ID# 164395Garden GroveCalifornia92844-
Duplicate_Duplicate_Marvel Clinical Research /ID# 167297Huntington BeachCalifornia92647-
Grossmont Ctr Clin Research /ID# 165120La MesaCalifornia91942-
National Research Institute /ID# 160952Los AngelesCalifornia90057-
Olympia Clinical Trials /ID# 201562Los AngelesCalifornia90036-4667-
Futura Research, Org /ID# 160924MontebelloCalifornia90640-
California Medical Research Associates /ID# 161481NorthridgeCalifornia91324-
Northern California Research /ID# 161561SacramentoCalifornia95821-2640-
MD Strategies Research Centers /ID# 161544San DiegoCalifornia92119-
Precision Research Institute - San Diego /ID# 163069San DiegoCalifornia92114-3643-
Health care Affiliates Medical Group /ID# 163324Santa AnaCalifornia92704-
Alta California Medical Group /ID# 163564Simi ValleyCalifornia93065-
Upland Clinical Research /ID# 164528UplandCalifornia91786-4027-
Bayview Research Group LLC /ID# 161484Valley VillageCalifornia91607-
Advanced RX Clinical Research /ID# 161599WestminsterCalifornia92683-4567-
Emerson Clinical Research Inst /ID# 162181Washington D.C.District of Columbia20011-
James A. Simon, MD, PC /ID# 160931Washington D.C.District of Columbia20036-
David Lubetkin MD LLC /ID# 203578Boca RatonFlorida33486-2269-
Women's Health Partners /ID# 203577Boca RatonFlorida33433-7041-
Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910BrandonFlorida33510-3107-
Omega Research Maitland, LLC /ID# 160857DeBaryFlorida32713-2260-
Midland Florida Clinical Research Center /ID# 161487DeLandFlorida32720-0920-
KO Clinical Research, LLC /ID# 160928Fort LauderdaleFlorida33316-
Sweet Hope Research Specialty Inc /ID# 163522HialeahFlorida33016-1897-
Solutions Through Adv Rch /ID# 160935JacksonvilleFlorida32256-
Altus Research, Inc /ID# 160912Lake WorthFlorida33461-
Wellington Anti-Aging Centre /ID# 203540Loxahatchee GrovesFlorida33470-4937-
South Florida Wellness & Clinic /ID# 161535MargateFlorida33063-
Healthcare Clinical Data, Inc /ID# 160888MiamiFlorida33161-
Invictus Clinical Research Group,LLC /ID# 160925MiamiFlorida33144-
Palmetto Professional Research /ID# 161442MiamiFlorida33172-
Vista Health Research, LLC /ID# 163044MiamiFlorida33176-1032-
Duplicate_Precision Research Organization /ID# 161522Miami LakesFlorida33016-1501-
Ocean Blue Medical Research Center, Inc /ID# 161549Miami SpringsFlorida33166-
Salom Tangir, LLC /ID# 162542MiramarFlorida33027-
Advanced Research Institute, Inc /ID# 163748New Port RicheyFlorida34653-
A Premier Medical Research of FL /ID# 201882Orange CityFlorida32763-2833-
Clinical Associates of Orlando /ID# 160889OrlandoFlorida32819-8900-
Oncova Clinical Research, Inc. /ID# 160937Saint CloudFlorida34769-
Physician Care Clin. Res., LLC /ID# 161547SarasotaFlorida34239-
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913St. PetersburgFlorida33709-3113-
Treasure Coast Research /ID# 161824StuartFlorida34996-
Discovery Clinical Research /ID# 160891SunriseFlorida33324-
Precision Clinical Research /ID# 165377SunriseFlorida33351-7311-
GCP Clinical Research, LLC /ID# 164593TampaFlorida33609-4044-
Jedidiah Clinical Research /ID# 167114TampaFlorida33617-
University of South Florida- Neuroscience Institute /ID# 160960TampaFlorida33613-
Virtus Research Consultants, LLC /ID# 160855WellingtonFlorida33414-
Comprehensive Clinical Trials LLC /ID# 161479West Palm BeachFlorida33409-
Journey Medical Research Insti /ID# 160958AlpharettaGeorgia30005-
Paramount Research Solutions /ID# 161557AlpharettaGeorgia30005-
AGILE Clinical Research Trials /ID# 160941AtlantaGeorgia30328-5532-
Atlanta Women's Research Institute /ID# 160844AtlantaGeorgia30342-
Medisense Inc /ID# 161494AtlantaGeorgia30363-
Mount Vernon Clinical Res, LLC /ID# 161491AtlantaGeorgia30328-
Duplicate_Atlanta Gynecology Research Institute /ID# 160851SuwaneeGeorgia30024-7159-
Bingham Memorial Hospital /ID# 201130BlackfootIdaho83221-
Leavitt Womens Healthcare /ID# 163419Idaho FallsIdaho83404-
Womens Healthcare Assoc, DBA /ID# 160933Idaho FallsIdaho83404-
Sonora Clinical Research /ID# 167610MeridianIdaho83646-1144-
Asr, Llc /Id# 162179NampaIdaho83687-
Women's Health Practice, LLC /ID# 161553ChampaignIllinois61820-
Duplicate_University of Chicago /ID# 162667ChicagoIllinois60637-
Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118ChicagoIllinois60605-2168-
Alliance for Multispecialty Research, LLC /ID# 160932Oak BrookIllinois60523-
Women's Health Advantage /ID# 161537Fort WayneIndiana46825-
Womens & Family Care, LLC dba /ID# 160890Shawnee MissionKansas66218-
Bluegrass Clinical Research /ID# 163485LouisvilleKentucky40291-1988-
Clinical Trials Management, LLC - Covington /ID# 160838CovingtonLouisiana70433-
Clinical Trials Management, LLC - Covington /ID# 160893CovingtonLouisiana70433-
Praetorian Pharmaceutical Research /ID# 161532MarreroLouisiana70072-
Ochsner Baptist Medical Centre /ID# 161507New OrleansLouisiana70115-
Women Under Study, LLC /ID# 163990New OrleansLouisiana70125-1923-
Willis-Knighton Pediatric GI S /ID# 161534ShreveportLouisiana71118-
Exordia Medical Research, Inc /ID# 160853Fall RiverMassachusetts02723-
Duplicate_Great Lakes Research Group, Inc. /ID# 161511Bay CityMichigan48602-
Wayne State University /ID# 160944DetroitMichigan48201-2013-
Saginaw Valley Med Res Group /ID# 160840SaginawMichigan48604-
Valley OB-Gyn Clinic - Saginaw /ID# 203579SaginawMichigan48602-4323-
Quad Clinical Research, LLC /ID# 200943St LouisMissouri63109-
Excel Clinical Research /ID# 165588Las VegasNevada89109-
Office of Edmond E. Pack, MD /ID# 162604Las VegasNevada89113-
Private practice: Dr. Rex G. Mabey JR /ID# 160915Las VegasNevada89128-
Jersey Shore University Medical Center /ID# 160916Neptune CityNew Jersey07753-4859-
Bosque Women's Care /ID# 162606AlbuquerqueNew Mexico87109-
Lovelace Scientific Resources /ID# 163644AlbuquerqueNew Mexico87108-
SUNY Downstate Medical Center /ID# 160922BrooklynNew York11203-
Duplicate_Northwell Health System - Manhasset /ID# 201058ManhassetNew York11030-3816-
Columbia Univ Medical Center /ID# 161519New YorkNew York10032-3725-
Hamburg Regional Gynecology Gr /ID# 161427Orchard ParkNew York14127-
DJL Clinical Research, PLLC /ID# 161548CharlotteNorth Carolina28211-
Carolina Women's Research and Wellness Center /ID# 160914DurhamNorth Carolina27713-7512-
Unified Women's Clinical Resea /ID# 163014RaleighNorth Carolina27607-
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490RaleighNorth Carolina27612-
Unified Women's Clinical Resea /ID# 160957Winston-SalemNorth Carolina27103-
Clinical Inquest Center Ltd /ID# 160892BeavercreekOhio45431-2573-
Duplicate_CTI Clinical Research Center /ID# 160942CincinnatiOhio45212-
Univ Hosp Cleveland /ID# 160953ClevelandOhio44106-
Central Ohio Clinical Research /ID# 201162ColumbusOhio43213-3399-
Duplicate_Optimed Research /ID# 165600ColumbusOhio43235-
Hilltop Obstetrics & Gynecology /ID# 203576MiddletownOhio45005-5200-
University of Toledo /ID# 160923ToledoOhio43614-
Oregon Medical Research Center /ID# 161514PortlandOregon97239-
OB/GYN Associates of Erie /ID# 161541EriePennsylvania16507-1423-
Penn State University and Milton S. Hershey Medical Center /ID# 160896HersheyPennsylvania17033-
DUP_Thomas Jefferson University /ID# 200304PhiladelphiaPennsylvania19107-
University of Pennsylvania /ID# 160936PhiladelphiaPennsylvania19104-5502-
Vista Clinical Research /ID# 160946ColumbiaSouth Carolina29201-
VitaLink Research-Spartanburg /ID# 164592SpartanburgSouth Carolina29303-
Duplicate_Chattanooga Medical Research /ID# 160885ChattanoogaTennessee37404-
WR-ClinSearch /ID# 160887ChattanoogaTennessee37421-1605-
The Jackson Clinic, PA /ID# 162496JacksonTennessee38305-
Research Memphis Associates, LLC /ID# 160939MemphisTennessee38119-3895-
Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542AustinTexas78758-5653-
OBGYN North /ID# 203580AustinTexas78758-5444-
Discovery Clinical Trials -HCWC /ID# 161543DallasTexas75230-2571-
Duplicate_The University of Texas Southwestern Medical Center /ID# 161496DallasTexas75390-8575-
Baylor Scott & White /ID# 161515Fort WorthTexas76104-4110-
Willowbend Health and Wellness - Frisco /ID# 160954FriscoTexas75035-
America's Adv. Wellness Center /ID# 167548HoustonTexas77080-
Centex Studies, Inc /ID# 163858HoustonTexas77058-2705-
Centex Studies, Inc. - Houston /ID# 160917HoustonTexas77058-
Precision Research Institute, LLC /ID# 161554HoustonTexas77036-
The Ob/Gyn Center /ID# 165928HoustonTexas77030-
The Woman's Hospital of Texas /ID# 160959HoustonTexas77054-
UAG Innovation Women Research, /ID# 167415HoustonTexas77074-
FMC Science /ID# 160886LampasasTexas76550-
Advances in Health, Inc. /ID# 160930PearlandTexas77854-
ClinRx Research, LLC /ID# 201170PlanoTexas75024-5280-
Clinical Trials of Texas, Inc /ID# 161510San AntonioTexas78229-
VIP Trials /ID# 161546San AntonioTexas78230-
Houston Ctr for Clin Research /ID# 160837Sugar LandTexas77479-
The Univ Texas HSC at Tyler /ID# 161533TylerTexas75708-
Center of Reproductive Medicine /ID# 162498WebsterTexas77598-
Univ of Virgnia Medical center /ID# 166283CharlottesvilleVirginia22908-0816-
Eastern Virginia Med School /ID# 160856NorfolkVirginia23507-1627-
Clinical Research Partners /ID# 160929North ChesterfieldVirginia23235-
Clinical Research Partners /ID# 160948North ChesterfieldVirginia23235-
Clinical Trials Virginia, Inc. /ID# 160943RichmondVirginia23225-
Specialists for Women /ID# 201129SuffolkVirginia23434-8151-
Tidewater Clinical Research /ID# 160949Virginia BeachVirginia23456-

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