Efficacy and Safety 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
NCT02654054
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 51 Years
Healthy Volunteers
Not accepted

Interventions

  • Elagolix — DRUG
    Film-coated tablets
  • Placebo for Estradiol/Norethindrone Acetate — DRUG
    Placebo capsules
  • Estradiol/Norethindrone Acetate — DRUG
    Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.
  • Placebo for Elagolix — DRUG
    Film-coated placebo tablets

Study Details

This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Key Dates

Start date
Dec 22, 2015
Status verified
Jun 2020
Primary completion
Jan 18, 2018
Completion
Dec 12, 2018

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Placebo for both elagolix twice daily (BID) and norethindrone acetate (E2/NETA) once daily (QD)
  • Experimental: Elagolix
    Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
  • Experimental: Elagolix + E2/NETA
    Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD

Primary Outcome Measure

Percentage of Participants Meeting the Criteria for Responder [ Time Frame: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6 ]

Locations (92)

FacilityCityStateZIP
Summers, Birmingham, AL /ID# 139684BirminghamAlabama35235
University of South Alabama /ID# 148763MobileAlabama36604-3302
WCCT Global, LLC /ID# 145666Costa MesaCalifornia92626
American Clinical Trials /ID# 147374Hawaiian GardensCalifornia90716
Grossmont Ctr Clin Research /ID# 144011La MesaCalifornia91942
Long Beach Clinical Trial Serv /ID# 152424Long BeachCalifornia90806
National Research Institute /ID# 151629Los AngelesCalifornia90057
University of California, Los Angeles /ID# 144107Los AngelesCalifornia90095
Beach OBGYN Medical Group /ID# 151414Newport BeachCalifornia92663-3657
Advanced RX Clinical Research /ID# 149168WestminsterCalifornia92683-4567
Bluebird Clinical Trials, LLC /ID# 144843Colorado SpringsColorado80923
Advanced Women's Health Institution /ID# 144108Greenwood VillageColorado80111
James A. Simon, MD, PC /ID# 139675Washington D.C.District of Columbia20036
Medstar Health Research Institute /ID# 145933Washington D.C.District of Columbia20010
Helix Biomedics, LLC /ID# 147114Boynton BeachFlorida33436-6634
Brandon Premier Health Care, PA /ID# 153130BrandonFlorida33510-3107
Florida Clin Res Group /ID# 139811CkearwaterFlorida33759
Universal Clinical Research A /ID# 139742DoralFlorida33166
Clinical Physiology Associates /ID# 139736Fort MyersFlorida33912
Meridien Research /ID# 139663Kenneth CityFlorida33709-3113
Altus Research, Inc /ID# 139662Lake WorthFlorida33461
South Florida Wellness & Clinic /ID# 143558MargateFlorida33063
Healthcare Clinical Data, Inc /ID# 139650MiamiFlorida33161
LCC Medical Research Institute /ID# 143551MiamiFlorida33126
Ocean Blue Med Research Ctr /ID# 139826MiamiFlorida33166
Salom Tangir, LLC /ID# 151732MiramarFlorida33027
Advanced Research Institute /ID# 143554New Port RicheyFlorida34653
Clinical Associates of Orlando /ID# 148123OrlandoFlorida32806
Omega Research Consultants /ID# 139648OrlandoFlorida32810
Unified Womens Clin Research /ID# 145169Panama CityFlorida32045
Comprehensive Clinical Trials /ID# 139644West Palm BeachFlorida33409
Atlanta Medical Research Insti /ID# 147117AlpharettaGeorgia30005-4419
Paramount Research Solutions /ID# 139645AlpharettaGeorgia30005
Agile Clinical Research Trials /ID# 143563AtlantaGeorgia30328
Perimeter Inst Clinical Resear /ID# 148298AtlantaGeorgia30338
Masters of Clinical Research, Inc. /ID# 139658AugustaGeorgia30909
Fellows Research Alliance, Inc /ID# 139655SavannahGeorgia31406
Boise Family Medical Center /ID# 139844BoiseIdaho83709
Women's Health Practice, LLC /ID# 143569ChampaignIllinois61820
Great Lakes Clinical Trials /ID# 148135ChicagoIllinois60640
Affinity Clinical Research /ID# 150980Oak BrookIllinois60523
American Health Network of IN /ID# 139822AvonIndiana46123
GTC Research /ID# 141854Kansas CityKansas66218
Cypress Medical Research Ctr /ID# 147116WichitaKansas67226
Research Integrity, LLC /ID# 139727OwensboroKentucky42303-1089
Clinical Trials Management, LLC - Covington /ID# 139651CovingtonLouisiana70433
Ochsner Baptist Medical Center /ID# 139740New OrleansLouisiana70115
Omni Fertility and Laser Insti /ID# 139836ShreveportLouisiana71118
Capital Women's Care /ID# 144109FrederickMaryland21708
Genesis Clinical Research - Fall River /ID# 148449Fall RiverMassachusetts02723
Great Lakes Research Group,Inc /ID# 139659Bay CityMichigan48706
Grand Rapids Womens Health /ID# 139705Grand RapidsMichigan49503
Wayne State University Physician Group - Southfield /ID# 139802SouthfieldMichigan48034
Mabey, Las Vegas, NV /ID# 148138Las VegasNevada89128
Office of Edmond E. Pack, MD /ID# 139792Las VegasNevada89113
Lawrence OB/GYN /ID# 143567LawrencevilleNew Jersey08648
Bosque Women's Care /ID# 145934AlbuquerqueNew Mexico87109
Manhattan Medical Research /ID# 144471New YorkNew York10016-6023
Cwrwc /Id# 139664DurhamNorth Carolina27713
Unified Women's Clinical Research-Greensboro /ID# 139829GreensboroNorth Carolina27408
Unified Women's Clinical Resea /ID# 139774RaleighNorth Carolina27607
PMG Research of Wilmington LLC /ID# 152563WilmingtonNorth Carolina28401
Unified Women's Clinical Resea /ID# 144721Winston-SalemNorth Carolina27103
University of Cincinnati /ID# 139820CincinnatiOhio45267-0585
Univ Hosp Cleveland /ID# 139741ClevelandOhio44106
Complete Healthcare for Women /ID# 139673ColumbusOhio43231
Miami Valley Hospital /ID# 144430DaytonOhio45409
University of Toledo /ID# 139787ToledoOhio43614
Legacy Medical Group-Portland /ID# 148807PortlandOregon97210
Main Line Fertility Center /ID# 150295Bryn MawrPennsylvania19010
Penn State University and Milton S. Hershey Medical Center /ID# 139733HersheyPennsylvania17033
Temple University Hospital /ID# 151429PhiladelphiaPennsylvania19140
Thomas Jefferson University /ID# 139812PhiladelphiaPennsylvania19107-4414
Clinical Trials Research Svcs /ID# 139707PittsburghPennsylvania15206
Medical University of South Carolina /ID# 148754CharlestonSouth Carolina29425
Vista Clinical Research /ID# 139797ColumbiaSouth Carolina29201
WR-ClinSearch /ID# 143538ChattanoogaTennessee37421-1605
Research Memphis Associates, LLC /ID# 139674MemphisTennessee38119-3895
Access Clinical Trials, Inc. /ID# 139730NashvilleTennessee37203
UT Southwestern Medical Center /ID# 143537DallasTexas75390-7208
Advances in Health, Inc. /ID# 139672HoustonTexas77030
Discovery Clinical Trials-San Antonio /ID# 139776San AntonioTexas78258
Victorium Clinical Research /ID# 149630San AntonioTexas78230
Houston Ctr for Clin Research /ID# 149149Sugar LandTexas77479
Center of Reproductive Medicin /ID# 139813WebsterTexas77598
Eastern Virginia Med School /ID# 139647NorfolkVirginia23507-1627
Clinical Research Partners, LL /ID# 143999North ChesterfieldVirginia23235-4722
Clinical Trials Virginia, Inc. /ID# 139801RichmondVirginia23225
Emerson Clinical Research /ID# 147373ViennaVirginia22182
Seattle Women's Health, Research, Gynecology /ID# 139768SeattleWashington98105
Premier Clinical Research /ID# 148145SpokaneWashington99202
Froedtert and Medical College /ID# 143566MilwaukeeWisconsin53226-3522

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By research site
Summers, Birmingham, AL· Birmingham, ALUniversity of South Alabama· Mobile, ALWCCT Global, LLC· Costa Mesa, CAAmerican Clinical Trials· Hawaiian Gardens, CAGrossmont Ctr Clin Research· La Mesa, CALong Beach Clinical Trial Serv· Long Beach, CA

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