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)

FacilityCityStateZIPSite coordinators
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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