An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT02925494
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Estradiol/Norethindrone Acetate — DRUG
    capsules
  • Elagolix — DRUG
    film-coated tablets

Study Details

This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.

Key Dates

Start date
Sep 14, 2016
Status verified
Jul 2021
Primary completion
May 7, 2018
Completion
Mar 22, 2019

Study Design

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

Arms

  • Experimental: Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA)
    Elagolix 300 mg twice daily (BID) and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD)
  • Experimental: Elagolix
    Elagolix 300 mg BID and placebo for 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: From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study) ]

Locations (121)

FacilityCityStateZIPSite coordinators
Alabama Clinical Therapeutics, LLC /ID# 153217BirminghamAlabama35235-3430-
Alabama Clinical Therapeutics, LLC /ID# 153336BirminghamAlabama35235-3430-
Choice Research, LLC /ID# 153492DothanAlabama36303-
Brown, Pearson, Guepet Gynecology /ID# 153278FairhopeAlabama36532-
Mobile, Ob-Gyn, P.C. /ID# 153442MobileAlabama36608-
University of South Alabama /ID# 153415MobileAlabama36604-3302-
Mesa Obstetricians and Gynecol /ID# 153269MesaArizona85209-
Core Healthcare Group /ID# 153282CerritosCalifornia90703-
Diagnamics Inc. /ID# 153347EncinitasCalifornia92024-
Grossmont Ctr Clin Research /ID# 153324La MesaCalifornia91942-
Futura Research, Inc. /ID# 153345NorwalkCalifornia90650-
Farid Yasharpour MD Medical Co /ID# 153482San FernandoCalifornia91340-
Advanced Women's Health Institution /ID# 153401Greenwood VillageColorado80111-
Emerson Clinical Research Inst /ID# 162755Washington D.C.District of Columbia20011-
James A. Simon, MD, PC /ID# 153323Washington D.C.District of Columbia20036-
Medstar Health Research Institute /ID# 153321Washington D.C.District of Columbia20010-
Helix Biomedics, LLC /ID# 153440Boynton BeachFlorida33436-6634-
Brandon Premier Health Care, PA /ID# 165791BrandonFlorida33510-3107-
Florida Fertility Institute /ID# 153308ClearwaterFlorida33759-
Omega Research Consultants, LLC /ID# 153381DeBaryFlorida32713-2260-
KO Clinical Research, LLC /ID# 153198Fort LauderdaleFlorida33316-
Clinical Physiology Assoc. /ID# 153444Fort MyersFlorida33916-
Solutions Through Adv Rch /ID# 153283JacksonvilleFlorida32256-
Meridien Research /ID# 153310Kenneth CityFlorida33709-3113-
Altus Research, Inc /ID# 153307Lake WorthFlorida33461-
South Florida Wellness & Clinic /ID# 153420MargateFlorida33063-
Healthcare Clinical Data, Inc /ID# 153425MiamiFlorida33161-
Invictus Clinical Research Group,LLC /ID# 153196MiamiFlorida33144-
LCC Medical Research Institute /ID# 153296MiamiFlorida33126-
Ocean Blue Med Research Ctr /ID# 153225MiamiFlorida33166-
Precision Research Org, LLC /ID# 153276Miami LakesFlorida33016-1501-
Advanced Research Institute /ID# 153413New Port RicheyFlorida34653-
Suncoast Clinical Research /ID# 153206New Port RicheyFlorida34652-
Clinical Associates of Orlando /ID# 153427OrlandoFlorida32806-
Unified Womens Clin Research /ID# 153229Panama CityFlorida32045-
All Wmns HC of West Broward /ID# 153434PlantationFlorida33324-
Oncova Clinical Research, Inc. /ID# 153497Saint CloudFlorida34769-
Physician Care Clin. Res., LLC /ID# 153210SarasotaFlorida34239-
Qps-Mra, Llc /Id# 153456South MiamiFlorida33143-
University of South Florida /ID# 153271TampaFlorida33612-
Axcess Medical Research /ID# 153500WellingtonFlorida33414-
Virtus Research Consultant,LLC /ID# 153398WellingtonFlorida33414-
Comprehensive Clinical Trials /ID# 153350West Palm BeachFlorida33409-
Atlanta Medical Research Insti /ID# 153298AlpharettaGeorgia30005-4419-
Paramount Research Solutions /ID# 153424AlpharettaGeorgia30005-
Paramount Research Solutions /ID# 160974AlpharettaGeorgia30005-
Atlanta Women's Research Inst /ID# 153212AtlantaGeorgia30342-
Mount Vernon Clinical Res, LLC /ID# 153403AtlantaGeorgia30328-
Masters of Clinical Research, Inc. /ID# 153295AugustaGeorgia30909-
Paramount Research Solutions /ID# 153351College ParkGeorgia30349-
Fellows Research Alliance, Inc /ID# 153227SavannahGeorgia31406-
Atlanta Gynecology Research Institute /ID# 200074SuwaneeGeorgia30024-7159-
Clinical Research Consultants of Atlanta /ID# 153285SuwaneeGeorgia30024-6988-
Sonora Clinical Research /ID# 153231MeridianIdaho83646-1144-
Affinity Clinical Research /ID# 153417Oak BrookIllinois60523-
Bluegrass Clinical Research /ID# 153280LouisvilleKentucky40291-
Clinical Trials Management, LLC - Covington /ID# 153211CovingtonLouisiana70433-
Clinical Trials Management, LLC - Covington /ID# 153439CovingtonLouisiana70433-
Ochsner Baptist Medical Center /ID# 153459New OrleansLouisiana70115-
Omni Fertility and Laser Insti /ID# 153228ShreveportLouisiana71118-
Baltimore Suburban Health /ID# 168386BaltimoreMaryland21208-
Genesis Clinical Research /ID# 153379Fall RiverMassachusetts02720-
NECCR Fall River LLC /ID# 153274Fall RiverMassachusetts02720-2972-
Great Lakes Research Group,Inc /ID# 153302Bay CityMichigan48706-
Saginaw Valley Med Res Group /ID# 153498SaginawMichigan48604-
Wayne State University Physician Group - Southfield /ID# 153418SouthfieldMichigan48034-
Accent Clinical Trials /ID# 153474Las VegasNevada89106-4017-
Mabey, Las Vegas, NV /ID# 153314Las VegasNevada89128-
Office of Edmond E. Pack, MD /ID# 153411Las VegasNevada89113-
Lawrence OB/GYN /ID# 153218LawrencevilleNew Jersey08648-
Jersey Shore University Medical Center /ID# 153495Neptune CityNew Jersey07753-4859-
Bosque Women's Care /ID# 153223AlbuquerqueNew Mexico87109-
SUNY Downstate Medical Center /ID# 153344BrooklynNew York11203-
Manhattan Medical Research /ID# 153386New YorkNew York10016-6023-
Weill Cornell Medicine /ID# 153275New YorkNew York10032-3725-
Cwrwc /Id# 153313DurhamNorth Carolina27713-
Unified Women's Clinical Research-Greensboro /ID# 153499GreensboroNorth Carolina27408-
Pinewest Ob-Gyn, Inc. /ID# 153197High PointNorth Carolina27262-
Eastern Carolina Women's Centr /ID# 153341New BernNorth Carolina28562-
Unified Women's Clinical Resea /ID# 153312RaleighNorth Carolina27607-
Wake Research Associates, LLC /ID# 153402RaleighNorth Carolina27612-
Unified Women's Clinical Resea /ID# 153297Winston-SalemNorth Carolina27103-
Clinical Inquest Center Ltd /ID# 153436BeavercreekOhio45432-
CTI Clinical Research Center /ID# 153201CincinnatiOhio45212-
University Hospitals Cleveland /ID# 153450ClevelandOhio44106-
University of Toledo /ID# 153409ToledoOhio43614-
Comprehensive Womens Care /ID# 153396WestervilleOhio43081-
Legacy Medical Group-Portland /ID# 168286PortlandOregon97210-
Main Line Fertility Center /ID# 153410Bryn MawrPennsylvania19010-
Penn State University and Milton S. Hershey Medical Center /ID# 153443HersheyPennsylvania17033-
Clinical Research of Philadelphia, LLC /ID# 153279PhiladelphiaPennsylvania19114-
Thomas Jefferson University /ID# 153319PhiladelphiaPennsylvania19107-4414-
University of Pennsylvania /ID# 153203PhiladelphiaPennsylvania19104-5502-
Reading Hosp Clncl Trials Ofc /ID# 153475West ReadingPennsylvania19611-
Medical University of South Carolina /ID# 153325CharlestonSouth Carolina29425-
Vista Clinical Research /ID# 153399ColumbiaSouth Carolina29201-
Chattanooga Medical Research /ID# 153405ChattanoogaTennessee37404-
WR-ClinSearch /ID# 153404ChattanoogaTennessee37421-1605-
Research Memphis Associates, LLC /ID# 153322MemphisTennessee38119-3895-
Women's Health Trials /ID# 153426MenphisTennessee38104-
Access Clinical Trials, Inc. /ID# 153441NashvilleTennessee37203-
Lotus Gynecology /ID# 153476AustinTexas78703-1448-
Texas Health Presbyterian Hosp /ID# 153339DallasTexas75231-
UT Southwestern Medical Center /ID# 153400DallasTexas75390-7208-
Baylor Scott & White /ID# 153273Fort WorthTexas76104-4110-
Willowbend Health and Wellness /ID# 153458FriscoTexas75035-
Advances in Health, Inc. /ID# 153414HoustonTexas77030-
The Woman's Hospital of Texas /ID# 153270HoustonTexas77054-
FMC Science /ID# 153289LampasasTexas76550-
Clinical Trials of Texas,Inc. /ID# 153209San AntonioTexas78229-
Discovery Clinical Trials-San Antonio /ID# 153315San AntonioTexas78258-
Houston Ctr for Clin Research /ID# 153221Sugar LandTexas77479-
Center of Reproductive Medicin /ID# 153320WebsterTexas77598-
Eastern Virginia Med School /ID# 153380NorfolkVirginia23507-1627-
Tidewater Physicians for Women /ID# 153432NorfolkVirginia23502-
Clinical Research Partners, LL /ID# 153412North ChesterfieldVirginia23235-4722-
Clinical Research Partners, LLC /ID# 153343RichmondVirginia23220-4459-
Clinical Trials Virginia, Inc. /ID# 153419RichmondVirginia23225-
Emerson Clinical Research Inst /ID# 153416ViennaVirginia22182-
Seattle Women's Health, Research, Gynecology /ID# 153306SeattleWashington98105-
Virginia Mason Medical Center /ID# 153342SeattleWashington98101-

Find similar trials in Birmingham, AL

By research site
Alabama Clinical Therapeutics, LLC· Birmingham, ALChoice Research, LLC· Dothan, ALBrown, Pearson, Guepet Gynecology· Fairhope, ALMobile, Ob-Gyn, P.C.· Mobile, ALUniversity of South Alabama· Mobile, ALMesa Obstetricians and Gynecol· Mesa, AZ

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