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 (Replicate Study)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT02691494
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
Feb 3, 2016
Status verified
Jul 2021
Primary completion
Feb 14, 2018
Completion
Jan 23, 2019

Study Design

Enrollment
378 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 (103)

FacilityCityStateZIPSite coordinators
Alabama Clinical Therapeutics, LLC /ID# 152258BirminghamAlabama35235-3430-
Choice Research, LLC /ID# 150988DothanAlabama36303-
Brown, Pearson, Guepet Gynecology /ID# 151020FairhopeAlabama36532-
Mobile, Ob-Gyn, P.C. /ID# 144294MobileAlabama36608-
Mesa Obstetricians and Gynecol /ID# 149139MesaArizona85209-
Visions Clinical Research-Tucs /ID# 151017TucsonArizona85712-
Core Healthcare Group /ID# 151016CerritosCalifornia90703-
Diagnamics Inc. /ID# 152469EncinitasCalifornia92024-
HCP Clinical Research LLC /ID# 154434Huntington BeachCalifornia92646-
Alliance Research Centers /ID# 149752Laguna HillsCalifornia92653-3621-
University of California, Los Angeles /ID# 149760Los AngelesCalifornia90095-
Futura Research, Inc. /ID# 149759NorwalkCalifornia90650-
Farid Yasharpour MD Medical Co /ID# 149770San FernandoCalifornia91340-
Clinical Trial Investigators /ID# 152470TustinCalifornia92780-
Bayview Research Group LLC /ID# 153799Valley VillageCalifornia91607-
Emerson Clinical Research Inst /ID# 152348Washington D.C.District of Columbia20011-
Ideal Clinical Research Inc. /ID# 149757AventuraFlorida33180-
Seffner Premier Health Care, P /ID# 167480BrandonFlorida33510-
Olympian Clinical Research /ID# 149756ClearwaterFlorida33756-
KO Clinical Research, LLC /ID# 144299Fort LauderdaleFlorida33316-
University of Florida /ID# 149751GainesvilleFlorida32610-
Solutions Through Adv Rch /ID# 151021JacksonvilleFlorida32256-
Meridien Research /ID# 167100Kenneth CityFlorida33709-3113-
Invictus Clinical Research Group,LLC /ID# 141859MiamiFlorida33144-
Precision Research Org, LLC /ID# 144335Miami LakesFlorida33016-1501-
Suncoast Clinical Research /ID# 149765New Port RicheyFlorida34652-
All Wmns HC of West Broward /ID# 144298PlantationFlorida33324-
Oncova Clinical Research, Inc. /ID# 149764Saint CloudFlorida34769-
Physician Care Clin. Res., LLC /ID# 149766SarasotaFlorida34239-
Qps-Mra, Llc /Id# 144325South MiamiFlorida33143-
Martin Health System Center /ID# 152263StuartFlorida34994-
University of South Florida /ID# 149754TampaFlorida33612-
Axcess Medical Research /ID# 149769WellingtonFlorida33414-
Virtus Research Consultant,LLC /ID# 144296WellingtonFlorida33414-
Paramount Research Solutions /ID# 149291AlpharettaGeorgia30005-
Agile Clinical Research Trials /ID# 167074AtlantaGeorgia30328-
Atlanta Women's Research Inst /ID# 144303AtlantaGeorgia30342-
Mount Vernon Clinical Res, LLC /ID# 144297AtlantaGeorgia30328-
Georgia Regents University /ID# 144295AugustaGeorgia30912-
Masters of Clinical Research, Inc. /ID# 167400AugustaGeorgia30909-
Meridian Clinical Research, LLC /ID# 149144SavannahGeorgia31406-2675-
Gyn-Care, Inc. /ID# 149341SmyrnaGeorgia30080-
Atlanta Gynecology Research Institute /ID# 151014SuwaneeGeorgia30024-7159-
Womens Healthcare Assoc, DBA /ID# 149762Idaho FallsIdaho83404-
Advanced Clinical Research /ID# 149767MeridianIdaho83642-
University of Chicago /ID# 152257ChicagoIllinois60637-1443-
Affinity Clinical Research /ID# 167119Oak BrookIllinois60523-
Center for Women's Research, Inc /ID# 144300Palos HeightsIllinois60463-1440-
Women's Health Advantage /ID# 144301Fort WayneIndiana46825-
The Iowa Clinic /ID# 150105West Des MoinesIowa50266-
PRN Professional Research Network of Kansas, LLC /ID# 152265WichitaKansas67205-
Bluegrass Clinical Research /ID# 150103LouisvilleKentucky40291-
Clinical Trials Management, LLC - Covington /ID# 144314CovingtonLouisiana70433-
Women Under Study, LLC /ID# 144312New OrleansLouisiana70125-1923-
Baltimore Suburban Health /ID# 154638BaltimoreMaryland21208-
Womens Health Center /ID# 154209Glen BurnieMaryland21063-
Maryland Ctr for Sexual Health /ID# 149778LuthervilleMaryland21093-
NECCR Fall River LLC /ID# 149584Fall RiverMassachusetts02720-2972-
Saginaw Valley Med Res Group /ID# 149768SaginawMichigan48604-
Accent Clinical Trials /ID# 149753Las VegasNevada89106-4017-
Jersey Shore University Medical Center /ID# 149779Neptune CityNew Jersey07753-4859-
Rowan University SOM /ID# 152697StratfordNew Jersey08084-
SUNY Downstate Medical Center /ID# 144311BrooklynNew York11203-
Manhattan Medical Research /ID# 167077New YorkNew York10016-6023-
Weill Cornell Medicine /ID# 149585New YorkNew York10032-3725-
Montefiore Medical Center /ID# 149582The BronxNew York10461-
Duplicate_Unified Women's Clinical Research-Fayetteville /ID# 149587FayettevilleNorth Carolina28304-
Unified Women's Clinical Research-Greensboro /ID# 149588GreensboroNorth Carolina27408-
Pinewest Ob-Gyn, Inc. /ID# 145671High PointNorth Carolina27262-
Eastern Carolina Women's Centr /ID# 144309New BernNorth Carolina28562-
Wake Research Associates, LLC /ID# 144307RaleighNorth Carolina27612-
Clinical Inquest Center Ltd /ID# 148728BeavercreekOhio45432-
CTI Clinical Research Center /ID# 149761CincinnatiOhio45212-
The Christ Hospital /ID# 150104CincinnatiOhio45219-
Alpha Research Associates LLC /ID# 152471DaytonOhio45417-
Comprehensive Womens Care /ID# 144306WestervilleOhio43081-
Family Medical Associates /ID# 145668LevittownPennsylvania19056-
Clinical Research of Philadelphia, LLC /ID# 151015PhiladelphiaPennsylvania19114-
University of Pennsylvania /ID# 149586PhiladelphiaPennsylvania19104-5502-
Reading Hosp Clncl Trials Ofc /ID# 149583West ReadingPennsylvania19611-
Holston Medical Group /ID# 149763BristolTennessee37620-7346-
Chattanooga Medical Research /ID# 145667ChattanoogaTennessee37404-
Chattanooga Women for Women /ID# 167051HixsonTennessee37343-3992-
The Jackson Clinic, PA /ID# 145670JacksonTennessee38305-
The Womens Physician Group /ID# 144317MemphisTennessee38104-
Access Clinical Trials, Inc. /ID# 167333NashvilleTennessee37203-
Lotus Gynecology /ID# 149140AustinTexas78703-1448-
Inquest Clinical Research /ID# 149755BaytownTexas77521-2415-
Texas Health Presbyterian Hosp /ID# 149142DallasTexas75231-
Baylor College of Medicine /ID# 149141HoustonTexas77030-3411-
BI Research Center /ID# 149143HoustonTexas77084-
Centex Studies, Inc. - Houston /ID# 150106HoustonTexas77058-
The Woman's Hospital of Texas /ID# 144319HoustonTexas77054-
FMC Science /ID# 151802LampasasTexas76550-
Willowbend Health and Wellness /ID# 144318PlanoTexas75035-
Clinical Trials of Texas,Inc. /ID# 144322San AntonioTexas78229-
Center of Reproductive Medicin /ID# 167235WebsterTexas77598-
Southampton Women's Health /ID# 152325FranklinVirginia23851-
Tidewater Physicians for Women /ID# 144321NorfolkVirginia23502-
Alliance Womens Health /ID# 152468RichmondVirginia23226-1930-
Clinical Research Partners, LLC /ID# 144310RichmondVirginia23220-4459-
Zain Research /ID# 151018RichlandWashington99352-
Virginia Mason Medical Center /ID# 149758SeattleWashington98101-

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, ALMesa Obstetricians and Gynecol· Mesa, AZVisions Clinical Research-Tucs· Tucson, AZ

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