A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT03213457
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • Estradiol/Norethindrone Acetate — DRUG
    Tablets
  • Placebo for Elagolix — DRUG
    Tablet
  • Elagolix — DRUG
    Tablet
  • Placebo for E2/NETA — DRUG
    Tablets

Study Details

The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.

Key Dates

Start date
Jul 7, 2017
Status verified
Nov 2024
Primary completion
Mar 27, 2020
Completion
Dec 6, 2023

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Placebo for elagolix administered twice daily (BID) plus placebo for estradiol/norethindrone acetate (E2/NETA) administered once daily (QD) for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
  • Experimental: Elagolix / Elagolix + E2/NETA
    Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
  • Experimental: Elagolix + E2/NETA
    Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.

Primary Outcome Measure

Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment [ Time Frame: Month 6, Month 12 ]

Locations (188)

FacilityCityStateZIPSite coordinators
Alabama Clinical Therapeutics, LLC /ID# 145503BirminghamAlabama35235-3430-
Alabama Clinical Therapeutics, LLC /ID# 151468BirminghamAlabama35235-3430-
Central Research Associates /ID# 163087BirminghamAlabama35205-
Southern Women's Specialists PC /ID# 148750FairhopeAlabama36532-3029-
Mobile, Ob-Gyn, P.C. /ID# 145364MobileAlabama36608-
University of South Alabama /ID# 148774MobileAlabama36604-3302-
Women's Health Alliance of Mobile /ID# 150083MobileAlabama36604-1410-
Mesa Obstetricians and Gynecologists /ID# 147320MesaArizona85209-
Arizona Research Assoc /ID# 161703TucsonArizona85712-
Eclipse Clinical Research /ID# 155600TucsonArizona85745-
Unity Health- Searcy Medical Center /ID# 203674SearcyArkansas72143-4802-
Core Healthcare Group /ID# 149321CerritosCalifornia90703-
HRC Fertility /ID# 154143EncinoCalifornia91436-
Glendale Adventist Medical Ctr /ID# 160530GlendaleCalifornia91206-
HCP Clinical Research LLC /ID# 152045Huntington BeachCalifornia92646-
Alliance Research Centers /ID# 151240IrvineCalifornia92612-1245-
Long Beach Clinical Trial Serv /ID# 152428Long BeachCalifornia90806-
Olympia Clinical Trials /ID# 202325Los AngelesCalifornia90036-4667-
California Medical Research As /ID# 154746NorthridgeCalifornia91324-
Futura Research, Org /ID# 145406NorwalkCalifornia90650-
Huntington Medical Foundation /ID# 154750PasadenaCalifornia91105-
Northern California Research /ID# 159753SacramentoCalifornia95821-2640-
MD Strategies Research Centers /ID# 152429San DiegoCalifornia92119-
Precision Research Institute - San Diego /ID# 152557San DiegoCalifornia92114-3643-
Alta California Medical Group /ID# 155706Simi ValleyCalifornia93065-
Downtown Womens Health Care /ID# 147955DenverColorado80209-
Advanced Women's Health Institute /ID# 145396Greenwood VillageColorado80111-
Red Rocks OB/GYN /ID# 145325LakewoodColorado80228-1810-
The Women's Health Group - Thornton /ID# 203707ThorntonColorado80229-4385-
James A. Simon, MD, PC /ID# 145480Washington D.C.District of Columbia20036-
Helix Biomedics, LLC /ID# 147108Boynton BeachFlorida33436-6634-
Gulf Coast Research Group /ID# 162895BrandonFlorida33510-
Olympian Clinical Research /ID# 148167ClearwaterFlorida33756-
Omega Research Maitland, LLC /ID# 145167DeBaryFlorida32713-2260-
KO Clinical Research, LLC /ID# 145410Fort LauderdaleFlorida33316-
Clinical Physiology Associates /ID# 145237Fort MyersFlorida33912-
Solutions Through Adv Rch /ID# 148768JacksonvilleFlorida32256-
Vida Clinical Research /ID# 150282KissimmeeFlorida34741-2345-
Axcess Medical Center /ID# 148169Loxahatchee GrovesFlorida33470-
Genoma Research Group, Inc /ID# 152558MiamiFlorida33165-
Palmetto Professional Research /ID# 153838MiamiFlorida33186-1309-
Vista Health Research LLC - Miami /ID# 151455MiamiFlorida33176-1032-
Precision Research Organization /ID# 145337Miami LakesFlorida33016-1501-
Ocean Blue Medical Research Center, Inc /ID# 145514Miami SpringsFlorida33166-
Salom Tangir, LLC /ID# 148739MiramarFlorida33027-
Suncoast Clinical Research /ID# 145484New Port RicheyFlorida34652-
Oncova Clinical Research, Inc. /ID# 148175Saint CloudFlorida34769-
Physician Care Clin. Res., LLC /ID# 145511SarasotaFlorida34239-
Meridien Research - St Petersburg /ID# 145345St. PetersburgFlorida33709-3113-
Treasure Coast Research /ID# 148174StuartFlorida34996-
Stedman Clinical Trials /ID# 152554TampaFlorida33613-
University of South Florida /ID# 145424TampaFlorida33612-
Virtus Research Consultants, LLC /ID# 147101WellingtonFlorida33414-
Comprehensive Clinical Trials /ID# 145148West Palm BeachFlorida33409-
Paramount Research Solutions /ID# 145226AlpharettaGeorgia30005-
Paramount Research Solutions /ID# 149320AlpharettaGeorgia30005-
Agile Clinical Research Trials /ID# 145494AtlantaGeorgia30328-5532-
Atlanta Women's Research Inst /ID# 145543AtlantaGeorgia30342-
Apogee Women's Health Inc. /ID# 145149College ParkGeorgia30349-
Columbus Regional Research Ins /ID# 159752ColumbusGeorgia31904-
Meridian Clinical Research, LLC /ID# 148176SavannahGeorgia31406-2675-
Atlanta Gynecology Research Institute /ID# 149322SuwaneeGeorgia30024-7159-
Clinical Research Prime /ID# 161724Idaho FallsIdaho83404-
Womens Healthcare Assoc, DBA /ID# 148744Idaho FallsIdaho83404-
Advanced Clinical Research /ID# 147086MeridianIdaho83642-
Sonora Clinical Research /ID# 145541MeridianIdaho83646-1144-
Asr, Llc /Id# 161680NampaIdaho83687-
Women's Health Practice, LLC /ID# 145517ChampaignIllinois61820-
Affinity Clinical Research /ID# 151469Oak BrookIllinois60523-
Center for Women's Research, Inc /ID# 145486Palos HeightsIllinois60463-1440-
The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 151459Park RidgeIllinois60068-
American Health Network of Ind /ID# 167996AvonIndiana46123-7960-
Women's Health Advantage /ID# 145495Fort WayneIndiana46825-
The Iowa Clinic /ID# 145409West Des MoinesIowa50266-
Womens & Family Care, LLC dba /ID# 145211Shawnee MissionKansas66218-
Cypress Medical Research Ctr /ID# 147159WichitaKansas67226-
PRN Professional Research Network of Kansas, LLC /ID# 151463WichitaKansas67205-
Bluegrass Clinical Research /ID# 151209LouisvilleKentucky40291-1988-
University of Louisville /ID# 154751LouisvilleKentucky40202-
Clinical Trials Management, LLC - Covington /ID# 145220CovingtonLouisiana70433-
Clinical Trials Management, LLC - Covington /ID# 145520CovingtonLouisiana70433-
Horizon Research Group /ID# 148171EuniceLouisiana70535-
Praetorian Pharmaceutical Res /ID# 145405MarreroLouisiana70072-
Ochsner Baptist OB/GYN Clinic /ID# 147144New OrleansLouisiana70115-
Women Under Study, LLC /ID# 151216New OrleansLouisiana70125-1923-
Omni Fertility and Laser Insti /ID# 145532ShreveportLouisiana71118-
Women's Health Clinic /ID# 155707ShreveportLouisiana71118-3133-
Eastern Maine Medical Center /ID# 161681BangorMaine04401-
Baltimore Suburban Health /ID# 147164BaltimoreMaryland21208-
Univ Maryland School Medicine /ID# 151739BaltimoreMaryland21201-
Continental Clinical Solutions /ID# 152041TowsonMaryland21204-
Genesis Clinical Research - Fall River /ID# 148573Fall RiverMassachusetts02723-
NECCR Fall River LLC /ID# 145329Fall RiverMassachusetts02720-2972-
ClinSite, LLC /ID# 145314Ann ArborMichigan48105-
Great Lakes Research Group, Inc. /ID# 145308Bay CityMichigan48602-
Saginaw Valley Med Res Group /ID# 145527SaginawMichigan48604-
Wayne State University Physician Group - Southfield /ID# 145431SouthfieldMichigan48034-
Prism Research /ID# 159751Saint PaulMinnesota55114-
Womens Clinic of Lincoln, P.C. /ID# 145366LincolnNebraska68510-
Accent Clinical Trials /ID# 147109Las VegasNevada89106-4017-
Office of Edmond E. Pack, MD /ID# 148747Las VegasNevada89113-
R. Garn Mabey Jr, MD Chartered /ID# 145361Las VegasNevada89128-
Jersey Shore University Medical Center /ID# 148756Neptune CityNew Jersey07753-4859-
Rutgers Robert Wood Johnson /ID# 152858New BrunswickNew Jersey08901-
St. Joseph's Regional Medical /ID# 157759TotowaNew Jersey07512-
Albuquerque Clinical Trials, Inc /ID# 154747AlbuquerqueNew Mexico87102-
Bosque Women's Care /ID# 147084AlbuquerqueNew Mexico87109-
SUNY Downstate Medical Center /ID# 148749BrooklynNew York11203-
Scott Research Inc. /ID# 161704LaureltonNew York11413-
Columbia Univ Medical Center /ID# 145334New YorkNew York10032-3725-
Manhattan Medical Research /ID# 145175New YorkNew York10016-6023-
Hamburg Regional Gynecology Gr /ID# 161705Orchard ParkNew York14127-
OB.GYN Associates of WNY /ID# 161665West SenecaNew York14224-
DJL Clinical Research, PLLC /ID# 154679CharlotteNorth Carolina28210-8508-
PMG Research of Charlotte /ID# 145432CharlotteNorth Carolina28209-
Carolina Women's Research and Wellness Center /ID# 145356DurhamNorth Carolina27713-
Unified Women's Clinical Research-Greensboro /ID# 155543GreensboroNorth Carolina27408-
Pinewest Ob-Gyn, Inc. /ID# 151743High PointNorth Carolina27262-
Eastern Carolina Women's Centr /ID# 145386New BernNorth Carolina28562-
Unified Women's Clinical Resea /ID# 145353RaleighNorth Carolina27607-
PMG Research of Wilmington /ID# 152555WilmingtonNorth Carolina28401-6638-
Trinity Health Center Town /ID# 147102MinotNorth Dakota58701-
Clinical Inquest Center Ltd /ID# 147107BeavercreekOhio45431-2573-
CTI Clinical Research Center /ID# 145428CincinnatiOhio45212-
The Christ Hospital /ID# 149244CincinnatiOhio45219-
University of Cincinnati /ID# 145496CincinnatiOhio45267-0585-
Univ Hosp Cleveland /ID# 148741ClevelandOhio44106-
Aventiv Research, Inc. /ID# 145492ColumbusOhio43213-
Aventiv Research, Inc. /ID# 162896ColumbusOhio43213-
The Ohio State University /ID# 145444ColumbusOhio43210-1257-
Wright State University & CTRA /ID# 145512FairbornOhio45324-
University of Toledo /ID# 145403ToledoOhio43614-
Oregon Health and Science University /ID# 155705PortlandOregon97239-
Main Line Fertility Center /ID# 150099Bryn MawrPennsylvania19010-
OB/GYN Associates of Erie /ID# 157935EriePennsylvania16507-1423-
Penn State University and Milton S. Hershey Medical Center /ID# 145231HersheyPennsylvania17033-
Drexel Univ College of Med /ID# 149789PhiladelphiaPennsylvania19129-
University of Pennsylvania /ID# 145470PhiladelphiaPennsylvania19104-5502-
Frontier Clinical Research /ID# 162091SmithfieldPennsylvania15478-
Vista Clinical Research /ID# 148767ColumbiaSouth Carolina29201-
University Medical Group /ID# 148777GreenvilleSouth Carolina29605-
Venus Gynecology, LLC /ID# 145336Myrtle BeachSouth Carolina29572-
James T. Martin, Jr., MD., Obs /ID# 148755North CharlestonSouth Carolina29406-
Palmetto Clinical Research /ID# 150992SummervilleSouth Carolina29485-7539-
Brown Clinic, PLLP /ID# 154372WatertownSouth Dakota57201-
Holston Medical Group /ID# 145449BristolTennessee37620-7346-
Chattanooga Medical Research /ID# 145184ChattanoogaTennessee37404-
WR-ClinSearch /ID# 145205ChattanoogaTennessee37421-1605-
The Jackson Clinic, PA /ID# 145303JacksonTennessee38305-
Research Memphis Associates, LLC /ID# 150100MemphisTennessee38119-3895-
Access Clinical Trials, Inc. /ID# 145224NashvilleTennessee37203-
AA (Austin Area) ObGyn PLLC /ID# 205696AustinTexas78758-5653-
Lotus Gynecology /ID# 148479AustinTexas78703-1448-
Sirius Clinical Research, LLC /ID# 154749AustinTexas78759-
Gadolin Research, LLC /ID# 201383BeaumontTexas77702-1100-
Center for Assisted Reprod. /ID# 154748BedfordTexas76022-
Texas Health Presbyterian Hosp /ID# 150098DallasTexas75231-
UT Southwestern Medical Center /ID# 145201DallasTexas75390-7208-
Baylor Scott & White /ID# 170430Fort WorthTexas76104-4110-
Signature Gyn Services /ID# 145534Fort WorthTexas76104-
Willowbend Health and Wellness - Frisco /ID# 145245FriscoTexas75035-
Advances in Health, Inc. /ID# 145425HoustonTexas77030-
Centex Studies, Inc /ID# 148776HoustonTexas77058-2705-
Houston Methodist Hospital /ID# 170586HoustonTexas77030-
Next Innovative Clinical Research /ID# 203863HoustonTexas77004-6031-
Precision Research Institute - Houston /ID# 154370HoustonTexas77036-
The Woman's Hospital of Texas /ID# 145316HoustonTexas77054-
FMC Science /ID# 150981LampasasTexas76550-
Clinical Trials of Texas, Inc /ID# 147100San AntonioTexas78229-
Discovery Clinical Trials-San Antonio /ID# 145363San AntonioTexas78258-
VIP Trials /ID# 151745San AntonioTexas78230-
Houston Ctr for Clin Research /ID# 148799Sugar LandTexas77479-
Center of Reproductive Medicin /ID# 145467WebsterTexas77598-
Corner Canyon Obstetrics and G /ID# 145519DraperUtah84020-
Tanner Clinic /ID# 148786LaytonUtah84041-
Revere Health /ID# 145540Pleasant GroveUtah84062-
Southampton Women's Health /ID# 151691FranklinVirginia23851-
Health Research of Hampton Roads, Inc. (HRHR) /ID# 156477Newport NewsVirginia23606-
Clinical Research Partners, LL /ID# 145392North ChesterfieldVirginia23235-4722-
Clinical Research Partners, LL /ID# 145416North ChesterfieldVirginia23235-4722-
Alliance Womens Health /ID# 148770RichmondVirginia23226-1930-
Clinical Trials Virginia, Inc. /ID# 145430RichmondVirginia23225-
Tidewater Clinical Research /ID# 145397Virginia BeachVirginia23456-
Clinical Research Adv, Inc. /ID# 149257PuyallupWashington98372-
Seattle Women's Health, Research, Gynecology /ID# 145341SeattleWashington98105-
Virginia Mason Medical Center /ID# 145387SeattleWashington98101-
North Spokane Women's Health /ID# 145382SpokaneWashington99207-
Madigan Army Medical Center /ID# 145186TacomaWashington98431-

Find similar trials in Birmingham, AL

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
Alabama Clinical Therapeutics, LLC· Birmingham, ALCentral Research Associates· Birmingham, ALSouthern Women's Specialists PC· Fairhope, ALMobile, Ob-Gyn, P.C.· Mobile, ALUniversity of South Alabama· Mobile, ALWomen's Health Alliance of Mobile· Mobile, AL

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