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)

PHASE3CompletedINTERVENTIONAL
Enrollment

378

Participants

Timeline

Start Date

February 3, 2016

Primary Completion Date

February 14, 2018

Study Completion Date

January 23, 2019

Conditions
Uterine FibroidsHeavy Menstrual Bleeding
Interventions
DRUG

Elagolix

Film-coated tablets

DRUG

Placebo for Estradiol/Norethindrone Acetate

Placebo capsules

DRUG

Estradiol/Norethindrone Acetate

Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.

DRUG

Placebo for Elagolix

Film-coated placebo tablets

Trial Locations (105)

10461

Montefiore Medical Center /ID# 149582, The Bronx

11203

SUNY Downstate Medical Center /ID# 144311, Brooklyn

19056

Family Medical Associates /ID# 145668, Levittown

19114

Clinical Research of Philadelphia, LLC /ID# 151015, Philadelphia

19611

Reading Hosp Clncl Trials Ofc /ID# 149583, West Reading

20011

Emerson Clinical Research Inst /ID# 152348, Washington D.C.

21063

Womens Health Center /ID# 154209, Glen Burnie

21093

Maryland Ctr for Sexual Health /ID# 149778, Lutherville

21208

Baltimore Suburban Health /ID# 154638, Baltimore

23502

Tidewater Physicians for Women /ID# 144321, Norfolk

23851

Southampton Women's Health /ID# 152325, Franklin

27262

Pinewest Ob-Gyn, Inc. /ID# 145671, High Point

27408

Unified Women's Clinical Research-Greensboro /ID# 149588, Greensboro

27612

Wake Research Associates, LLC /ID# 144307, Raleigh

28304

Duplicate_Unified Women's Clinical Research-Fayetteville /ID# 149587, Fayetteville

28562

Eastern Carolina Women's Centr /ID# 144309, New Bern

30005

Paramount Research Solutions /ID# 149291, Alpharetta

30080

Gyn-Care, Inc. /ID# 149341, Smyrna

30328

Agile Clinical Research Trials /ID# 167074, Atlanta

Mount Vernon Clinical Res, LLC /ID# 144297, Atlanta

30342

Atlanta Women's Research Inst /ID# 144303, Atlanta

30909

Masters of Clinical Research, Inc. /ID# 167400, Augusta

30912

Georgia Regents University /ID# 144295, Augusta

32256

Solutions Through Adv Rch /ID# 151021, Jacksonville

32610

University of Florida /ID# 149751, Gainesville

33143

Qps-Mra, Llc /Id# 144325, South Miami

33144

Invictus Clinical Research Group,LLC /ID# 141859, Miami

33180

Ideal Clinical Research Inc. /ID# 149757, Aventura

33316

KO Clinical Research, LLC /ID# 144299, Fort Lauderdale

33324

All Wmns HC of West Broward /ID# 144298, Plantation

33414

Axcess Medical Research /ID# 149769, Wellington

Virtus Research Consultant,LLC /ID# 144296, Wellington

33510

Seffner Premier Health Care, P /ID# 167480, Brandon

33612

University of South Florida /ID# 149754, Tampa

33756

Olympian Clinical Research /ID# 149756, Clearwater

34239

Physician Care Clin. Res., LLC /ID# 149766, Sarasota

34652

Suncoast Clinical Research /ID# 149765, New Port Richey

34769

Oncova Clinical Research, Inc. /ID# 149764, Saint Cloud

34994

Martin Health System Center /ID# 152263, Stuart

36303

Choice Research, LLC /ID# 150988, Dothan

36532

Brown, Pearson, Guepet Gynecology /ID# 151020, Fairhope

36608

Mobile, Ob-Gyn, P.C. /ID# 144294, Mobile

37203

Access Clinical Trials, Inc. /ID# 167333, Nashville

37404

Chattanooga Medical Research /ID# 145667, Chattanooga

38104

The Womens Physician Group /ID# 144317, Memphis

38305

The Jackson Clinic, PA /ID# 145670, Jackson

40291

Bluegrass Clinical Research /ID# 150103, Louisville

43081

Comprehensive Womens Care /ID# 144306, Westerville

45212

CTI Clinical Research Center /ID# 149761, Cincinnati

45219

The Christ Hospital /ID# 150104, Cincinnati

45417

Alpha Research Associates LLC /ID# 152471, Dayton

45432

Clinical Inquest Center Ltd /ID# 148728, Beavercreek

46825

Women's Health Advantage /ID# 144301, Fort Wayne

48604

Saginaw Valley Med Res Group /ID# 149768, Saginaw

50266

The Iowa Clinic /ID# 150105, West Des Moines

60523

Affinity Clinical Research /ID# 167119, Oak Brook

67205

PRN Professional Research Network of Kansas, LLC /ID# 152265, Wichita

70433

Clinical Trials Management, LLC - Covington /ID# 144314, Covington

75035

Willowbend Health and Wellness /ID# 144318, Plano

75231

Texas Health Presbyterian Hosp /ID# 149142, Dallas

76550

FMC Science /ID# 151802, Lampasas

77054

The Woman's Hospital of Texas /ID# 144319, Houston

77058

Centex Studies, Inc. - Houston /ID# 150106, Houston

77084

BI Research Center /ID# 149143, Houston

77598

Center of Reproductive Medicin /ID# 167235, Webster

78229

Clinical Trials of Texas,Inc. /ID# 144322, San Antonio

83404

Womens Healthcare Assoc, DBA /ID# 149762, Idaho Falls

83642

Advanced Clinical Research /ID# 149767, Meridian

85209

Mesa Obstetricians and Gynecol /ID# 149139, Mesa

85712

Visions Clinical Research-Tucs /ID# 151017, Tucson

90095

University of California, Los Angeles /ID# 149760, Los Angeles

90650

Futura Research, Inc. /ID# 149759, Norwalk

90703

Core Healthcare Group /ID# 151016, Cerritos

91340

Farid Yasharpour MD Medical Co /ID# 149770, San Fernando

91607

Bayview Research Group LLC /ID# 153799, Valley Village

92024

Diagnamics Inc. /ID# 152469, Encinitas

92646

HCP Clinical Research LLC /ID# 154434, Huntington Beach

92780

Clinical Trial Investigators /ID# 152470, Tustin

98101

Virginia Mason Medical Center /ID# 149758, Seattle

99352

Zain Research /ID# 151018, Richland

35235-3430

Alabama Clinical Therapeutics, LLC /ID# 152258, Birmingham

92653-3621

Alliance Research Centers /ID# 149752, Laguna Hills

33709-3113

Meridien Research /ID# 167100, Kenneth City

33016-1501

Precision Research Org, LLC /ID# 144335, Miami Lakes

31406-2675

Meridian Clinical Research, LLC /ID# 149144, Savannah

30024-7159

Atlanta Gynecology Research Institute /ID# 151014, Suwanee

60637-1443

University of Chicago /ID# 152257, Chicago

60463-1440

Center for Women's Research, Inc /ID# 144300, Palos Heights

70125-1923

Women Under Study, LLC /ID# 144312, New Orleans

02720-2972

NECCR Fall River LLC /ID# 149584, Fall River

89106-4017

Accent Clinical Trials /ID# 149753, Las Vegas

07753-4859

Jersey Shore University Medical Center /ID# 149779, Neptune City

08084

Rowan University SOM /ID# 152697, Stratford

10016-6023

Manhattan Medical Research /ID# 167077, New York

10032-3725

Weill Cornell Medicine /ID# 149585, New York

19104-5502

University of Pennsylvania /ID# 149586, Philadelphia

37620-7346

Holston Medical Group /ID# 149763, Bristol

37343-3992

Chattanooga Women for Women /ID# 167051, Hixson

78703-1448

Lotus Gynecology /ID# 149140, Austin

77521-2415

Inquest Clinical Research /ID# 149755, Baytown

77030-3411

Baylor College of Medicine /ID# 149141, Houston

23220-4459

Clinical Research Partners, LLC /ID# 144310, Richmond

23226-1930

Alliance Womens Health /ID# 152468, Richmond

P3A 1W8

Medicor Research Inc. /ID# 153406, Greater Sudbury

N8W 5R7

Victory Reproductive Care /ID# 150247, Windsor

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY