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

PHASE3CompletedINTERVENTIONAL
Enrollment

433

Participants

Timeline

Start Date

September 14, 2016

Primary Completion Date

May 7, 2018

Study Completion Date

March 22, 2019

Conditions
Uterine FibroidsHeavy Menstrual Bleeding
Interventions
DRUG

Estradiol/Norethindrone Acetate

capsules

DRUG

Elagolix

film-coated tablets

Trial Locations (124)

11203

SUNY Downstate Medical Center /ID# 153344, Brooklyn

17033

Penn State University and Milton S. Hershey Medical Center /ID# 153443, Hershey

19010

Main Line Fertility Center /ID# 153410, Bryn Mawr

19114

Clinical Research of Philadelphia, LLC /ID# 153279, Philadelphia

19611

Reading Hosp Clncl Trials Ofc /ID# 153475, West Reading

20010

Medstar Health Research Institute /ID# 153321, Washington D.C.

20011

Emerson Clinical Research Inst /ID# 162755, Washington D.C.

20036

James A. Simon, MD, PC /ID# 153323, Washington D.C.

21208

Baltimore Suburban Health /ID# 168386, Baltimore

22182

Emerson Clinical Research Inst /ID# 153416, Vienna

23225

Clinical Trials Virginia, Inc. /ID# 153419, Richmond

23502

Tidewater Physicians for Women /ID# 153432, Norfolk

27103

Unified Women's Clinical Resea /ID# 153297, Winston-Salem

27262

Pinewest Ob-Gyn, Inc. /ID# 153197, High Point

27408

Unified Women's Clinical Research-Greensboro /ID# 153499, Greensboro

27607

Unified Women's Clinical Resea /ID# 153312, Raleigh

27612

Wake Research Associates, LLC /ID# 153402, Raleigh

27713

Cwrwc /Id# 153313, Durham

28562

Eastern Carolina Women's Centr /ID# 153341, New Bern

29201

Vista Clinical Research /ID# 153399, Columbia

29425

Medical University of South Carolina /ID# 153325, Charleston

30005

Paramount Research Solutions /ID# 153424, Alpharetta

Paramount Research Solutions /ID# 160974, Alpharetta

30328

Mount Vernon Clinical Res, LLC /ID# 153403, Atlanta

30342

Atlanta Women's Research Inst /ID# 153212, Atlanta

30349

Paramount Research Solutions /ID# 153351, College Park

30909

Masters of Clinical Research, Inc. /ID# 153295, Augusta

31406

Fellows Research Alliance, Inc /ID# 153227, Savannah

32045

Unified Womens Clin Research /ID# 153229, Panama City

32256

Solutions Through Adv Rch /ID# 153283, Jacksonville

32806

Clinical Associates of Orlando /ID# 153427, Orlando

33063

South Florida Wellness & Clinic /ID# 153420, Margate

33126

LCC Medical Research Institute /ID# 153296, Miami

33143

Qps-Mra, Llc /Id# 153456, South Miami

33144

Invictus Clinical Research Group,LLC /ID# 153196, Miami

33161

Healthcare Clinical Data, Inc /ID# 153425, Miami

33166

Ocean Blue Med Research Ctr /ID# 153225, Miami

33316

KO Clinical Research, LLC /ID# 153198, Fort Lauderdale

33324

All Wmns HC of West Broward /ID# 153434, Plantation

33409

Comprehensive Clinical Trials /ID# 153350, West Palm Beach

33414

Axcess Medical Research /ID# 153500, Wellington

Virtus Research Consultant,LLC /ID# 153398, Wellington

33461

Altus Research, Inc /ID# 153307, Lake Worth

33612

University of South Florida /ID# 153271, Tampa

33759

Florida Fertility Institute /ID# 153308, Clearwater

33916

Clinical Physiology Assoc. /ID# 153444, Fort Myers

34239

Physician Care Clin. Res., LLC /ID# 153210, Sarasota

34652

Suncoast Clinical Research /ID# 153206, New Port Richey

34653

Advanced Research Institute /ID# 153413, New Port Richey

34769

Oncova Clinical Research, Inc. /ID# 153497, Saint Cloud

36303

Choice Research, LLC /ID# 153492, Dothan

36532

Brown, Pearson, Guepet Gynecology /ID# 153278, Fairhope

36608

Mobile, Ob-Gyn, P.C. /ID# 153442, Mobile

37203

Access Clinical Trials, Inc. /ID# 153441, Nashville

37404

Chattanooga Medical Research /ID# 153405, Chattanooga

38104

Women's Health Trials /ID# 153426, Menphis

40291

Bluegrass Clinical Research /ID# 153280, Louisville

43081

Comprehensive Womens Care /ID# 153396, Westerville

43614

University of Toledo /ID# 153409, Toledo

44106

University Hospitals Cleveland /ID# 153450, Cleveland

45212

CTI Clinical Research Center /ID# 153201, Cincinnati

45432

Clinical Inquest Center Ltd /ID# 153436, Beavercreek

48034

Wayne State University Physician Group - Southfield /ID# 153418, Southfield

48604

Saginaw Valley Med Res Group /ID# 153498, Saginaw

48706

Great Lakes Research Group,Inc /ID# 153302, Bay City

60523

Affinity Clinical Research /ID# 153417, Oak Brook

70115

Ochsner Baptist Medical Center /ID# 153459, New Orleans

70433

Clinical Trials Management, LLC - Covington /ID# 153211, Covington

Clinical Trials Management, LLC - Covington /ID# 153439, Covington

71118

Omni Fertility and Laser Insti /ID# 153228, Shreveport

75035

Willowbend Health and Wellness /ID# 153458, Frisco

75231

Texas Health Presbyterian Hosp /ID# 153339, Dallas

76550

FMC Science /ID# 153289, Lampasas

77030

Advances in Health, Inc. /ID# 153414, Houston

77054

The Woman's Hospital of Texas /ID# 153270, Houston

77479

Houston Ctr for Clin Research /ID# 153221, Sugar Land

77598

Center of Reproductive Medicin /ID# 153320, Webster

78229

Clinical Trials of Texas,Inc. /ID# 153209, San Antonio

78258

Discovery Clinical Trials-San Antonio /ID# 153315, San Antonio

80111

Advanced Women's Health Institution /ID# 153401, Greenwood Village

85209

Mesa Obstetricians and Gynecol /ID# 153269, Mesa

87109

Bosque Women's Care /ID# 153223, Albuquerque

89113

Office of Edmond E. Pack, MD /ID# 153411, Las Vegas

89128

Mabey, Las Vegas, NV /ID# 153314, Las Vegas

90650

Futura Research, Inc. /ID# 153345, Norwalk

90703

Core Healthcare Group /ID# 153282, Cerritos

91340

Farid Yasharpour MD Medical Co /ID# 153482, San Fernando

91942

Grossmont Ctr Clin Research /ID# 153324, La Mesa

92024

Diagnamics Inc. /ID# 153347, Encinitas

97210

Legacy Medical Group-Portland /ID# 168286, Portland

98101

Virginia Mason Medical Center /ID# 153342, Seattle

98105

Seattle Women's Health, Research, Gynecology /ID# 153306, Seattle

35235-3430

Alabama Clinical Therapeutics, LLC /ID# 153217, Birmingham

Alabama Clinical Therapeutics, LLC /ID# 153336, Birmingham

36604-3302

University of South Alabama /ID# 153415, Mobile

33436-6634

Helix Biomedics, LLC /ID# 153440, Boynton Beach

33510-3107

Brandon Premier Health Care, PA /ID# 165791, Brandon

32713-2260

Omega Research Consultants, LLC /ID# 153381, DeBary

33709-3113

Meridien Research /ID# 153310, Kenneth City

33016-1501

Precision Research Org, LLC /ID# 153276, Miami Lakes

30005-4419

Atlanta Medical Research Insti /ID# 153298, Alpharetta

30024-6988

Clinical Research Consultants of Atlanta /ID# 153285, Suwanee

30024-7159

Atlanta Gynecology Research Institute /ID# 200074, Suwanee

83646-1144

Sonora Clinical Research /ID# 153231, Meridian

02720-2972

NECCR Fall River LLC /ID# 153274, Fall River

02720

Genesis Clinical Research /ID# 153379, Fall River

89106-4017

Accent Clinical Trials /ID# 153474, Las Vegas

08648

Lawrence OB/GYN /ID# 153218, Lawrenceville

07753-4859

Jersey Shore University Medical Center /ID# 153495, Neptune City

10016-6023

Manhattan Medical Research /ID# 153386, New York

10032-3725

Weill Cornell Medicine /ID# 153275, New York

19104-5502

University of Pennsylvania /ID# 153203, Philadelphia

19107-4414

Thomas Jefferson University /ID# 153319, Philadelphia

37421-1605

WR-ClinSearch /ID# 153404, Chattanooga

38119-3895

Research Memphis Associates, LLC /ID# 153322, Memphis

78703-1448

Lotus Gynecology /ID# 153476, Austin

75390-7208

UT Southwestern Medical Center /ID# 153400, Dallas

76104-4110

Baylor Scott & White /ID# 153273, Fort Worth

23507-1627

Eastern Virginia Med School /ID# 153380, Norfolk

23235-4722

Clinical Research Partners, LL /ID# 153412, North Chesterfield

23220-4459

Clinical Research Partners, LLC /ID# 153343, Richmond

N8W 5R7

Victory Reproductive Care /ID# 153299, Windsor

00917

Rodriguez-Ginorio, San Juan /ID# 153328, San Juan

00935

School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 153329, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY