Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

PHASE3CompletedINTERVENTIONAL
Enrollment

478

Participants

Timeline

Start Date

September 13, 2017

Primary Completion Date

June 28, 2024

Study Completion Date

June 28, 2024

Conditions
Heavy Menstrual BleedingUterine Fibroids
Interventions
DRUG

Elagolix

Film-coated 300 mg tablets

DRUG

Estradiol /norethindrone acetate (E2/NETA)

Estradiol 1 mg/norethindrone acetate 0.5 mg capsules

OTHER

E2/NETA Placebo

Placebo capsules

OTHER

Elagolix Placebo

Film-coated placebo tablets

Trial Locations (157)

11203

SUNY Downstate Medical Center /ID# 160922, Brooklyn

14127

Hamburg Regional Gynecology Gr /ID# 161427, Orchard Park

17033

Penn State University and Milton S. Hershey Medical Center /ID# 160896, Hershey

19107

DUP_Thomas Jefferson University /ID# 200304, Philadelphia

20011

Emerson Clinical Research Inst /ID# 162181, Washington D.C.

20036

James A. Simon, MD, PC /ID# 160931, Washington D.C.

23225

Clinical Trials Virginia, Inc. /ID# 160943, Richmond

23235

Clinical Research Partners /ID# 160929, North Chesterfield

Clinical Research Partners /ID# 160948, North Chesterfield

23456

Tidewater Clinical Research /ID# 160949, Virginia Beach

27103

Unified Women's Clinical Resea /ID# 160957, Winston-Salem

27607

Unified Women's Clinical Resea /ID# 163014, Raleigh

27612

Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490, Raleigh

28211

DJL Clinical Research, PLLC /ID# 161548, Charlotte

29201

Vista Clinical Research /ID# 160946, Columbia

29303

VitaLink Research-Spartanburg /ID# 164592, Spartanburg

30005

Journey Medical Research Insti /ID# 160958, Alpharetta

Paramount Research Solutions /ID# 161557, Alpharetta

30328

Mount Vernon Clinical Res, LLC /ID# 161491, Atlanta

30342

Atlanta Women's Research Institute /ID# 160844, Atlanta

30363

Medisense Inc /ID# 161494, Atlanta

32256

Solutions Through Adv Rch /ID# 160935, Jacksonville

33027

Salom Tangir, LLC /ID# 162542, Miramar

33063

South Florida Wellness & Clinic /ID# 161535, Margate

33144

Invictus Clinical Research Group,LLC /ID# 160925, Miami

33161

Healthcare Clinical Data, Inc /ID# 160888, Miami

33166

Ocean Blue Medical Research Center, Inc /ID# 161549, Miami Springs

33172

Palmetto Professional Research /ID# 161442, Miami

33316

KO Clinical Research, LLC /ID# 160928, Fort Lauderdale

33324

Discovery Clinical Research /ID# 160891, Sunrise

33409

Comprehensive Clinical Trials LLC /ID# 161479, West Palm Beach

33414

Virtus Research Consultants, LLC /ID# 160855, Wellington

33461

Altus Research, Inc /ID# 160912, Lake Worth

33613

University of South Florida- Neuroscience Institute /ID# 160960, Tampa

33617

Jedidiah Clinical Research /ID# 167114, Tampa

34239

Physician Care Clin. Res., LLC /ID# 161547, Sarasota

34653

Advanced Research Institute, Inc /ID# 163748, New Port Richey

34769

Oncova Clinical Research, Inc. /ID# 160937, Saint Cloud

34996

Treasure Coast Research /ID# 161824, Stuart

35801

E Squared Research /ID# 163645, Huntsville

36303

Choice Research, LLC /ID# 161498, Dothan

36608

Mobile, OBGYN P.C. /ID# 161530, Mobile

37404

Duplicate_Chattanooga Medical Research /ID# 160885, Chattanooga

38305

The Jackson Clinic, PA /ID# 162496, Jackson

43235

Duplicate_Optimed Research /ID# 165600, Columbus

43614

University of Toledo /ID# 160923, Toledo

44106

Univ Hosp Cleveland /ID# 160953, Cleveland

45212

Duplicate_CTI Clinical Research Center /ID# 160942, Cincinnati

46825

Women's Health Advantage /ID# 161537, Fort Wayne

48602

Duplicate_Great Lakes Research Group, Inc. /ID# 161511, Bay City

48604

Saginaw Valley Med Res Group /ID# 160840, Saginaw

60523

Alliance for Multispecialty Research, LLC /ID# 160932, Oak Brook

60637

Duplicate_University of Chicago /ID# 162667, Chicago

61820

Women's Health Practice, LLC /ID# 161553, Champaign

63109

Quad Clinical Research, LLC /ID# 200943, St Louis

66218

Womens & Family Care, LLC dba /ID# 160890, Shawnee Mission

70072

Praetorian Pharmaceutical Research /ID# 161532, Marrero

70115

Ochsner Baptist Medical Centre /ID# 161507, New Orleans

70433

Clinical Trials Management, LLC - Covington /ID# 160838, Covington

Clinical Trials Management, LLC - Covington /ID# 160893, Covington

71118

Willis-Knighton Pediatric GI S /ID# 161534, Shreveport

75035

Willowbend Health and Wellness - Frisco /ID# 160954, Frisco

75708

The Univ Texas HSC at Tyler /ID# 161533, Tyler

76550

FMC Science /ID# 160886, Lampasas

77030

The Ob/Gyn Center /ID# 165928, Houston

77036

Precision Research Institute, LLC /ID# 161554, Houston

77054

The Woman's Hospital of Texas /ID# 160959, Houston

77058

Centex Studies, Inc. - Houston /ID# 160917, Houston

77074

UAG Innovation Women Research, /ID# 167415, Houston

77080

America's Adv. Wellness Center /ID# 167548, Houston

77479

Houston Ctr for Clin Research /ID# 160837, Sugar Land

77598

Center of Reproductive Medicine /ID# 162498, Webster

77854

Advances in Health, Inc. /ID# 160930, Pearland

78229

Clinical Trials of Texas, Inc /ID# 161510, San Antonio

78230

VIP Trials /ID# 161546, San Antonio

83221

Bingham Memorial Hospital /ID# 201130, Blackfoot

83404

Leavitt Womens Healthcare /ID# 163419, Idaho Falls

Womens Healthcare Assoc, DBA /ID# 160933, Idaho Falls

83687

Asr, Llc /Id# 162179, Nampa

85209

Mesa Obstetricians and Gynecologists /ID# 160955, Mesa

85704

Noble Clinical Research /ID# 166949, Tucson

85712

Vision's Clinical Research-Tucson /ID# 161508, Tucson

85745

Eclipse Clinical Research /ID# 161516, Tucson

87108

Lovelace Scientific Resources /ID# 163644, Albuquerque

87109

Bosque Women's Care /ID# 162606, Albuquerque

89109

Excel Clinical Research /ID# 165588, Las Vegas

89113

Office of Edmond E. Pack, MD /ID# 162604, Las Vegas

89128

Private practice: Dr. Rex G. Mabey JR /ID# 160915, Las Vegas

90057

National Research Institute /ID# 160952, Los Angeles

90640

Futura Research, Org /ID# 160924, Montebello

90703

Duplicate_Core Healthcare Group /ID# 160858, Cerritos

91324

California Medical Research Associates /ID# 161481, Northridge

91436

HRC Fertility /ID# 161493, Encino

91607

Bayview Research Group LLC /ID# 161484, Valley Village

91942

Grossmont Ctr Clin Research /ID# 165120, La Mesa

92024

Diagnamics Inc. /ID# 160950, Encinitas

92119

MD Strategies Research Centers /ID# 161544, San Diego

92647

Duplicate_Duplicate_Marvel Clinical Research /ID# 167297, Huntington Beach

92704

Health care Affiliates Medical Group /ID# 163324, Santa Ana

92844

SC Clinical Research /ID# 164395, Garden Grove

93065

Alta California Medical Group /ID# 163564, Simi Valley

97239

Oregon Medical Research Center /ID# 161514, Portland

35235-3430

Alabama Clinical Therapeutics /ID# 160835, Birmingham

Alabama Clinical Therapeutics /ID# 160927, Birmingham

36532-3029

Southern Women's Specialists PC /ID# 161531, Fairhope

36604-1410

Women's Health Alliance of Mobile /ID# 161443, Mobile

90036-4667

Olympia Clinical Trials /ID# 201562, Los Angeles

95821-2640

Northern California Research /ID# 161561, Sacramento

92114-3643

Precision Research Institute - San Diego /ID# 163069, San Diego

91786-4027

Upland Clinical Research /ID# 164528, Upland

92683-4567

Advanced RX Clinical Research /ID# 161599, Westminster

33433-7041

Women's Health Partners /ID# 203577, Boca Raton

33486-2269

David Lubetkin MD LLC /ID# 203578, Boca Raton

33510-3107

Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910, Brandon

32713-2260

Omega Research Maitland, LLC /ID# 160857, DeBary

32720-0920

Midland Florida Clinical Research Center /ID# 161487, DeLand

33016-1897

Sweet Hope Research Specialty Inc /ID# 163522, Hialeah

33470-4937

Wellington Anti-Aging Centre /ID# 203540, Loxahatchee Groves

33176-1032

Vista Health Research, LLC /ID# 163044, Miami

33016-1501

Duplicate_Precision Research Organization /ID# 161522, Miami Lakes

32763-2833

A Premier Medical Research of FL /ID# 201882, Orange City

32819-8900

Clinical Associates of Orlando /ID# 160889, Orlando

33709-3113

Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913, St. Petersburg

33351-7311

Precision Clinical Research /ID# 165377, Sunrise

33609-4044

GCP Clinical Research, LLC /ID# 164593, Tampa

30328-5532

AGILE Clinical Research Trials /ID# 160941, Atlanta

30024-7159

Duplicate_Atlanta Gynecology Research Institute /ID# 160851, Suwanee

83646-1144

Sonora Clinical Research /ID# 167610, Meridian

60605-2168

Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118, Chicago

40291-1988

Bluegrass Clinical Research /ID# 163485, Louisville

70125-1923

Women Under Study, LLC /ID# 163990, New Orleans

02723

Exordia Medical Research, Inc /ID# 160853, Fall River

48201-2013

Wayne State University /ID# 160944, Detroit

48602-4323

Valley OB-Gyn Clinic - Saginaw /ID# 203579, Saginaw

07753-4859

Jersey Shore University Medical Center /ID# 160916, Neptune City

11030-3816

Duplicate_Northwell Health System - Manhasset /ID# 201058, Manhasset

10032-3725

Columbia Univ Medical Center /ID# 161519, New York

27713-7512

Carolina Women's Research and Wellness Center /ID# 160914, Durham

45431-2573

Clinical Inquest Center Ltd /ID# 160892, Beavercreek

43213-3399

Central Ohio Clinical Research /ID# 201162, Columbus

45005-5200

Hilltop Obstetrics & Gynecology /ID# 203576, Middletown

16507-1423

OB/GYN Associates of Erie /ID# 161541, Erie

19104-5502

University of Pennsylvania /ID# 160936, Philadelphia

37421-1605

WR-ClinSearch /ID# 160887, Chattanooga

38119-3895

Research Memphis Associates, LLC /ID# 160939, Memphis

78758-5444

OBGYN North /ID# 203580, Austin

78758-5653

Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542, Austin

75230-2571

Discovery Clinical Trials -HCWC /ID# 161543, Dallas

75390-8575

Duplicate_The University of Texas Southwestern Medical Center /ID# 161496, Dallas

76104-4110

Baylor Scott & White /ID# 161515, Fort Worth

77058-2705

Centex Studies, Inc /ID# 163858, Houston

75024-5280

ClinRx Research, LLC /ID# 201170, Plano

22908-0816

Univ of Virgnia Medical center /ID# 166283, Charlottesville

23507-1627

Eastern Virginia Med School /ID# 160856, Norfolk

23434-8151

Specialists for Women /ID# 201129, Suffolk

00917-5022

Henry A. Rodriguez Ginorio, MD /ID# 160861, San Juan

00935

School of Medicine University of Puerto Rico-Medical Science Campus /ID# 160862, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
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AbbVie

INDUSTRY