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

PHASE3CompletedINTERVENTIONAL
Enrollment

413

Participants

Timeline

Start Date

December 22, 2015

Primary Completion Date

January 18, 2018

Study Completion Date

December 12, 2018

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 (96)

15206

Clinical Trials Research Svcs /ID# 139707, Pittsburgh

17033

Penn State University and Milton S. Hershey Medical Center /ID# 139733, Hershey

19010

Main Line Fertility Center /ID# 150295, Bryn Mawr

19140

Temple University Hospital /ID# 151429, Philadelphia

20010

Medstar Health Research Institute /ID# 145933, Washington D.C.

20036

James A. Simon, MD, PC /ID# 139675, Washington D.C.

21708

Capital Women's Care /ID# 144109, Frederick

22182

Emerson Clinical Research /ID# 147373, Vienna

23225

Clinical Trials Virginia, Inc. /ID# 139801, Richmond

27103

Unified Women's Clinical Resea /ID# 144721, Winston-Salem

27408

Unified Women's Clinical Research-Greensboro /ID# 139829, Greensboro

27607

Unified Women's Clinical Resea /ID# 139774, Raleigh

27713

Cwrwc /Id# 139664, Durham

28401

PMG Research of Wilmington LLC /ID# 152563, Wilmington

29201

Vista Clinical Research /ID# 139797, Columbia

29425

Medical University of South Carolina /ID# 148754, Charleston

30005

Paramount Research Solutions /ID# 139645, Alpharetta

30328

Agile Clinical Research Trials /ID# 143563, Atlanta

30338

Perimeter Inst Clinical Resear /ID# 148298, Atlanta

30909

Masters of Clinical Research, Inc. /ID# 139658, Augusta

31406

Fellows Research Alliance, Inc /ID# 139655, Savannah

32045

Unified Womens Clin Research /ID# 145169, Panama City

32806

Clinical Associates of Orlando /ID# 148123, Orlando

32810

Omega Research Consultants /ID# 139648, Orlando

33027

Salom Tangir, LLC /ID# 151732, Miramar

33063

South Florida Wellness & Clinic /ID# 143558, Margate

33126

LCC Medical Research Institute /ID# 143551, Miami

33161

Healthcare Clinical Data, Inc /ID# 139650, Miami

33166

Universal Clinical Research A /ID# 139742, Doral

Ocean Blue Med Research Ctr /ID# 139826, Miami

33409

Comprehensive Clinical Trials /ID# 139644, West Palm Beach

33461

Altus Research, Inc /ID# 139662, Lake Worth

33759

Florida Clin Res Group /ID# 139811, Ckearwater

33912

Clinical Physiology Associates /ID# 139736, Fort Myers

34653

Advanced Research Institute /ID# 143554, New Port Richey

35235

Summers, Birmingham, AL /ID# 139684, Birmingham

37203

Access Clinical Trials, Inc. /ID# 139730, Nashville

43231

Complete Healthcare for Women /ID# 139673, Columbus

43614

University of Toledo /ID# 139787, Toledo

44106

Univ Hosp Cleveland /ID# 139741, Cleveland

45409

Miami Valley Hospital /ID# 144430, Dayton

46123

American Health Network of IN /ID# 139822, Avon

48034

Wayne State University Physician Group - Southfield /ID# 139802, Southfield

48706

Great Lakes Research Group,Inc /ID# 139659, Bay City

49503

Grand Rapids Womens Health /ID# 139705, Grand Rapids

60523

Affinity Clinical Research /ID# 150980, Oak Brook

60640

Great Lakes Clinical Trials /ID# 148135, Chicago

61820

Women's Health Practice, LLC /ID# 143569, Champaign

66218

GTC Research /ID# 141854, Kansas City

67226

Cypress Medical Research Ctr /ID# 147116, Wichita

70115

Ochsner Baptist Medical Center /ID# 139740, New Orleans

70433

Clinical Trials Management, LLC - Covington /ID# 139651, Covington

71118

Omni Fertility and Laser Insti /ID# 139836, Shreveport

77030

Advances in Health, Inc. /ID# 139672, Houston

77479

Houston Ctr for Clin Research /ID# 149149, Sugar Land

77598

Center of Reproductive Medicin /ID# 139813, Webster

78230

Victorium Clinical Research /ID# 149630, San Antonio

78258

Discovery Clinical Trials-San Antonio /ID# 139776, San Antonio

80111

Advanced Women's Health Institution /ID# 144108, Greenwood Village

80923

Bluebird Clinical Trials, LLC /ID# 144843, Colorado Springs

83709

Boise Family Medical Center /ID# 139844, Boise

87109

Bosque Women's Care /ID# 145934, Albuquerque

89113

Office of Edmond E. Pack, MD /ID# 139792, Las Vegas

89128

Mabey, Las Vegas, NV /ID# 148138, Las Vegas

90057

National Research Institute /ID# 151629, Los Angeles

90095

University of California, Los Angeles /ID# 144107, Los Angeles

90716

American Clinical Trials /ID# 147374, Hawaiian Gardens

90806

Long Beach Clinical Trial Serv /ID# 152424, Long Beach

91942

Grossmont Ctr Clin Research /ID# 144011, La Mesa

92626

WCCT Global, LLC /ID# 145666, Costa Mesa

97210

Legacy Medical Group-Portland /ID# 148807, Portland

98105

Seattle Women's Health, Research, Gynecology /ID# 139768, Seattle

99202

Premier Clinical Research /ID# 148145, Spokane

36604-3302

University of South Alabama /ID# 148763, Mobile

92663-3657

Beach OBGYN Medical Group /ID# 151414, Newport Beach

92683-4567

Advanced RX Clinical Research /ID# 149168, Westminster

33436-6634

Helix Biomedics, LLC /ID# 147114, Boynton Beach

33510-3107

Brandon Premier Health Care, PA /ID# 153130, Brandon

33709-3113

Meridien Research /ID# 139663, Kenneth City

30005-4419

Atlanta Medical Research Insti /ID# 147117, Alpharetta

42303-1089

Research Integrity, LLC /ID# 139727, Owensboro

02723

Genesis Clinical Research - Fall River /ID# 148449, Fall River

08648

Lawrence OB/GYN /ID# 143567, Lawrenceville

10016-6023

Manhattan Medical Research /ID# 144471, New York

45267-0585

University of Cincinnati /ID# 139820, Cincinnati

19107-4414

Thomas Jefferson University /ID# 139812, Philadelphia

37421-1605

WR-ClinSearch /ID# 143538, Chattanooga

38119-3895

Research Memphis Associates, LLC /ID# 139674, Memphis

75390-7208

UT Southwestern Medical Center /ID# 143537, Dallas

23507-1627

Eastern Virginia Med School /ID# 139647, Norfolk

23235-4722

Clinical Research Partners, LL /ID# 143999, North Chesterfield

53226-3522

Froedtert and Medical College /ID# 143566, Milwaukee

B3K 6R8

IWK Health Center /ID# 149066, Halifax

K1H 8L6

The Ottawa Hospital /ID# 148695, Ottawa

00917

Rodriguez-Ginorio, San Juan /ID# 139847, San Juan

00935

School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139848, San Juan

Sponsors

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All Listed Sponsors
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INDUSTRY