Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

PHASE3CompletedINTERVENTIONAL
Enrollment

526

Participants

Timeline

Start Date

April 20, 2017

Primary Completion Date

April 14, 2020

Study Completion Date

April 12, 2021

Conditions
Uterine FibroidsHeavy Menstrual Bleeding
Interventions
DRUG

OBE2109

OBE2109 100mg tablets for oral administration once daily

DRUG

Placebo to match OBE2109

Placebo to match OBE2109 100mg tablets for oral administration once daily

DRUG

Placebo to match Add-back

Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily

DRUG

Add-back

Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily

Trial Locations (116)

10016

Site reference ID 188, New York

10306

Site reference ID 133, Staten Island

11203

Site reference ID 175, Brooklyn

11764

Site reference ID 208, Port Jefferson

15243

Site reference ID 210, Pittsburgh

15478

Site reference ID 148, Smithfield

15701

Site reference ID 222, Indiana

17033

Site reference ID 195, Hershey

19010

Site reference ID 116, Bryn Mawr

19046

Site reference ID 165, Jenkintown

20036

Site reference ID 105, Washington D.C.

20910

Site reference ID 226, Silver Spring

21204

Site reference ID 228, Towson

21702

Site reference ID 248, Frederick

23233

Site reference ID 123, Richmond

23507

Site reference ID 103, Norfolk

Site reference ID 171, Norfolk

27103

Site reference ID 119, Winston-Salem

27408

Site reference ID 104, Greensboro

27607

Site reference ID 102, Raleigh

28374

Site reference ID 187, Southern Pines

28557

Site reference ID 131, Morehead City

29301

Site reference ID 358, Spartanburg

29406

Site reference ID 351, North Charleston

30092

Site reference ID 158, Norcross

30093

Site reference ID 151, Norcross

30328

Site reference ID 150, Sandy Springs

31904

Site reference ID 163, Columbus

32256

Site reference ID 191, Jacksonville

32720

Site reference ID 233, DeLand

32801

Site reference ID 141, Orlando

32806

Site reference ID 140, Orlando

33012

Site reference ID 135, Hialeah

Site reference ID 146, Hialeah

33016

Site reference ID 169, Dothan

Site reference ID 117, Miami Lakes

Site reference ID 134, Miami Lakes

33027

Site reference ID 107, Miramar

33130

Site reference ID 137, Miami

33144

Site reference ID 142, Miami

33165

Site reference ID 110, Miami

33166

Site reference ID 129, Miami Springs

33176

Site reference ID 106, Miami

Site reference ID 127, Miami

33316

Site reference ID 197, Fort Lauderdale

33433

Site reference ID 231, Boca Raton

33470

Site reference ID 204, Loxahatchee Groves

33486

Site reference ID 190, Boca Raton

33613

Site reference ID 113, Tampa

33709

Site reference ID 207, St. Petersburg

33759

Site reference ID 168, Clearwater

34653

Site reference ID 124, New Port Richey

35205

Site reference ID 192, Birmingham

35216

Site reference ID 232, Vestavia Hills

36608

Site reference ID 353, Mobile

37404

Site reference ID 159, Chattanooga

37920

Site reference ID 235, Knoxville

38119

Site reference ID 205, Memphis

38120

Site reference ID 180, Memphis

44122

Site reference ID 164, Cleveland

45005

Site reference ID 213, Franklin

45014

Site reference ID 230, Fairfield

45212

Site reference ID 186, Cincinnati

48034

Site reference ID 145, Detroit

48602

Site reference ID 214, Saginaw

48604

Site reference ID 170, Saginaw

48706

Site reference ID 100, Bay City

59808

Site reference ID 138, Missoula

60523

Site reference ID 182, Oak Brook

61820

Site reference ID 174, Champaign

66218

Site reference ID 178, Shawnee Mission

67207

Site reference ID 354, Wichita

70072

Site reference ID 109, Marrero

70601

Site reference ID 176, Lake Charles

75035

Site reference ID 115, Frisco

75231

Site reference ID 183, Dallas

Site reference ID 216, Dallas

75234

Site reference ID 200, Dallas

76104

Site reference ID 250, Fort Worth

76132

Site reference ID 244, Fort Worth

77030

Site reference ID 157, Houston

77054

Site reference ID 120, Houston

77071

Site reference ID 219, Houston

77074

Site reference ID 217, Houston

77505

Site reference ID 218, Pasadena

77598

Site reference ID 128, Webster

77702

Site reference ID 201, Beaumont

78258

Site reference ID 172, San Antonio

78412

Site reference ID 247, Corpus Christi

78726

Site reference ID 238, Austin

78758

Site reference ID 155, Austin

80112

Site reference ID 246, Englewood

80229

Site reference ID 234, Thornton

80246

Site reference ID 144, Denver

83404

Site reference ID 359, Idaho Falls

83642

Site reference ID 352, Meridian

84088

Site reference ID 125, West Jordan

85015

Site reference ID 242, Phoenix

85712

Site reference ID 355, Tucson

89109

Site reference ID 236, Las Vegas

90255

Site reference ID 154, Huntington Park

Site reference ID 185, Los Angeles

90703

Site reference ID 184, Cerritos

91007

Site reference ID 211, Arcadia

91324

Site reference ID 199, Northridge

91402

Site reference ID 111, Panorama City

91786

Site reference ID 239, Upland

92108

Site reference ID 101, San Diego

92683

Site reference ID 112, Westminster

92866

Site reference ID 147, Escondido

95821

Site reference ID 166, Sacramento

98007

Site reference ID 237, Bellevue

06519

Site reference ID 189, New Haven

02720

Site reference ID 149, Fall River

02721

Site reference ID 126, Fall River

08648

Site reference ID 245, Lawrenceville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ObsEva SA

INDUSTRY