LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

PHASE3CompletedINTERVENTIONAL
Enrollment

388

Participants

Timeline

Start Date

April 26, 2017

Primary Completion Date

April 29, 2019

Study Completion Date

August 24, 2020

Conditions
Heavy Menstrual BleedingUterine Fibroid
Interventions
DRUG

Relugolix

Relugolix (40 mg) tablet administered orally once daily.

DRUG

Estradiol/norethindrone acetate

E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.

DRUG

Estradiol/norethindrone acetate placebo

E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the capsule containing E2/NETA in size, shape, color, and odor.

DRUG

Relugolix placebo

Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.

Trial Locations (110)

1724

Roodepoort, Roodepoort

4052

Durban, Durban

4126

Durban, Durban

6001

Port Elizabeth, Port Elizabeth

10126

Torino, Torino

14221

Williamsville, Williamsville

16132

Genova, Genova

19104

Philadelphia, Philadelphia

20132

Milano, Milan

23507

Norfolk, Norfolk

27612

Raleigh, Raleigh

27713

Durham, Durham

28557

Morehead City, Morehead City

29201

Columbia, Columbia

29406

Charleston, Charleston

29605

Greenville, Greenville

29910

Bluffton, Bluffton

30342

Atlanta, Atlanta

30349

College Park, College Park

30912

Augusta, Augusta

32207

Jacksonville, Jacksonville

32806

Orlando, Orlando

32808

Orlando, Orlando

33012

Hialeah, Hialeah

33016

Hialeah, Hialeah

33063

Margate, Margate

33143

South Miami, South Miami

33155

Miami, Miami

33165

Miami, Miami

33176

Miami, Miami

33180

Aventura, Aventura

33319

Lauderdale Lakes, Lauderdale Lakes

33327

Weston, Weston

33409

West Palm Beach, West Palm Beach

33510

Brandon, Brandon

33613

Tampa, Tampa

33759

Clearwater, Clearwater

33912

Fort Myers, Fort Myers

34684

Palm Harbor, Palm Harbor

34711

Clermont, Clermont

36420

Andalusia, Andalusia

36608

Mobile, Mobile

37404

Chattanooga, Chattanooga

38119

Memphis, Memphis

38120

Memphis, Memphis

40138

Bologna, Bologna

41124

Modena, Modena

45219

Cincinnati, Cincinnati

45267

Cincinnati, Cincinnati

45322

Englewood, Englewood

45409

Dayton, Dayton

47905

Lafayette, Lafayette

49074

Atlanta, Atlanta

50134

Fiernze, Florence

53100

Siena, Siena

58103

Fargo, Fargo

58501

Bismarck, Bismarck

58701

Minot, Minot

60523

Oakbrook, Oakbrook Terrace

63141

St. Louis, St Louis

68124

Omaha, Omaha

68510

Lincoln, Lincoln

70433

Covington, Covington

71118

Shreveport, Shreveport

72205

Little Rock, Little Rock

75062

Irving, Irving

76104

Fort Worth, Fort Worth

77054

Houston, Houston

77074

Houston, Houston

77479

Sugar Land, Sugar Land

77598

Webster, Webster

78229

San Antonio, San Antonio

80131

Napoli, Napoli

80209

Denver, Denver

84107

Salt Lake City, Salt Lake City

84124

Salt Lake City, Salt Lake City

87109

Albuquerque, Albuquerque

88100

Catanzaro, Catanzaro

89106

Las Vegas, Las Vegas

89128

Las Vegas, Las Vegas

90650

Norwalk, Norwalk

90717

Lomita, Lomita

91942

La Mesa, La Mesa

92056

Oceanside, Oceanside

92108

San Diego, San Diego

92111

San Diego, San Diego

98105

Seattle, Seattle

99352

Richland, Richland

08648

Lawrenceville, Lawrenceville

80430-160

Curitiba, Curitiba

90510-040

Porto Alegre, Porto Alegre

14049-900

Ribeirao Preto, Ribeirão Preto

09190-510

Santo Andre, Santo André

01317-000

Sao Paulo, São Paulo

09042

Monserrato, Monserrato

00161

Roma, Roma

00168

Roma, Roma

40-123

Katowice, Katowice

90-602

Lodz, Lodz

91-308

Lodz, Lodz

20-093

Lublin, Lublin

20-632

Lublin, Lublin

60-535

Poznan, Poznan

71-270

Szczecin, Szczecin

02-201

Warszawa, Warsaw

02-507

Warszawa, Warsaw

B15 2TG

Birmingham, Birmingham

TW7 6AF

Isleworth, Isleworth

SE5 9NY

London, London

NG7 2FT

Nottingham, Nottingham

Sponsors
All Listed Sponsors
lead

Myovant Sciences GmbH

INDUSTRY