LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

PHASE3CompletedINTERVENTIONAL
Enrollment

382

Participants

Timeline

Start Date

June 14, 2017

Primary Completion Date

July 10, 2019

Study Completion Date

September 16, 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

Relugolix placebo

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

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.

Trial Locations (127)

1070

Brussels, Brussels

1090

Jette, Jette

1106

Budapest, Budapest

1200

Brussels, Brussels

4025

Debrecen, Debrecen

4032

Debrecen, Debrecen

4400

Nyíregyháza, Nyíregyháza

5700

Gyula, Gyula

6000

Kecskemét, Kecskemét

6600

Szentes, Szentes

7100

La Louvière, La Louvière

7405

Cape Town, Cape Town

7500

Parow, Parow

7624

Pecs, Pécs

9000

Ghent, Ghent

9301

Bloemfontein, Bloemfontein

10022

New York, New York

10038

New York, New York

11201

Brooklyn, Brooklyn

14642

Rochester, Rochester

15224

Białystok, Bialystok

15464

Bialystok, Bialystok

19611

West Reading, West Reading

20036

Washington, Washington D.C.

21204

Towson, Towson

21208

Baltimore, Baltimore

23225

Richmond, Richmond

23502

Virginia Beach, Norfolk

27103

Winston Salem, Winston-Salem

27607

Raleigh, Raleigh

27713

Durham, Durham

29406

Charleston, Charleston

30034

Decatur, Decatur

30093

Norcross, Norcross

30097

Duluth, Duluth

30114

Krakow, Krakow

30312

Atlanta, Atlanta

30328

Sandy Springs, Sandy Springs

31406

Savannah, Savannah

32055

Lake City, Lake City

32720

DeLand, DeLand

32765

Oviedo, Oviedo

33126

Miami, Miami

33155

Miami, Miami

33161

North Miami, North Miami

33166

Miami Springs, Miami Springs

33180

Aventura, Aventura

33316

Ft. Lauderdale, Fort Lauderdale

33324

Plantation, Plantation

33409

West Palm Beach, West Palm Beach

33414

Wellington, Wellington

33458

Jupiter, Jupiter

33470

Loxahachee, Loxahatchee Groves

33606

Tampa, Tampa

34239

Sarasota, Sarasota

34652

New Port Richey, New Port Richey

34769

Saint Cloud, Saint Cloud

34952

Port St. Lucie, Port Saint Lucie

34996

Stuart, Stuart

35205

Birmingham, Birmingham

35302

Rzeszów, Rzeszów

39701

Pisek, Písek

40724

Katowice, Katowice

43231

Columbus, Columbus

45212

Cincinnati, Cincinnati

46123

Avon, Avon

48187

Canton, Canton

48201

Detroit, Detroit

48604

Saginaw, Saginaw

48706

Bay City, Bay City

54701

Nachod, Náchod

60523

Oakbrook, Oak Brook

60540

Naperville, Naperville

60611

Chicago, Chicago

61820

Champaign, Champaign

66128

Shawnee, Shawnee Mission

68701

Norfolk, Norfolk

70006

Metairie, Metairie

70072

Marrero, Marrero

70115

New Orleans, New Orleans

75035

Frisco, Frisco

75231

Dallas, Dallas

75234

Dallas, Dallas

75605

Longview, Longview

76104

Fort Worth, Fort Worth

77030

Houston, Houston

77054

Houston, Houston

77702

Beaumont, Beaumont

78258

San Antonio, San Antonio

80209

Denver, Denver

80228

Lakewood, Lakewood

80850

Gdańsk, Gdansk

83404

Idaho Falls, Idaho Falls

83686

Nampa, Nampa

85209

Mesa, Mesa

85704

Tucson, Tucson

85712

Tuscon, Tucson

87102

Albuquerque, Albuquerque

89106

Las Vegas, Las Vegas

89109

Las Vegas, Las Vegas

89113

Las Vegas, Las Vegas

90036

Los Angeles, Los Angeles

90057

Los Angeles, Los Angeles

90806

Long Beach, Long Beach

91303

Canoga Park, Canoga Park

91402

Panorama, Panorama City

91786

Upland, Upland

92114

San Diego, San Diego

92647

Huntington Beach, Huntington Beach

98042

Covington, Covington

98372

Puyallup, Puyallup

99207

Spokane, Spokane

7510186

Santiago, Santiago

8320165

Santiago, Santiago

8360160

Santiago, Santiago

8880465

San Ramon, San Ramón

08901

New Brunswick, New Brunswick

18618-686

Botucatu, Botucatu

90035-903

Porto Alegre, Porto Alegre

90510-040

Porto Alegre, Porto Alegre

04266-010

São Paulo, São Paulo

370 01

Ceské Budejovice, České Budějovice

586 33

Jihlava, Jihlava

772 00

Olomouc, Olomouc

708 52

Ostrava, Ostrava

60-192

Poznan, Poznan

00157

Centurion, Centurion

Sponsors
All Listed Sponsors
lead

Myovant Sciences GmbH

INDUSTRY

NCT03103087 - LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids | Biotech Hunter | Biotech Hunter