SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

802

Participants

Timeline

Start Date

May 22, 2018

Primary Completion Date

December 16, 2021

Study Completion Date

January 31, 2023

Conditions
Endometriosis
Interventions
DRUG

Relugolix

Relugolix 40-mg tablet administered orally once daily

DRUG

Estradiol/norethindrone acetate

Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily

Trial Locations (169)

1034

Kyiv, Kyiv

1050

Remuera, Remuera

1070

Brussels, Brussels

1233

Sofia, Sofia

1336

Sofia, Sofia

1431

Sofia, Sofia

1504

Sofia, Sofia

1724

Roodepoort, Roodepoort

2000

Sydney, Sydney

2232

Kyiv, Kyiv

2522

Wollongong, Wollongong

2700

Blagoevgrad, Blagoevgrad

3000

Leuven, Leuven

3148

Kiev, Kiev

4024

Debrecen, Debrecen

4025

Debrecen, Debrecen

4032

Debrecen, Debrecen

4050

Kyiv, Kyiv

4068

Taringa, Taringa

4112

Kiev, Kiev

4126

Durban, Durban

4400

Nyíregyháza, Nyíregyháza

4442

Palmerston North, Palmerston North

5000

Adelaide, Adelaide

5600

Békéscsaba, Békéscsaba

5700

Gyula, Gyula

5809

Pleven, Pleven

6000

Kecskemét, Kecskemét

6001

Port Elizabeth, Port Elizabeth

6003

Stara Zagora, Stara Zagora

6009

Nedlands, Nedlands

6725

Szeged, Szeged

7100

La Louvière, La Louvière

7405

Cape Town, Cape Town

7624

Pécs, Pécs

8013

Christchurch, Christchurch

9000

Gent, Ghent

9002

Varna, Varna

9042

Monserrato, Monserrato

20036

Washington, Washington D.C.

20475

București, Bucharest

21204

Towson, Towson

23235

Richmond, Richmond

23502

Virginia Beach, Virginia Beach

23507

Norfolk, Norfolk

27100

Pavia, Pavia

27103

Winston Salem, Winston-Salem

27713

Durham, Durham

28041

Madrid, Madrid

28562

New Bern, New Bern

29201

Columbia, Columbia

30093

Norcross, Norcross

30312

Atlanta, Atlanta

30363

Atlanta, Atlanta

30909

Augusta, Augusta

33012

Hialeah, Hialeah

33016

Hialeah, Hialeah

33063

Margate, Margate

33126

Miami, Miami

33155

Miami, Miami

33180

Aventura, Aventura

33606

Tampa, Tampa

33912

Fort Myers, Fort Myers

34239

Sarasota, Sarasota

36420

Andalusia, Andalusia

37404

Chattanooga, Chattanooga

38120

Memphis, Memphis

43235

Columbus, Columbus

44313

Akron, Akron

45322

Englewood, Englewood

46010

Valencia, Valencia

48602

Saginaw, Saginaw

58001

Chernivtsi, Chernivtsi

60068

Park Ridge, Park Ridge

60523

Oakbrook, Oakbrook Terrace

61052

Kharkiv, Kharkiv

63141

St. Louis, St Louis

65109

Jefferson City, Jefferson City

66218

Shawnee, Shawnee Mission

68130

Omaha, Omaha

69063

Zaporizhzhya, Zaporizhzhya

69065

Zaporizhzhya, Zaporizhzhya

69068

Zaporizhzhya, Zaporizhzhya

69071

Zaporizhzhya, Zaporizhzhya

70072

Marrero, Marrero

70100

Kuopio, Kuopio

70433

Los Angeles, Los Angeles

75062

Irving, Irving

75231

Dallas, Dallas

76018

Ivano-Frankivsk, Ivano-Frankivsk

76104

Fort Worth, Fort Worth

77030

Houston, Houston

77054

Houston, Houston

77479

Sugar Land, Sugar Land

77598

Webster, Webster

77702

Beaumont, Beaumont

78258

San Antonio, San Antonio

78412

Corpus Christi, Corpus Christi

80111

Greenwood Village, Greenwood Village

80131

Napoli, Napoli

83404

Idaho Falls, Idaho Falls

84102

Salt Lake City, Salt Lake City

84107

Salt Lake City, Salt Lake City

84124

Salt Lake City, Salt Lake City

85251

Scottsdale, Scottsdale

85704

Tucson, Tucson

85712

Tuscon, Tucson

88100

Catanzaro, Catanzaro

89113

Las Vegas, Las Vegas

90100

Oulu, Oulu

91303

Canoga Park, Canoga Park

92111

San Diego, San Diego

98105

Seattle, Seattle

500091

Brasov, Brasov

7510186

Santiago, Santiago

8320143

Santiago, Santiago

8880465

Santiago, Santiago

17033-0850

Hershey, Hershey

C1128AAF

Ciudad de Buenos Aires, Ciudad de Buenos Aires

B1642CKL

San Isidro, San Isidro

S2000PRB

Rosario, Rosario

X5000JHQ

Cordoba, Córdoba

99010-080

Passo Fundo, Passo Fundo

90430-001

Porto Alegre, Porto Alegre

90510-040

Porto Alegre, Porto Alegre

90610-000

Porto Alegre, Porto Alegre

90035-903

Porto Alegre, Porto Alegre

09715-090

São Bernardo do Campo, São Bernardo do Campo

04023-062

São Paulo, São Paulo

04266-010

Sao Paulo, São Paulo

04708-001

São Paulo, São Paulo

01317-000

Sao Paulo, São Paulo

T4N 6V7

Red Deer, Red Deer

N2J1C4

Waterloo, Waterloo

G6P 6P6

Victoriaville, Victoriaville

390 03

Tábor, Tábor

397 01

Písek, Písek

389 01

Vodňany, Vodňany

547 01

Náchod, Náchod

100 34

Praha 10, Prague

128 08

Praha 2, Prague

370 01

České Budějovice, České Budějovice

772 00

Olomouc, Olomouc

180 81

Praha 8 - Libeň, Praha 8 - Libeň

00260

Helsinki, Helsinki

0159

Tbilisi, Tbilisi

00168

Roma, Roma

60-185

Skórzewo, Skórzewo

20-064

Lublin, Lublin

20-093

Lublin, Lublin

20-632

Lublin, Lublin

20-880

Lublin, Lublin

02-066

Warszawa, Warsaw

02-201

Warszawa, Warsaw

02-929

Warszawa, Warsaw

15-224

Białystok, Bialystok

40-081

Katowice, Katowice

40-301

Katowice, Katowice

71-434

Szczecin, Szczecin

90-602

Łódź, Lodz

2805-267

Almada, Almada

3000-075

Coimbra, Coimbra

6200-251

Covilhã, Covilha

4099-001

Porto, Porto

012071

Bucuresti, Bucharest

022441

Bucuresti, Bucharest

024091

Bucuresti, Bucharest

0157

Centurion, Centurion

04053

Kyiv, Kyiv

Sponsors
All Listed Sponsors
lead

Myovant Sciences GmbH

INDUSTRY

NCT03654274 - SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain | Biotech Hunter | Biotech Hunter