SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

623

Participants

Timeline

Start Date

November 1, 2017

Primary Completion Date

April 1, 2020

Study Completion Date

May 31, 2021

Conditions
Endometriosis Related Pain
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)/NETA (0.5 mg) 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 E2/NETA capsule 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 (91)

1050

Remuera, Remuera

2000

Sydney, Sydney

2522

Wollongong, Wollongong

3112

Tauranga, Tauranga

4075

Sherwood, Sherwood

4442

Palmerston North, Palmerston North

5000

Adelaide, Adelaide

6009

Nedlands, Nedlands

8013

Christchurch, Christchurch

10038

New York, New York

20036

Washington DC, Washington D.C.

20475

București, Bucharest

20502

Malmö, Malmo

21204

Towson, Towson

23502

Virginia Beach, Virginia Beach

27100

Pavia, Pavia

28562

New Bern, New Bern

29201

Columbia, Columbia

29301

Spartanburg, Spartanburg

30312

Atlanta, Atlanta

32720

Deland, DeLand

33012

Hialeah, Hialeah

33016

Hialeah, Hialeah

33063

Margate, Margate

33176

Miami, Miami

33180

Aventura, Aventura

33606

Tampa, Tampa

34952

Port St. Lucie, Port Saint Lucie

36420

Andalusia, Andalusia

37404

Chattanooga, Chattanooga

39701

Písek, Písek

43231

Columbus, Columbus

43235

Columbus, Columbus

44313

Akron, Akron

45005

Franklin, Franklin

47905

Lafayette, Lafayette

48602

Saginaw, Saginaw

60068

Park Ridge, Park Ridge

63141

St. Louis, St Louis

68124

Omaha, Omaha

70072

Marrero, Marrero

70433

Covington, Covington

75062

Irving, Irving

75231

Dallas, Dallas

76104

Fort Worth, Fort Worth

77054

Houston, Houston

77479

Sugar Land, Sugar Land

77702

Beaumont, Beaumont

78258

San Antonio, San Antonio

78412

Corpus Christi, Corpus Christi

80131

Napoli, Napoli

83404

Idaho Falls, Idaho Falls

84062

Pleasant Grove, Pleasant Grove

84102

Salt Lake City, Salt Lake City

87102

Albuquerque, Albuquerque

88100

Catanzaro, Catanzaro

500091

Brasov, Brasov

7510186

Santiago, Santiago

8320165

Santiago, Santiago

8360160

Santiago, Santiago

8880465

Santiago, Santiago

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

01317-000

São Paulo, São Paulo

01323-900

São Paulo, São Paulo

04023-062

São Paulo, São Paulo

04266-010

São Paulo, São Paulo

04708-001

São Paulo, São Paulo

390 03

Tábor, Tábor

128 08

Praha 2, Prague

370 01

Ceské Budejovice, České Budějovice

0159

Tbilisi, Tbilisi

09042

Monserrato, Monserrato

00168

Roma, Roma

0626

Birkenhead, Birkenhead

60-185

Poznan, Poznan

20-064

Lublin, Lublin

20-093

Lublin, Lublin

02-066

Warszawa, Warsaw

02-201

Warszawa, Warsaw

02-929

Warszawa, Warsaw

15-224

Bialystok, Bialystok

15-464

Białystok, Bialystok

40-301

Katowice, Katowice

90-602

Lodz, Lodz

012071

Bucuresti, Bucharest

022441

Bucuresti, Bucharest

Sponsors
All Listed Sponsors
lead

Myovant Sciences GmbH

INDUSTRY