SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

638

Participants

Timeline

Start Date

December 7, 2017

Primary Completion Date

June 9, 2020

Study Completion Date

April 8, 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 (123)

1027

Budapest, Budapest

1062

Budapest, Budapest

1070

Brussels, Brussels

1135

Budapest, Budapest

1233

Sofia, Sofia

1336

Sofia, Sofia

1431

Sofia, Sofia

1504

Sofia, Sofia

1606

Sofia, Sofia

1724

Roodepoort, Roodepoort

2700

Blagoevgrad, Blagoevgrad

3000

Leuven, Leuven

4001

Durban, Durban

4024

Debrecen, Debrecen

4025

Debrecen, Debrecen

4032

Debrecen, Debrecen

4400

Nyíregyháza, Nyíregyháza

5600

Békéscsaba, Békéscsaba

5700

Gyula, Gyula

5809

Pleven, Pleven

6000

Kecskemét, Kecskemét

6001

Port Elizabeth, Port Elizabeth

6003

Stara Zagora, Stara Zagora

6725

Szeged, Szeged

7100

La Louvière, La Louvière

7405

Cape Town, Cape Town

7624

Pécs, Pécs

9000

Gent, Ghent

9005

Varna, Varna

11777

Port Jefferson, Port Jefferson

17033

Hershey, Hershey

19104

Philadelphia, Philadelphia

21101

Vinnytsya, Vinnytsia

23235

Richmond, Richmond

23507

Norfolk, Norfolk

27103

Winston Salem, Winston-Salem

27612

Raleigh, Raleigh

27713

Durham, Durham

28041

Madrid, Madrid

30093

Norcross, Norcross

30363

Atlanta, Atlanta

30909

Augusta, Augusta

32765

Oviedo, Oviedo

32808

Orlando, Orlando

33126

Miami, Miami

33155

Miami, Miami

33324

Plantation, Plantation

33470

Loxahatchee, Loxahatchee Groves

33912

Fort Myers, Fort Myers

34239

Sarasota, Sarasota

36303

Dothan, Dothan

37130

Murfreesboro, Murfreesboro

38120

Memphis, Memphis

45322

Englewood, Englewood

46010

Valencia, Valencia

54701

Nachod, Náchod

58001

Chernivtsi, Chernivtsi

60523

Oakbrook, Oak Brook

61052

Kharkiv, Kharkiv

65109

Jefferson City, Jefferson City

66218

Shawnee, Shawnee Mission

69065

Zaporizhzhya, Zaporizhzhya

69068

Zaporizhzhya, Zaporizhzhya

69071

Zaporizhzhya, Zaporizhzhya

69663

Zaporizhzhya, Zaporizhzhya

70115

New Orleans, New Orleans

76018

Ivano-Frankivsk, Ivano-Frankivsk

77030

Houston, Houston

77598

Webster, Webster

78705

Austin, Austin

80111

Greenwood Village, Greenwood Village

83404

Idaho Falls, Idaho Falls

84107

Salt Lake City, Salt Lake City

84124

Salt Lake City, Salt Lake City

85209

Mesa, Mesa

85251

Scottsdale, Scottsdale

85704

Tucson, Tucson

85712

Tucson, Tucson

89113

Las Vegas, Las Vegas

90100

Oulu, Oulu

90806

Long Beach, Long Beach

91303

Canoga Park, Canoga Park

92111

San Diego, San Diego

98105

Seattle, Seattle

C1128AAF

Ciudad de Buenos Aires, Ciudad de Buenos Aires

B1642CKL

San Isidro, San Isidro

S2000PRB

Rosario, Rosario

X5000JHQ

Córdoba, Córdoba

T4N 6V7

Red Deer, Red Deer

N2J1C4

Waterloo, Waterloo

G6P 6P6

Victoriaville, Victoriaville

100 34

Praha 10, Prague

772 00

Olomouc, Olomouc

180 81

Praha 8 - Libeň, Praha 8 - Libeň

389 01

Vodnany, Vodňany

566 01

Vysoké Mýto, Vysoké Mýto

FI-70110

Kuopio, Kuopio

00260

Helsinki, Helsinki

60-535

Poznań, Poznan

601-85

Skórzewo, Skórzewo

31-121

Kraków, Krakow

20-064

Lublin, Lublin

20-632

Lublin, Lublin

20-880

Lublin, Lublin

02-066

Warszawa, Warsaw

Katowice, Katowice

02-929

Warszawa, Warsaw

15-224

Białystok, Bialystok

40-081

Katowice, Katowice

71-434

Szczecin, Szczecin

90-602

Lódz, Lódz

2805-267

Almada, Almada

3000-075

Coimbra, Coimbra

6200-251

Covilhã, Covilha

1069-089

Lisbon, Lisbon

4099-001

Porto, Porto

0157

Centurion, Centurion

02232

Kyiv, Kyiv

04050

Kyiv, Kyiv

01034

Kyiv, Kyiv

03148

Kiev, Kiev

04053

Kiev, Kiev

04112

Kiev, Kiev

Sponsors
All Listed Sponsors
lead

Myovant Sciences GmbH

INDUSTRY

NCT03204318 - SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain | Biotech Hunter | Biotech Hunter