NCT03751124 - Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids | Biotech Hunter

Enrollment

229

Participants

Timeline

Start Date

October 16, 2018

Primary Completion Date

February 19, 2021

Study Completion Date

October 20, 2021

Conditions

Uterine LeiomyomaUterine Fibroids

Interventions

DRUG

Relugolix

Relugolix 40 mg tablet administered orally once daily

DRUG

Estradiol/norethindrone acetate

Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily

DRUG

Placebo for relugolix

Placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor

DRUG

Placebo for E2/NETA

Placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor

Trial Locations (104)

1724

Roodepoort, Roodepoort

4024

Debrecen, Debrecen

4025

Debrecen, Debrecen

4126

Durban, Durban

4400

Nyíregyháza, Nyíregyháza

5700

Gyula, Gyula

6000

Kecskemét, Kecskemét

6600

Szentes, Szentes

7405

Cape Town, Cape Town

7500

Cape Town, Cape Town

9301

Bloemfontein, Bloemfontein

10126

Torino, Torino

14221

Williamsville, Williamsville

21204

Towson, Towson

21208

Baltimore, Baltimore

23225

Richmond, Richmond

23507

Norfolk, Norfolk

27103

Winston Salem, Winston-Salem

27607

Raleigh, Raleigh

27612

Raleigh, Raleigh

27713

Durham, Durham

29201

Columbia, Columbia

29406

Charleston, Charleston

29910

Bluffton, Bluffton

30034

Dacatur, Decatur

30080

Smyrna, Smyrna

30093

Norcross, Norcross

30097

Duluth, Duluth

30342

Atlanta, Atlanta

30349

College Park, College Park

30912

Augusta, Augusta

31406

Savannah, Savannah

32207

Jacksonville, Jacksonville

32720

Deland, DeLand

32765

Oviedo, Oviedo

33063

Margate, Margate

33126

Miami, Miami

33155

Miami, Miami

33165

Miami, Miami

33180

Aventura, Aventura

33316

Ft. Lauderdale, Fort Lauderdale

33327

Weston, Weston

33409

United States, Florida, West Palm Beach

West Palm Beach, West Palm Beach

33458

Jupiter, Jupiter

33613

Tampa, Tampa

33759

Clearwater, Clearwater

Orlando, Orlando

33912

Fort Myers, Fort Myers

34239

Sarasota, Sarasota

35205

Birmingham, Birmingham

37404

Chattanooga, Chattanooga

38119

Memphis, Memphis

38120

Memphis, Memphis

39701

Pisek, Písek

45219

Cincinnati, Cincinnati

48187

Canton, Canton

48201

Detroit, Detroit

53100

SIENA, Siena

60523

Oak brook, Oak Brook

60611

Chicago, Chicago

66218

Shawnee, Shawnee Mission

70006

Metairie, Metairie

70072

Marrero, Marrero

70433

Covington, Covington

75231

Dallas, Dallas

75605

Longview, Longview

77030

Houston, Houston

77054

Houston, Houston

77598

Webster, Webster

78229

San Antonio, San Antonio

78258

San Antonio, San Antonio

80209

Denver, Denver

80228

Lakewood, Lakewood

85209

Mesa, Mesa

85712

Tucson, Tucson

88100

Catanzaro, Catanzaro

89109

Las Vegas, Las Vegas

89128

Las Vegas, Las Vegas

90057

Los Angeles, Los Angeles

90650

Norwalk, Norwalk

91303

Canoga Park, Canoga Park

91942

La Mesa, La Mesa

92111

San Diego, San Diego

92647

Huntington Beach, Huntington Beach

99207

Spokane, Spokane

7510186

Providencia, Providencia

8360160

Santiago, Santiago

8880465

San Ramon, San Ramón

08648

Lawrenceville, Lawrenceville

90510-040

Porto Alegre, Porto Alegre

09715-090

São Bernardo do Campo, São Bernardo do Campo

01317-000

Sao Paulo, São Paulo

04266-010

São Paulo, São Paulo

370 01

České Budějovice, České Budějovice

772 00

Olomouc, Olomouc

00168

Roma, Roma

71-270

Szczecin, Szczecin

15-464

Bialystok, Bialystok

40-123

Katowice, Katowice

60-192

Poznan, Poznan

02-201

Warszawa, Warsaw

0157

Centurion, Centurion