Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,570

Participants

Timeline

Start Date

December 30, 2019

Primary Completion Date

February 8, 2024

Study Completion Date

February 8, 2024

Conditions
Vasomotor SymptomsMenopausal Symptoms
Interventions
DRUG

Estetrol

Estetrol oral tablet: administered orally once daily

DRUG

Placebo

Placebo oral tablet: administered orally once daily

DRUG

Progesterone

Progesterone oral tablet: administered orally once daily

Trial Locations (224)

1012

IDIM - Instituto de Investigaciones Metabolicas, Buenos Aires

1425

Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada, Caba

2000

Instituto Medico de la Fundacion Estudios Clinicos, Rosario

4024

Szent Anna Privat Surgery-Szent Anna Maganrendelo, Debrecen

6600

Csongrad Megyei Dr. Bugyi Istvan Korhaz, Szentes

6725

Univ. of Szeged Faculty of General Medicine Albert Szent-Gyaergyi, Szeged

7624

Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) - Klinikai Kozpont Szuleszeti es Nogyogyaszati Klinika, Pécs

11025

Sana Monitoring, Bucharest

13766

Centrul Medical Unirea - Spitalul Baneasa, Bucharest

18081

Gynekologicko-porodnicka klinika, Prague

19114

Estetra Study Site, Philadelphia

23456

Tidewater Clinical Research Inc, Virginia Beach

23507

Estetra Study Site, Norfolk

26505

IMA Clinical Research, Morgantown

27713

Estetra Study Site, Durham

28009

Instituto Palacios, Salud y Medicina de la Mujer, Madrid

28040

Hospital Clinico San Carlos, Madrid

28209

PMG Research of Charlotte, LLC, Charlotte

29572

Magnolia Ob/Gyn Research Center, Myrtle Beach

30100

Gynekologicka ambulance Gyncare MUDr. Michael Svec s.r.o., Pilsen

30260

Infinite Clinical Trials, Morrow

30342

Estetra Study Site, Atlanta

31406

Fellows Research Alliance, Inc., Savannah

32174

Estetra Study Site, Ormond Beach

32256

Clinical Neuroscience Solutions, Inc., Jacksonville

32701

Estetra Study Site, Altamonte Springs

32801

Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare, Orlando

33014

San Marcus Research Clinic, Inc., Miami Lakes

33016

Estetra Study Site, Hialeah

33027

Estetra Study Site, Pembroke Pines

33073

Estetra Study Site, Coconut Creek

33134

Medical Research Center of Miami II, Miami

33155

Miami Clinical Research, Miami

33161

Estetra Study Site, North Miami

33165

Genoma Research Group, Inc., Miami

33186

Estetra Study Site, Miami

33461

Altus Research, Lake Worth

33609

Estetra Study Site, Tampa

33782

Estetra Study Site, Pinellas Park

34239

Physician Care Clinical Research, LLC, Sarasota

34653

Estetra Study Site, New Port Richey

34684

Estetra Study Site, Palm Harbor

34761

Estetra Study Site, Ocoee

34952

Estetra Study Site, Port Saint Lucie

35218

Estetra Study Site, Birmingham

37001

Dr. Jiri Tiser MD, Office of, České Budějovice

GYN-Mika s.r.o., České Budějovice

37404

Estetra Study Site, Chattanooga

39003

Dr. Tereza Smrhova-Kovacs MD, Office of, Tábor

40138

Ginecologia e Fisiopatologia della Riproduzione Umana,UO Ostetricia e Ginecologia,Policlinico S.Orsola-Malpighi, Bologna

41013

Hospital Universitario Virgen del Rocio, Hospital de la Mujer, Seville

41124

Azienda Ospedaliero - Universitaria Policlinico di Modena, Modena

43231

Estetra Study Site, Columbus

45322

Estetra Study Site, Englewood

50002

MUDr. Martin Stepan s.r.o., Hradec Králové

50134

Universita degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi, DAI Materno Infantile, SOD Ginecologia e Ostetricia, Florence

51601

Vestra Clinics, Rychnov nad Kněžnou

54701

MUDr. Jan Kestranek - gynekologicka ambulance, Náchod

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

60200

Gynekologie Meda Brno, Brno

68701

Meridian Clinical Research, Norfolk

70072

Praetorian Pharmaceutical Research, Marrero

75062

Cedar Health Research LLC, Irving

75093

Estetra Study Site, Plano

75251

Cedar Health Research, LLC, Dallas

76140

Signature Gyn Services, Fort Worth

77054

Estetra Study Site, Houston

77084

Biopharma Informatic, Inc. Research Center, Houston

Estetra Study Site, Houston

77130

Estetra Study Site, Olomouc

77900

NEUMED gynekologicka ambulance s.r.o., Olomouc

78229

Estetra Study Site, San Antonio

78233

Estetra Study Site, San Antonio

78258

Estetra Study Site, San Antonio

80209

Velocity Clinical Research, Denver

83404

Clinical Research Prime, Idaho Falls

84062

Estetra Study Site, Pleasant Grove

85018

Estetra Study Site, Phoenix

85032

Precision Trials AZ, LLC, Phoenix

85206

Estetra Study Site, Mesa

85704

Noble Clinical Research, Tucson

88100

Ospedale Pugliese, Calabria

89106

Jubilee Clinical Research, Inc, Las Vegas

89109

Excel Clinical Research, Las Vegas

91303

Hope Clinical Research, LLC, Canoga Park

91360

Estetra Study Site, Thousand Oaks

91767

Estetra Study Site, Pomona

91790

Estetra Study Site, West Covina

95821

Clinical Trials Research, Sacramento

Estetra Study Site, Sacramento

97300

IRMED Osrodek Badan Klinicznych, Piotrkow Trybunalski

98007

Northwest Clinical Research Center, Bellevue

105554

LLC Olla-Med, Moscow

117997

Scientific Centre Of Obsterics, Gynecology And Perinatology n.a.academican V.I.Kulakov of Federal Agency of High Tech Medical Care, Moscow

192174

Saint-Petersburg State Healthcare Institution Maternity hospital, Saint Petersburg

199034

The Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott - Center Menopause and Women's Health, Saint Petersburg

199226

Astarta Clinic, Saint Petersburg

200541

Vitaplus Medclin SRL, Craiova

235200

Spitalul Municipal Caracal, Caracal

344011

Clinical diagnostic center Zdorovye, Rostov-on-Don

443067

Closed Joint Stock Company Medical Company Idk, Samara

500091

Centrul Medical Unirea Policlinica Brasov, Brasov

500283

Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL, Brasov

540136

Spitalul De Urgenta Targu Mures-Emergency University County Hospital, Târgu Mureş

540139

SC Centrul Medical Unirea SRL, Târgu Mureş

630099

JCS Avicenna, Novosibirsk

660022

Krasnoyarsk State Medical University named after Prof. V.F. VoinoYasenetsky, Krasnoyarsk

664003

Scientific Center for Family Health Problems and Human Reproduction, Irkutsk

900001

Centrul Medical Unirea, Constanța

08009

Hassman Research Institute, Berlin

87109-4640

Bosque Women's Care, Albuquerque

C1128AAF

Mautalen Salud e Investigacion, Buenos Aires

C1426ABP

Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.L, Buenos Aires

C1430CKE

Glenny Corp. S. A. / Bioclinica Argentina, Buenos Aires

B1824KAJ

Centro de Investigacion Medico Lanus-CIMEL, Lanús

B7600FYK

Centro De Investigaciones Medicas Mar Del Plata, Mar del Plata

B7600FZO

Instituto de Investigaciones Clinicas Mar del Plata, Mar del Plata

30110-051

Centro De Medicina Reprodutiva Ltda - Clinica Origen, Belo Horizonte

18618-686

Faculdade de Medicina de Botucatu - UNESP, Botucatu

71625-175

Centro De Pesquisa Clinica Do Brasil, Brasília

13060-080

IPCC-Instituto de Pesquisa Clinica de Campinas, Campinas

13083-888

University of Campinas Medical School, Campinas

89801-355

Centro de Oncologia de Santa Catarina Ltda / Supera Oncologia, Chapecó

78043-306

Instituto Tropical de Medicina Reprodutiva - Clinica INTRO, Cuiabá

80030-220

CEPEME / CERHFAC Centro De Estudos E Pesquisas Em Reproducao Humana E Fertilizacao Assistida De Curitiba Ltda, Curitiba

60430-270

Federal University Of Ceara, Fortaleza

59012-310

Universidade Federal Do Rio Grande Do Norte/ Maternidade Escola Januario Cicco, Natal

99010-080

Hospital Sao Vicente de Paulo, Associacao Hospitalar Beneficente Sao Vicente de Paulo, Passo Fundo

90035-903

Hospital de Clinicas de Porto Alegre (HCPA), Porto Alegre

90430-001

Nucleo de Pesquisa Clinica do Rio Grande do Sul Ltda, Porto Alegre

90510-040

Unidade de Pesquisa Clínica - Centro de Medicina Reprodutiva, Porto Alegre

90610-000

Hospital Sao Lucas da PUC, Porto Alegre

20241-180

lnstituto Brasil De Pesquisa Clinica S.A (IBPCLIN), Rio de Janeiro

09715-090

CEMEC - Faculdade de Medicina do ABC, São Bernardo do Campo

01228-000

CPQuali Pesquisa Clinica LTDA, São Paulo

01228-200

CPClin- Centro de Pesquisas Clinicas Ltda./Clinica Dr. Freddy Goldberg Eliaschewitz, São Paulo

01317-000

Hospital Perola Byington/ Centro de Referencia da Saude da Mulher, São Paulo

04039-001

Universidade Federal De Sao Paulo (Unifesp) - Hospital Sao Paulo (Hsp), São Paulo

04266-010

CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda, São Paulo

04534-002

College - Centro De Pesquisa Clinica E Servicos Medicos Ltda College - Centro De Pesquisa Clinica (Baby Center Medicina Reprodutiva), São Paulo

29055-450

CEDOES - Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo, Vitória

15500-003

Santa Casa De Votuporanga-Philanthropic hospital, Votuporanga

L6T 0G1

Aggarwal and Associates Limited, Brampton

G1N 4V3

DIEX Research Quebec, Québec

G1S 2L6

Clinique Rsf Inc., Québec

G1W4R4

Estetra Study Site, Québec

G2J0C4

Alpha Recherche Clinique, Québec

G3K 2P8

Alpha Recherche Clinique, Québec

H1M1B1

Estetra Study Site, Québec

N7T4X3

Estetra Study Site, Sarnia

J1L 0H8

Diex Research Sherbrooke Inc., Sherbrooke

G6P 6P6

Diex Recherche, Victoriaville

N2J 1C4

Fadia El Boreky Medicine Professional Corporation, Waterloo

602 00

Dr. Vladimir Dvorak MD, Office Of, Brno

350 02

Gynekologie Cheb s.r.o., Cheb

370 01

MUDr. Petr Sak, České Budějovice

586 01

Gynekologie Jihlava, Jihlava

772 00

G-CENTRUM Olomouc, s.r.o., Olomouc

702 00

Dr. Karel Buchta MD, Office of, Ostrava

301 00

Dr. Martina Maresova Rosenbergova MD, Office of, Pilsen

155 00

Mediva s.r.o, Prague

190 16

Dr. Lubomir Mikulasek, MD office Of, Prague

566 01

Dr. Ivana Salamonova MD, Office of, Vysoké

06129

Universita degli Studi di Perugia - Policlinico Monteluce - Centro di Medicina Perinatale e della Riproduzione, Perugia

00161

Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma, Roma

00168

Policlinico Univ. Agostino Gemelli, Roma

LT-49449

Saules Family Medicine Centre, Kaunas

LT-50128

UAB VAKK - Dr. Kildos Klinika, Kaunas

LT-93200

Klaipedos Miesto Poliklinika, Klaipėda

LT-01117

Public Institution Centro Poliklinika, Vilnius

LT-01118

UAB Seimos gydytojas, Vilnius

LT-03225

JSC Maxmeda, Vilnius

LT-05263

JSC Kardiolita, Vilnius

LT-08661

Vilnius University Hospital Santaros klinikos, Vilnius

15-224

Prywatna Klinika Polozniczo - Ginekologiczna Sp. Z O.O., Bialystok

15-464

Centrum Ginekologii Endokrynologii i Medycyny Rozrodu Artemida, Bialystok

85-048

Osrodek Badan Klinicznych IN-VIVO, Bydgoszcz

85-080

Przychodnia Srodmiescie Sp. z o.o., Bydgoszcz

82-300

Mital Site Badania Kliniczne, Elblag

80-462

Copernicus Podmiot Leczniczy - Szpital sw. Wojciecha, Gdansk

40-065

Centrum Medyczne Mikolowska Dr Adam Sipinski, Katowice

40-156

Clinical Medical Research sp. z o.o., Katowice

40-301

NZOZ Sanas, Katowice

40-611

Centrum Medyczne Angelius Provita, Katowice

40-648

Pro Familia Altera Sp. z o.o., Katowice

40-748

NZOZ Vita Longa Sp. z o.o., Katowice

40-851

Gyncentrum Sp. z o.o., Katowice

30-510

Pratia MCM Krakow, Krakow

31-315

Grazyna Bogutyn Medico Praktyka Lekarska, Krakow

91-211

Salve Medica-Przychodnia, Lodz

93-312

NZOZ Medican, Lodz

20-093

Centrum Medyczne Chodzki, Lublin

20-362

KO-MED Centra Kliniczne Sp. z o.o., Osrodek Badan Klinicznych w Lublinie II, Lublin

20-880

Niepubliczny Zak¿ad Opieki Zdrowotnej PROFI-MED, Lublin

10-117

ETYKA Osrodek Badan Klinicznych, Olsztyn

05-500

Centrum Innowacyjnych Terapii Sp. z o.o., Piaseczno

60-848

Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Spolka Komandytowa, Poznan

60-185

Estetra Study Site, Skorzewo

71-434

Twoja Przychodnia - Szczecinskie Centrum Medyczne, Szczecin

02-201

Nzoz Zieniewicz Medical, Warsaw

02-679

Centrum Badawcze Wspolczesnej Terapii Prywatny Gabinet Lekarski Dr Anna Bochenek-Mularczyk, Warsaw

02-793

ETG Warszawa, Warsaw

02-798

Medical Concierge Centrum Medyczne, Warsaw

50-547

Marek Elias Gabinety Ginekologiczne, Wroclaw

22-400

ETG Zamosc, Zamość

011858

SC Centrul Medical Unirea SRL, Bucharest

012071

SC Quantum Medical Center SRL, Bucharest

020762

Centrul Medical Euromed, Bucharest

Spitalul Clinic Nicolae Malaxa, Bucharest

Unknown

Woman's consulting center #22, Saint Petersburg

018 41

MCM GYNPED, s.r.o., Dubnica nad Váhom

058 01

BrenCare, s. r. o., Poprad

08850

Diatros S.L.P, Gavà

NN18 9EZ

Accellacare - (MeDiNova Limited) - Northamptonshire, Corby

CV3 4FJ

Accellacare (Previously MeDiNova) Warwickshire Quality Research Site, Coventry

G20 0XA

CPS Research, Glasgow

HP11 2QW

Egin Research Ltd, High Wycombe

W12 0NN

Queen Charlotte's and Chelsea Hospital - Imperial College Healthcare NHS Trust, London

HA6 2RN

Accellacare - (MeDiNova Limited) - North London, Northwood

BR5 3QG

Accellacare - South London, Orpington

Estetra Study Site, Orpington

RM1 3PJ

Accellacare - (MeDiNova Limited) - East London, Romford

BD18 3SA

Accellacare - (MeDiNova Limited) - Yorkshire, Shipley

RG40 1XS

Accellacare - (MeDiNova Limited) - West London, Wokingham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

ICON Clinical Research

INDUSTRY

lead

Estetra

INDUSTRY