Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)
A Randomized Double-blind Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)
1 other identifier
interventional
1,570
14 countries
224
Brief Summary
This is a two-part study designed to evaluate the effect of Estetrol (E4) 15 or 20 mg, or placebo on the severity and frequency of vasomotor symptoms (VMS) (Efficacy Study Part) and the safety of E4 20 mg (Endometrial and General Safety Study Part)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2019
Typical duration for phase_3
224 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2019
CompletedFirst Posted
Study publicly available on registry
December 24, 2019
CompletedStudy Start
First participant enrolled
December 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2024
CompletedJanuary 29, 2025
October 1, 2024
4.1 years
December 20, 2019
January 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Mean change in weekly frequency of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 4 (Efficacy Study Part)
The weekly frequency of moderate to severe VMS at Baseline and Week 4 is defined as the total number (sum) of all recorded moderate to severe VMS experienced during the last 7 consecutive days prior randomization for Baseline and at Week 4. Mean change = mean weekly frequency at Week 4 - mean weekly frequency at Baseline
Baseline and Week 4
Mean change in weekly frequency of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 12 (Efficacy Study Part)
The weekly frequency of moderate to severe VMS at Baseline and Week 12 is defined as the total number (sum) of all recorded moderate to severe VMS experienced during the last 7 consecutive days prior randomization for Baseline and at Week 12. Mean change = mean weekly frequency at Week 12 - mean weekly frequency at Baseline
Baseline and Week 12
Mean change in severity of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 4 (Efficacy Study Part)
The severity score is derived as follows: mild = 1, moderate = 2, and severe = 3. The mean severity score of VMS at Baseline and Week 4 is defined as the arithmetic mean of the daily severity score values of moderate and severe VMS observed from the last 7 days prior randomization for Baseline and of moderate and severe VMS observed at Week 4. Baseline and Week 4 severity score = \[(2 x number of moderate VMS) + (3 x number of severe VMS)\]/ (total number of moderate + severe VMS). Mean change = mean severity score at Week 4 - mean severity score at Baseline
Baseline and Week 4
Mean change in severity of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 12 (Efficacy Study Part)
The severity score is derived as follows: mild = 1, moderate = 2, and severe = 3. The mean severity score of VMS at Baseline and Week 12 is defined as the arithmetic mean of the daily severity score values of moderate and severe VMS observed from the last 7 days prior randomization for Baseline and of moderate and severe VMS observed at Week 12. Baseline and Week 12 severity score = \[(2 x number of moderate VMS) + (3 x number of severe VMS)\]/ (total number of moderate + severe VMS). Mean change = mean severity score at Week 12 - mean severity score at Baseline
Baseline and Week 12
Incidence of endometrial hyperplasia with up to 12 months of treatment based on endometrial biopsies (Endometrial and General Safety Study Part)
Endometrial biopsies will be centrally evaluated by three independent expert pathologists from different institutions, blinded to treatment group and to each other's readings. The concurrence of two of the three pathologists will be accepted as the final diagnosis. If there is no agreement among the three pathologists, the most severe pathologic diagnosis, i.e., atypical hyperplasia \>complex hyperplasia \>simple hyperplasia \>benign endometrium, will be used as the final diagnosis.
Screening and Week 53
Secondary Outcomes (81)
Mean change from Baseline to Week 1 in the weekly frequency and severity of moderate to severe vasomotor symptoms (VMS) (Efficacy Study Part)
Baseline and Week 1
Mean change from Baseline to Week 2 in the weekly frequency and severity of moderate to severe vasomotor symptoms (VMS) (Efficacy Study Part)
Baseline and Week 2
Mean change from Baseline to Week 3 in the weekly frequency and severity of moderate to severe vasomotor symptoms (VMS) ((Efficacy Study Part)
Baseline and Week 3
Mean change from Baseline to Week 4 in the weekly frequency and severity of moderate to severe vasomotor symptoms (VMS) (Efficacy part)
Baseline and Week 4
Mean change from Baseline to Week 5 in the weekly frequency and severity of moderate to severe vasomotor symptoms (VMS) (Efficacy Study Part)
Baseline and Week 5
- +76 more secondary outcomes
Study Arms (4)
Estetrol 15 mg - Efficacy Part
EXPERIMENTALEstetrol (E4) 15 mg was administered orally once daily for a minimum of 12 weeks and not longer than 13 weeks.
Estetrol 20 mg - Efficacy Part
EXPERIMENTALEstetrol (E4) 20 mg was administered orally once daily for a minimum of 12 weeks and not longer than 13 weeks.
Placebo - Efficacy Part
PLACEBO COMPARATORPlacebo was administered orally once daily for a minimum of 12 weeks and not longer than 13 weeks.
Estetrol 20 mg + P4 100 mg - Safety Part
EXPERIMENTALEstetrol (E4) 20 mg and Progesterone (P4) 100 mg was administered once daily for up to 53 weeks.
Interventions
Estetrol oral tablet: administered orally once daily
Progesterone oral tablet: administered orally once daily
Eligibility Criteria
You may qualify if:
- Signed and dated written informed consent form and any required privacy authorization prior to the initiation of any trial procedure, after the nature of the trial has been explained according to local regulatory requirements;
- Females, ≥ 40 up to ≤ 65 years of age at randomization;
- For hysterectomized subjects: documented hysterectomy must have occurred at least 6 weeks prior to the start of screening. Hysterectomy can be total or subtotal (i.e., cervix was not removed);
- For non-hysterectomized subjects: uterus with bi-layer endometrial thickness ≤ 4 mm on TVUS;
- For non-hysterectomized subjects: an evaluable endometrial biopsy taken during screening that reveals no abnormal results, i.e., presence of hyperplasia (simple or complex, with or without atypia), presence of carcinoma, and presence of disordered proliferative endometrium findings. The screening biopsy should have sufficient endometrial tissue for diagnosis;
- Seeking treatment for relief of VMS associated with menopause;
- For the Efficacy Study part: at least 7 moderate to severe bothersome VMS per day or at least 50 moderate to severe bothersome VMS per week in the last 7 consecutive days during the Screening period;
- For the Endometrial and General Safety Study part: at least 1 moderate to severe VMS per week;
- Body mass index ≥ 18.0 kg/m\^2 to ≤ 38.0 kg/m\^2;
- A mammogram that shows no sign of significant disease performed during screening or within 9 months prior to the start of screening ;
- Post-menopausal status defined as any of the following:
- For non-hysterectomized subjects:
You may not qualify if:
- or at least 6 weeks postsurgical bilateral oophorectomy;
- For hysterectomized subjects:
- or at least 6 weeks post-surgical bilateral oophorectomy.
- Good physical and mental health, in the judgement of the Investigator as based on medical history, physical and gynecological examination and clinical assessments performed prior Visit 1;
- Able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions;
- Able and willing to complete trial daily paper diaries (if applicable) and questionnaires.
- History of malignancy with the exception of basal cell or squamous cell carcinoma of the skin if diagnosed more than 1 year prior to the Screening visit;
- Any clinically significant findings found by the Investigator at the breast examination and/or on mammography suspicious of breast malignancy that would require additional clinical testing to rule out breast cancer (however, simple cysts confirmed by ultrasound are allowed);
- Papanicolaou (PAP) test with atypical squamous cells undetermined significance (ASC-US) or higher (low-grade intraepithelial lesion \[LSIL\], atypical squamous cells- cannot exclude high-grade intraepithelial lesion \[HSIL\] \[ASC-H\], HSIL, dysplastic or malignant cells) in sub-totally hysterectomized and non-hysterectomized subjects . Note: ASC-US is allowed if a reflex human papilloma virus (HPV) testing is performed and is negative for high risk oncogene HPV subtypes 16 and 18;
- For non-hysterectomized subjects:
- History or presence of uterine cancer, endometrial hyperplasia, or disordered proliferative endometrium;
- Presence of endometrial polyps;
- Undiagnosed vaginal bleeding or undiagnosed abnormal uterine bleeding;
- Endometrial ablation;
- Any uterine/endometrial abnormality that in the judgment of the investigator contraindicates the use of estrogen and/or progestin therapy. This includes presence or history of adenomyosis or significant myoma;
- +33 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Estetralead
- ICON Clinical Researchcollaborator
Study Sites (224)
Estetra Study Site
Birmingham, Alabama, 35218, United States
Estetra Study Site
Mesa, Arizona, 85206, United States
Estetra Study Site
Phoenix, Arizona, 85018, United States
Precision Trials AZ, LLC
Phoenix, Arizona, 85032, United States
Noble Clinical Research
Tucson, Arizona, 85704, United States
Hope Clinical Research, LLC
Canoga Park, California, 91303, United States
Estetra Study Site
Pomona, California, 91767, United States
Clinical Trials Research
Sacramento, California, 95821, United States
Estetra Study Site
Sacramento, California, 95821, United States
Estetra Study Site
Thousand Oaks, California, 91360, United States
Estetra Study Site
West Covina, California, 91790, United States
Velocity Clinical Research
Denver, Colorado, 80209, United States
Estetra Study Site
Altamonte Springs, Florida, 32701, United States
Estetra Study Site
Coconut Creek, Florida, 33073, United States
Estetra Study Site
Hialeah, Florida, 33016, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Altus Research
Lake Worth, Florida, 33461, United States
Medical Research Center of Miami II
Miami, Florida, 33134, United States
Miami Clinical Research
Miami, Florida, 33155, United States
Genoma Research Group, Inc.
Miami, Florida, 33165, United States
Estetra Study Site
Miami, Florida, 33186, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014, United States
Estetra Study Site
New Port Richey, Florida, 34653, United States
Estetra Study Site
North Miami, Florida, 33161, United States
Estetra Study Site
Ocoee, Florida, 34761, United States
Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare
Orlando, Florida, 32801, United States
Estetra Study Site
Ormond Beach, Florida, 32174, United States
Estetra Study Site
Palm Harbor, Florida, 34684, United States
Estetra Study Site
Pembroke Pines, Florida, 33027, United States
Estetra Study Site
Pinellas Park, Florida, 33782, United States
Estetra Study Site
Port Saint Lucie, Florida, 34952, United States
Physician Care Clinical Research, LLC
Sarasota, Florida, 34239, United States
Estetra Study Site
Tampa, Florida, 33609, United States
Estetra Study Site
Atlanta, Georgia, 30342, United States
Infinite Clinical Trials
Morrow, Georgia, 30260, United States
Fellows Research Alliance, Inc.
Savannah, Georgia, 31406, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
Praetorian Pharmaceutical Research
Marrero, Louisiana, 70072, United States
Meridian Clinical Research
Norfolk, Nebraska, 68701, United States
Jubilee Clinical Research, Inc
Las Vegas, Nevada, 89106, United States
Excel Clinical Research
Las Vegas, Nevada, 89109, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Bosque Women's Care
Albuquerque, New Mexico, 87109-4640, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209, United States
Estetra Study Site
Durham, North Carolina, 27713, United States
Estetra Study Site
Columbus, Ohio, 43231, United States
Estetra Study Site
Englewood, Ohio, 45322, United States
Estetra Study Site
Philadelphia, Pennsylvania, 19114, United States
Magnolia Ob/Gyn Research Center
Myrtle Beach, South Carolina, 29572, United States
Estetra Study Site
Chattanooga, Tennessee, 37404, United States
Cedar Health Research, LLC
Dallas, Texas, 75251, United States
Signature Gyn Services
Fort Worth, Texas, 76140, United States
Estetra Study Site
Houston, Texas, 77054, United States
Biopharma Informatic, Inc. Research Center
Houston, Texas, 77084, United States
Estetra Study Site
Houston, Texas, 77084, United States
Cedar Health Research LLC
Irving, Texas, 75062, United States
Estetra Study Site
Plano, Texas, 75093, United States
Estetra Study Site
San Antonio, Texas, 78229, United States
Estetra Study Site
San Antonio, Texas, 78233, United States
Estetra Study Site
San Antonio, Texas, 78258, United States
Estetra Study Site
Pleasant Grove, Utah, 84062, United States
Estetra Study Site
Norfolk, Virginia, 23507, United States
Tidewater Clinical Research Inc
Virginia Beach, Virginia, 23456, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
IMA Clinical Research
Morgantown, West Virginia, 26505, United States
IDIM - Instituto de Investigaciones Metabolicas
Buenos Aires, 1012, Argentina
Mautalen Salud e Investigacion
Buenos Aires, C1128AAF, Argentina
Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.L
Buenos Aires, C1426ABP, Argentina
Glenny Corp. S. A. / Bioclinica Argentina
Buenos Aires, C1430CKE, Argentina
Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
Caba, 1425, Argentina
Centro de Investigacion Medico Lanus-CIMEL
Lanús, B1824KAJ, Argentina
Centro De Investigaciones Medicas Mar Del Plata
Mar del Plata, B7600FYK, Argentina
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata, B7600FZO, Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, 2000, Argentina
Centro De Medicina Reprodutiva Ltda - Clinica Origen
Belo Horizonte, 30110-051, Brazil
Faculdade de Medicina de Botucatu - UNESP
Botucatu, 18618-686, Brazil
Centro De Pesquisa Clinica Do Brasil
Brasília, 71625-175, Brazil
IPCC-Instituto de Pesquisa Clinica de Campinas
Campinas, 13060-080, Brazil
University of Campinas Medical School
Campinas, 13083-888, Brazil
Centro de Oncologia de Santa Catarina Ltda / Supera Oncologia
Chapecó, 89801-355, Brazil
Instituto Tropical de Medicina Reprodutiva - Clinica INTRO
Cuiabá, 78043-306, Brazil
CEPEME / CERHFAC Centro De Estudos E Pesquisas Em Reproducao Humana E Fertilizacao Assistida De Curitiba Ltda
Curitiba, 80030-220, Brazil
Federal University Of Ceara
Fortaleza, 60430-270, Brazil
Universidade Federal Do Rio Grande Do Norte/ Maternidade Escola Januario Cicco
Natal, 59012-310, Brazil
Hospital Sao Vicente de Paulo, Associacao Hospitalar Beneficente Sao Vicente de Paulo
Passo Fundo, 99010-080, Brazil
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre, 90035-903, Brazil
Nucleo de Pesquisa Clinica do Rio Grande do Sul Ltda
Porto Alegre, 90430-001, Brazil
Unidade de Pesquisa Clínica - Centro de Medicina Reprodutiva
Porto Alegre, 90510-040, Brazil
Hospital Sao Lucas da PUC
Porto Alegre, 90610-000, Brazil
lnstituto Brasil De Pesquisa Clinica S.A (IBPCLIN)
Rio de Janeiro, 20241-180, Brazil
CEMEC - Faculdade de Medicina do ABC
São Bernardo do Campo, 09715-090, Brazil
CPQuali Pesquisa Clinica LTDA
São Paulo, 01228-000, Brazil
CPClin- Centro de Pesquisas Clinicas Ltda./Clinica Dr. Freddy Goldberg Eliaschewitz
São Paulo, 01228-200, Brazil
Hospital Perola Byington/ Centro de Referencia da Saude da Mulher
São Paulo, 01317-000, Brazil
Universidade Federal De Sao Paulo (Unifesp) - Hospital Sao Paulo (Hsp)
São Paulo, 04039-001, Brazil
CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
São Paulo, 04266-010, Brazil
College - Centro De Pesquisa Clinica E Servicos Medicos Ltda College - Centro De Pesquisa Clinica (Baby Center Medicina Reprodutiva)
São Paulo, 04534-002, Brazil
CEDOES - Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo
Vitória, 29055-450, Brazil
Santa Casa De Votuporanga-Philanthropic hospital
Votuporanga, 15500-003, Brazil
Aggarwal and Associates Limited
Brampton, L6T 0G1, Canada
DIEX Research Quebec
Québec, G1N 4V3, Canada
Clinique Rsf Inc.
Québec, G1S 2L6, Canada
Estetra Study Site
Québec, G1W4R4, Canada
Alpha Recherche Clinique
Québec, G2J0C4, Canada
Alpha Recherche Clinique
Québec, G3K 2P8, Canada
Estetra Study Site
Québec, H1M1B1, Canada
Estetra Study Site
Sarnia, N7T4X3, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, J1L 0H8, Canada
Diex Recherche
Victoriaville, G6P 6P6, Canada
Fadia El Boreky Medicine Professional Corporation
Waterloo, N2J 1C4, Canada
Dr. Vladimir Dvorak MD, Office Of
Brno, 602 00, Czechia
Gynekologie Meda Brno
Brno, 60200, Czechia
Gynekologie Cheb s.r.o.
Cheb, 350 02, Czechia
MUDr. Petr Sak
České Budějovice, 370 01, Czechia
Dr. Jiri Tiser MD, Office of
České Budějovice, 37001, Czechia
GYN-Mika s.r.o.
České Budějovice, 37001, Czechia
MUDr. Martin Stepan s.r.o.
Hradec Králové, 50002, Czechia
Gynekologie Jihlava
Jihlava, 586 01, Czechia
MUDr. Jan Kestranek - gynekologicka ambulance
Náchod, 54701, Czechia
Estetra Study Site
Olomouc, 77130, Czechia
G-CENTRUM Olomouc, s.r.o.
Olomouc, 772 00, Czechia
NEUMED gynekologicka ambulance s.r.o.
Olomouc, 77900, Czechia
Dr. Karel Buchta MD, Office of
Ostrava, 702 00, Czechia
Dr. Martina Maresova Rosenbergova MD, Office of
Pilsen, 301 00, Czechia
Gynekologicka ambulance Gyncare MUDr. Michael Svec s.r.o.
Pilsen, 30100, Czechia
Mediva s.r.o
Prague, 155 00, Czechia
Gynekologicko-porodnicka klinika
Prague, 18081, Czechia
Dr. Lubomir Mikulasek, MD office Of
Prague, 190 16, Czechia
Vestra Clinics
Rychnov nad Kněžnou, 51601, Czechia
Dr. Tereza Smrhova-Kovacs MD, Office of
Tábor, 39003, Czechia
Dr. Ivana Salamonova MD, Office of
Vysoké, 566 01, Czechia
Szent Anna Privat Surgery-Szent Anna Maganrendelo
Debrecen, 4024, Hungary
Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) - Klinikai Kozpont Szuleszeti es Nogyogyaszati Klinika
Pécs, 7624, Hungary
Univ. of Szeged Faculty of General Medicine Albert Szent-Gyaergyi
Szeged, 6725, Hungary
Csongrad Megyei Dr. Bugyi Istvan Korhaz
Szentes, 6600, Hungary
Ginecologia e Fisiopatologia della Riproduzione Umana,UO Ostetricia e Ginecologia,Policlinico S.Orsola-Malpighi
Bologna, 40138, Italy
Ospedale Pugliese
Calabria, 88100, Italy
Universita degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi, DAI Materno Infantile, SOD Ginecologia e Ostetricia
Florence, 50134, Italy
Azienda Ospedaliero - Universitaria Policlinico di Modena
Modena, 41124, Italy
Universita degli Studi di Perugia - Policlinico Monteluce - Centro di Medicina Perinatale e della Riproduzione
Perugia, 06129, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
Roma, 00161, Italy
Policlinico Univ. Agostino Gemelli
Roma, 00168, Italy
Saules Family Medicine Centre
Kaunas, LT-49449, Lithuania
UAB VAKK - Dr. Kildos Klinika
Kaunas, LT-50128, Lithuania
Klaipedos Miesto Poliklinika
Klaipėda, LT-93200, Lithuania
Public Institution Centro Poliklinika
Vilnius, LT-01117, Lithuania
UAB Seimos gydytojas
Vilnius, LT-01118, Lithuania
JSC Maxmeda
Vilnius, LT-03225, Lithuania
JSC Kardiolita
Vilnius, LT-05263, Lithuania
Vilnius University Hospital Santaros klinikos
Vilnius, LT-08661, Lithuania
Prywatna Klinika Polozniczo - Ginekologiczna Sp. Z O.O.
Bialystok, 15-224, Poland
Centrum Ginekologii Endokrynologii i Medycyny Rozrodu Artemida
Bialystok, 15-464, Poland
Osrodek Badan Klinicznych IN-VIVO
Bydgoszcz, 85-048, Poland
Przychodnia Srodmiescie Sp. z o.o.
Bydgoszcz, 85-080, Poland
Mital Site Badania Kliniczne
Elblag, 82-300, Poland
Copernicus Podmiot Leczniczy - Szpital sw. Wojciecha
Gdansk, 80-462, Poland
Centrum Medyczne Mikolowska Dr Adam Sipinski
Katowice, 40-065, Poland
Clinical Medical Research sp. z o.o.
Katowice, 40-156, Poland
NZOZ Sanas
Katowice, 40-301, Poland
Centrum Medyczne Angelius Provita
Katowice, 40-611, Poland
Pro Familia Altera Sp. z o.o.
Katowice, 40-648, Poland
NZOZ Vita Longa Sp. z o.o.
Katowice, 40-748, Poland
Gyncentrum Sp. z o.o.
Katowice, 40-851, Poland
Pratia MCM Krakow
Krakow, 30-510, Poland
Grazyna Bogutyn Medico Praktyka Lekarska
Krakow, 31-315, Poland
Salve Medica-Przychodnia
Lodz, 91-211, Poland
NZOZ Medican
Lodz, 93-312, Poland
Centrum Medyczne Chodzki
Lublin, 20-093, Poland
KO-MED Centra Kliniczne Sp. z o.o., Osrodek Badan Klinicznych w Lublinie II
Lublin, 20-362, Poland
Niepubliczny Zak¿ad Opieki Zdrowotnej PROFI-MED
Lublin, 20-880, Poland
ETYKA Osrodek Badan Klinicznych
Olsztyn, 10-117, Poland
Centrum Innowacyjnych Terapii Sp. z o.o.
Piaseczno, 05-500, Poland
IRMED Osrodek Badan Klinicznych
Piotrkow Trybunalski, 97300, Poland
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Spolka Komandytowa
Poznan, 60-848, Poland
Estetra Study Site
Skorzewo, 60-185, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
Nzoz Zieniewicz Medical
Warsaw, 02-201, Poland
Centrum Badawcze Wspolczesnej Terapii Prywatny Gabinet Lekarski Dr Anna Bochenek-Mularczyk
Warsaw, 02-679, Poland
ETG Warszawa
Warsaw, 02-793, Poland
Medical Concierge Centrum Medyczne
Warsaw, 02-798, Poland
Marek Elias Gabinety Ginekologiczne
Wroclaw, 50-547, Poland
ETG Zamosc
Zamość, 22-400, Poland
Centrul Medical Unirea Policlinica Brasov
Brasov, 500091, Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
Brasov, 500283, Romania
SC Centrul Medical Unirea SRL
Bucharest, 011858, Romania
SC Quantum Medical Center SRL
Bucharest, 012071, Romania
Centrul Medical Euromed
Bucharest, 020762, Romania
Spitalul Clinic Nicolae Malaxa
Bucharest, 020762, Romania
Sana Monitoring
Bucharest, 11025, Romania
Centrul Medical Unirea - Spitalul Baneasa
Bucharest, 13766, Romania
Spitalul Municipal Caracal
Caracal, 235200, Romania
Centrul Medical Unirea
Constanța, 900001, Romania
Vitaplus Medclin SRL
Craiova, 200541, Romania
Spitalul De Urgenta Targu Mures-Emergency University County Hospital
Târgu Mureş, 540136, Romania
SC Centrul Medical Unirea SRL
Târgu Mureş, 540139, Romania
Scientific Center for Family Health Problems and Human Reproduction
Irkutsk, 664003, Russia
Krasnoyarsk State Medical University named after Prof. V.F. VoinoYasenetsky
Krasnoyarsk, 660022, Russia
LLC Olla-Med
Moscow, 105554, Russia
Scientific Centre Of Obsterics, Gynecology And Perinatology n.a.academican V.I.Kulakov of Federal Agency of High Tech Medical Care
Moscow, 117997, Russia
JCS Avicenna
Novosibirsk, 630099, Russia
Clinical diagnostic center Zdorovye
Rostov-on-Don, 344011, Russia
Saint-Petersburg State Healthcare Institution Maternity hospital
Saint Petersburg, 192174, Russia
The Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott - Center Menopause and Women's Health
Saint Petersburg, 199034, Russia
Astarta Clinic
Saint Petersburg, 199226, Russia
Woman's consulting center #22
Saint Petersburg, Russia
Closed Joint Stock Company Medical Company Idk
Samara, 443067, Russia
MCM GYNPED, s.r.o.
Dubnica nad Váhom, 018 41, Slovakia
BrenCare, s. r. o.
Poprad, 058 01, Slovakia
Diatros S.L.P
Gavà, 08850, Spain
Instituto Palacios, Salud y Medicina de la Mujer
Madrid, 28009, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario Virgen del Rocio, Hospital de la Mujer
Seville, 41013, Spain
Accellacare - (MeDiNova Limited) - Northamptonshire
Corby, NN18 9EZ, United Kingdom
Accellacare (Previously MeDiNova) Warwickshire Quality Research Site
Coventry, CV3 4FJ, United Kingdom
CPS Research
Glasgow, G20 0XA, United Kingdom
Egin Research Ltd
High Wycombe, HP11 2QW, United Kingdom
Queen Charlotte's and Chelsea Hospital - Imperial College Healthcare NHS Trust
London, W12 0NN, United Kingdom
Accellacare - (MeDiNova Limited) - North London
Northwood, HA6 2RN, United Kingdom
Accellacare - South London
Orpington, BR5 3QG, United Kingdom
Estetra Study Site
Orpington, BR5 3QG, United Kingdom
Accellacare - (MeDiNova Limited) - East London
Romford, RM1 3PJ, United Kingdom
Accellacare - (MeDiNova Limited) - Yorkshire
Shipley, BD18 3SA, United Kingdom
Accellacare - (MeDiNova Limited) - West London
Wokingham, RG40 1XS, United Kingdom
Related Publications (2)
Panay N, Simoncini T, Taziaux M, Bouchard C, Black A, Kapoor E, Utian W, Foidart JM, Lobo RA. Estetrol for the treatment of moderate to severe vasomotor symptoms in postmenopausal women: The design of the E4COMFORT I and II trials. Maturitas. 2026 Jan;204:108781. doi: 10.1016/j.maturitas.2025.108781. Epub 2025 Nov 17.
PMID: 41289787DERIVEDGaspard U, Taziaux M, Jost M, Coelingh Bennink HJT, Utian WH, Lobo RA, Foidart JM. A multicenter, randomized, placebo-controlled study to select the minimum effective dose of estetrol in postmenopausal participants (E4Relief): part 2-vaginal cytology, genitourinary syndrome of menopause, and health-related quality of life. Menopause. 2023 May 1;30(5):480-489. doi: 10.1097/GME.0000000000002167. Epub 2023 Feb 20.
PMID: 36809193DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- This study consists of 3 blinded arms (efficacy part) and 1 open-label arm (safety part).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2019
First Posted
December 24, 2019
Study Start
December 30, 2019
Primary Completion
February 8, 2024
Study Completion
February 8, 2024
Last Updated
January 29, 2025
Record last verified: 2024-10