A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause

PHASE3CompletedINTERVENTIONAL
Enrollment

396

Participants

Timeline

Start Date

August 27, 2021

Primary Completion Date

July 25, 2023

Study Completion Date

November 27, 2023

Conditions
Vasomotor Symptoms Associated With MenopauseHot Flashes
Interventions
DRUG

Elinzanetant (BAY3427080)

120 mg elinzanetant orally once daily

DRUG

Placebo

Matching placebo orally once daily

Trial Locations (89)

1134

TritonLife Medical Center, XIII.kerulet, Budapest

2900

Komaromi Selye Janos Korhaz, Komárom

4028

NAP-MED Egeszsegugyi Szolgaltato Kft, Debrecen

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

8000

Rub-Int Noi Egeszsegcentrum, Székesfehérvár

11528

ARETAIEION University Hospital, Athens

14224

Circuit Clinical OB/GYN Associates of WNY, West Seneca

19114

Clinical Research of Philadelphia, LLC, Philadelphia

20036

Office of Dr. James A. Simon, MD, Washington D.C.

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

20132

Ospedale San Raffaele s.r.l., Milan

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

27103

United Women's Clinical Research - Lyndhurst, Winston-Salem

27612

Wake Research, Inc., Raleigh

28277

OnSite Clinical Solutions, LLC, Charlotte

29572

Venus Gynecology, LLC former Magnolia OB/GYN Research Center, Myrtle Beach

30034

Soapstone Center for Clinical Research, Decatur

30060

Drug Studies America, Marietta

30126

Mount Vernon Clinical Research, LLC, Sandy Springs

30349

Paramount Research Solutions-College Park, College Park

30363

Medisense, Inc., Atlanta

33912

Alliance for Multispecialty Research, LLC - Fort Meyers, Fort Myers

34239

Physician Care Clinical Research, Sarasota

34684

Suncoast Clinical Research, Palm Harbor

37404

Chattanooga Medical Research, LLC, Chattanooga

43213

Centricity Research formerly Aventiv - Columbus, Columbus

43302

Women's Care Research Institute/Marion OBGYN, Inc., Marion

44124

University Hospitals Landerbrook Health Center, Mayfield Heights

45500

Ioannina University General Hospital, Ioannina

46112

Investigators Research Group, LLC, Brownsburg

48127

Revive Research Institute, Inc. - Women's Health, Dearborn Heights

48602

Valley OB-GYN Clinic, Saginaw

50023

The Iowa Clinic - Ankeny, Ankeny

50134

A.O.U. Careggi, Florence

56126

A.O.U. Pisana, Pisa

56403

General Hospital of Thessaloniki Papageorgiou, Thessaloniki

68510

Women's Clinic of Lincoln, PC, Lincoln

70001

Southern Clinical Research Associates LLC, Metairie

72212

Applied Research Center of Arkansas, Little Rock

75251

Cedar Health Research, LLC, Dallas

77573

Maximos Ob/Gyn, League City

78233

Northeast Clinical Research of San Antonio, LLC, San Antonio

78705

Women Partners in Health Obstetrics & Gynecology (OB/GYN), Austin

83404

Clinical Research Prime, Idaho Falls

85206

Mesa Obstetricians and Gynecologists, Mesa

85251

MomDoc Women For Women, Scottsdale

85704

Noble Clinical Research, Tucson

85715

Del Sol Research Management LLC, Tucson

87107

Velocity Clinical Research - Albuquerque, Albuquerque

87109

Bosque Womens Care, Albuquerque

89106

Jubilee Clinical Research, Inc, Las Vegas

89113

Office of Dr. Edmond Pack, Las Vegas

89123

Wake Research - Clinical Research Center of Nevada, LLC, Las Vegas

92024

Diagnamics, Inc., Encinitas

93534

Om Research, LLC, Lancaster

95123

A.O.U. Policlinico G.Rodolico-San Marco, Catania

98105

Seattle Clinical Research Center, Seattle

2210001

Health Corporation of Galilee Medical Center, Nahariya

4428164

Meir Medical Center, Kfar Saba

5154475

Mayanei HaYeshua Medical Center, Bnei Brak

9112001

Hadassah Hebrew University Hospital Ein Kerem, Jerusalem

Alabama

"Alabama Clinical Therapeutics , Birmingham, AL"

"Central Research Associates , Birmingham, AL"

California

"Northern California Research , Sacramento"

"Alliance Research Institute , Bell Gardens, CA"

Maryland

"Continental Clinical Solutions , Towson, MD"

New Jersey

"The Center for Womens Health & Wellness, LLC , Lawrenceville, NJ"

08901

Rutgers Robert Wood Johnson Medical School, New Brunswick

Ohio

"Axia Women's Health , Seven Hills Women's Health Centers - Montgomery"

"HWC Women's Research Center , Englewood, OH"

45005-2593

HillTop Obstetrics & Gynecology, Franklin

South Carolina

"Medical University of South Carolina , MUSC Center for Womens Health - Department of Obstetrics and Gynecology"

"Coastal Carolina Research Center , Mount Pleasant, SC"

Styria

"Medizinische Univ Graz , Frauenheilkunde & Geburtshilfe"

Tyrol

"MedUni Innsbruck , Klinik fur Gyn Endo und Reproduktionsmed"

Unknown

"AKH Wien , Allg. Gynaekologie & gynaekologische Onkologie"

"AKH Wien , Gyn. Endokrinologie & Reproduktionsmedizin"

Flevoziekenhuis, Almere Stad

"St. Antonius Ziekenhuis , Utrecht - R&D Interne Geneeskunde"

602 00

Gynekologie MEDA s.r.o., Brno

350 02

Gynekologie Cheb s.r.o., Cheb

370 01

GYN-MIKA s.r.o., České Budějovice

500 02

MUDr. Stepan s.r.o., Hradec Králové

500 03

GYN-F s.r.o., Hradec Králové

547 01

Kestr-gyn s.r.o., Náchod

772 00

G-Centrum Olomouc s.r.o. Dr. Skrivanek, Olomouc

383 01

PT-MEDICA s.r.o., Prachatice

711 10

University General Hospital of Heraklion, Heraklion

3582 KE

Diakonessenhuis, Utrecht

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY