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 52 Weeks in Women Who Have Been Through the Menopause

PHASE3CompletedINTERVENTIONAL
Enrollment

628

Participants

Timeline

Start Date

August 27, 2021

Primary Completion Date

March 29, 2023

Study Completion Date

February 12, 2024

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 (83)

1000

CHU Saint-Pierre/UMC Sint-Pieter, Bruxelles - Brussel

1233

Spec. Hospital for Active Treatment of Oncological Diseases, Sofia

1330

MHAT for Women's Health - Nadezhda OOD, Sofia

1431

DCC Aleksandrovska, Sofia

1606

Medical Center Panaceya, Sofia

2000

MHAT Samokov, Samokov

2600

MC Asklepii OOD, Dupnitsa

2730

Sanos Clinic - Herlev, Herlev

3000

UZ Leuven Gasthuisberg, Leuven

3300

Femicare vzw, Tienen

4000

CHR de la Citadelle - Department of Gynaecology & Obstetrics, Liège

Multiprofile Hospital for Activ Treatment Plovdiv, Plovdiv

4002

Spec.Hospital for obstetrics and gynecology Selena OOD, Plovdiv

5800

MHAT Avis Medika, Pleven

6000

MHAT Niamed, Stara Zagora

7100

Sanos Clinic - Syddanmark, Vejle

9000

UZ Gent, Ghent

SHOGAT Prof Dimitar Stamatov, Varna

9362

Sanos Clinic - Nordjylland, Gandrup

19114

Clinical Research of Philadelphia, LLC, Philadelphia

20036

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

23502

Tidewater Physicians for Women, Norfolk

27612

Wake Research, Inc., Raleigh

28009

Instituto Palacios de Salud y Medicina de la Mujer, Madrid

28023

Hospital Sanitas La Zarzuela, Aravaca

29572

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

30349

Paramount Research Solutions-College Park, College Park

32207

University of Florida College of Medicine, Jacksonville

33100

Terveystalo Tampere, Tampere

33435

Helix Biomedics, LLC, Boynton Beach

33486

David I Lubetkin, MD, LLC, Boca Raton

34239

Physician Care Clinical Research, Sarasota

34652

Suncoast Clinical Research Center, Inc., New Port Richey

34684

Suncoast Clinical Research, Palm Harbor

43213

Columbus OB-GYN/Radiant Research, Columbus

45322

HWC Women's Research Center, Englewood

46112

Investigators Research Group, LLC, Brownsburg

59405

Boeson Research - Great Falls OBGYN, Great Falls

59804

Boeson Research - Missoula, Missoula

70001

Southern Clinical Research Associates LLC, Metairie

70100

Mehiläinen Kuopio, Kuopio

70791

Southern Clinical Research, LLC, Zachary

77024

UT Health Women's Research Center at Memorial City, Houston

77030

Advances in Health, Inc., Houston

77450

Women's Health Texas, Katy

77573

Maximos Ob/Gyn, League City

80100

Pihlajalinna Lääkärikeskus Oy, Savo-Karjala, Joensuu

85206

Mesa Obstetricians and Gynecologists, Mesa

89030

Las Vegas Clinical Trials, LLC, North Las Vegas

89113

Office of Dr. Edmond Pack, Las Vegas

89119

AMR Las Vegas, Las Vegas

90100

Lääkärikeskus Gyneko, Oulu

91767

Empire Clinical Research, Pomona

92647

Marvel Clinical Research, LLC, Huntington Beach

92844

National Institute of Clinical Research - Garden Grove, Garden Grove

98105

Seattle Clinical Research Center, Seattle

36608-6703

Mobile Ob-Gyn, PC, Mobile

06320

Coastal Connecticut Research, LLC, New London

Maryland

"Johns Hopkins Univ School Med, Johns Hopkins Hosp Dept Gyn/Ob"

Virginia

"Eastern Virginia Medical School , OB/GYN Clinical Research Center"

L7M 4Y1

Manna Research (Burlington North), Burlington

K2J 4A7

Manna Research (Ottawa), Nepean

K1H 7W9

Ottawa Hospital-Riverside Campus, Ottawa

M1P 2T7

Viable Clinical Research Corporation, Scarborough Village

G6W 0M5

Manna Research (Quebec), Lévis

H9R 4S3

Manna Research (Montreal), Pointe-Claire

G2J 0C4

Alpha Recherche Clinique LB9, Québec

00029

HUS / Naistenklinikka, Helsinki

15-244

Gabinet Ginekologiczny Janusz Tomaszewski, Bialystok

40-156

CLINICAL MEDICAL RESEARCH Sp. z o. o., Katowice

40-611

Centrum Medyczne Angelius Provita, Katowice

40-748

Vita Longa Sp. z o.o., Katowice

71-434

Twoja Przychodnia - Szczecinskie Centrum Medyczne, Szczecin

02-679

Centrum Badawcze Wspolczesnej Terapii, Warsaw

Unknown

"Hospital de la Santa Creu i Sant Pau , Gynecology Department"

"H Univ. 12 de Octubre , Ginecología y Obstetricia"

"H Univ. Virgen Rocío , Ginecología"

"Hospital Clinico Universitario , Gynecology and Obstetrics Department"

MAC Research Centre Blackpool, Blackpool

"Glasgow Royal Infirmary , Haematology"

MAC Research Centre - Manchester, Manchester

L8 7SS

Liverpool Womens Hospital, Liverpool

W12 0NN

Queen Charlottes & Chelseas Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY