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 (OASIS-2)

PHASE3CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

October 29, 2021

Primary Completion Date

June 13, 2023

Study Completion Date

October 10, 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 (95)

1011

Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne

1605

Kirkeparken Spesialistpraksis, Fredrikstad

4005

Medicus Stavanger AS, Stavanger

5404

Kantonsspital Baden, Baden

7014

Medicus AS, Trondheim

8091

UniversitätsSpital Zürich, Zurich

10032

Columbia University Medical Center, New York

10128

A.O. Ordine Mauriziano, Turin

10629

emovis GmbH, Berlin

12627

Synexus Berlin Clinical Research Centre, Berlin

20705

Ob and Gyn Physicians MidAtlantic - SKYCRNG, Oxon Hill

22903

University of Virginia Midlife Health Center, Charlottesville

23456

Tidewater Clinical Research, Inc., Norfolk

27607

Unified Women's Clinical Research - Raleigh, Raleigh

28562

Eastern Carolina Women's Center, New Bern

29607

Tribe Clinical Research, Greenville

31406

Fellows Research Alliance - Savannah, Savannah

33016

Sweet Hope Research Specialty, Inc. - Miami Lakes, Hialeah

33166

Ocean Blue Medical Research Center, Inc., Miami Springs

33435

Helix Biomedics, LLC, Boynton Beach

33603

Clinical Research of West Florida, Inc - Clearwater, Clearwater

33765

Clinical Research of West Florida, Inc., Clearwater

34652

Suncoast Clinical Research Center, Inc., New Port Richey

34761

Sensible Healthcare, LLC, Ocoee

35218

Accel Research Sites - Cahaba Medical Care, Birmingham

36604

Women's Health Alliance of Mobile, Mobile

37126

A.O.U.I. Verona, Verona

38120

Medical Research Center of Memphis, LLC, Memphis

Memphis Obstetrics and Gynecological Association, PC, Memphis

39003

Gynpraxetabor s.r.o., Tábor

39202

Metro Jackson OB-GYN, Jackson

45355

Frauenärzte am Schloss Borbeck, Essen

47799

Medplus Nordrhein, Krefeld

48604

Saginaw Valley Medical Research Group, LLC, Saginaw

52074

Praxis Hr. Dr. S. Fiedler, Aachen

60313

Synexus Frankfurt Clinical Research Centre, Frankfurt am Main

70072

Tandem Clinical Research, Marrero

70433

Clinical Trials Management, LLC - Covington, Covington

75024

ClinRx Research, LLC, Plano

77024

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

77030

Advances in Health, Inc., Houston

77802

DiscoveResearch, Inc., Bryan

78413

South Texas Clinical Research, Corpus Christi

78660

Austin Regional Clinic, Pflugerville

80111

Advanced Women's Health Institute, Greenwood Village

80131

A.O.U. Policlinico Federico II Napoli, Napoli

80228

Physicians Research Options, LLC, Lakewood

83713

Family Care Research, Boise

85381

Onyx Clinical Research - Peoria, Peoria

90717

Torrance Clinical Research- Lomita, Lomita

92111

Womens Health Care Research Corporation, San Diego

92844

National Institute of Clinical Research - Garden Grove, Garden Grove

95648

Clinical Trials Research, Lincoln

Idaho

"Leavitt Clinical Research , Idaho Falls, ID"

Illinois

"Affinity Health Research Institute , Oak Brook, IL"

08648

Lawrence OB/GYN Associates, Lawrenceville

Oregon

"Oregon Health and Science Univ , OHSU OBGYN-Women's Hlth Res"

76104-4145

Signature GYN Services, Pllc, Fort Worth

T5A 4L8

Alta Clinical Research, Edmonton

G7H 0S7

Ecogene21, Chicoutimi

H1M 1B1

Recherche GCP Research, Montreal

H4P 2S4

Clinique OVO, Montreal

J1L 0H8

Diex Recherche Sherbrooke Inc., Sherbrooke

G3K 2P8

ALPHA Recherche Clinique, Val-Bélair

G6P 6P6

Diex Recherche Victoriaville Inc., Victoriaville

G1V 4T3

Diex Recherche Quebec Inc., Québec

Unknown

"Alpha Recherche Clinique , Lebourgneuf"

"Centro Hospitalar de Lisboa Ocidental , Clin Res Dept"

794 01

GynPorCentrum s.r.o., Krnov

301 00

MUDr. Martina Maresova Rosenbergova, gynekologie, Pilsen

160 00

Gynekologie Studentsky dum s.r.o., Prague

337 01

GYNEVI s.r.o., Rokycany

04103

Synexus Leipzig Clinical Research Centre, Leipzig

06406

Praxis f. Gynäkologie und Geburtshilfe, Bernburg

06110

Frauenarztpraxis Dr. Inka Kiesche, Halle

07545

Femme Frauenarztpraxis, Gera

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

0161

Medicus Oslo AS, Oslo

0450

OUS Ullevål Gynecology Department, Oslo

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

10-117

Etyka Osrodek Badan Klinicznych, Olsztyn

71-434

Twoja Przychodnia - Szczecinskie Centrum Medyczne, Szczecin

Lisbon District

"Luz Saude , Hospital Beatriz Angelo - Centro de Investigacao Clinica"

4464-513

ULSM - Hospital Pedro Hispano, Matosinhos Municipality

2900-722

Hospital da Luz - Setubal, Setúbal

3004-561

CHUC - Hospitais da U. Coimbra - Servico de Ginecologia, Coimbra

1649-035

CHULN - H. Sta.Maria (Centro de Investigacao Clinica), Lisbon

4050-651

CHUP - Servico de Investigacao Clinica, Porto

986 01

GYNARIN, s.r.o., Fiľakovo

920 01

ULMUS, s r.o., Hlohovec

040 15

Nemocnica AGEL Kocice-Saca a.s., Kosice - Saca

984 01

GA Lucenec s.r.o, Lučenec

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY