Trial Condition(s):

Vasomotor symptoms associated with menopause, Hot Flashes

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-1)

Bayer Identifier:

21651

ClinicalTrials.gov Identifier:

NCT05042362

EudraCT Number:

2020-004908-33

Recruiting

Trial Purpose

Researchers are looking for a better way to treat women who have hot flashes after women have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman’s body has been through the menopause. Menopause is when women stop having a menstrual cycle, also called a period. During the menopause, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life.
The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. It works by blocking a protein called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. There are treatments for hot flashes in women who have been through the menopause, but may cause medical problems for some people.
In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes. A placebo looks like a treatment but does not have any medicine in it. To compare these study treatments, the doctors will ask the participants to record information about the participants’ hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe the hot flashes are. The researchers will look at the results from before treatment, after 4 weeks, and after 12 weeks of treatment.
The participants in this study will take two capsules of either elinzanetant or the placebo once a day. The participants who take elinzanetant will take it for 26 weeks. The participants who take the placebo will take it for 12 weeks and then take elinzanetant for the next 14 weeks.
During the study, the participants will visit the site approximately 9 times and perform 1 visit by phone. Each participant will be in the study for approximately 36 weeks. The treatment duration will be 26 weeks.
During the study, the participants will:
•    record information about the participants’ hot flashes in an electronic diary
•    answer questions about the participants’ symptoms
The doctors will:
•    check the participants’ health
•    take blood samples
•    ask the participants questions about what medicines the participants are taking and if the participants are having adverse events
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if doctors do not think the adverse events might be related to the study treatments.

Inclusion Criteria
- Postmenopausal, defined as:
       a. at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or
       b. at least 6 months of spontaneous amenorrhea prior to signing of informed consent with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or
       c. at least 6 months after hysterectomy at signing of informed consent with serum FSH levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or
       d. surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks prior to signing of informed consent.
  - Moderate to severe hot flash (HF) associated with the menopause and seeking treatment for this condition.
  - Participant has completed Hot Flash Daily Diary (HFDD) for at least 11 days during the two weeks preceding baseline visit, and participant has recorded at least 50 moderate or severe HF (including night-time HF) over the last 7 days that the HFDD was completed (assessed at the Baseline Visit).
Exclusion Criteria
- Any clinically significant prior or ongoing history of arrhythmias, heart block and QT prolongation either determined through clinical history or on ECG evaluation.
  - Any active ongoing condition that could cause difficulty in interpreting vasomotor symptoms (VMS) such as: infection that could cause pyrexia, pheochromocytoma, carcinoid syndrome.
  - Current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors). Women receiving adjuvant endocrine therapy (e.g. tamoxifen, aromatase inhibitors, GnRH analogues) cannot be enrolled in this study.
  - Uncontrolled or treatment-resistant hypertension. Women with mild hypertension can be included in the study if these women are medically cleared prior to study participation.
  - Untreated hyperthyroidism or hypothyroidism. 
• Treated hyperthyroidism with no abnormal increase of thyroid function laboratory parameters and no relevant clinical signs for > 6 months before signing of informed consent is acceptable.
• Treated hypothyroidism with normal thyroid function test results during screening and a stable (for ≥ 3 months before signing of informed consent) dose of replacement therapy is acceptable.
  - Any unexplained post-menopausal uterine bleeding.
  - Clinically relevant abnormal findings on mammogram.
  - Abnormal liver parameters.
  - Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer diagnosed based on endometrial biopsy during screening.

Trial Summary

Enrollment Goal
370
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
BAY3427080
Accepts Healthy Volunteers
No

Where to Participate

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Gynekologie MEDA s.r.o.

Brno, Czech Republic, 602 00

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AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie

Wien, Austria, 1090

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Recruiting
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AKH Wien | Gyn. Endokrinologie & Reproduktionsmedizin

Wien, Austria, 1090

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Medizinische Univ Graz | Frauenheilkunde & Geburtshilfe

Graz, Austria, 8036

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MedUni Innsbruck | Klinik fur Gyn Endo und Reproduktionsmed

Innsbruck, Austria, 6020

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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

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

Catania, Italy, 95123

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Fondazione IRCCS Policlinico San Matteo

Pavia, Italy, 27100

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Ospedale San Raffaele s.r.l.

Milano, Italy, 20132

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A.O.U. Careggi

Firenze, Italy, 50134

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Clinical Research of Philadelphia, LLC

Philadelphia, United States, 19114

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Wake Research, Inc.

Raleigh, United States, 27612

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Suncoast Clinical Research

Palm Harbor, United States, 34684

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Recruiting
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Women's Clinic of Lincoln, PC

Lincoln, United States, 68510

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Completed
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Venus Gynecology, LLC former Magnolia OB/GYN Research Center

Myrtle Beach, United States, 29572

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Recruiting
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Mesa Obstetricians and Gynecologists

Mesa, United States, 85206

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PT-MEDICA s.r.o.

Prachatice, Czech Republic, 383 01

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Southern Clinical Research Associates LLC

Metairie, United States, 70001

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Om Research, LLC

Lancaster, United States, 93534

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Aventiv Research - Columbus

Columbus, United States, 43213

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Mount Vernon Clinical Research, LLC

Sandy Springs, United States, 30126

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Chattanooga Medical Research, LLC

Chattanooga, United States, 37404

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Cedar Health Research, LLC

Dallas, United States, 75251

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Coastal Carolina Research Center

Mt. Pleasant, United States, 29464

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Women's Health Research Center, LLC

Lawrenceville, United States, 08648

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Completed
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Diagnamics, Inc.

Encinitas, United States, 92024

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Alliance for Multispecialty Research, LLC - Fort Meyers

Fort Myers, United States, 33912

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University Hospitals Landerbrook Health Center

Mayfield Heights, United States, 44124

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Soapstone Center for Clinical Research

Decatur, United States, 30034

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United Women's Clinical Research - Lyndhurst

Winston-Salem, United States, 27103

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HillTop Obstetrics & Gynecology

Franklin, United States, 45005-2593

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Continental Clinical Solutions, LLC

Towson, United States, 21204

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St. Vincent's Hospital - Birmingham

Birmingham, United States, 35205

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Noble Clinical Research

Tucson, United States, 85704

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

Austin, United States, 78705

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Valley OB-GYN Clinic

Saginaw, United States, 48602

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Office of Dr. James A. Simon, MD

Washington, United States, 20036

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Recruiting
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Medical University of South Carolina

Charleston, United States, 29425

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Bosque Womens Care

Albuquerque, United States, 87109

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Physician Care Clinical Research

Sarasota, United States, 34239

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Houston Center for Clinical Research, LLC

Sugarland, United States, 77479

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Alliance Research Institute

Tarzana, United States, 91356

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HWC Women’s Research Center

Englewood, United States, 45322

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Rutgers Robert Wood Johnson Medical School

New Brunswick, United States, 08901

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MUDr. Stepan s.r.o.

Hradec Kralove, Czech Republic, 500 02

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Kestr-gyn s.r.o.

Nachod, Czech Republic, 547 01

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Del Sol Research Management LLC

Tucson, United States, 85715

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Wake Research - Clinical Research Center of Nevada, LLC

Las Vegas, United States, 89123

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Recruiting
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MomDoc Women For Women

Scottsdale, United States, 85251

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Recruiting
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A.O.U. Pisana

Pisa, Italy, 56126

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

Olomouc, Czech Republic, 772 00

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Gynekologie Cheb s.r.o.

Cheb, Czech Republic, 350 02

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St. Antonius Ziekenhuis

Nieuwegein, Netherlands, 3435 CM

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Flevoziekenhuis

Almere, Netherlands

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Diakonessenhuis

UTRECHT, Netherlands, 3582 KE

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Canisius Wilhelmina Ziekenhuis

NIJMEGEN, Netherlands, 6532 SZ

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Medisense, Inc.

Atlanta, United States, 30363

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Clinical Research Prime

Idaho Falls, United States, 83404

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Health Corporation of Galilee Medical Center

Nahariya, Israel, 2210001

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Meir Medical Center

Kfar Saba, Israel, 4428164

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Clalit Health Services through HaEmek Medical Center

Afula, Israel, 1834111

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Mayanei HaYeshua Medical Center

Bnei Brak, Israel, 5154475

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Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel, 9112001

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Jubilee Clinical Research, Inc

Las Vegas, United States, 89106

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University General Hospital ATTIKON

Chaidari, Greece, 12462

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ARETAIEION University Hospital

Athens, Greece, 11528

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General Hospital of Thessaloniki Papageorgiou

Thessaloniki, Greece, 56403

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University General Hospital of Patras | Univ Obs & Gynae Cli

Patra, Greece, 26504

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Hippokration General Hospital of Thessaloniki

Thessaloniki, Greece, 54642

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Ioannina University General Hospital

Ioannina, Greece, 45500

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University General Hospital of Heraklion

Heraklion, Greece, 711 10

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Recruiting
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Circuit Clinical OB/GYN Associates of WNY

West Seneca, United States, 14224

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Recruiting
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Pecsi Tudomanyegyetem Klinikai Kozpont

Pecs, Hungary, 7624

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NAP - Rendelo, Private Clinic

Debrecen, Hungary, 4028

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Komaromi Selye Janos Korhaz

Komarom, Hungary, 2900

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Recruiting
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Tritonlife Medical Center

Budapest, Hungary, 1134

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Rub-Int Noi Egeszsegcentrum

Szekesfehervar, Hungary, 8000

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Recruiting
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Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

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Recruiting
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GYN-MIKA s.r.o.

Ceske Budejovice, Czech Republic, 370 01

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Recruiting
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GYN-F s.r.o.

Hradec Kralove, Czech Republic, 500 03

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Recruiting
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The Iowa Clinic - Ankeny

Ankeny, United States, 50023

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Not yet recruiting
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Revive Research Institute, Inc. - Women's Health

Dearborn Heights, United States, 48127

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Not yet recruiting
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Applied Research Center of Arkansas

Little Rock, United States, 72212

Status
Not yet recruiting
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OnSite Clinical Solutions, LLC

Charlotte, United States, 28277

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Not yet recruiting
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Axia Women's Health - Seven Hills Women's Health Centers

Cincinnati, United States, 45242

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Not yet recruiting
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Drug Studies America

Marietta, United States, 30060

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Trial Design