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 52 weeks in women who have been through the menopause (OASIS-3)

Bayer Identifier:

21810

ClinicalTrials.gov Identifier:

NCT05030584

EudraCT Number:

2021-000059-38

Recruitment Complete

Trial Purpose

Researchers are looking for a better way to treat women who have hot flashes after they 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 is a treatment that looks like a medicine but does not have any medicine in it. To compare these study treatments, the participants will record information about their hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe they are. They will study the results from before treatment 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 will take the study treatments for 52 weeks.
During the study, the participants will visit their study site approximately 11 times and perform 2 visits by phone. Each participant will be in the study for approximately 62 weeks.
During the study, the participants will:
•    record information about their hot flashes in an electronic diary
•    answer questions about their symptoms
The doctors will:
•    check the participants’ health
•    take blood samples
•    ask the participants questions about what medicines they are taking and if they 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 they 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 is showing eligibility with respect to previous inclusion criterion during this time period.
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 they 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
508
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Elinzanetant (BAY3427080)
Accepts Healthy Volunteers
No

Where to Participate

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Queen Charlottes & Chelseas Hospital

London, United Kingdom, W12 0NN

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Liverpool Womens Hospital

Liverpool, United Kingdom, L8 7SS

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Glasgow Royal Infirmary | Haematology

Glasgow, United Kingdom, G4 0SF

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Southern Clinical Research Associates LLC

Metairie, United States, 70001

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Advances in Health, Inc.

Houston, United States, 77030

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Suncoast Clinical Research Center, Inc.

New Port Richey, United States, 34652

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Paramount Research Solutions-College Park

College Park, United States, 30349

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Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain, 08041

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Hospital Sanitas La Zarzuela

Aravaca, Spain, 28023

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H Univ. 12 de Octubre | Ginecología y Obstetricia

Madrid, Spain, 28041

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Sanos Clinic - Nordjylland

Gandrup, Denmark, 9362

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Sanos Clinic - Syddanmark

Vejle, Denmark, 7100

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Sanos Clinic - Herlev

Herlev, Denmark, 2730

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MC Asklepii OOD

Dupnitza, Bulgaria, 2600

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Medical Center Panaceya

Sofia, Bulgaria, 1606

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MHAT Avis Medika

Pleven, Bulgaria, 5800

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MHAT Niamed

Stara Zagora, Bulgaria, 6000

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Multiprofile Hospital for Activ Treatment Plovdiv

Plovdiv, Bulgaria, 4000

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SHOGAT Prof Dimitar Stamatov

Varna, Bulgaria, 9000

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MHAT Samokov

Samokov, Bulgaria, 2000

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DCC Aleksandrovska

Sofia, Bulgaria, 1431

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Helix Biomedics, LLC

Boynton Beach, United States, 33435

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University of Florida College of Medicine

Jacksonville, United States, 32207

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Tidewater Physicians for Women

Norfolk, United States, 23502

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Office of Dr. Edmond Pack

Las Vegas, United States, 89113

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Physician Care Clinical Research

Sarasota, United States, 34239

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Seattle Clinical Research Center

Seattle, United States, 98105

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Marvel Clinical Research, LLC

Huntington Beach, United States, 92647

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Las Vegas Clinical Trials, LLC

North Las Vegas, United States, 89030

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Suncoast Clinical Research

Palm Harbor, United States, 34684

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Wake Research, Inc.

Raleigh, United States, 27612

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Mesa Obstetricians and Gynecologists

Mesa, United States, 85206

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Venus Gynecology, LLC former Magnolia OB/GYN Research Center

Myrtle Beach, United States, 29572

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Clinical Research of Philadelphia, LLC

Philadelphia, United States, 19114

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Women's Health Texas

Katy, United States, 77450

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Office of Dr. James A. Simon, MD

Washington, United States, 20036

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David I Lubetkin, MD, LLC

Boca Raton, United States, 33486

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Mobile Ob-Gyn, PC

Mobile, United States, 36608-6703

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Eastern Virginia Medical School

Norfolk, United States, 23507

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UT Health Women’s Research Center at Memorial City

Houston, United States, 77024

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Columbus OB-GYN/Radiant Research

Columbus, United States, 43213

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Empire Clinical Research

Pomona, United States, 91767

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Coastal Connecticut Research, LLC

New London, United States, 06320

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Johns Hopkins Univ School Med|Johns Hopkins Hosp Dept Gyn/Ob

Baltimore, United States, 21287

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Gabinet Ginekologiczny Janusz Tomaszewski

Bialystok, Poland, 15-244

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Vita Longa Sp. z o.o.

Katowice, Poland, 40-748

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Centrum Medyczne Angelius Provita

Katowice, Poland, 40-611

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Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, Poland, 71-434

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CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, Poland, 40-156

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Centrum Badawcze Wspolczesnej Terapii

Warszawa, Poland, 02-679

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Hospital Clínico Univ. Valencia | Ginecología y obstetricia

Valencia, Spain, 46010

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Instituto Palacios de Salud y Medicina de la Mujer

Madrid, Spain, 28009

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MAC Research Centre Blackpool

Blackpool, United Kingdom

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AMR Las Vegas

Las Vegas, United States, 89119

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Ottawa Hospital-Riverside Campus

Ottawa, Canada, K1H 7W9

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Alpha Recherche Clinique LB9

Quebec, Canada, G2J 0C4

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Viable Clinical Research Corporation

Scarborough, Canada, M1P 2T7

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Manna Research (Ottawa)

Nepean, Canada, K2J 4A7

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Manna Research (Burlington North)

Burlington, Canada, L7M 4Y1

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Manna Research (Montreal)

Pointe-Claire, Canada, H9R 4S3

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Manna Research (Quebec)

Levis, Canada, G6W 0M5

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UZ Gent

GENT, Belgium, 9000

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UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

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CHR de la Citadelle - Department of Gynaecology & Obstetrics

LIEGE, Belgium, 4000

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CHU Saint-Pierre/UMC Sint-Pieter

BRUXELLES - BRUSSEL, Belgium, 1000

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Femicare vzw

Tienen, Belgium, 3300

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Lääkärikeskus Gyneko

Oulu, Finland, 90100

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HUS / Naistenklinikka

Helsinki, Finland, 00029

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Mehiläinen Kuopio

Kuopio, Finland, 70100

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Terveystalo Tampere

Tampere, Finland, 33100

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H Univ. Virgen Rocío | Ginecología

Sevilla, Spain, 41013

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Pihlajalinna Lääkärikeskus Oy, Savo-Karjala

Joensuu, Finland, 80100

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National Institute of Clinical Research - Garden Grove

Garden Grove, United States, 92844

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Southern Clinical Research, LLC

Zachary, United States, 70791

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Investigators Research Group, LLC

Brownsburg, United States, 46112

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Boeson Research - Missoula

Missoula, United States, 59804

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MHAT for Women's Health - Nadezhda OOD

Sofia, Bulgaria, 1330

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Spec. Hospital for Active Treatment of Oncological Diseases

Sofia, Bulgaria, 1233

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Maximos Ob/Gyn

League City, United States, 77573

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MAC Research Centre - Manchester

Manchester, United Kingdom

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Boeson Research - Great Falls OBGYN

Great Falls, United States, 59405

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HWC Women’s Research Center

Englewood, United States, 45322

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Spec.Hospital for obstetrics and gynecology Selena OOD

Plovdiv, Bulgaria, 4002

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Trial Design