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

NCT ID: NCT05030584

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 628 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-27
• Study Completion Date: 2024-02-12

Brief Summary

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.

Conditions

Vasomotor Symptoms Associated With Menopause; Hot Flashes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Elinzanetant (BAY3427080)

Participants will receive 120 mg elinzanetant orally once daily.

Group Type: EXPERIMENTAL

Elinzanetant (BAY3427080)

Intervention Type: DRUG

120 mg elinzanetant orally once daily

Placebo

Participants will receive matching placebo orally once daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo orally once daily.

Interventions

Elinzanetant (BAY3427080)

120 mg elinzanetant orally once daily

Intervention Type: DRUG

Placebo

Matching placebo orally once daily.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Postmenopausal, defined as:

1. at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or

2. 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

3. 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

4. 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mobile ObGyn, P.C. | Mobile, AL

Mobile, Alabama, United States

Mesa Obstetricians and Gynecologists | Research Department

Mesa, Arizona, United States

National Institute of Clinical Research - Garden Grove

Garden Grove, California, United States

Marvel Clinical Research | Huntington Beach, CA

Huntington Beach, California, United States

Empire Clinical Research | Pomona, CA

Pomona, California, United States

Coastal Connecticut Research | New London, CT

New London, Connecticut, United States

IntimMedicine | Washington, DC

Washington D.C., District of Columbia, United States

Boca Midwifery

Boca Raton, Florida, United States

Helix Biomedics LLC | Boynton Beach, FL

Boynton Beach, Florida, United States

UF Health Women's Specialists - Emerson

Jacksonville, Florida, United States

Suncoast Clinical Research - Palm Harbor

Palm Harbor, Florida, United States

Physician Care Clinical Research LLC | Sarasota, FL

Sarasota, Florida, United States

Suncoast Clinical Research - New Port Richey

Trinity, Florida, United States

Paramount Research Solutions | College Park Location

College Park, Georgia, United States

Investigators Research Group, LLC

Brownsburg, Indiana, United States

Southern Clinical Research Associates

Metairie, Louisiana, United States

Southern Clinical Research, LLC

Zachary, Louisiana, United States

Johns Hopkins Hospital - Gynecology and Obstetrics

Baltimore, Maryland, United States

Boeson Research | Great Falls, MT

Great Falls, Montana, United States

Boeson Research | Missoula, MT

Missoula, Montana, United States

Affiliated Clinical Research, Inc. | Las Vegas, NV

Las Vegas, Nevada, United States

AMR - Las Vegas

Las Vegas, Nevada, United States

Elite Clinical Network (ECN) | Las Vegas Clinical Trials, LLC

North Las Vegas, Nevada, United States

M3 Wake Research | Raleigh, NC

Raleigh, North Carolina, United States

ClinOhio Research Services, LLC. | Columbus, OH

Columbus, Ohio, United States

HWC Women's Research Center | Englewood, OH

Englewood, Ohio, United States

Clinical Research Philadelphia | Philadelphia, PA

Philadelphia, Pennsylvania, United States

Venus Gynecology, LLC | Myrtle Beach, SC

Myrtle Beach, South Carolina, United States

Advances in Health, INC. | Houston, TX

Houston, Texas, United States

UTHealth Womens Research Program | Memorial City

Houston, Texas, United States

Elligo Health Research | Medical Colleagues of Texas

Hurst, Texas, United States

Elligo Health Research | Protenium Clinical Research

Katy, Texas, United States

Maximos Ob/Gyn

League City, Texas, United States

Tidewater Clinical Research - Norfolk

Norfolk, Virginia, United States

Eastern Virginia Medical School | OB/GYN Clinical Research Center

Norfolk, Virginia, United States

Seattle Clinical Research Center

Seattle, Washington, United States

CHU Saint-Pierre/UMC Sint-Pieter

Bruxelles - Brussel, , Belgium

UZ Gent

Ghent, , Belgium

UZ Leuven Gasthuisberg

Leuven, , Belgium

CHU de Liege | CHR Citadel - Department of Gyneacology and Obstetrics

Liège, , Belgium

Femicare vzw | Tienen, BE

Tienen, , Belgium

Medical Centre Asklepii OOD | Dupnitsa, Bulgaria

Dupnitsa, , Bulgaria

Multiprofile Hospital for Active Treatment | Avis Medica - Obstetrics and Gynecology

Pleven, , Bulgaria

Multiprofile Hospital for Active Treatment Plovdiv | Obstetrics and Gynecology

Plovdiv, , Bulgaria

Spec.Hospital for obstetrics and gynecology Selena OOD

Plovdiv, , Bulgaria

Multiprofile Hospital for Active Treatment Samokov | Gynecology Department

Samokov, , Bulgaria

Specialized Hospital for Active Treatment of Oncological Diseases Sofia Region | Oncological Gynecology Department

Sofia, , Bulgaria

Multiprofile Hospital for Active Treatment for Women's Health Nadezhda | Department of Obstetrics and Gynecology

Sofia, , Bulgaria

Diagnostic-Consultative Center Alexandrovska | Sofia, Bulgaria

Sofia, , Bulgaria

Medical Center Panacea OOD | Sofia, Bulgaria

Sofia, , Bulgaria

Multiprofile Hospital for Active Treatment Niamed OOD | Department of Obstetrics and Gynecology

Stara Zagora, , Bulgaria

SBAGAL Dr. Dimitar Stamatov | Varna, Bulgaria

Varna, , Bulgaria

IWK Health Centre | Department of Obstetrics and Gynaecology

Halifax, Nova Scotia, Canada

Manna Research (Burlington North)

Burlington, Ontario, Canada

Manna Research (Ottawa)

Nepean, Ontario, Canada

Ottawa Hospital-Riverside Campus

Ottawa, Ontario, Canada

Viable Clinical Research | Mississauga, Canada

Scarborough Village, Ontario, Canada

Manna Research (Quebec)

Lévis, Quebec, Canada

Manna Research (Montreal)

Pointe-Claire, Quebec, Canada

Alpha Recherche Clinique | Lebourgneuf

Québec, , Canada

Sanos Clinic | Gandrup, Denmark

Gandrup, , Denmark

Sanos Clinic | Herlev, Denmark

Herlev, , Denmark

Sanos Clinic | Syddanmark, Vejle, Denmark

Vejle, , Denmark

HUS / Naistenklinikka

Helsinki, , Finland

Pihlajalinna Lääkärikeskus Oy, Savo-Karjala

Joensuu, , Finland

Mehilainen | Mehilainen Kuopio

Kuopio, , Finland

Lääkärikeskus Gyneko, Gynaecological Medical Center | Oulu, Finland

Oulu, , Finland

Terveystalo | Terveystalo Tampere Research Unit

Tampere, , Finland

Gabinet Ginekologiczny Janusz Tomaszewski

Bialystok, , Poland

CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, , Poland

Centrum Medyczne Angelius Provita

Katowice, , Poland

Vita Longa Sp. z o.o.

Katowice, , Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, , Poland

Centrum Badawcze Wspolczesnej Terapii

Warsaw, , Poland

Hospital Universitario La Zarzuela - Ginecologia

Aravaca, Madrid, Spain

Hospital de la Santa Creu i Sant Pau | Gynecology Department

Barcelona, , Spain

Instituto Palacios | Investigation Research Unit - Gynecology department

Madrid, , Spain

Hospital Clinico San Carlos | Women´s Health Institute

Madrid, , Spain

Hospital Universitario 12 de Octubre | Department of Obstetrics and Gynecology

Madrid, , Spain

Virgen del Rocio University Hospital | Gynecology Unit

Seville, , Spain

Hospital Clinico Universitario | Gynecology and Obstetrics Department

Valencia, , Spain

MAC Clinical Research | Lancashire - Clinical Research Centre

Blackpool, , United Kingdom

NHS Greater Glasgow and Clyde | Glasgow Royal Infirmary - Gynaecology

Glasgow, , United Kingdom

Liverpool Women's NHS Foundation Trust | Liverpool Women's Hospital - Gynaecology

Liverpool, , United Kingdom

Imperial College Healthcare NHS Trust| Queen Charlotte's and Chelsea Hospital - Gynaecology

London, , United Kingdom

MAC Clinical Research | Greater Manchester Early Phase - Clinical Research Centre

Manchester, , United Kingdom

Countries

United States; Belgium; Bulgaria; Canada; Denmark; Finland; Poland; Spain; United Kingdom

References

Panay N, Joffe H, Maki PM, Nappi RE, Pinkerton JV, Simon JA, Soares CN, Thurston RC, Francuski M, Caetano C, Genga K, Haberland C, Haseli Mashhadi N, Laapas K, Parke S, Seitz C, Schwarz J, Zuurman L. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial. JAMA Intern Med. 2025 Nov 1;185(11):1319-1327. doi: 10.1001/jamainternmed.2025.4421.

Reference Type: DERIVED

PMID: 40920404 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.bayer.com/study/21810

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards

Other Identifiers

2021-000059-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

21810

Identifier Type: -

Identifier Source: org_study_id