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

NCT05030584 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 218102021-000059-38
• Study Type: interventional
• Target: 628
• Locations: 9 countries
• Sites: 86

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

Keywords

Menopause

Outcome Measures

Primary Outcomes (1)

• Mean Change in Frequency of Moderate to Severe Hot Flashes (HFs) From Baseline to Week 12 (Assessed by Hot Flash Daily Diary [HFDD])

  The HFDD items assess the number of mild, moderate, and severe HF experienced during the day and during the night. Mild HF are defined as a "sensation of heat without sweating", moderate HF are defined as a "sensation of heat with sweating, but able to continue activity", and severe HF are defined as a "sensation of heat with sweating, causing cessation (stopping) of activity".

  Baseline to Week 12

Secondary Outcomes (2)

• Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline Over Time.

  Baseline to Week 56

• Mean Change in Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline Over Time

  Baseline to Week 56

Study Arms (2)

Elinzanetant (BAY3427080)

EXPERIMENTAL

Participants will receive 120 mg elinzanetant orally once daily.

Drug: Elinzanetant (BAY3427080)

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo orally once daily.

Drug: Placebo

Interventions

Elinzanetant (BAY3427080) DRUG

120 mg elinzanetant orally once daily

Elinzanetant (BAY3427080)

Placebo DRUG

Matching placebo orally once daily.

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal, defined as:
• at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or
• 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
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (86)

Mobile ObGyn, P.C. | Mobile, AL

Mobile, Alabama, 36608, United States

Location

Mesa Obstetricians and Gynecologists | Research Department

Mesa, Arizona, 85206, United States

Location

National Institute of Clinical Research - Garden Grove

Garden Grove, California, 92844, United States

Location

Marvel Clinical Research | Huntington Beach, CA

Huntington Beach, California, 92647, United States

Location

Empire Clinical Research | Pomona, CA

Pomona, California, 91767, United States

Location

Coastal Connecticut Research | New London, CT

New London, Connecticut, 06320, United States

Location

IntimMedicine | Washington, DC

Washington D.C., District of Columbia, 20036, United States

Location

Boca Midwifery

Boca Raton, Florida, 33486, United States

Location

Helix Biomedics LLC | Boynton Beach, FL

Boynton Beach, Florida, 33435, United States

Location

UF Health Women's Specialists - Emerson

Jacksonville, Florida, 32207, United States

Location

Suncoast Clinical Research - Palm Harbor

Palm Harbor, Florida, 34684, United States

Location

Physician Care Clinical Research LLC | Sarasota, FL

Sarasota, Florida, 34239, United States

Location

Suncoast Clinical Research - New Port Richey

Trinity, Florida, 34655, United States

Location

Paramount Research Solutions | College Park Location

College Park, Georgia, 30349, United States

Location

Investigators Research Group, LLC

Brownsburg, Indiana, 46112, United States

Location

Southern Clinical Research Associates

Metairie, Louisiana, 70001, United States

Location

Southern Clinical Research, LLC

Zachary, Louisiana, 70791, United States

Location

Johns Hopkins Hospital - Gynecology and Obstetrics

Baltimore, Maryland, 21287, United States

Location

Boeson Research | Great Falls, MT

Great Falls, Montana, 59405, United States

Location

Boeson Research | Missoula, MT

Missoula, Montana, 59804, United States

Location

Affiliated Clinical Research, Inc. | Las Vegas, NV

Las Vegas, Nevada, 89113, United States

Location

AMR - Las Vegas

Las Vegas, Nevada, 89119, United States

Location

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

North Las Vegas, Nevada, 89030, United States

Location

M3 Wake Research | Raleigh, NC

Raleigh, North Carolina, 27612, United States

Location

ClinOhio Research Services, LLC. | Columbus, OH

Columbus, Ohio, 43213, United States

Location

HWC Women's Research Center | Englewood, OH

Englewood, Ohio, 45322, United States

Location

Clinical Research Philadelphia | Philadelphia, PA

Philadelphia, Pennsylvania, 19114, United States

Location

Venus Gynecology, LLC | Myrtle Beach, SC

Myrtle Beach, South Carolina, 29572, United States

Location

Advances in Health, INC. | Houston, TX

Houston, Texas, 77030, United States

Location

UTHealth Womens Research Program | Memorial City

Houston, Texas, 77054, United States

Location

Elligo Health Research | Medical Colleagues of Texas

Hurst, Texas, 76054, United States

Location

Elligo Health Research | Protenium Clinical Research

Katy, Texas, 77493, United States

Location

Maximos Ob/Gyn

League City, Texas, 77573, United States

Location

Tidewater Clinical Research - Norfolk

Norfolk, Virginia, 23502, United States

Location

Eastern Virginia Medical School | OB/GYN Clinical Research Center

Norfolk, Virginia, 23507, United States

Location

Seattle Clinical Research Center

Seattle, Washington, 98105, United States

Location

CHU Saint-Pierre/UMC Sint-Pieter

Bruxelles - Brussel, 1000, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

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

Liège, 4000, Belgium

Location

Femicare vzw | Tienen, BE

Tienen, 3300, Belgium

Location

Medical Centre Asklepii OOD | Dupnitsa, Bulgaria

Dupnitsa, 2600, Bulgaria

Location

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

Pleven, 5800, Bulgaria

Location

Multiprofile Hospital for Active Treatment Plovdiv | Obstetrics and Gynecology

Plovdiv, 4000, Bulgaria

Location

Spec.Hospital for obstetrics and gynecology Selena OOD

Plovdiv, 4002, Bulgaria

Location

Multiprofile Hospital for Active Treatment Samokov | Gynecology Department

Samokov, 2000, Bulgaria

Location

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

Sofia, 1233, Bulgaria

Location

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

Sofia, 1330, Bulgaria

Location

Diagnostic-Consultative Center Alexandrovska | Sofia, Bulgaria

Sofia, 1431, Bulgaria

Location

Medical Center Panacea OOD | Sofia, Bulgaria

Sofia, 1606, Bulgaria

Location

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

Stara Zagora, 6000, Bulgaria

Location

SBAGAL Dr. Dimitar Stamatov | Varna, Bulgaria

Varna, 9000, Bulgaria

Location

IWK Health Centre | Department of Obstetrics and Gynaecology

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Manna Research (Burlington North)

Burlington, Ontario, L7M 4Y1, Canada

Location

Manna Research (Ottawa)

Nepean, Ontario, K2J 4A7, Canada

Location

Ottawa Hospital-Riverside Campus

Ottawa, Ontario, K1H 7W9, Canada

Location

Viable Clinical Research | Mississauga, Canada

Scarborough Village, Ontario, M1P 2T7, Canada

Location

Manna Research (Quebec)

Lévis, Quebec, G6W 0M5, Canada

Location

Manna Research (Montreal)

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Alpha Recherche Clinique | Lebourgneuf

Québec, G2J 0C4, Canada

Location

Sanos Clinic | Gandrup, Denmark

Gandrup, 9362, Denmark

Location

Sanos Clinic | Herlev, Denmark

Herlev, 2730, Denmark

Location

Sanos Clinic | Syddanmark, Vejle, Denmark

Vejle, 7100, Denmark

Location

HUS / Naistenklinikka

Helsinki, 29, Finland

Location

Pihlajalinna Lääkärikeskus Oy, Savo-Karjala

Joensuu, 80100, Finland

Location

Mehilainen | Mehilainen Kuopio

Kuopio, 70100, Finland

Location

Lääkärikeskus Gyneko, Gynaecological Medical Center | Oulu, Finland

Oulu, 90100, Finland

Location

Terveystalo | Terveystalo Tampere Research Unit

Tampere, 33100, Finland

Location

Gabinet Ginekologiczny Janusz Tomaszewski

Bialystok, 15-224, Poland

Location

CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, 40-156, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland

Location

Vita Longa Sp. z o.o.

Katowice, 40-748, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-500, Poland

Location

Centrum Badawcze Wspolczesnej Terapii

Warsaw, 02-679, Poland

Location

Hospital Universitario La Zarzuela - Ginecologia

Aravaca, Madrid, 28023, Spain

Location

Hospital de la Santa Creu i Sant Pau | Gynecology Department

Barcelona, 8041, Spain

Location

Instituto Palacios | Investigation Research Unit - Gynecology department

Madrid, 28009, Spain

Location

Hospital Clinico San Carlos | Women´s Health Institute

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre | Department of Obstetrics and Gynecology

Madrid, 28041, Spain

Location

Virgen del Rocio University Hospital | Gynecology Unit

Seville, 41013, Spain

Location

Hospital Clinico Universitario | Gynecology and Obstetrics Department

Valencia, 46010, Spain

Location

MAC Clinical Research | Lancashire - Clinical Research Centre

Blackpool, FY2 0JH, United Kingdom

Location

NHS Greater Glasgow and Clyde | Glasgow Royal Infirmary - Gynaecology

Glasgow, G4 0SF, United Kingdom

Location

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

Liverpool, L8 7SS, United Kingdom

Location

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

London, W12 0NN, United Kingdom

Location

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

Manchester, M13 9NQ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40920404 DERIVED

Related Links

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

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer AG

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 1, 2021
• Study Start: August 27, 2021
• Primary Completion: March 29, 2023
• Study Completion: February 12, 2024
• Last Updated: December 1, 2025
• Results First Posted: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (36); BE (5); CA (8); GB (5); ES (7); BU (11); DK (3); PL (6); FI (5)