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

NCT05042362 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 216512020-004908-33
• Study Type: interventional
• Target: 396
• Locations: 8 countries
• Sites: 99

Brief Summary

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.

Conditions

Hot Flashes; Vasomotor Symptoms Associated With Menopause

Keywords

Menopause

Outcome Measures

Primary Outcomes (4)

• Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD]).

  The frequency of moderate to severe HF for each week during the treatment period was calculated using the available data during that particular week. Specifically for Week 4, Days 22-28 were used (Day 1 corresponds to start of treatment). Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week

  From baseline to Week 4

• Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD).

  The frequency of moderate to severe HF for each week during the treatment period was calculated using the available data during that particular week. Specifically for Week 12, Days 78-84 were used (Day 1 corresponds to start of treatment). Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week

  From baseline to Week 12

• Mean Change in Severity of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD).

  In the HFDD, hot flash (HF) severity is scored as 1=mild, 2=moderate, and 3=severe; a decrease indicates improvement. The diary records the number of mild, moderate, and severe HFs during day and night. Mild HFs are a "sensation of heat without sweating"; moderate are "heat with sweating but able to continue activity"; severe are "heat with sweating that stops activity." Baseline mean daily severity is calculated as: (2×moderateHFs+3×severeHFs)÷(totalmoderate+severeHFs).(2 × moderate HFs + 3 × severe HFs) ÷ (total moderate + severe HFs).(2×moderateHFs+3×severeHFs)÷(totalmoderate+severeHFs). If none occur, severity=0. Weekly severity during treatment is based on available days (Week 4: Days 22-28; Week 12: Days 78-84; Day 1=start of treatment), averaging the mean daily severity for that week. If more than 2 days are missing, the weekly value is set to missing.

  From baseline to Week 4

• Mean Change in Severity of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD).

  In the HFDD, hot flash (HF) severity is categorized as 1=mild, 2=moderate, 3=severe; thus, a decrease indicates improvement. The HFDD records the number of mild, moderate, and severe HFs during day and night. Mild HFs are a "sensation of heat without sweating"; moderate involve "heat with sweating but able to continue activity"; severe involve "heat with sweating that stops activity." Mean daily severity at baseline is calculated as: (2 × moderate HFs) + (3 × severe HFs)\\\] ÷ (total moderate + severe HFs). If none occur, severity is set to 0. Weekly severity during treatment is based on available days (Week 4: Days 22-28; Week 12: Days 78-84; Day 1=start of treatment), averaging mean daily severity across that week. If more than 2 days are missing, the week is set to missing.

  From baseline to Week 12

Secondary Outcomes (6)

• Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 1 (Assessed by HFDD).

  From baseline to Week 1

• Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time.

  From baseline to Week 30

• Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline to Week 12.

  From baseline to Week 12

• Mean Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline to Week 12.

  From baseline to Week 12

• Mean Beck Depression Inventory (BDI-II) Total Score From Baseline to Week 12.

  From baseline to Week 12

Study Arms (2)

Elinzanetant (BAY3427080)

EXPERIMENTAL

Participants will receive 120 mg elinzanetant orally once daily for 26 weeks.

Drug: Elinzanetant (BAY3427080)

Placebo + elinzanetant

PLACEBO COMPARATOR

Participants will receive matching placebo orally once daily for 12 weeks, followed by elinzanetant 120 mg for 14 weeks.

Drug: Elinzanetant (BAY3427080); Drug: Placebo

Interventions

Elinzanetant (BAY3427080) DRUG

120 mg elinzanetant orally once daily

Elinzanetant (BAY3427080); Placebo + elinzanetant

Placebo DRUG

Matching placebo orally once daily

Placebo + elinzanetant

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.
• 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).

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 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (99)

Alabama Clinical Therapeutics | Birmingham, AL

Birmingham, Alabama, 35205, United States

Location

Central Research Associates | Birmingham, AL

Birmingham, Alabama, 35205, United States

Location

Mesa Obstetricians and Gynecologists | Research Department

Mesa, Arizona, 85206, United States

Location

MomDoc Women's Health Research | Scottsdale, AZ

Scottsdale, Arizona, 85251, United States

Location

Noble Clinical Research | Tucson, AZ

Tucson, Arizona, 85704, United States

Location

Del Sol Research | Women Health studies

Tucson, Arizona, 85715, United States

Location

Applied Research Center of Arkansas

Little Rock, Arkansas, 72205, United States

Location

Alliance Research Institute | Bell Gardens, CA

Bell Gardens, California, 90201, United States

Location

Diagnamics | Encinitas, CA

Encinitas, California, 92024, United States

Location

Om Research LLC | Lancaster, CA

Lancaster, California, 93534, United States

Location

Northern California Research | Sacramento

Sacramento, California, 95821, United States

Location

IntimMedicine | Washington, DC

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

Location

AMR - Fort Myers, FL

Fort Myers, Florida, 33912, United States

Location

Suncoast Clinical Research Inc | Pinellas

Palm Harbor, Florida, 34684, United States

Location

Physician Care Clinical Research LLC | Sarasota, FL

Sarasota, Florida, 34239, United States

Location

Medisense Inc. | Atlanta, GA

Atlanta, Georgia, 30363, United States

Location

Paramount Research Solutions | College Park Location

College Park, Georgia, 30349, United States

Location

Soapstone Center for Clinical Research, Inc. | Decatur, GA

Decatur, Georgia, 30033-3500, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

M3 Wake Research Atlanta

Sandy Springs, Georgia, 30126, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Investigators Research Group, LLC

Brownsburg, Indiana, 46112, United States

Location

The Iowa Clinic - Ankeny

Ankeny, Iowa, 50023, United States

Location

Southern Clinical Research Associates | Metairie, LA

Metairie, Louisiana, 70001, United States

Location

Continental Clinical Solutions | Towson, MD

Towson, Maryland, 21204, United States

Location

Revive Research Institute, Inc. - Women's Health

Dearborn Heights, Michigan, 48127, United States

Location

Valley OBGYN

Saginaw, Michigan, 48602, United States

Location

Women's Clinic of Lincoln, P.C. | Lincoln, NE

Lincoln, Nebraska, 68510, United States

Location

Jubilee Clinical Research Inc | Las Vegas, NV

Las Vegas, Nevada, 89106, United States

Location

Affiliated Clinical Research, Inc. | Las Vegas, NV

Las Vegas, Nevada, 89113, United States

Location

M3 Wake Research - Clinical Research Center of Nevada

Las Vegas, Nevada, 89123, United States

Location

The Center for Womens Health & Wellness, LLC | Lawrenceville, NJ

Lawrenceville, New Jersey, 08648, United States

Location

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Velocity Clinical Research - Albuquerque

Albuquerque, New Mexico, 87107, United States

Location

Bosque Women's Care | Albuquerque, NM

Albuquerque, New Mexico, 87109, United States

Location

Circuit Clinical | OB GYN Associates of WNY

West Seneca, New York, 14224, United States

Location

OnSite Clinical Solutions - Charlotte

Charlotte, North Carolina, 28277, United States

Location

M3 Wake Research | Raleigh, NC

Raleigh, North Carolina, 27612, United States

Location

Unified Women's Clinical Research | Lyndhurst Clinical Research, Winston-Salem, NC

Winston-Salem, North Carolina, 27103, United States

Location

Axia Women's Health - Anderson Township

Cincinnati, Ohio, 45242, United States

Location

Centricity Research - Women's Health - Dublin, OH

Dublin, Ohio, 43016, United States

Location

HWC Women's Research Center | Englewood, OH

Englewood, Ohio, 45322, United States

Location

Hilltop Obstetrics & Gynecolofy

Franklin, Ohio, 45005, United States

Location

Women's Care Research Institute/Marion OBGYN, Inc.

Marion, Ohio, 43302, United States

Location

University Hospitals | UH Cleveland Medical Center - MacDonald Clinical Trials Unit

Mayfield Heights, Ohio, 44124, United States

Location

Clinical Research Philadelphia | Philadelphia, PA

Philadelphia, Pennsylvania, 19114, United States

Location

MUSC Women's Health - Cannon St.

Charleston, South Carolina, 29425, United States

Location

Venus Gynecology, LLC | Myrtle Beach, SC

Myrtle Beach, South Carolina, 29572, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Chattanooga Medical Research, LLC. | Chattanooga, TN

Chattanooga, Tennessee, 37404, United States

Location

Elligo Health Research | Women Partners in Health PLLC

Austin, Texas, 78705, United States

Location

Cedar Health Research, LLC. | DFW-East Clinical Site

Dallas, Texas, 75251, United States

Location

Maximos Ob/Gyn

League City, Texas, 77573, United States

Location

Northeast Clinical Research of San Antonio, LLC

San Antonio, Texas, 78233, United States

Location

Seattle Women's | Seattle, WA

Seattle, Washington, 98105, United States

Location

Medical University of Graz | Division of Gynecology and Obstetrics

Graz, Styria, 8036, Austria

Location

Medizinische Universitat Innsbruck | Klinik fur Gyn Endokrinologie und Reproduktionsmedizin

Innsbruck, Tyrol, 6020, Austria

Location

Kepler Campus IV | Gyn, Gburtshilfe & gyn. Endokrinologie

Linz, Upper Austria, 4020, Austria

Location

AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie

Vienna, 1090, Austria

Location

Medizinische Universitat Wien | Universitatsklinik fur Frauenheilkunde Klinische Abteilung fur Gynakologische Endokrinologie

Vienna, 1090, Austria

Location

Gynekologie MEDA s.r.o.

Brno, 602 00, Czechia

Location

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

České Budějovice, 370 01, Czechia

Location

GYN-MIKA s.r.o.

České Budějovice, 370 01, Czechia

Location

Gynekologie Cheb s.r.o.

České Budějovice, 370 01, Czechia

Location

MUDr. Stepan s.r.o.

České Budějovice, 370 01, Czechia

Location

GYN-F s.r.o.

Hradec Králové, 500 03, Czechia

Location

Kestr-gyn s.r.o.

Náchod, 547 01, Czechia

Location

PT-MEDICA s.r.o.

Prachatice, 383 01, Czechia

Location

GYNERA

Prague, 156 00, Czechia

Location

Gynekologie Studentsky dum s.r.o.

Prague, 160 00, Czechia

Location

ARETAIEION University Hospital

Athens, 11528, Greece

Location

University General Hospital of Athens "ATTIKON"

Chaïdári, 12462, Greece

Location

University General Hospital of Heraklion - Department of Paediatrics

Heraklion, 711 10, Greece

Location

Univ. General Hospital of Ioannina - Department of Paediatrics, Nephrology Unit

Ioannina, 45500, Greece

Location

University General Hospital of Patras | Univ Obs & Gynae Cli

Pátrai, 26504, Greece

Location

Hippokration General Hospital of Thessaloniki

Thessaloniki, 54642, Greece

Location

General Hospital of Thessaloniki Papageorgiou

Thessaloniki, 56403, Greece

Location

TritonLife Medical Center, XIII.kerulet

Budapest, 1134, Hungary

Location

NAP-MED Egeszsegugyi Szolgaltato Kft

Debrecen, 4028, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Komaromi Selye Janos Korhaz

Komárom, 2900, Hungary

Location

SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

Szeged, 6720, Hungary

Location

Rub-Int Noi Egeszsegcentrum

Székesfehérvár, 8000, Hungary

Location

HaEmek Medical Center | Internal Medicine C Department - Research Unit

Afula, 1834111, Israel

Location

Mayanei HaYeshua Medical Center

Bnei Brak, 5154475, Israel

Location

Hillel Yaffe Medical Center

Hadera, 3810101, Israel

Location

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, 9112001, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Health Corporation of Galilee Medical Center

Nahariya, 2210001, Israel

Location

University Hospital Of Ferrara - Ostetricia e Ginecologia

Ferrara, Emilia-Romagna, 44124, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

Location

Ospedale San Raffaele s.r.l. - Ginecologia Ostetricia e Medicina della Riproduzione

Milan, Lombardy, 20132, Italy

Location

IRCCS Fondazione Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania

Catania, Sicily, 95123, Italy

Location

Careggi University Hospital

Florence, Tuscany, 50134, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56126, Italy

Location

Flevoziekenhuis

Almere Stad, MISSING, Netherlands

Location

St. Antonius Ziekenhuis | Utrecht - R&D Interne Geneeskunde

Nieuwegein, 3435 CM, Netherlands

Location

Diakonessenhuis

Utrecht, 3582 KE, Netherlands

Location

Related Publications (1)

• Pinkerton JV, Simon JA, Joffe H, Maki PM, Nappi RE, Panay N, Soares CN, Thurston RC, Caetano C, Haberland C, Haseli Mashhadi N, Krahn U, Mellinger U, Parke S, Seitz C, Zuurman L. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials. JAMA. 2024 Aug 22;332(16):1343-54. doi: 10.1001/jama.2024.14618. Online ahead of print.

  PMID: 39172446 DERIVED

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe
• Related Info
• Study\_Synopsis-21651.docx attachment has been generated from the Study Synopsis template. Data may be populated from the following (as available) : Study (44.0), Protocol (0.4), Results(0.1)

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

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 13, 2021
• Study Start: August 27, 2021
• Primary Completion: July 25, 2023
• Study Completion: November 27, 2023
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); HU (6); US (55); GR (7); NL (3); IL (6); IT (7); CZ (10)