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Vasomotor Symptoms Associated With MenopausePhase 3OASIS-3NCT05030584

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

A Phase 3 study testing Elinzanetant (BAY3427080) in people with Vasomotor Symptoms Associated With Menopause and Hot Flashes, run by Bayer at 86 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years, women only
What is being tested?
Elinzanetant (BAY3427080)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
628 participants
Where
86 sitesin 9 countries
Study dates
27 Aug 2021to 12 Feb 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 is showing eligibility with respect to previous inclusion criterion during this time period.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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 locations and contacts

86 sites in 9 countries.

86 sites in 9 countries

United States36 sites

  • Johns Hopkins Hospital - Gynecology and Obstetrics

    Baltimore, Maryland, 21287

  • Boca Midwifery

    Boca Raton, Florida, 33486

  • Helix Biomedics LLC | Boynton Beach, FL

    Boynton Beach, Florida, 33435

  • Investigators Research Group, LLC

    Brownsburg, Indiana, 46112

  • Paramount Research Solutions | College Park Location

    College Park, Georgia, 30349

  • ClinOhio Research Services, LLC. | Columbus, OH

    Columbus, Ohio, 43213

  • HWC Women's Research Center | Englewood, OH

    Englewood, Ohio, 45322

  • National Institute of Clinical Research - Garden Grove

    Garden Grove, California, 92844

  • Boeson Research | Great Falls, MT

    Great Falls, Montana, 59405

  • Advances in Health, INC. | Houston, TX

    Houston, Texas, 77030

  • UTHealth Womens Research Program | Memorial City

    Houston, Texas, 77054

  • Marvel Clinical Research | Huntington Beach, CA

    Huntington Beach, California, 92647

  • Elligo Health Research | Medical Colleagues of Texas

    Hurst, Texas, 76054

  • UF Health Women's Specialists - Emerson

    Jacksonville, Florida, 32207

  • Elligo Health Research | Protenium Clinical Research

    Katy, Texas, 77493

  • Affiliated Clinical Research, Inc. | Las Vegas, NV

    Las Vegas, Nevada, 89113

  • AMR - Las Vegas

    Las Vegas, Nevada, 89119

  • Maximos Ob/Gyn

    League City, Texas, 77573

  • Mesa Obstetricians and Gynecologists | Research Department

    Mesa, Arizona, 85206

  • Southern Clinical Research Associates

    Metairie, Louisiana, 70001

  • Boeson Research | Missoula, MT

    Missoula, Montana, 59804

  • Mobile ObGyn, P.C. | Mobile, AL

    Mobile, Alabama, 36608

  • Venus Gynecology, LLC | Myrtle Beach, SC

    Myrtle Beach, South Carolina, 29572

  • Coastal Connecticut Research | New London, CT

    New London, Connecticut, 06320

  • Tidewater Clinical Research - Norfolk

    Norfolk, Virginia, 23502

  • Eastern Virginia Medical School | OB/GYN Clinical Research Center

    Norfolk, Virginia, 23507

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

    North Las Vegas, Nevada, 89030

  • Suncoast Clinical Research - Palm Harbor

    Palm Harbor, Florida, 34684

  • Clinical Research Philadelphia | Philadelphia, PA

    Philadelphia, Pennsylvania, 19114

  • Empire Clinical Research | Pomona, CA

    Pomona, California, 91767

  • M3 Wake Research | Raleigh, NC

    Raleigh, North Carolina, 27612

  • Physician Care Clinical Research LLC | Sarasota, FL

    Sarasota, Florida, 34239

  • Seattle Clinical Research Center

    Seattle, Washington, 98105

  • Suncoast Clinical Research - New Port Richey

    Trinity, Florida, 34655

  • IntimMedicine | Washington, DC

    Washington D.C., District of Columbia, 20036

  • Southern Clinical Research, LLC

    Zachary, Louisiana, 70791

Other trials in United States

Bulgaria11 sites

  • Medical Centre Asklepii OOD | Dupnitsa, Bulgaria

    Dupnitsa, 2600

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

    Pleven, 5800

  • Multiprofile Hospital for Active Treatment Plovdiv | Obstetrics and Gynecology

    Plovdiv, 4000

  • Spec.Hospital for obstetrics and gynecology Selena OOD

    Plovdiv, 4002

  • Multiprofile Hospital for Active Treatment Samokov | Gynecology Department

    Samokov, 2000

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

    Sofia, 1233

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

    Sofia, 1330

  • Diagnostic-Consultative Center Alexandrovska | Sofia, Bulgaria

    Sofia, 1431

  • Medical Center Panacea OOD | Sofia, Bulgaria

    Sofia, 1606

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

    Stara Zagora, 6000

  • SBAGAL Dr. Dimitar Stamatov | Varna, Bulgaria

    Varna, 9000

Other trials in Bulgaria

Canada8 sites

  • Manna Research (Burlington North)

    Burlington, Ontario, L7M 4Y1

  • IWK Health Centre | Department of Obstetrics and Gynaecology

    Halifax, Nova Scotia, B3K 6R8

  • Manna Research (Quebec)

    Lévis, Quebec, G6W 0M5

  • Manna Research (Ottawa)

    Nepean, Ontario, K2J 4A7

  • Ottawa Hospital-Riverside Campus

    Ottawa, Ontario, K1H 7W9

  • Manna Research (Montreal)

    Pointe-Claire, Quebec, H9R 4S3

  • Alpha Recherche Clinique | Lebourgneuf

    Québec, G2J 0C4

  • Viable Clinical Research | Mississauga, Canada

    Scarborough Village, Ontario, M1P 2T7

Other trials in Canada

Spain7 sites

  • Hospital Universitario La Zarzuela - Ginecologia

    Aravaca, Madrid, 28023

  • Hospital de la Santa Creu i Sant Pau | Gynecology Department

    Barcelona, 8041

  • Instituto Palacios | Investigation Research Unit - Gynecology department

    Madrid, 28009

  • Hospital Clinico San Carlos | Women´s Health Institute

    Madrid, 28040

  • Hospital Universitario 12 de Octubre | Department of Obstetrics and Gynecology

    Madrid, 28041

  • Virgen del Rocio University Hospital | Gynecology Unit

    Seville, 41013

  • Hospital Clinico Universitario | Gynecology and Obstetrics Department

    Valencia, 46010

Other trials in Spain

Poland6 sites

  • Gabinet Ginekologiczny Janusz Tomaszewski

    Bialystok, 15-224

  • CLINICAL MEDICAL RESEARCH Sp. z o. o.

    Katowice, 40-156

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611

  • Vita Longa Sp. z o.o.

    Katowice, 40-748

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-500

  • Centrum Badawcze Wspolczesnej Terapii

    Warsaw, 02-679

Other trials in Poland

Belgium5 sites

  • CHU Saint-Pierre/UMC Sint-Pieter

    Bruxelles - Brussel, 1000

  • UZ Gent

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

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

    Liège, 4000

  • Femicare vzw | Tienen, BE

    Tienen, 3300

Other trials in Belgium

Finland5 sites

  • HUS / Naistenklinikka

    Helsinki, 29

  • Pihlajalinna Lääkärikeskus Oy, Savo-Karjala

    Joensuu, 80100

  • Mehilainen | Mehilainen Kuopio

    Kuopio, 70100

  • Lääkärikeskus Gyneko, Gynaecological Medical Center | Oulu, Finland

    Oulu, 90100

  • Terveystalo | Terveystalo Tampere Research Unit

    Tampere, 33100

Other trials in Finland

United Kingdom5 sites

  • MAC Clinical Research | Lancashire - Clinical Research Centre

    Blackpool, FY2 0JH

  • NHS Greater Glasgow and Clyde | Glasgow Royal Infirmary - Gynaecology

    Glasgow, G4 0SF

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

    Liverpool, L8 7SS

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

    London, W12 0NN

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

    Manchester, M13 9NQ

Other trials in United Kingdom

Denmark3 sites

  • Sanos Clinic | Gandrup, Denmark

    Gandrup, 9362

  • Sanos Clinic | Herlev, Denmark

    Herlev, 2730

  • Sanos Clinic | Syddanmark, Vejle, Denmark

    Vejle, 7100

Other trials in Denmark

About this study

Official title: A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 52 Weeks in Postmenopausal Women

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.

Read more

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.
Being tested
Elinzanetant (BAY3427080), Placebo
Keywords
Menopause
Medical subject headings
Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elinzanetant (BAY3427080)Drug

    120 mg elinzanetant orally once daily

  • PlaceboDrug

    Matching placebo orally once daily.

Study groups in NCT05030584
Study groupRoleWhat they receive
Elinzanetant (BAY3427080)ExperimentalParticipants will receive 120 mg elinzanetant orally once daily.
Receives: Drug: Elinzanetant (BAY3427080)
PlaceboPlacebo comparatorParticipants will receive matching placebo orally once daily.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: Baseline to Week 12

Secondary outcomes (2)

  1. 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.

    The PROMIS SD SF 8b includes 8 items assessing sleep disturbance over the past 7 days. Items assess sleep quality, sleep depth and restoration associated with sleep, perceived difficulties with getting to sleep or staying asleep and perceptions of the adequacy of and satisfaction with sleep. Participants respond to the items on a 5-point scale from "not at all", "never" or "very poor" to "very much", "always" or "very good". Four of the items are scored reversely. Individual item scores are aggregated to total raw scores which range from 8 to 40. Total raw scores are converted into T-scores for comparison with population norms, with a mean of 50 and standard deviation of 10. T-scores range from 28.9 to 76.5. For both raw and T-scores higher scores indicate greater severity of sleep disturbance. According to available score cut points from PROMIS developers, T-scores can be interpreted as indicating mild (55-59), moderate (60-69), or severe (>70) sleep disturbance.

    Measured: Baseline to Week 56

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

    The MENQOL questionnaire is comprised of 29 items assessing the presence of menopausal symptoms and the impact of menopause on health-related quality of life over the past week. The items assess four domains of symptoms and functioning: Vasomotor functioning, psychosocial functioning, physical functioning, and sexual functioning. For each item, the participant indicates if they have experienced the symptom (yes/no). If they select yes, they rate how bothered they were by the symptom using a six-point verbal descriptor scale, with response options ranging from 0 'not at all bothered' to 6 'extremely bothered'. Based on the individual responses, item scores, domain scores, and a total MENQOL score are calculated. Each score ranges from 1-8, higher scores indicate greater bother.

    Measured: Baseline to Week 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2021
  2. Study start27 Aug 2021
  3. Primary completion29 Mar 2023
  4. Study completion12 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
628 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05030584
Sponsor's protocol ID
21810
Other IDs
2021-000059-38
Acronym
OASIS-3
Status last verified
Nov 2025
First submitted
27 Aug 2021
Last updated
1 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Publications

  • 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.

    PubMed 40920404

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elinzanetant (BAY3427080) in people with Vasomotor Symptoms Associated With Menopause and Hot Flashes, run by Bayer at 86 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Bulgaria, Canada, Spain, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Frequency of Moderate to Severe Hot Flashes (HFs) From Baseline to Week 12 (Assessed by Hot Flash Daily Diary [HFDD]) (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05030584, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.

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