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New pill could cool menopause hot flashes without hormones

NCT ID NCT05030584

Symptom relief Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a daily pill called elinzanetant for treating hot flashes in 628 postmenopausal women. The drug blocks a protein thought to trigger hot flashes. Participants took either elinzanetant or a placebo for 52 weeks and recorded their hot flashes in a diary. The main goal was to see if the drug reduced the number and severity of hot flashes after 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
elinzanetant
What this could lead to
If it works, this could offer a new non-hormonal option to reduce hot flashes and improve sleep for postmenopausal women.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not prove significantly better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

628 people

The number who actually took part.

Started

Aug 2021

Finished

Feb 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 65 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Hot Flashes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hot flashes Vasomotor symptoms associated with menopause

Contacts and locations

Locations

  • AMR - Las Vegas

    Las Vegas, Nevada, 89119, United States

  • Advances in Health, INC. | Houston, TX

    Houston, Texas, 77030, United States

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

    Las Vegas, Nevada, 89113, United States

  • Alpha Recherche Clinique | Lebourgneuf

    Québec, G2J 0C4, Canada

  • Boca Midwifery

    Boca Raton, Florida, 33486, United States

  • Boeson Research | Great Falls, MT

    Great Falls, Montana, 59405, United States

  • Boeson Research | Missoula, MT

    Missoula, Montana, 59804, United States

  • CHU Saint-Pierre/UMC Sint-Pieter

    Bruxelles - Brussel, 1000, Belgium

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

    Liège, 4000, Belgium

  • CLINICAL MEDICAL RESEARCH Sp. z o. o.

    Katowice, 40-156, Poland

  • Centrum Badawcze Wspolczesnej Terapii

    Warsaw, 02-679, Poland

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611, Poland

  • ClinOhio Research Services, LLC. | Columbus, OH

    Columbus, Ohio, 43213, United States

  • Clinical Research Philadelphia | Philadelphia, PA

    Philadelphia, Pennsylvania, 19114, United States

  • Coastal Connecticut Research | New London, CT

    New London, Connecticut, 06320, United States

  • Diagnostic-Consultative Center Alexandrovska | Sofia, Bulgaria

    Sofia, 1431, Bulgaria

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

    Norfolk, Virginia, 23507, United States

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

    North Las Vegas, Nevada, 89030, United States

  • Elligo Health Research | Medical Colleagues of Texas

    Hurst, Texas, 76054, United States

  • Elligo Health Research | Protenium Clinical Research

    Katy, Texas, 77493, United States

  • Empire Clinical Research | Pomona, CA

    Pomona, California, 91767, United States

  • Femicare vzw | Tienen, BE

    Tienen, 3300, Belgium

  • Gabinet Ginekologiczny Janusz Tomaszewski

    Bialystok, 15-224, Poland

  • HUS / Naistenklinikka

    Helsinki, 29, Finland

  • HWC Women's Research Center | Englewood, OH

    Englewood, Ohio, 45322, United States

  • Helix Biomedics LLC | Boynton Beach, FL

    Boynton Beach, Florida, 33435, United States

  • Hospital Clinico San Carlos | Women´s Health Institute

    Madrid, 28040, Spain

  • Hospital Clinico Universitario | Gynecology and Obstetrics Department

    Valencia, 46010, Spain

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

    Madrid, 28041, Spain

  • Hospital Universitario La Zarzuela - Ginecologia

    Aravaca, Madrid, 28023, Spain

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

    Barcelona, 8041, Spain

  • IWK Health Centre | Department of Obstetrics and Gynaecology

    Halifax, Nova Scotia, B3K 6R8, Canada

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

    London, W12 0NN, United Kingdom

  • Instituto Palacios | Investigation Research Unit - Gynecology department

    Madrid, 28009, Spain

  • IntimMedicine | Washington, DC

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

  • Investigators Research Group, LLC

    Brownsburg, Indiana, 46112, United States

  • Johns Hopkins Hospital - Gynecology and Obstetrics

    Baltimore, Maryland, 21287, United States

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

    Liverpool, L8 7SS, United Kingdom

  • Lääkärikeskus Gyneko, Gynaecological Medical Center | Oulu, Finland

    Oulu, 90100, Finland

  • M3 Wake Research | Raleigh, NC

    Raleigh, North Carolina, 27612, United States

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

    Manchester, M13 9NQ, United Kingdom

  • MAC Clinical Research | Lancashire - Clinical Research Centre

    Blackpool, FY2 0JH, United Kingdom

  • Manna Research (Burlington North)

    Burlington, Ontario, L7M 4Y1, Canada

  • Manna Research (Montreal)

    Pointe-Claire, Quebec, H9R 4S3, Canada

  • Manna Research (Ottawa)

    Nepean, Ontario, K2J 4A7, Canada

  • Manna Research (Quebec)

    Lévis, Quebec, G6W 0M5, Canada

  • Marvel Clinical Research | Huntington Beach, CA

    Huntington Beach, California, 92647, United States

  • Maximos Ob/Gyn

    League City, Texas, 77573, United States

  • Medical Center Panacea OOD | Sofia, Bulgaria

    Sofia, 1606, Bulgaria

  • Medical Centre Asklepii OOD | Dupnitsa, Bulgaria

    Dupnitsa, 2600, Bulgaria

  • Mehilainen | Mehilainen Kuopio

    Kuopio, 70100, Finland

  • Mesa Obstetricians and Gynecologists | Research Department

    Mesa, Arizona, 85206, United States

  • Mobile ObGyn, P.C. | Mobile, AL

    Mobile, Alabama, 36608, United States

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

    Stara Zagora, 6000, Bulgaria

  • Multiprofile Hospital for Active Treatment Plovdiv | Obstetrics and Gynecology

    Plovdiv, 4000, Bulgaria

  • Multiprofile Hospital for Active Treatment Samokov | Gynecology Department

    Samokov, 2000, Bulgaria

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

    Sofia, 1330, Bulgaria

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

    Pleven, 5800, Bulgaria

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

    Glasgow, G4 0SF, United Kingdom

  • National Institute of Clinical Research - Garden Grove

    Garden Grove, California, 92844, United States

  • Ottawa Hospital-Riverside Campus

    Ottawa, Ontario, K1H 7W9, Canada

  • Paramount Research Solutions | College Park Location

    College Park, Georgia, 30349, United States

  • Physician Care Clinical Research LLC | Sarasota, FL

    Sarasota, Florida, 34239, United States

  • Pihlajalinna Lääkärikeskus Oy, Savo-Karjala

    Joensuu, 80100, Finland

  • SBAGAL Dr. Dimitar Stamatov | Varna, Bulgaria

    Varna, 9000, Bulgaria

  • Sanos Clinic | Gandrup, Denmark

    Gandrup, 9362, Denmark

  • Sanos Clinic | Herlev, Denmark

    Herlev, 2730, Denmark

  • Sanos Clinic | Syddanmark, Vejle, Denmark

    Vejle, 7100, Denmark

  • Seattle Clinical Research Center

    Seattle, Washington, 98105, United States

  • Southern Clinical Research Associates

    Metairie, Louisiana, 70001, United States

  • Southern Clinical Research, LLC

    Zachary, Louisiana, 70791, United States

  • Spec.Hospital for obstetrics and gynecology Selena OOD

    Plovdiv, 4002, Bulgaria

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

    Sofia, 1233, Bulgaria

  • Suncoast Clinical Research - New Port Richey

    Trinity, Florida, 34655, United States

  • Suncoast Clinical Research - Palm Harbor

    Palm Harbor, Florida, 34684, United States

  • Terveystalo | Terveystalo Tampere Research Unit

    Tampere, 33100, Finland

  • Tidewater Clinical Research - Norfolk

    Norfolk, Virginia, 23502, United States

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-500, Poland

  • UF Health Women's Specialists - Emerson

    Jacksonville, Florida, 32207, United States

  • UTHealth Womens Research Program | Memorial City

    Houston, Texas, 77054, United States

  • UZ Gent

    Ghent, 9000, Belgium

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

  • Venus Gynecology, LLC | Myrtle Beach, SC

    Myrtle Beach, South Carolina, 29572, United States

  • Viable Clinical Research | Mississauga, Canada

    Scarborough Village, Ontario, M1P 2T7, Canada

  • Virgen del Rocio University Hospital | Gynecology Unit

    Seville, 41013, Spain

  • Vita Longa Sp. z o.o.

    Katowice, 40-748, Poland

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Other studies related to the condition(s) this trial covers.