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New pill cuts hot flashes in half for menopausal women

NCT ID NCT05042362

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called elinzanetant in 396 postmenopausal women with hot flashes. Participants took either the drug or a placebo daily for up to 26 weeks. The goal was to see if elinzanetant could reduce how often and how severe hot flashes are. Results showed a meaningful decrease in both frequency and severity compared to placebo.

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 quality of life for postmenopausal women.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all women. Some people may still have side effects or not respond well.

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

396 people

The number who actually took part.

Started

Aug 2021

Finished

Nov 2023

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 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). 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 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.

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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

  • AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie

    Vienna, 1090, Austria

  • AMR - Fort Myers, FL

    Fort Myers, Florida, 33912, United States

  • ARETAIEION University Hospital

    Athens, 11528, Greece

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

    Las Vegas, Nevada, 89113, United States

  • Alabama Clinical Therapeutics | Birmingham, AL

    Birmingham, Alabama, 35205, United States

  • Alliance Research Institute | Bell Gardens, CA

    Bell Gardens, California, 90201, United States

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72205, United States

  • Axia Women's Health - Anderson Township

    Cincinnati, Ohio, 45242, United States

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56126, Italy

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

    Catania, Sicily, 95123, Italy

  • Bosque Women's Care | Albuquerque, NM

    Albuquerque, New Mexico, 87109, United States

  • Careggi University Hospital

    Florence, Tuscany, 50134, Italy

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

    Dallas, Texas, 75251, United States

  • Central Research Associates | Birmingham, AL

    Birmingham, Alabama, 35205, United States

  • Centricity Research - Women's Health - Dublin, OH

    Dublin, Ohio, 43016, United States

  • Chattanooga Medical Research, LLC. | Chattanooga, TN

    Chattanooga, Tennessee, 37404, United States

  • Circuit Clinical | OB GYN Associates of WNY

    West Seneca, New York, 14224, United States

  • Clinical Research Philadelphia | Philadelphia, PA

    Philadelphia, Pennsylvania, 19114, United States

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404, United States

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405, United States

  • Continental Clinical Solutions | Towson, MD

    Towson, Maryland, 21204, United States

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Del Sol Research | Women Health studies

    Tucson, Arizona, 85715, United States

  • Diagnamics | Encinitas, CA

    Encinitas, California, 92024, United States

  • Diakonessenhuis

    Utrecht, 3582 KE, Netherlands

  • Drug Studies America

    Marietta, Georgia, 30060, United States

  • Elligo Health Research | Women Partners in Health PLLC

    Austin, Texas, 78705, United States

  • Flevoziekenhuis

    Almere Stad, MISSING, Netherlands

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122, Italy

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

    České Budějovice, 370 01, Czechia

  • GYN-F s.r.o.

    Hradec Králové, 500 03, Czechia

  • GYN-MIKA s.r.o.

    České Budějovice, 370 01, Czechia

  • GYNERA

    Prague, 156 00, Czechia

  • General Hospital of Thessaloniki Papageorgiou

    Thessaloniki, 56403, Greece

  • Gynekologie Cheb s.r.o.

    České Budějovice, 370 01, Czechia

  • Gynekologie MEDA s.r.o.

    Brno, 602 00, Czechia

  • Gynekologie Studentsky dum s.r.o.

    Prague, 160 00, Czechia

  • HWC Women's Research Center | Englewood, OH

    Englewood, Ohio, 45322, United States

  • HaEmek Medical Center | Internal Medicine C Department - Research Unit

    Afula, 1834111, Israel

  • Hadassah Hebrew University Hospital Ein Kerem

    Jerusalem, 9112001, Israel

  • Health Corporation of Galilee Medical Center

    Nahariya, 2210001, Israel

  • Hillel Yaffe Medical Center

    Hadera, 3810101, Israel

  • Hilltop Obstetrics & Gynecolofy

    Franklin, Ohio, 45005, United States

  • Hippokration General Hospital of Thessaloniki

    Thessaloniki, 54642, Greece

  • IRCCS Fondazione Policlinico San Matteo

    Pavia, Lombardy, 27100, Italy

  • IntimMedicine | Washington, DC

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

  • Investigators Research Group, LLC

    Brownsburg, Indiana, 46112, United States

  • Jubilee Clinical Research Inc | Las Vegas, NV

    Las Vegas, Nevada, 89106, United States

  • Kepler Campus IV | Gyn, Gburtshilfe & gyn. Endokrinologie

    Linz, Upper Austria, 4020, Austria

  • Kestr-gyn s.r.o.

    Náchod, 547 01, Czechia

  • Komaromi Selye Janos Korhaz

    Komárom, 2900, Hungary

  • M3 Wake Research - Clinical Research Center of Nevada

    Las Vegas, Nevada, 89123, United States

  • M3 Wake Research Atlanta

    Sandy Springs, Georgia, 30126, United States

  • M3 Wake Research | Raleigh, NC

    Raleigh, North Carolina, 27612, United States

  • MUDr. Stepan s.r.o.

    České Budějovice, 370 01, Czechia

  • MUSC Women's Health - Cannon St.

    Charleston, South Carolina, 29425, United States

  • Maximos Ob/Gyn

    League City, Texas, 77573, United States

  • Mayanei HaYeshua Medical Center

    Bnei Brak, 5154475, Israel

  • Medical University of Graz | Division of Gynecology and Obstetrics

    Graz, Styria, 8036, Austria

  • Medisense Inc. | Atlanta, GA

    Atlanta, Georgia, 30363, United States

  • Medizinische Universitat Innsbruck | Klinik fur Gyn Endokrinologie und Reproduktionsmedizin

    Innsbruck, Tyrol, 6020, Austria

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

    Vienna, 1090, Austria

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • Mesa Obstetricians and Gynecologists | Research Department

    Mesa, Arizona, 85206, United States

  • MomDoc Women's Health Research | Scottsdale, AZ

    Scottsdale, Arizona, 85251, United States

  • NAP-MED Egeszsegugyi Szolgaltato Kft

    Debrecen, 4028, Hungary

  • Noble Clinical Research | Tucson, AZ

    Tucson, Arizona, 85704, United States

  • Northeast Clinical Research of San Antonio, LLC

    San Antonio, Texas, 78233, United States

  • Northern California Research | Sacramento

    Sacramento, California, 95821, United States

  • Om Research LLC | Lancaster, CA

    Lancaster, California, 93534, United States

  • OnSite Clinical Solutions - Charlotte

    Charlotte, North Carolina, 28277, United States

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

    Milan, Lombardy, 20132, Italy

  • PT-MEDICA s.r.o.

    Prachatice, 383 01, Czechia

  • Paramount Research Solutions | College Park Location

    College Park, Georgia, 30349, United States

  • Physician Care Clinical Research LLC | Sarasota, FL

    Sarasota, Florida, 34239, United States

  • Revive Research Institute, Inc. - Women's Health

    Dearborn Heights, Michigan, 48127, United States

  • Rub-Int Noi Egeszsegcentrum

    Székesfehérvár, 8000, Hungary

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901, United States

  • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

    Szeged, 6720, Hungary

  • Seattle Women's | Seattle, WA

    Seattle, Washington, 98105, United States

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

    Decatur, Georgia, 30033-3500, United States

  • Southern Clinical Research Associates | Metairie, LA

    Metairie, Louisiana, 70001, United States

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

    Nieuwegein, 3435 CM, Netherlands

  • Suncoast Clinical Research Inc | Pinellas

    Palm Harbor, Florida, 34684, United States

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

    Lawrenceville, New Jersey, 08648, United States

  • The Iowa Clinic - Ankeny

    Ankeny, Iowa, 50023, United States

  • TritonLife Medical Center, XIII.kerulet

    Budapest, 1134, Hungary

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

    Winston-Salem, North Carolina, 27103, United States

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

    Ioannina, 45500, Greece

  • University General Hospital of Athens "ATTIKON"

    Chaïdári, 12462, Greece

  • University General Hospital of Heraklion - Department of Paediatrics

    Heraklion, 711 10, Greece

  • University General Hospital of Patras | Univ Obs & Gynae Cli

    Pátrai, 26504, Greece

  • University Hospital Of Ferrara - Ostetricia e Ginecologia

    Ferrara, Emilia-Romagna, 44124, Italy

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

    Mayfield Heights, Ohio, 44124, United States

  • Valley OBGYN

    Saginaw, Michigan, 48602, United States

  • Velocity Clinical Research - Albuquerque

    Albuquerque, New Mexico, 87107, United States

  • Venus Gynecology, LLC | Myrtle Beach, SC

    Myrtle Beach, South Carolina, 29572, United States

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

    Marion, Ohio, 43302, United States

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

    Lincoln, Nebraska, 68510, United States

More trials for these conditions

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