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 (OASIS-2)
A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 26 Weeks in Postmenopausal Women
2 other identifiers
interventional
400
12 countries
113
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2021
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2021
CompletedFirst Posted
Study publicly available on registry
October 29, 2021
CompletedStudy Start
First participant enrolled
October 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2023
CompletedResults Posted
Study results publicly available
February 12, 2026
CompletedFebruary 12, 2026
January 1, 2026
1.6 years
October 19, 2021
November 4, 2025
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD)
Participants' assessments of HF were recorded electronically twice daily using the sponsor developed Hot Flash Daily Diary (HFDD). The HFDD was completed in the morning after waking up (morning diary) and each evening at bedtime (evening diary) on the hand-held device. The HFDD items assessed the number of mild, moderate, and severe HF experienced during the day and during the night. Mild HF was defined as a "sensation of heat without sweating", moderate HF was defined as a "sensation of heat with sweating, but able to continue activity", and severe HF was defined as a "sensation of heat with sweating, causing cessation (stopping) of activity". 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, Day 22-28 were used (Day 1 corresponds to start of treatment).
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, Day 78-84 were used (Day 1 corresponds to start of treatment).
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 (Assessed by HFDD)
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 Change in Menopause-specific Quality of Life Scale (MENQOL) Total Score From Baseline to Week 12
From baseline to Week 12
Mean Change in Beck Depression Inventory (BDI-II) Total Score From Baseline to Week 12
From baseline to Week 12
- +1 more secondary outcomes
Study Arms (2)
Elinzanetant (BAY3427080)
EXPERIMENTALParticipants will receive 120 mg elinzanetant orally once daily for 26 weeks.
Placebo + elinzanetant
PLACEBO COMPARATORParticipants will receive matching placebo orally once daily for 12 weeks, followed by elinzanetant 120 mg for 14 weeks.
Interventions
120 mg elinzanetant orally once daily
Eligibility Criteria
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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (113)
Accel Research Sites | Cahaba Medical Care - Birmingham, AL
Birmingham, Alabama, 35218, United States
Women's Health Alliance of Mobile
Mobile, Alabama, 36604, United States
Onyx Clinical Research - Peoria
Peoria, Arizona, 85381, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72204, United States
National Institute of Clinical Research - Garden Grove
Garden Grove, California, 92844, United States
Clinical Trials Research - Lincoln
Lincoln, California, 95648, United States
Torrance Clinical Research Institute, Inc. | Lomita, CA
Lomita, California, 90717, United States
Women's Health Care Research | San Diego, CA
San Diego, California, 92111, United States
Advanced Women's Health Institute | Denver Office, Greenwood Village, CO
Greenwood Village, Colorado, 80111, United States
Physicians' Research Options, LLC | Red Rocks OBGYN
Lakewood, Colorado, 80228, United States
Helix Biomedics, LLC
Boynton Beach, Florida, 33435, United States
Clinical Research of West Florida | Clearwater, FL
Clearwater, Florida, 33765, United States
Sweet Hope Research Specialty, Inc. - Miami Lakes
Hialeah, Florida, 33016, United States
Ocean Blue Medical Research Center, Inc | Miami Springs, FL
Miami Springs, Florida, 33166, United States
Suncoast Clinical Research Inc. | Pasco
New Port Richey, Florida, 34652, United States
Sensible Healthcare, LLC
Ocoee, Florida, 34761, United States
Clinical Research of West Florida | Tampa, FL
Tampa, Florida, 33606, United States
Fellows Research Alliance, Inc | Savannah, GA
Savannah, Georgia, 31406, United States
Family Care Research | Boise, ID
Boise, Idaho, 83713, United States
Leavitt Clinical Research | Idaho Falls, ID
Idaho Falls, Idaho, 83404, United States
University of Chicago | Laboratory of Dr. Al-Hendy
Chicago, Illinois, 60637, United States
AMR - Chicago
Oak Brook, Illinois, 60523, United States
Clinical Trials Management | Northshore Office
Covington, Louisiana, 70433, United States
Tandem Clinical Research | Marrero, LA
Marrero, Louisiana, 70072, United States
Ob and Gyn Physicians MidAtlantic - SKYCRNG
Oxon Hill, Maryland, 20705, United States
Genesis Clinical Research and Consulting, LLC
Fall River, Massachusetts, 02723, United States
Saginaw Valley Medical Research Group, LLC | Saginaw, MI
Saginaw, Michigan, 48604, United States
Metro Jackson OBGYN | Jackson, MS
Jackson, Mississippi, 39202, United States
R. Garn Mabey Jr. M.D. Gynecology
Las Vegas, Nevada, 89128, United States
Capital Health | Capital Health OBGYN Lawrenceville
Lawrenceville, New Jersey, 08648, United States
Columbia University Medical Center
New York, New York, 10032, United States
Eastern Carolina Women's Center | New Bern, NC
New Bern, North Carolina, 28562, United States
Unified Women's Clinical Research | Raleigh, NC
Raleigh, North Carolina, 27607, United States
OHSU Hospital - OB-GYN - Women's Health Research Unit
Portland, Oregon, 97239, United States
UPMC Magee-Women's Hospital - Gynecology
Pittsburgh, Pennsylvania, 15213, United States
Tribe clinical Research LLC | Greenville, SC
Greenville, South Carolina, 29607, United States
Medical Research Center of Memphis | Memphis, TN
Memphis, Tennessee, 38120, United States
Research Memphis Associates, LLC | Memphis, TN
Memphis, Tennessee, 38120, United States
Austin Regional Clinic | ARC Kelly Lane
Austin, Texas, 78731, United States
DiscoveResearch, Inc.
Bryan, Texas, 77802, United States
South Texas Clinical Research
Corpus Christi, Texas, 78404, United States
Sig Gyn Services (Dr. John A. Whitfield, MD) | Fort Worth, TX
Fort Worth, Texas, 76104-4145, United States
Advances in Health, INC. | Houston, TX
Houston, Texas, 77030, United States
UTHealth Womens Research Program | Memorial City
Houston, Texas, 77054, United States
ClinRx Research, LLC
Plano, Texas, 75024, United States
The Woman's Place - Midlife Health
Charlottesville, Virginia, 22903, United States
Tidewater Clinical Research, Inc.
Norfolk, Virginia, 23456, United States
Northwest Clinical Research Center | Bellevue, WA
Bellevue, Washington, 98007, United States
Alta Clinical Research Inc | Edmonton, Canada
Edmonton, Alberta, T5A 4L8, Canada
IWK Health Centre | Department of Obstetrics and Gynaecology
Halifax, Nova Scotia, B3K 6R8, Canada
Ecogene 21
Chicoutimi, Quebec, G7H 0S7, Canada
GCP Research | Montreal, Canada
Montreal, Quebec, H1M 1B1, Canada
Clinique Ovo | R&D Department
Montreal, Quebec, H4P 2S4, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8, Canada
Alpha Recherche Clinique | Val-Belair
Val-Bélair, Quebec, G3K 2P8, Canada
Diex Recherche Victoriaville Inc.
Victoriaville, Quebec, G6P 6P6, Canada
Diex Recherche Quebec Inc.
Québec, G1V 4T3, Canada
Alpha Recherche Clinique | Lebourgneuf
Québec, G2J 0C4, Canada
GynPorCentrum s.r.o.
Krnov, 794 01, Czechia
MUDr. Martina Maresova Rosenbergova, gynekologie
Pilsen, 301 00, Czechia
Gynekologie Studentsky dum s.r.o.
Prague, 160 00, Czechia
GYNEVI s.r.o.
Rokycany, 337 01, Czechia
Gynpraxetabor s.r.o.
Tábor, 390 03, Czechia
Synexus Frankfurt Clinical Research Centre
Frankfurt am Main, Hesse, 60313, Germany
Praxis Hr. Dr. S. Fiedler
Aachen, North Rhine-Westphalia, 52074, Germany
Frauenärzte am Schloss Borbeck
Essen, North Rhine-Westphalia, 45355, Germany
Medplus Nordrhein
Krefeld, North Rhine-Westphalia, 47799, Germany
Synexus Leipzig Clinical Research Centre
Leipzig, Saxony, 04177, Germany
Praxis f. Gynäkologie und Geburtshilfe
Bernburg, Saxony-Anhalt, 6406, Germany
Frauenarztpraxis Dr. Inka Kiesche
Halle, Saxony-Anhalt, 06110, Germany
Femme Frauenarztpraxis
Gera, Thuringia, 7545, Germany
emovis GmbH
Berlin, 10629, Germany
Synexus Berlin Clinical Research Centre
Berlin, 12627, Germany
A.O.U. Policlinico Federico II Napoli
Naples, Campania, 80131, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168, Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino
Turin, Piedmont, 10128, Italy
Azienda Ospedaliera Universitaria Integrata Verona_Borgo Trento - Ostetricia e Ginecologia B
Verona, Veneto, 37126, Italy
Kirkeparken Spesialistpraksis
Fredrikstad, 1605, Norway
Medicus | Oslo, Norway
Oslo, 161, Norway
Oslo University Hospital | Division of Obstetrics and Gynecology, Department of Research
Oslo, 450, Norway
Medicus | Stavanger, Norway
Stavanger, 4005, Norway
Medicus AS
Trondheim, 7014, Norway
Gabinet Ginekologiczny Janusz Tomaszewski
Bialystok, 15-224, Poland
CLINICAL MEDICAL RESEARCH Sp. z o. o.
Katowice, 40-156, Poland
Centrum Medyczne Angelius Provita
Katowice, 40-611, Poland
Vita Longa Sp. z o.o.
Katowice, 40-748, Poland
Etyka Osrodek Badan Klinicznych
Olsztyn, 10-117, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-500, Poland
Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica
Loures, Lisbon District, 2674-514, Portugal
Hospital Santa Maria | Centro de Investigacao Clinica
Missing, Lisbon District, 1649-035, Portugal
Hospital Pedro Hispano | Clinical Research Center
Matosinhos Municipality, Porto District, 4464-513, Portugal
Luz Saude | Hospital da Luz Setubal - Clinical Research Department
Setúbal, Setúbal District, 2900-722, Portugal
Centro Hospitalar e Universitario de Coimbra, E.P.E. | Department of Gynecology
Coimbra, 3000-075, Portugal
Centro Hospitalar de Lisboa Ocidental | Clinical Research Department
Lisbon, 1449-005, Portugal
Centro Hospitalar Universitario do Porto | Servico de Investigacao Clinica
Porto, 4050-651, Portugal
RC Medical
Novosibirsk, 630091, Russia
Univerzitna nemocnica Bratislava, Nem. Sv. Cyrila a Metoda
Bratislava, 851 07, Slovakia
GYNARIN, s.r.o.
Fiľakovo, 986 01, Slovakia
ULMUS, s r.o.
Hlohovec, 920 01, Slovakia
Nemocnica AGEL Kocice-Saca a.s.
Kosice - Saca, 040 15, Slovakia
GA Lucenec s.r.o
Lučenec, 984 01, Slovakia
Virina sano, s.r.o. Gynekologicko porodnicka ambulancia
Veľký Krtíš, 990 01, Slovakia
Kantonsspital Baden
Baden, Canton of Aargau, 5404, Switzerland
Universitätsspital Basel
Basel, Canton of Basel-City, 4056, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011, Switzerland
Inselspital Universitätsspital Bern
Bern, 3010, Switzerland
UniversitätsSpital Zürich
Zurich, 8091, Switzerland
Ivano-Frankivsk Regional Perinatal Center
Ivano-Frankivsk, 76018, Ukraine
Instr. of Pediatrics, Obstetrics & Gynecology
Kiev, 4050, Ukraine
Center of innovative medical technologies of NAS of Ukraine
Kiev, 4053, Ukraine
Medical Center LLC "Verum Expert Clinic"
Kyiv, 3039, Ukraine
Medical Center Motor Sich
Zaporizhzhya, 69068, Ukraine
CNE "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia regional council
Zaporizhzhya, 69600, Ukraine
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: 39172446DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer AG
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
October 19, 2021
First Posted
October 29, 2021
Study Start
October 29, 2021
Primary Completion
June 13, 2023
Study Completion
October 10, 2023
Last Updated
February 12, 2026
Results First Posted
February 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
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.