Vasomotor Symptoms Associated With MenopausePhase 3OASIS-1NCT05042362
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
A Phase 3 study testing Elinzanetant (BAY3427080) in people with Vasomotor Symptoms Associated With Menopause and Hot Flashes, run by Bayer at 99 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Vasomotor Symptoms Associated With Menopause, Hot Flashes
- 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
- 396 participants
- Where
- 99 sitesin 8 countries
- Study dates
- 27 Aug 2021to 27 Nov 2023
- Phase
- Phase 3
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 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).
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 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.
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- 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
99 sites in 8 countries.
99 sites in 8 countries
United States55 sites
Velocity Clinical Research - Albuquerque
Albuquerque, New Mexico, 87107
Bosque Women's Care | Albuquerque, NM
Albuquerque, New Mexico, 87109
The Iowa Clinic - Ankeny
Ankeny, Iowa, 50023
Medisense Inc. | Atlanta, GA
Atlanta, Georgia, 30363
Elligo Health Research | Women Partners in Health PLLC
Austin, Texas, 78705
Alliance Research Institute | Bell Gardens, CA
Bell Gardens, California, 90201
Alabama Clinical Therapeutics | Birmingham, AL
Birmingham, Alabama, 35205
Central Research Associates | Birmingham, AL
Birmingham, Alabama, 35205
Investigators Research Group, LLC
Brownsburg, Indiana, 46112
MUSC Women's Health - Cannon St.
Charleston, South Carolina, 29425
OnSite Clinical Solutions - Charlotte
Charlotte, North Carolina, 28277
Chattanooga Medical Research, LLC. | Chattanooga, TN
Chattanooga, Tennessee, 37404
Axia Women's Health - Anderson Township
Cincinnati, Ohio, 45242
Paramount Research Solutions | College Park Location
College Park, Georgia, 30349
Cedar Health Research, LLC. | DFW-East Clinical Site
Dallas, Texas, 75251
Revive Research Institute, Inc. - Women's Health
Dearborn Heights, Michigan, 48127
Soapstone Center for Clinical Research, Inc. | Decatur, GA
Decatur, Georgia, 30033-3500
Centricity Research - Women's Health - Dublin, OH
Dublin, Ohio, 43016
Diagnamics | Encinitas, CA
Encinitas, California, 92024
HWC Women's Research Center | Englewood, OH
Englewood, Ohio, 45322
AMR - Fort Myers, FL
Fort Myers, Florida, 33912
Hilltop Obstetrics & Gynecolofy
Franklin, Ohio, 45005
Clinical Research Prime
Idaho Falls, Idaho, 83404
Om Research LLC | Lancaster, CA
Lancaster, California, 93534
Jubilee Clinical Research Inc | Las Vegas, NV
Las Vegas, Nevada, 89106
Affiliated Clinical Research, Inc. | Las Vegas, NV
Las Vegas, Nevada, 89113
M3 Wake Research - Clinical Research Center of Nevada
Las Vegas, Nevada, 89123
The Center for Womens Health & Wellness, LLC | Lawrenceville, NJ
Lawrenceville, New Jersey, 08648
Maximos Ob/Gyn
League City, Texas, 77573
Women's Clinic of Lincoln, P.C. | Lincoln, NE
Lincoln, Nebraska, 68510
Applied Research Center of Arkansas
Little Rock, Arkansas, 72205
Drug Studies America
Marietta, Georgia, 30060
Women's Care Research Institute/Marion OBGYN, Inc.
Marion, Ohio, 43302
University Hospitals | UH Cleveland Medical Center - MacDonald Clinical Trials Unit
Mayfield Heights, Ohio, 44124
Mesa Obstetricians and Gynecologists | Research Department
Mesa, Arizona, 85206
Southern Clinical Research Associates | Metairie, LA
Metairie, Louisiana, 70001
Venus Gynecology, LLC | Myrtle Beach, SC
Myrtle Beach, South Carolina, 29572
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Suncoast Clinical Research Inc | Pinellas
Palm Harbor, Florida, 34684
Clinical Research Philadelphia | Philadelphia, PA
Philadelphia, Pennsylvania, 19114
M3 Wake Research | Raleigh, NC
Raleigh, North Carolina, 27612
Northern California Research | Sacramento
Sacramento, California, 95821
Valley OBGYN
Saginaw, Michigan, 48602
Northeast Clinical Research of San Antonio, LLC
San Antonio, Texas, 78233
M3 Wake Research Atlanta
Sandy Springs, Georgia, 30126
Physician Care Clinical Research LLC | Sarasota, FL
Sarasota, Florida, 34239
MomDoc Women's Health Research | Scottsdale, AZ
Scottsdale, Arizona, 85251
Seattle Women's | Seattle, WA
Seattle, Washington, 98105
Continental Clinical Solutions | Towson, MD
Towson, Maryland, 21204
Noble Clinical Research | Tucson, AZ
Tucson, Arizona, 85704
Del Sol Research | Women Health studies
Tucson, Arizona, 85715
IntimMedicine | Washington, DC
Washington D.C., District of Columbia, 20036
Circuit Clinical | OB GYN Associates of WNY
West Seneca, New York, 14224
Unified Women's Clinical Research | Lyndhurst Clinical Research, Winston-Salem, NC
Winston-Salem, North Carolina, 27103
Czechia10 sites
Gynekologie MEDA s.r.o.
Brno, 602 00
G-Centrum Olomouc s.r.o. Dr. Skrivanek
České Budějovice, 370 01
GYN-MIKA s.r.o.
České Budějovice, 370 01
Gynekologie Cheb s.r.o.
České Budějovice, 370 01
MUDr. Stepan s.r.o.
České Budějovice, 370 01
GYN-F s.r.o.
Hradec Králové, 500 03
Kestr-gyn s.r.o.
Náchod, 547 01
PT-MEDICA s.r.o.
Prachatice, 383 01
GYNERA
Prague, 156 00
Gynekologie Studentsky dum s.r.o.
Prague, 160 00
Greece7 sites
ARETAIEION University Hospital
Athens, 11528
University General Hospital of Athens "ATTIKON"
Chaïdári, 12462
University General Hospital of Heraklion - Department of Paediatrics
Heraklion, 711 10
Univ. General Hospital of Ioannina - Department of Paediatrics, Nephrology Unit
Ioannina, 45500
University General Hospital of Patras | Univ Obs & Gynae Cli
Pátrai, 26504
Hippokration General Hospital of Thessaloniki
Thessaloniki, 54642
General Hospital of Thessaloniki Papageorgiou
Thessaloniki, 56403
Italy7 sites
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Catania, Sicily, 95123
University Hospital Of Ferrara - Ostetricia e Ginecologia
Ferrara, Emilia-Romagna, 44124
Careggi University Hospital
Florence, Tuscany, 50134
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Ospedale San Raffaele s.r.l. - Ginecologia Ostetricia e Medicina della Riproduzione
Milan, Lombardy, 20132
IRCCS Fondazione Policlinico San Matteo
Pavia, Lombardy, 27100
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126
Hungary6 sites
TritonLife Medical Center, XIII.kerulet
Budapest, 1134
NAP-MED Egeszsegugyi Szolgaltato Kft
Debrecen, 4028
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Komaromi Selye Janos Korhaz
Komárom, 2900
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
Szeged, 6720
Rub-Int Noi Egeszsegcentrum
Székesfehérvár, 8000
Israel6 sites
HaEmek Medical Center | Internal Medicine C Department - Research Unit
Afula, 1834111
Mayanei HaYeshua Medical Center
Bnei Brak, 5154475
Hillel Yaffe Medical Center
Hadera, 3810101
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, 9112001
Meir Medical Center
Kfar Saba, 4428164
Health Corporation of Galilee Medical Center
Nahariya, 2210001
Austria5 sites
Medical University of Graz | Division of Gynecology and Obstetrics
Graz, Styria, 8036
Medizinische Universitat Innsbruck | Klinik fur Gyn Endokrinologie und Reproduktionsmedizin
Innsbruck, Tyrol, 6020
Kepler Campus IV | Gyn, Gburtshilfe & gyn. Endokrinologie
Linz, Upper Austria, 4020
AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie
Vienna, 1090
Medizinische Universitat Wien | Universitatsklinik fur Frauenheilkunde Klinische Abteilung fur Gynakologische Endokrinologie
Vienna, 1090
Netherlands3 sites
Flevoziekenhuis
Almere Stad, MISSING
St. Antonius Ziekenhuis | Utrecht - R&D Interne Geneeskunde
Nieuwegein, 3435 CM
Diakonessenhuis
Utrecht, 3582 KE
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 26 Weeks in Postmenopausal Women
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.
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 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.
- 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 group | Role | What they receive |
|---|---|---|
| Elinzanetant (BAY3427080) | Experimental | Participants will receive 120 mg elinzanetant orally once daily for 26 weeks. Receives: 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. Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
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 1, Days 2-8 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
Measured: From baseline to Week 1
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time.
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 1 Days 2-8 were used instead of 1-7, because the intake started on Day 1 only before going to bed, for Week 4 Days 22-28 were used and for Week 12 Days 78-84 were used (Day 1 corresponds to start of treatment). These data were aggregated to a mean daily frequency as (total number of moderate to severe HF during that week) / (total number of available days with data during that week). In case data was not available for more than 2 days within a week, the value for that particular week was set to missing.
Measured: 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.
In controversy of what you have been proposing above here you are just explaining the PROMIS SD SF 8b scores, not the secondary endpoint which is the change in the T-scores from BL to week 12
The PROMIS Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) measures sleep disturbance over the past 7 days using 8 items assessing sleep quality, depth, restorative sleep, difficulty falling or staying asleep, and perceptions of sleep adequacy and satisfaction. Items use 5-point response options that vary by item (e.g., Not at all → Very much; Never → Always; Very poor → Very good). Item scores sum to a raw score of 8-40, which is converted to a T-score (mean 50, SD 10; range 28.9-76.5). Higher scores reflect greater sleep disturbance. PROMIS cut points classify T-scores of 55-59 as mild, 60-69 as moderate, and ≥70 as severe disturbance.
Measured: From baseline to Week 12
Mean Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline to Week 12.
The MENQOL questionnaire was 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 assessed four domains of symptoms and functioning: VMS, psychosocial functioning, physical functioning, and sexual functioning. For each item, the participant indicated if they had experienced the symptom (yes/no). If participants selected yes, participants rated 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 were calculated. Each score ranged from 1-8, higher scores indicated greater bother.
Measured: From baseline to Week 12
Mean Beck Depression Inventory (BDI-II) Total Score From Baseline to Week 12.
The BDI-II was a 21-item questionnaire assessed the intensity of depressive symptoms over the past 2 weeks. Each item was a list of four statements arranged in increasing levels of severity about a particular symptom of depression. Items used a 4-point verbal response scale ranging from 0 (not at all) to 3 (extreme form of each symptom); specific response options were tailored to the aspect of depression being measured in each item. A total score ranging from 0 to 63 was calculated with scores of 0-13 indicating mild minimal range, 14 - 19 mild depression, 20 - 28 indicating moderate and 29 - 63 severe depression (higher score = greater depression).
Measured: From baseline to Week 12
Mean Change in BDI-II Total Score From Baseline to Week 26.
The BDI-II was a 21-item questionnaire assessing the intensity of depressive symptoms over the past 2 weeks. Each item was a list of four statements arranged in increasing levels of severity about a particular symptom of depression. Items used a 4-point verbal response scale ranging from 0 (not at all) to 3 (extreme form of each symptom); specific response options were tailored to the aspect of depression being measured in each item. A total score ranging from 0 to 63 was calculated with scores of 0-13 indicating mild minimal range, 14 - 19 mild depression, 20 - 28 indicating moderate and 29 - 63 severe depression (higher score = greater depression).
Measured: From baseline to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start27 Aug 2021
- Primary completion25 Jul 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vasomotor Symptoms Associated With MenopauseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042362
- Sponsor's protocol ID
- 21651
- Other IDs
- 2020-004908-33
- Acronym
- OASIS-1
- Status last verified
- Jan 2026
- First submitted
- 26 Aug 2021
- Last updated
- 12 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39172446