AzTrials
AzTrials

Vasomotor Symptoms Associated With MenopausePhase 3NCT05099159

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 Phase 3 study testing Elinzanetant (BAY3427080) in people with Vasomotor Symptoms Associated With Menopause and Hot Flashes, run by Bayer at 113 sites in 12 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 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
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
400 participants
Where
113 sitesin 12 countries
Study dates
29 Oct 2021to 10 Oct 2023
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 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 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

113 sites in 12 countries.

113 sites in 12 countries

United States48 sites

  • Austin Regional Clinic | ARC Kelly Lane

    Austin, Texas, 78731

  • Northwest Clinical Research Center | Bellevue, WA

    Bellevue, Washington, 98007

  • Accel Research Sites | Cahaba Medical Care - Birmingham, AL

    Birmingham, Alabama, 35218

  • Family Care Research | Boise, ID

    Boise, Idaho, 83713

  • Helix Biomedics, LLC

    Boynton Beach, Florida, 33435

  • DiscoveResearch, Inc.

    Bryan, Texas, 77802

  • The Woman's Place - Midlife Health

    Charlottesville, Virginia, 22903

  • University of Chicago | Laboratory of Dr. Al-Hendy

    Chicago, Illinois, 60637

  • Clinical Research of West Florida | Clearwater, FL

    Clearwater, Florida, 33765

  • South Texas Clinical Research

    Corpus Christi, Texas, 78404

  • Clinical Trials Management | Northshore Office

    Covington, Louisiana, 70433

  • Genesis Clinical Research and Consulting, LLC

    Fall River, Massachusetts, 02723

  • Sig Gyn Services (Dr. John A. Whitfield, MD) | Fort Worth, TX

    Fort Worth, Texas, 76104-4145

  • National Institute of Clinical Research - Garden Grove

    Garden Grove, California, 92844

  • Tribe clinical Research LLC | Greenville, SC

    Greenville, South Carolina, 29607

  • Advanced Women's Health Institute | Denver Office, Greenwood Village, CO

    Greenwood Village, Colorado, 80111

  • Sweet Hope Research Specialty, Inc. - Miami Lakes

    Hialeah, Florida, 33016

  • Advances in Health, INC. | Houston, TX

    Houston, Texas, 77030

  • UTHealth Womens Research Program | Memorial City

    Houston, Texas, 77054

  • Leavitt Clinical Research | Idaho Falls, ID

    Idaho Falls, Idaho, 83404

  • Metro Jackson OBGYN | Jackson, MS

    Jackson, Mississippi, 39202

  • Physicians' Research Options, LLC | Red Rocks OBGYN

    Lakewood, Colorado, 80228

  • R. Garn Mabey Jr. M.D. Gynecology

    Las Vegas, Nevada, 89128

  • Capital Health | Capital Health OBGYN Lawrenceville

    Lawrenceville, New Jersey, 08648

  • Clinical Trials Research - Lincoln

    Lincoln, California, 95648

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72204

  • Torrance Clinical Research Institute, Inc. | Lomita, CA

    Lomita, California, 90717

  • Tandem Clinical Research | Marrero, LA

    Marrero, Louisiana, 70072

  • Medical Research Center of Memphis | Memphis, TN

    Memphis, Tennessee, 38120

  • Research Memphis Associates, LLC | Memphis, TN

    Memphis, Tennessee, 38120

  • Ocean Blue Medical Research Center, Inc | Miami Springs, FL

    Miami Springs, Florida, 33166

  • Women's Health Alliance of Mobile

    Mobile, Alabama, 36604

  • Eastern Carolina Women's Center | New Bern, NC

    New Bern, North Carolina, 28562

  • Suncoast Clinical Research Inc. | Pasco

    New Port Richey, Florida, 34652

  • Columbia University Medical Center

    New York, New York, 10032

  • Tidewater Clinical Research, Inc.

    Norfolk, Virginia, 23456

  • AMR - Chicago

    Oak Brook, Illinois, 60523

  • Sensible Healthcare, LLC

    Ocoee, Florida, 34761

  • Ob and Gyn Physicians MidAtlantic - SKYCRNG

    Oxon Hill, Maryland, 20705

  • Onyx Clinical Research - Peoria

    Peoria, Arizona, 85381

  • UPMC Magee-Women's Hospital - Gynecology

    Pittsburgh, Pennsylvania, 15213

  • ClinRx Research, LLC

    Plano, Texas, 75024

  • OHSU Hospital - OB-GYN - Women's Health Research Unit

    Portland, Oregon, 97239

  • Unified Women's Clinical Research | Raleigh, NC

    Raleigh, North Carolina, 27607

  • Saginaw Valley Medical Research Group, LLC | Saginaw, MI

    Saginaw, Michigan, 48604

  • Women's Health Care Research | San Diego, CA

    San Diego, California, 92111

  • Fellows Research Alliance, Inc | Savannah, GA

    Savannah, Georgia, 31406

  • Clinical Research of West Florida | Tampa, FL

    Tampa, Florida, 33606

Other trials in United States

Canada10 sites

  • Ecogene 21

    Chicoutimi, Quebec, G7H 0S7

  • Alta Clinical Research Inc | Edmonton, Canada

    Edmonton, Alberta, T5A 4L8

  • IWK Health Centre | Department of Obstetrics and Gynaecology

    Halifax, Nova Scotia, B3K 6R8

  • GCP Research | Montreal, Canada

    Montreal, Quebec, H1M 1B1

  • Clinique Ovo | R&D Department

    Montreal, Quebec, H4P 2S4

  • Diex Recherche Quebec Inc.

    Québec, G1V 4T3

  • Alpha Recherche Clinique | Lebourgneuf

    Québec, G2J 0C4

  • Diex Recherche Sherbrooke Inc.

    Sherbrooke, Quebec, J1L 0H8

  • Alpha Recherche Clinique | Val-Belair

    Val-Bélair, Quebec, G3K 2P8

  • Diex Recherche Victoriaville Inc.

    Victoriaville, Quebec, G6P 6P6

Other trials in Canada

Germany10 sites

  • Praxis Hr. Dr. S. Fiedler

    Aachen, North Rhine-Westphalia, 52074

  • emovis GmbH

    Berlin, 10629

  • Synexus Berlin Clinical Research Centre

    Berlin, 12627

  • Praxis f. Gynäkologie und Geburtshilfe

    Bernburg, Saxony-Anhalt, 6406

  • Frauenärzte am Schloss Borbeck

    Essen, North Rhine-Westphalia, 45355

  • Synexus Frankfurt Clinical Research Centre

    Frankfurt am Main, Hesse, 60313

  • Femme Frauenarztpraxis

    Gera, Thuringia, 7545

  • Frauenarztpraxis Dr. Inka Kiesche

    Halle, Saxony-Anhalt, 06110

  • Medplus Nordrhein

    Krefeld, North Rhine-Westphalia, 47799

  • Synexus Leipzig Clinical Research Centre

    Leipzig, Saxony, 04177

Other trials in Germany

Portugal7 sites

  • Centro Hospitalar e Universitario de Coimbra, E.P.E. | Department of Gynecology

    Coimbra, 3000-075

  • Centro Hospitalar de Lisboa Ocidental | Clinical Research Department

    Lisbon, 1449-005

  • Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica

    Loures, Lisbon District, 2674-514

  • Hospital Pedro Hispano | Clinical Research Center

    Matosinhos Municipality, Porto District, 4464-513

  • Hospital Santa Maria | Centro de Investigacao Clinica

    Missing, Lisbon District, 1649-035

  • Centro Hospitalar Universitario do Porto | Servico de Investigacao Clinica

    Porto, 4050-651

  • Luz Saude | Hospital da Luz Setubal - Clinical Research Department

    Setúbal, Setúbal District, 2900-722

Other trials in Portugal

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

  • Etyka Osrodek Badan Klinicznych

    Olsztyn, 10-117

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-500

Other trials in Poland

Slovakia6 sites

  • Univerzitna nemocnica Bratislava, Nem. Sv. Cyrila a Metoda

    Bratislava, 851 07

  • GYNARIN, s.r.o.

    Fiľakovo, 986 01

  • ULMUS, s r.o.

    Hlohovec, 920 01

  • Nemocnica AGEL Kocice-Saca a.s.

    Kosice - Saca, 040 15

  • GA Lucenec s.r.o

    Lučenec, 984 01

  • Virina sano, s.r.o. Gynekologicko porodnicka ambulancia

    Veľký Krtíš, 990 01

Other trials in Slovakia

Ukraine6 sites

  • Ivano-Frankivsk Regional Perinatal Center

    Ivano-Frankivsk, 76018

  • Instr. of Pediatrics, Obstetrics & Gynecology

    Kiev, 4050

  • Center of innovative medical technologies of NAS of Ukraine

    Kiev, 4053

  • Medical Center LLC "Verum Expert Clinic"

    Kyiv, 3039

  • Medical Center Motor Sich

    Zaporizhzhya, 69068

  • CNE "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia regional council

    Zaporizhzhya, 69600

Other trials in Ukraine

Czechia5 sites

  • GynPorCentrum s.r.o.

    Krnov, 794 01

  • MUDr. Martina Maresova Rosenbergova, gynekologie

    Pilsen, 301 00

  • Gynekologie Studentsky dum s.r.o.

    Prague, 160 00

  • GYNEVI s.r.o.

    Rokycany, 337 01

  • Gynpraxetabor s.r.o.

    Tábor, 390 03

Other trials in Czechia

Norway5 sites

  • Kirkeparken Spesialistpraksis

    Fredrikstad, 1605

  • Medicus | Oslo, Norway

    Oslo, 161

  • Oslo University Hospital | Division of Obstetrics and Gynecology, Department of Research

    Oslo, 450

  • Medicus | Stavanger, Norway

    Stavanger, 4005

  • Medicus AS

    Trondheim, 7014

Other trials in Norway

Switzerland5 sites

  • Kantonsspital Baden

    Baden, Canton of Aargau, 5404

  • Universitätsspital Basel

    Basel, Canton of Basel-City, 4056

  • Inselspital Universitätsspital Bern

    Bern, 3010

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, Canton of Vaud, 1011

  • UniversitätsSpital Zürich

    Zurich, 8091

Other trials in Switzerland

Italy4 sites

  • A.O.U. Policlinico Federico II Napoli

    Naples, Campania, 80131

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168

  • Azienda Ospedaliera Ordine Mauriziano Di Torino

    Turin, Piedmont, 10128

  • Azienda Ospedaliera Universitaria Integrata Verona_Borgo Trento - Ostetricia e Ginecologia B

    Verona, Veneto, 37126

Other trials in Italy

Russia1 site

  • RC Medical

    Novosibirsk, 630091

Other trials in Russia

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 groups in NCT05099159
Study groupRoleWhat they receive
Elinzanetant (BAY3427080)ExperimentalParticipants will receive 120 mg elinzanetant orally once daily for 26 weeks.
Receives: Drug: Elinzanetant (BAY3427080)
Placebo + elinzanetantPlacebo comparatorParticipants 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.

  1. 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).

    Measured: From baseline to Week 4

  2. 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).

    Measured: From baseline to Week 12

  3. 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

  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)

  1. Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 1 (Assessed by HFDD)

    Participants' assessments of HF were recorded electronically twice daily using the sponsor developed 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.

    Measured: From baseline to Week 1

  2. Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (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 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 is not available for more than 2 days within a week, the value for that particular week was be set to missing.

    Measured: From baseline to Week 30

  3. 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

  4. Mean Change in 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 participants 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. The four domain scores were calculated as a mean of converted single item scores (range 1-8), and the mean of the four domain scores yielded the MENQOL total score. Higher scores indicated greater bother.

    Measured: From baseline to Week 12

  5. Mean Change in Beck Depression Inventory (BDI-II) Total Score From Baseline to Week 12

    The BDI-II consisted of 21 items to assess the severity of depression 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 indicating mild depression, 20 - 28 indicating moderate and 29 - 63 indicating severe depression (higher score = greater depression).

    Measured: From baseline to Week 12

  6. Mean Change in BDI-II Total Score From Baseline to Week 26

    The BDI-II consisted of 21 items to assess the severity of depression 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 indicating mild depression, 20 - 28 indicating moderate and 29 - 63 indicating 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.

  1. First posted29 Oct 2021
  2. Study start29 Oct 2021
  3. Primary completion13 Jun 2023
  4. Study completion10 Oct 2023

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05099159
Sponsor's protocol ID
21652
Other IDs
2020-004855-34
Status last verified
Jan 2026
First submitted
19 Oct 2021
Last updated
12 Feb 2026
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

  • 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

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 113 sites in 12 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 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States, Canada, Germany, Portugal, Poland and 7 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 12 Feb 2026). 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 HF From Baseline to Week 4 (Assessed by HFDD) (time frame: From baseline to Week 4). The study lists 4 primary outcomes in all. 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 NCT05099159, 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 12 Feb 2026.

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