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

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.

Study Overview

• Status: Completed
• Conditions: Hot Flashes; Vasomotor Symptoms Associated With Menopause
• Intervention / Treatment: Drug: Elinzanetant (BAY3427080); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, G1V 4T3
    • Diex Recherche Quebec Inc.
  • Québec, Canada, G2J 0C4
    • Alpha Recherche Clinique | Lebourgneuf
  • Alberta
    • Edmonton, Alberta, Canada, T5A 4L8
      • Alta Clinical Research Inc | Edmonton, Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • IWK Health Centre | Department of Obstetrics and Gynaecology
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 0S7
      • Ecogene 21
    • Montreal, Quebec, Canada, H1M 1B1
      • GCP Research | Montreal, Canada
    • Montreal, Quebec, Canada, H4P 2S4
      • Clinique Ovo | R&D Department
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • DIEX Recherche Sherbrooke Inc.
    • Val-Bélair, Quebec, Canada, G3K 2P8
      • Alpha Recherche Clinique | Val-Belair
    • Victoriaville, Quebec, Canada, G6P 6P6
      • Diex Recherche Victoriaville Inc.
• Czechia
  • Krnov, Czechia, 794 01
    • GynPorCentrum s.r.o.
  • Pilsen, Czechia, 301 00
    • MUDr. Martina Maresova Rosenbergova, gynekologie
  • Prague, Czechia, 160 00
    • Gynekologie Studentsky dum s.r.o.
  • Rokycany, Czechia, 337 01
    • GYNEVI s.r.o.
  • Tábor, Czechia, 390 03
    • Gynpraxetabor s.r.o.
• Germany
  • Berlin, Germany, 10629
    • emovis GmbH
  • Berlin, Germany, 12627
    • Synexus Berlin Clinical Research Centre
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60313
      • Synexus Frankfurt Clinical Research Centre
  • North Rhine-Westphalia
    • Aachen, North Rhine-Westphalia, Germany, 52074
      • Praxis Hr. Dr. S. Fiedler
    • Essen, North Rhine-Westphalia, Germany, 45355
      • Frauenärzte am Schloss Borbeck
    • Krefeld, North Rhine-Westphalia, Germany, 47799
      • Medplus Nordrhein
  • Saxony
    • Leipzig, Saxony, Germany, 04177
      • Synexus Leipzig Clinical Research Centre
  • Saxony-Anhalt
    • Bernburg, Saxony-Anhalt, Germany, 6406
      • Praxis f. Gynäkologie und Geburtshilfe
    • Halle, Saxony-Anhalt, Germany, 06110
      • Frauenarztpraxis Dr. Inka Kiesche
  • Thuringia
    • Gera, Thuringia, Germany, 7545
      • Femme Frauenarztpraxis
• Italy
  • Campania
    • Naples, Campania, Italy, 80131
      • A.O.U. Policlinico Federico II Napoli
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Piedmont
    • Turin, Piedmont, Italy, 10128
      • Azienda Ospedaliera Ordine Mauriziano di Torino
  • Veneto
    • Verona, Veneto, Italy, 37126
      • Azienda Ospedaliera Universitaria Integrata Verona_Borgo Trento - Ostetricia e Ginecologia B
• Norway
  • Fredrikstad, Norway, 1605
    • Kirkeparken Spesialistpraksis
  • Oslo, Norway, 161
    • Medicus | Oslo, Norway
  • Oslo, Norway, 450
    • Oslo University Hospital | Division of Obstetrics and Gynecology, Department of Research
  • Stavanger, Norway, 4005
    • Medicus | Stavanger, Norway
  • Trondheim, Norway, 7014
    • Medicus AS
• Poland
  • Bialystok, Poland, 15-224
    • Gabinet Ginekologiczny Janusz Tomaszewski
  • Katowice, Poland, 40-156
    • CLINICAL MEDICAL RESEARCH Sp. z o. o.
  • Katowice, Poland, 40-748
    • Vita Longa Sp. z o.o.
  • Katowice, Poland, 40-611
    • Centrum Medyczne Angelius Provita
  • Olsztyn, Poland, 10-117
    • Etyka Osrodek Badan Klinicznych
  • Szczecin, Poland, 71-500
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
• Portugal
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar e Universitario de Coimbra, E.P.E. | Department of Gynecology
  • Lisbon, Portugal, 1449-005
    • Centro Hospitalar de Lisboa Ocidental | Clinical Research Department
  • Porto, Portugal, 4050-651
    • Centro Hospitalar Universitario do Porto | Servico de Investigacao Clinica
  • Lisbon District
    • Loures, Lisbon District, Portugal, 2674-514
      • Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica
    • Missing, Lisbon District, Portugal, 1649-035
      • Hospital Santa Maria | Centro de Investigacao Clinica
  • Porto District
    • Matosinhos Municipality, Porto District, Portugal, 4464-513
      • Hospital Pedro Hispano | Clinical Research Center
  • Setúbal District
    • Setúbal, Setúbal District, Portugal, 2900-722
      • Luz Saude | Hospital da Luz Setubal - Clinical Research Department
• Russia
  • Novosibirsk, Russia, 630091
    • RC Medical
• Slovakia
  • Bratislava, Slovakia, 851 07
    • Univerzitna nemocnica Bratislava, Nem. Sv. Cyrila a Metoda
  • Fiľakovo, Slovakia, 986 01
    • GYNARIN, s.r.o.
  • Hlohovec, Slovakia, 920 01
    • ULMUS, s r.o.
  • Kosice - Saca, Slovakia, 040 15
    • Nemocnica AGEL Kocice-Saca a.s.
  • Lučenec, Slovakia, 984 01
    • GA Lucenec s.r.o
  • Veľký Krtíš, Slovakia, 990 01
    • Virina sano, s.r.o. Gynekologicko porodnicka ambulancia
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Universitatsspital Bern
  • Zurich, Switzerland, 8091
    • UniversitätsSpital Zürich
  • Canton of Aargau
    • Baden, Canton of Aargau, Switzerland, 5404
      • Kantonsspital Baden
  • Canton of Basel-City
    • Basel, Canton of Basel-City, Switzerland, 4056
      • Universitätsspital Basel
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois (CHUV)
• Ukraine
  • Ivano-Frankivsk, Ukraine, 76018
    • Ivano-Frankivsk Regional Perinatal Center
  • Kiev, Ukraine, 4050
    • Instr. of Pediatrics, Obstetrics & Gynecology
  • Kiev, Ukraine, 4053
    • Center of innovative medical technologies of NAS of Ukraine
  • Kyiv, Ukraine, 3039
    • Medical Center LLC "Verum Expert Clinic"
  • Zaporizhzhya, Ukraine, 69600
    • CNE "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia regional council
  • Zaporizhzhya, Ukraine, 69068
    • Medical Center Motor Sich
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35218
      • Accel Research Sites | Cahaba Medical Care - Birmingham, AL
    • Mobile, Alabama, United States, 36604
      • Women's Health Alliance of Mobile
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Onyx Clinical Research - Peoria
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Lynn Institute of the Ozarks
  • California
    • Garden Grove, California, United States, 92844
      • National Institute of Clinical Research - Garden Grove
    • Lincoln, California, United States, 95648
      • Clinical Trials Research - Lincoln
    • Lomita, California, United States, 90717
      • Torrance Clinical Research Institute, Inc. | Lomita, CA
    • San Diego, California, United States, 92111
      • Women's Health Care Research | San Diego, CA
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Advanced Women's Health Institute | Denver Office, Greenwood Village, CO
    • Lakewood, Colorado, United States, 80228
      • Physicians' Research Options, LLC | Red Rocks OBGYN
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Helix Biomedics, LLC
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida | Clearwater, FL
    • Hialeah, Florida, United States, 33016
      • Sweet Hope Research Specialty, Inc. - Miami Lakes
    • Miami Springs, Florida, United States, 33166
      • Ocean Blue Medical Research Center, Inc | Miami Springs, FL
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research Inc. | Pasco
    • Ocoee, Florida, United States, 34761
      • Sensible HealthCare, LLC
    • Tampa, Florida, United States, 33606
      • Clinical Research of West Florida | Tampa, FL
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Fellows Research Alliance, Inc | Savannah, GA
  • Idaho
    • Boise, Idaho, United States, 83713
      • Family Care Research | Boise, ID
    • Idaho Falls, Idaho, United States, 83404
      • Leavitt Clinical Research | Idaho Falls, ID
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago | Laboratory of Dr. Al-Hendy
    • Oak Brook, Illinois, United States, 60523
      • AMR - Chicago
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Clinical Trials Management | Northshore Office
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research | Marrero, LA
  • Maryland
    • Oxon Hill, Maryland, United States, 20705
      • Ob and Gyn Physicians MidAtlantic - SKYCRNG
  • Massachusetts
    • Fall River, Massachusetts, United States, 02723
      • Genesis Clinical Research and Consulting, LLC
  • Michigan
    • Saginaw, Michigan, United States, 48604
      • Saginaw Valley Medical Research Group, LLC | Saginaw, MI
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Metro Jackson OBGYN | Jackson, MS
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • R. Garn Mabey Jr. M.D. Gynecology
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Capital Health | Capital Health OBGYN Lawrenceville
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • New Bern, North Carolina, United States, 28562
      • Eastern Carolina Women's Center | New Bern, NC
    • Raleigh, North Carolina, United States, 27607
      • Unified Women's Clinical Research | Raleigh, NC
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Hospital - OB-GYN - Women's Health Research Unit
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Magee-Women's Hospital - Gynecology
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Tribe clinical Research LLC | Greenville, SC
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Medical Research Center of Memphis | Memphis, TN
    • Memphis, Tennessee, United States, 38120
      • Research Memphis Associates, LLC | Memphis, TN
  • Texas
    • Austin, Texas, United States, 78731
      • Austin Regional Clinic | ARC Kelly Lane
    • Bryan, Texas, United States, 77802
      • DiscoveResearch, Inc.
    • Corpus Christi, Texas, United States, 78404
      • South Texas Clinical Research
    • Fort Worth, Texas, United States, 76104-4145
      • Sig Gyn Services (Dr. John A. Whitfield, MD) | Fort Worth, TX
    • Houston, Texas, United States, 77030
      • Advances in Health, INC. | Houston, TX
    • Houston, Texas, United States, 77054
      • UTHealth Womens Research Program | Memorial City
    • Plano, Texas, United States, 75024
      • ClinRx Research, LLC
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • The Woman's Place - Midlife Health
    • Norfolk, Virginia, United States, 23456
      • Tidewater Clinical Research, Inc.
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center | Bellevue, WA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elinzanetant (BAY3427080); Participants will receive 120 mg elinzanetant orally once daily for 26 weeks.	Drug: Elinzanetant (BAY3427080); 120 mg elinzanetant orally once daily
Placebo Comparator: Placebo + elinzanetant; Participants will receive matching placebo orally once daily for 12 weeks, followed by elinzanetant 120 mg for 14 weeks.	Drug: Elinzanetant (BAY3427080); 120 mg elinzanetant orally once daily; Drug: Placebo; Matching placebo orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to Week 1
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.	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.	From baseline to Week 12
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.	From baseline to Week 12
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).	From baseline to Week 12
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).	From baseline to Week 26

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General 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.

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe
• Related Info
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Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2021
• Primary Completion (Actual): June 13, 2023
• Study Completion (Actual): October 10, 2023

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Menopause
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hot Flashes
• Other Study ID Numbers: 21652; 2020-004855-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No