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-1)

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): 396
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie
  • Vienna, Austria, 1090
    • Medizinische Universitat Wien | Universitatsklinik fur Frauenheilkunde Klinische Abteilung fur Gynakologische Endokrinologie
  • Styria
    • Graz, Styria, Austria, 8036
      • Medical University of Graz | Division of Gynecology and Obstetrics
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medizinische Universitat Innsbruck | Klinik fur Gyn Endokrinologie und Reproduktionsmedizin
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Kepler Campus IV | Gyn, Gburtshilfe & gyn. Endokrinologie
• Czechia
  • Brno, Czechia, 602 00
    • Gynekologie MEDA s.r.o.
  • Hradec Králové, Czechia, 500 03
    • GYN-F s.r.o.
  • Náchod, Czechia, 547 01
    • Kestr-gyn s.r.o.
  • Prachatice, Czechia, 383 01
    • PT-MEDICA s.r.o.
  • Prague, Czechia, 160 00
    • Gynekologie Studentsky dum s.r.o.
  • Prague, Czechia, 156 00
    • GYNERA
  • České Budějovice, Czechia, 370 01
    • G-Centrum Olomouc s.r.o. Dr. Skrivanek
  • České Budějovice, Czechia, 370 01
    • GYN-MIKA s.r.o.
  • České Budějovice, Czechia, 370 01
    • Gynekologie Cheb s.r.o.
  • České Budějovice, Czechia, 370 01
    • MUDr. Stepan s.r.o.
• Greece
  • Athens, Greece, 11528
    • ARETAIEION University Hospital
  • Chaïdári, Greece, 12462
    • University General Hospital of Athens "Attikon"
  • Heraklion, Greece, 711 10
    • University General Hospital of Heraklion - Department of Paediatrics
  • Ioannina, Greece, 45500
    • Univ. General Hospital of Ioannina - Department of Paediatrics, Nephrology Unit
  • Pátrai, Greece, 26504
    • University General Hospital of Patras | Univ Obs & Gynae Cli
  • Thessaloniki, Greece, 54642
    • Hippokration General Hospital of Thessaloniki
  • Thessaloniki, Greece, 56403
    • General Hospital Of Thessaloniki Papageorgiou
• Hungary
  • Budapest, Hungary, 1134
    • TritonLife Medical Center, XIII.kerulet
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Debrecen, Hungary, 4028
    • NAP-MED Egeszsegugyi Szolgaltato Kft
  • Komárom, Hungary, 2900
    • Komaromi Selye Janos Korhaz
  • Szeged, Hungary, 6720
    • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
  • Székesfehérvár, Hungary, 8000
    • Rub-Int Noi Egeszsegcentrum
• Israel
  • Afula, Israel, 1834111
    • HaEmek Medical Center | Internal Medicine C Department - Research Unit
  • Bnei Brak, Israel, 5154475
    • Mayanei HaYeshua Medical Center
  • Hadera, Israel, 3810101
    • Hillel Yaffe Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah Hebrew University Hospital Ein Kerem
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Nahariya, Israel, 2210001
    • Health Corporation of Galilee Medical Center
• Italy
  • Emilia-Romagna
    • Ferrara, Emilia-Romagna, Italy, 44124
      • University Hospital Of Ferrara - Ostetricia e Ginecologia
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    • Milan, Lombardy, Italy, 20132
      • Ospedale San Raffaele s.r.l. - Ginecologia Ostetricia e Medicina della Riproduzione
    • Pavia, Lombardy, Italy, 27100
      • Irccs Fondazione Policlinico San Matteo
  • Sicily
    • Catania, Sicily, Italy, 95123
      • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
  • Tuscany
    • Florence, Tuscany, Italy, 50134
      • Careggi University Hospital
    • Pisa, Tuscany, Italy, 56126
      • Azienda Ospedaliero Universitaria Pisana
• Netherlands
  • Almere Stad, Netherlands, MISSING
    • Flevoziekenhuis
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis | Utrecht - R&D Interne Geneeskunde
  • Utrecht, Netherlands, 3582 KE
    • Diakonessenhuis
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates | Birmingham, AL
    • Birmingham, Alabama, United States, 35205
      • Alabama Clinical Therapeutics | Birmingham, AL
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Mesa Obstetricians and Gynecologists | Research Department
    • Scottsdale, Arizona, United States, 85251
      • MomDoc Women's Health Research | Scottsdale, AZ
    • Tucson, Arizona, United States, 85704
      • Noble Clinical Research | Tucson, AZ
    • Tucson, Arizona, United States, 85715
      • Del Sol Research | Women Health studies
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Applied Research Center of Arkansas
  • California
    • Bell Gardens, California, United States, 90201
      • Alliance Research Institute | Bell Gardens, CA
    • Encinitas, California, United States, 92024
      • Diagnamics | Encinitas, CA
    • Lancaster, California, United States, 93534
      • Om Research LLC | Lancaster, CA
    • Sacramento, California, United States, 95821
      • Northern California Research | Sacramento
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20036
      • IntimMedicine | Washington, DC
  • Florida
    • Fort Myers, Florida, United States, 33912
      • AMR - Fort Myers, FL
    • Palm Harbor, Florida, United States, 34684
      • Suncoast Clinical Research Inc | Pinellas
    • Sarasota, Florida, United States, 34239
      • Physician Care Clinical Research LLC | Sarasota, FL
  • Georgia
    • Atlanta, Georgia, United States, 30363
      • Medisense Inc. | Atlanta, GA
    • College Park, Georgia, United States, 30349
      • Paramount Research Solutions | College Park Location
    • Decatur, Georgia, United States, 30033-3500
      • Soapstone Center for Clinical Research, Inc. | Decatur, GA
    • Marietta, Georgia, United States, 30060
      • Drug Studies America
    • Sandy Springs, Georgia, United States, 30126
      • M3 Wake Research Atlanta
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime
  • Indiana
    • Brownsburg, Indiana, United States, 46112
      • Investigators Research Group, Llc
  • Iowa
    • Ankeny, Iowa, United States, 50023
      • The Iowa Clinic - Ankeny
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Southern Clinical Research Associates | Metairie, LA
  • Maryland
    • Towson, Maryland, United States, 21204
      • Continental Clinical Solutions | Towson, MD
  • Michigan
    • Dearborn Heights, Michigan, United States, 48127
      • Revive Research Institute, Inc. - Women's Health
    • Saginaw, Michigan, United States, 48602
      • Valley OBGYN
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln, P.C. | Lincoln, NE
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Affiliated Clinical Research, Inc. | Las Vegas, NV
    • Las Vegas, Nevada, United States, 89123
      • M3 Wake Research - Clinical Research Center of Nevada
    • Las Vegas, Nevada, United States, 89106
      • Jubilee Clinical Research Inc | Las Vegas, NV
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • The Center for Womens Health & Wellness, LLC | Lawrenceville, NJ
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Robert Wood Johnson Medical School
  • New Mexico
    • Albuquerque, New Mexico, United States, 87107
      • Velocity Clinical Research - Albuquerque
    • Albuquerque, New Mexico, United States, 87109
      • Bosque Women's Care | Albuquerque, NM
  • New York
    • West Seneca, New York, United States, 14224
      • Circuit Clinical | OB GYN Associates of WNY
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • OnSite Clinical Solutions - Charlotte
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research | Raleigh, NC
    • Winston-Salem, North Carolina, United States, 27103
      • Unified Women's Clinical Research | Lyndhurst Clinical Research, Winston-Salem, NC
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Axia Women's Health - Anderson Township
    • Dublin, Ohio, United States, 43016
      • Centricity Research - Women's Health - Dublin, OH
    • Englewood, Ohio, United States, 45322
      • HWC Women's Research Center | Englewood, OH
    • Franklin, Ohio, United States, 45005
      • Hilltop Obstetrics & Gynecolofy
    • Marion, Ohio, United States, 43302
      • Women's Care Research Institute/Marion OBGYN, Inc.
    • Mayfield Heights, Ohio, United States, 44124
      • University Hospitals | UH Cleveland Medical Center - MacDonald Clinical Trials Unit
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research Philadelphia | Philadelphia, PA
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC Women's Health - Cannon St.
    • Myrtle Beach, South Carolina, United States, 29572
      • Venus Gynecology, LLC | Myrtle Beach, SC
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research, LLC. | Chattanooga, TN
  • Texas
    • Austin, Texas, United States, 78705
      • Elligo Health Research | Women Partners in Health PLLC
    • Dallas, Texas, United States, 75251
      • Cedar Health Research, LLC. | DFW-East Clinical Site
    • League City, Texas, United States, 77573
      • Maximos Ob/Gyn
    • San Antonio, Texas, United States, 78233
      • Northeast Clinical Research of San Antonio, LLC
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Women's | Seattle, 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 these women are medically cleared prior to study participation.

• Untreated hyperthyroidism or hypothyroidism.

  • Treated hyperthyroidism with no abnormal increase of thyroid function laboratory parameters and no relevant clinical signs for > 6 months before signing of informed consent is acceptable.
  • Treated hypothyroidism with normal thyroid function test results during screening and a stable (for ≥ 3 months before signing of informed consent) dose of replacement therapy is acceptable.
• Any unexplained post-menopausal uterine bleeding.
• Clinically relevant abnormal findings on mammogram.
• Abnormal liver parameters.
• Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer diagnosed based on endometrial biopsy during screening.

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 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	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	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).	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	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.	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 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.	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).	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).	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
• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.
• Related Info
• Study_Synopsis-21651.docx attachment has been generated from the Study Synopsis template. Data may be populated from the following (as available) : Study (44.0), Protocol (0.4), Results(0.1)

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2021
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 13, 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: 21651; 2020-004908-33 (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