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)

April 12, 2024 updated by: Bayer

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4T3
        • Diex Recherche Quebec Inc.
      • Quebec, Canada, G2J 0C4
        • Alpha Recherche Clinique LB9
    • Alberta
      • Edmonton, Alberta, Canada, T5A 4L8
        • Alta Clinical Research
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 0S7
        • Ecogene21
      • Montreal, Quebec, Canada, H1M 1B1
        • Recherche GCP Research
      • Montreal, Quebec, Canada, H4P 2S4
        • Clinique OVO
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • DIEX Recherche Sherbrooke Inc.
      • Val-Bélair, Quebec, Canada, G3K 2P8
        • Alpha Recherche Clinique
      • Victoriaville, Quebec, Canada, G6P 6P6
        • Diex Recherche Victoriaville Inc.
  • Czechia
      • Krnov, Czechia, 794 01
        • GynPorCentrum s.r.o.
      • Plzen, Czechia, 301 00
        • MUDr. Martina Maresova Rosenbergova, gynekologie
      • Praha 6, Czechia, 160 00
        • Gynekologie Studentsky dum s.r.o.
      • Rokycany, Czechia, 337 01
        • GYNEVI s.r.o.
      • Tabor, Czechia, 39003
        • Gynpraxetabor s.r.o.
  • Germany
      • Berlin, Germany, 10629
        • emovis GmbH
      • Berlin, Germany, 12627
        • Synexus Clinical Research GmbH
    • Hessen
      • Frankfurt, Hessen, Germany, 60313
        • Synexus Frankfurt Clinical Research Centre
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
        • Praxis Hr. Dr. S. Fiedler
      • Essen, Nordrhein-Westfalen, Germany, 45355
        • Frauenärzte am Schloss Borbeck
      • Krefeld, Nordrhein-Westfalen, Germany, 47799
        • Medplus Nordrhein
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Synexus Leipzig Clinical Research Centre
    • Sachsen-Anhalt
      • Bernburg, Sachsen-Anhalt, Germany, 06406
        • Praxis f. Gynäkologie und Geburtshilfe
      • Halle, Sachsen-Anhalt, Germany, 06110
        • Frauenarztpraxis Dr. Inka Kiesche
    • Thüringen
      • Gera, Thüringen, Germany, 07545
        • Femme Frauenarztpraxis
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • A.O.U. Policlinico Federico II Napoli
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli Irccs
    • Piemonte
      • Torino, Piemonte, Italy, 10128
        • A.O. Ordine Mauriziano
    • Veneto
      • Verona, Veneto, Italy, 37126
        • A.O.U.I. Verona
  • Norway
      • Fredrikstad, Norway, 1605
        • Kirkeparken Spesialistpraksis
      • Oslo, Norway, 0161
        • Medicus Oslo AS
      • Oslo, Norway, 0450
        • OUS Ullevål Gynecology Department
      • Stavanger, Norway, 4005
        • Medicus Stavanger AS
      • Trondheim, Norway, 7014
        • Medicus AS
  • Poland
      • Bialystok, Poland, 15-244
        • 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, 71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Portugal
      • Coimbra, Portugal, 3004-561
        • CHUC - Hospitais da U. Coimbra - Servico de Ginecologia
      • Lisboa, Portugal, 1449-005
        • Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
      • Lisboa, Portugal, 1649-035
        • CHULN - H. Sta.Maria (Centro de Investigacao Clinica)
      • Porto, Portugal, 4050-651
        • CHUP - Servico de Investigacao Clinica
    • Lisboa
      • Loures, Lisboa, Portugal, 2674-514
        • Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica
    • Porto
      • Matosinhos, Porto, Portugal, 4464-513
        • ULSM - Hospital Pedro Hispano
    • Setúbal
      • Setubal, Setúbal, Portugal, 2900-722
        • Hospital da Luz - Setubal
  • Slovakia
      • Filakovo, 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.
      • Lucenec, Slovakia, 984 01
        • GA Lucenec s.r.o
  • Switzerland
      • Zürich, Switzerland, 8091
        • Universitatsspital Zurich
    • Aargau
      • Baden, Aargau, Switzerland, 5404
        • Kantonsspital Baden
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois (Chuv)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35218
        • Accel Research Sites - Cahaba Medical Care
      • Mobile, Alabama, United States, 36604
        • Women's Health Alliance of Mobile
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Onyx Clinical Research - Peoria
    • California
      • Garden Grove, California, United States, 92844
        • National Institute of Clinical Research - Garden Grove
      • Lincoln, California, United States, 95648
        • Clinical Trials Research
      • Lomita, California, United States, 90717
        • Torrance Clinical Research- Lomita
      • San Diego, California, United States, 92111
        • Womens Health Care Research Corporation
    • Colorado
      • Greenwood Village, Colorado, United States, 80111
        • Advanced Women's Health Institute
      • Lakewood, Colorado, United States, 80228
        • Physicians Research Options, LLC
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Helix Biomedics, LLC
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc.
      • Clearwater, Florida, United States, 33603
        • Clinical Research of West Florida, Inc - Clearwater
      • Hialeah, Florida, United States, 33016
        • Sweet Hope Research Specialty, Inc. - Miami Lakes
      • Miami Springs, Florida, United States, 33166
        • Ocean Blue Medical Research Center, Inc.
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research Center, Inc.
      • Ocoee, Florida, United States, 34761
        • Sensible Healthcare, LLC
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Fellows Research Alliance - Savannah
    • Idaho
      • Boise, Idaho, United States, 83713
        • Family Care Research
      • Idaho Falls, Idaho, United States, 83404
        • Leavitt Clinical Research | Idaho Falls, ID
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • Affinity Health Research Institute | Oak Brook, IL
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Clinical Trials Management, LLC - Covington
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research
    • Maryland
      • Oxon Hill, Maryland, United States, 20705
        • Ob and Gyn Physicians MidAtlantic - SKYCRNG
    • Michigan
      • Saginaw, Michigan, United States, 48604
        • Saginaw Valley Medical Research Group, LLC
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Metro Jackson OB-GYN
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrence OB/GYN Associates
    • 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
      • Raleigh, North Carolina, United States, 27607
        • Unified Women's Clinical Research - Raleigh
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science Univ | OHSU OBGYN-Women's Hlth Res
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Medical Research Center of Memphis, LLC
      • Memphis, Tennessee, United States, 38120
        • Memphis Obstetrics and Gynecological Association, PC
    • Texas
      • Bryan, Texas, United States, 77802
        • DiscoveResearch, Inc.
      • Corpus Christi, Texas, United States, 78413
        • South Texas Clinical Research
      • Fort Worth, Texas, United States, 76104-4145
        • Signature GYN Services, Pllc
      • Houston, Texas, United States, 77030
        • Advances in Health, Inc.
      • Houston, Texas, United States, 77024
        • UT Health Women's Research Center at Memorial City
      • Pflugerville, Texas, United States, 78660
        • Austin Regional Clinic
      • Plano, Texas, United States, 75024
        • ClinRx Research, LLC
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Midlife Health Center
      • Norfolk, Virginia, United States, 23456
        • Tidewater Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame
Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])
Time Frame: Baseline to Week 4
Baseline to Week 4
Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)
Time Frame: Baseline to Week 12
Baseline to Week 12
Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD)
Time Frame: Baseline to Week 4
Baseline to Week 4
Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)
Time Frame: Baseline to Week 12
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)
Time Frame: Baseline to Week 1
Baseline to Week 1
Mean change in frequency of moderate to severe HF from baseline over time
Time Frame: Baseline to Week 26
Baseline to Week 26
Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12
Time Frame: Baseline to Week 12
The PROMIS SD SF 8b includes 8 items assessing sleep disturbance over the past 7 days. Items assess sleep quality, sleep depth and restoration associated with sleep, perceived difficulties with getting to sleep or staying asleep and perceptions of the adequacy of and satisfaction with sleep. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Four of the items are scored reversely. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance.
Baseline to Week 12
Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12
Time Frame: Baseline to Week 12
The MENQOL questionnaire is 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 assess four domains of symptoms and functioning: VMS, psychosocial functioning, physical functioning, and sexual functioning. For each item, the participant indicates if they have experienced the symptom (yes/no). If participants select yes, participants rate 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 are calculated. Each score ranges from 1-8, higher scores indicate greater bother.
Baseline to Week 12
Mean change in Beck depression inventory (BDI-II) total score from baseline to Week 12
Time Frame: Baseline to Week 12
The BDI-II consists of 21 items to assess the severity of depression over the past 2 weeks. Each item is a list of four statements arranged in increasing levels of severity about a particular symptom of depression. Items use a 4-point verbal response scale ranging from 0 (not at all) to 3 (extreme form of each symptom); specific response options are tailored to the aspect of depression being measured in each item. A total score ranging from 0 to 63 is 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).
Baseline to Week 12
Mean change in BDI-II total score from baseline to Week 26
Time Frame: Baseline to Week 26
The BDI-II consists of 21 items to assess the severity of depression over the past 2 weeks. Each item is a list of four statements arranged in increasing levels of severity about a particular symptom of depression. Items use a 4-point verbal response scale ranging from 0 (not at all) to 3 (extreme form of each symptom); specific response options are tailored to the aspect of depression being measured in each item. A total score ranging from 0 to 63 is 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).
Baseline to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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