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)
NCT ID: NCT05099159
Last Updated: 2024-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2021-10-29
2023-10-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Elinzanetant (BAY3427080)
Participants will receive 120 mg elinzanetant orally once daily for 26 weeks.
Elinzanetant (BAY3427080)
120 mg elinzanetant orally once daily
Placebo + elinzanetant
Participants will receive matching placebo orally once daily for 12 weeks, followed by elinzanetant 120 mg for 14 weeks.
Elinzanetant (BAY3427080)
120 mg elinzanetant orally once daily
Placebo
Matching placebo orally once daily
Interventions
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Elinzanetant (BAY3427080)
120 mg elinzanetant orally once daily
Placebo
Matching placebo orally once daily
Eligibility Criteria
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Inclusion Criteria
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 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.
40 Years
65 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Accel Research Sites - Cahaba Medical Care
Birmingham, Alabama, United States
Women's Health Alliance of Mobile
Mobile, Alabama, United States
Onyx Clinical Research - Peoria
Peoria, Arizona, United States
National Institute of Clinical Research - Garden Grove
Garden Grove, California, United States
Clinical Trials Research
Lincoln, California, United States
Torrance Clinical Research- Lomita
Lomita, California, United States
Womens Health Care Research Corporation
San Diego, California, United States
Advanced Women's Health Institute
Greenwood Village, Colorado, United States
Physicians Research Options, LLC
Lakewood, Colorado, United States
Helix Biomedics, LLC
Boynton Beach, Florida, United States
Clinical Research of West Florida, Inc - Clearwater
Clearwater, Florida, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Sweet Hope Research Specialty, Inc. - Miami Lakes
Hialeah, Florida, United States
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, United States
Suncoast Clinical Research Center, Inc.
New Port Richey, Florida, United States
Sensible Healthcare, LLC
Ocoee, Florida, United States
Fellows Research Alliance - Savannah
Savannah, Georgia, United States
Family Care Research
Boise, Idaho, United States
Leavitt Clinical Research | Idaho Falls, ID
Idaho Falls, Idaho, United States
Affinity Health Research Institute | Oak Brook, IL
Oak Brook, Illinois, United States
Clinical Trials Management, LLC - Covington
Covington, Louisiana, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Ob and Gyn Physicians MidAtlantic - SKYCRNG
Oxon Hill, Maryland, United States
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, United States
Metro Jackson OB-GYN
Jackson, Mississippi, United States
Lawrence OB/GYN Associates
Lawrenceville, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Eastern Carolina Women's Center
New Bern, North Carolina, United States
Unified Women's Clinical Research - Raleigh
Raleigh, North Carolina, United States
Oregon Health and Science Univ | OHSU OBGYN-Women's Hlth Res
Portland, Oregon, United States
Tribe Clinical Research
Greenville, South Carolina, United States
Medical Research Center of Memphis, LLC
Memphis, Tennessee, United States
Memphis Obstetrics and Gynecological Association, PC
Memphis, Tennessee, United States
DiscoveResearch, Inc.
Bryan, Texas, United States
South Texas Clinical Research
Corpus Christi, Texas, United States
Signature GYN Services, Pllc
Fort Worth, Texas, United States
UT Health Women's Research Center at Memorial City
Houston, Texas, United States
Advances in Health, Inc.
Houston, Texas, United States
Austin Regional Clinic
Pflugerville, Texas, United States
ClinRx Research, LLC
Plano, Texas, United States
University of Virginia Midlife Health Center
Charlottesville, Virginia, United States
Tidewater Clinical Research, Inc.
Norfolk, Virginia, United States
Alta Clinical Research
Edmonton, Alberta, Canada
Ecogene21
Chicoutimi, Quebec, Canada
Recherche GCP Research
Montreal, Quebec, Canada
Clinique OVO
Montreal, Quebec, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
ALPHA Recherche Clinique
Val-Bélair, Quebec, Canada
Diex Recherche Victoriaville Inc.
Victoriaville, Quebec, Canada
Diex Recherche Quebec Inc.
Québec, , Canada
Alpha Recherche Clinique | Lebourgneuf
Québec, , Canada
GynPorCentrum s.r.o.
Krnov, , Czechia
MUDr. Martina Maresova Rosenbergova, gynekologie
Pilsen, , Czechia
Gynekologie Studentsky dum s.r.o.
Prague, , Czechia
GYNEVI s.r.o.
Rokycany, , Czechia
Gynpraxetabor s.r.o.
Tábor, , Czechia
Synexus Frankfurt Clinical Research Centre
Frankfurt am Main, Hesse, Germany
Praxis Hr. Dr. S. Fiedler
Aachen, North Rhine-Westphalia, Germany
Frauenärzte am Schloss Borbeck
Essen, North Rhine-Westphalia, Germany
Medplus Nordrhein
Krefeld, North Rhine-Westphalia, Germany
Synexus Leipzig Clinical Research Centre
Leipzig, Saxony, Germany
Praxis f. Gynäkologie und Geburtshilfe
Bernburg, Saxony-Anhalt, Germany
Frauenarztpraxis Dr. Inka Kiesche
Halle, Saxony-Anhalt, Germany
Femme Frauenarztpraxis
Gera, Thuringia, Germany
emovis GmbH
Berlin, , Germany
Synexus Berlin Clinical Research Centre
Berlin, , Germany
A.O.U. Policlinico Federico II Napoli
Napoli, Campania, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
A.O. Ordine Mauriziano
Turin, Piedmont, Italy
A.O.U.I. Verona
Verona, Veneto, Italy
Kirkeparken Spesialistpraksis
Fredrikstad, , Norway
Medicus Oslo AS
Oslo, , Norway
OUS Ullevål Gynecology Department
Oslo, , Norway
Medicus Stavanger AS
Stavanger, , Norway
Medicus AS
Trondheim, , Norway
Gabinet Ginekologiczny Janusz Tomaszewski
Bialystok, , Poland
CLINICAL MEDICAL RESEARCH Sp. z o. o.
Katowice, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
Vita Longa Sp. z o.o.
Katowice, , Poland
Etyka Osrodek Badan Klinicznych
Olsztyn, , Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, , Poland
Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica
Loures, Lisbon District, Portugal
ULSM - Hospital Pedro Hispano
Matosinhos Municipality, Porto District, Portugal
Hospital da Luz - Setubal
Setúbal, Setúbal District, Portugal
CHUC - Hospitais da U. Coimbra - Servico de Ginecologia
Coimbra, , Portugal
Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
Lisbon, , Portugal
CHULN - H. Sta.Maria (Centro de Investigacao Clinica)
Lisbon, , Portugal
CHUP - Servico de Investigacao Clinica
Porto, , Portugal
GYNARIN, s.r.o.
Fiľakovo, , Slovakia
ULMUS, s r.o.
Hlohovec, , Slovakia
Nemocnica AGEL Kocice-Saca a.s.
Kosice - Saca, , Slovakia
GA Lucenec s.r.o
Lučenec, , Slovakia
Kantonsspital Baden
Baden, Canton of Aargau, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland
UniversitätsSpital Zürich
Zurich, , Switzerland
Countries
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References
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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.
Related Links
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Click here to find further information and, after study completion, the study results according to Bayer's transparency standards
Other Identifiers
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2020-004855-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
21652
Identifier Type: -
Identifier Source: org_study_id
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