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
NCT ID: NCT05042362
Last Updated: 2024-06-27
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
396 participants
INTERVENTIONAL
2021-08-27
2023-11-27
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 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.
40 Years
65 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Alabama Clinical Therapeutics | Birmingham, AL
Birmingham, Alabama, United States
Central Research Associates | Birmingham, AL
Birmingham, Alabama, United States
Mesa Obstetricians and Gynecologists
Mesa, Arizona, United States
MomDoc Women For Women
Scottsdale, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Del Sol Research Management LLC
Tucson, Arizona, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Diagnamics, Inc.
Encinitas, California, United States
Om Research, LLC
Lancaster, California, United States
Northern California Research | Sacramento
Sacramento, California, United States
Alliance Research Institute | Bell Gardens, CA
Tarzana, California, United States
Office of Dr. James A. Simon, MD
Washington D.C., District of Columbia, United States
Alliance for Multispecialty Research, LLC - Fort Meyers
Fort Myers, Florida, United States
Suncoast Clinical Research
Palm Harbor, Florida, United States
Physician Care Clinical Research
Sarasota, Florida, United States
Medisense, Inc.
Atlanta, Georgia, United States
Paramount Research Solutions-College Park
College Park, Georgia, United States
Soapstone Center for Clinical Research
Decatur, Georgia, United States
Drug Studies America
Marietta, Georgia, United States
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Investigators Research Group, LLC
Brownsburg, Indiana, United States
The Iowa Clinic - Ankeny
Ankeny, Iowa, United States
Southern Clinical Research Associates LLC
Metairie, Louisiana, United States
Continental Clinical Solutions | Towson, MD
Towson, Maryland, United States
Revive Research Institute, Inc. - Women's Health
Dearborn Heights, Michigan, United States
Valley OB-GYN Clinic
Saginaw, Michigan, United States
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, United States
Jubilee Clinical Research, Inc
Las Vegas, Nevada, United States
Office of Dr. Edmond Pack
Las Vegas, Nevada, United States
Wake Research - Clinical Research Center of Nevada, LLC
Las Vegas, Nevada, United States
The Center for Womens Health & Wellness, LLC | Lawrenceville, NJ
Lawrenceville, New Jersey, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Velocity Clinical Research - Albuquerque
Albuquerque, New Mexico, United States
Bosque Womens Care
Albuquerque, New Mexico, United States
Circuit Clinical OB/GYN Associates of WNY
West Seneca, New York, United States
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, United States
Wake Research, Inc.
Raleigh, North Carolina, United States
United Women's Clinical Research - Lyndhurst
Winston-Salem, North Carolina, United States
Axia Women's Health | Seven Hills Women's Health Centers - Montgomery
Cincinnati, Ohio, United States
Centricity Research formerly Aventiv - Columbus
Columbus, Ohio, United States
HWC Women's Research Center | Englewood, OH
Englewood, Ohio, United States
HillTop Obstetrics & Gynecology
Franklin, Ohio, United States
Women's Care Research Institute/Marion OBGYN, Inc.
Marion, Ohio, United States
University Hospitals Landerbrook Health Center
Mayfield Heights, Ohio, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, United States
Medical University of South Carolina | MUSC Center for Womens Health - Department of Obstetrics and Gynecology
Charleston, South Carolina, United States
Coastal Carolina Research Center | Mount Pleasant, SC
Mt. Pleasant, South Carolina, United States
Venus Gynecology, LLC former Magnolia OB/GYN Research Center
Myrtle Beach, South Carolina, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, United States
Women Partners in Health Obstetrics & Gynecology (OB/GYN)
Austin, Texas, United States
Cedar Health Research, LLC
Dallas, Texas, United States
Maximos Ob/Gyn
League City, Texas, United States
Northeast Clinical Research of San Antonio, LLC
San Antonio, Texas, United States
Seattle Clinical Research Center
Seattle, Washington, United States
Medizinische Univ Graz | Frauenheilkunde & Geburtshilfe
Graz, Styria, Austria
MedUni Innsbruck | Klinik fur Gyn Endo und Reproduktionsmed
Innsbruck, Tyrol, Austria
AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie
Vienna, , Austria
AKH Wien | Gyn. Endokrinologie & Reproduktionsmedizin
Vienna, , Austria
Gynekologie MEDA s.r.o.
Brno, , Czechia
Gynekologie Cheb s.r.o.
Cheb, , Czechia
GYN-MIKA s.r.o.
České Budějovice, , Czechia
MUDr. Stepan s.r.o.
Hradec Králové, , Czechia
GYN-F s.r.o.
Hradec Králové, , Czechia
Kestr-gyn s.r.o.
Náchod, , Czechia
G-Centrum Olomouc s.r.o. Dr. Skrivanek
Olomouc, , Czechia
PT-MEDICA s.r.o.
Prachatice, , Czechia
ARETAIEION University Hospital
Athens, , Greece
University General Hospital of Heraklion
Heraklion, , Greece
Ioannina University General Hospital
Ioannina, , Greece
General Hospital of Thessaloniki Papageorgiou
Thessaloniki, , Greece
TritonLife Medical Center, XIII.kerulet
Budapest, , Hungary
NAP-MED Egeszsegugyi Szolgaltato Kft
Debrecen, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Komaromi Selye Janos Korhaz
Komárom, , Hungary
Rub-Int Noi Egeszsegcentrum
Székesfehérvár, , Hungary
Mayanei HaYeshua Medical Center
Bnei Brak, , Israel
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Health Corporation of Galilee Medical Center
Nahariya, , Israel
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Ospedale San Raffaele s.r.l.
Milan, Lombardy, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy
A.O.U. Policlinico G.Rodolico-San Marco
Catania, Sicily, Italy
A.O.U. Careggi
Florence, Tuscany, Italy
A.O.U. Pisana
Pisa, Tuscany, Italy
Flevoziekenhuis
Almere Stad, , Netherlands
St. Antonius Ziekenhuis | Utrecht - R&D Interne Geneeskunde
Nieuwegein, , Netherlands
Diakonessenhuis
Utrecht, , Netherlands
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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2020-004908-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
21651
Identifier Type: -
Identifier Source: org_study_id
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