check_circleStudy Completed
Vasomotor symptoms associated with menopause, Hot flashes
Bayer Identifier:
21651
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial purpose
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.
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.
Key Participants Requirements
Sex
FemaleAge
40 - 65 YearsTrial summary
Enrollment Goal
396Trial Dates
August 2021 - November 2023Phase
Phase 3Could I Receive a placebo
YesProducts
Elinzanetant (BAY3427080)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Gynekologie MEDA s.r.o. | Brno, 602 00, Czechia |
Completed | AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie | Wien, 1090, Austria |
Completed | AKH Wien | Gyn. Endokrinologie & Reproduktionsmedizin | Wien, 1090, Austria |
Completed | Medizinische Univ Graz | Frauenheilkunde & Geburtshilfe | Graz, 8036, Austria |
Withdrawn | Kepler Campus IV | Gyn, Gburtshilfe & gyn. Endokrinologie | Linz, 4020, Austria |
Completed | MedUni Innsbruck | Klinik fur Gyn Endo und Reproduktionsmed | Innsbruck, 6020, Austria |
Completed | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano, 20122, Italy |
Completed | A.O.U. Policlinico G.Rodolico-San Marco | Catania, 95123, Italy |
Completed | Fondazione IRCCS Policlinico San Matteo | Pavia, 27100, Italy |
Completed | Ospedale San Raffaele s.r.l. | Milano, 20132, Italy |
Completed | A.O.U. Careggi | Firenze, 50134, Italy |
Withdrawn | A.O.U. di Ferrara | Ferrara, 44124, Italy |
Completed | Clinical Research of Philadelphia, LLC | Philadelphia, 19114, United States |
Completed | Wake Research, Inc. | Raleigh, 27612, United States |
Completed | Suncoast Clinical Research | Palm Harbor, 34684, United States |
Completed | Women's Clinic of Lincoln, PC | Lincoln, 68510, United States |
Completed | Venus Gynecology, LLC former Magnolia OB/GYN Research Center | Myrtle Beach, 29572, United States |
Completed | Mesa Obstetricians and Gynecologists | Mesa, 85206, United States |
Withdrawn | Gynekologie Studentsky dum s.r.o. | Praha 6, 160 00, Czechia |
Completed | PT-MEDICA s.r.o. | Prachatice, 383 01, Czechia |
Completed | Southern Clinical Research Associates LLC | Metairie, 70001, United States |
Completed | Om Research, LLC | Lancaster, 93534, United States |
Completed | Centricity Research formerly Aventiv - Columbus | Columbus, 43213, United States |
Withdrawn | Advanced Clinical Research | Salt Lake City, 84102, United States |
Completed | Mount Vernon Clinical Research, LLC | Sandy Springs, 30126, United States |
Completed | Chattanooga Medical Research, LLC | Chattanooga, 37404, United States |
Completed | Cedar Health Research, LLC | Dallas, 75251, United States |
Completed | Coastal Carolina Research Center | Mount Pleasant, SC | Mt. Pleasant, 29464, United States |
Completed | The Center for Womens Health & Wellness, LLC | Lawrenceville, NJ | Lawrenceville, 08648, United States |
Completed | Diagnamics, Inc. | Encinitas, 92024, United States |
Completed | Alliance for Multispecialty Research, LLC - Fort Meyers | Fort Myers, 33912, United States |
Completed | University Hospitals Landerbrook Health Center | Mayfield Heights, 44124, United States |
Completed | Soapstone Center for Clinical Research | Decatur, 30034, United States |
Completed | United Women's Clinical Research - Lyndhurst | Winston-Salem, 27103, United States |
Completed | HillTop Obstetrics & Gynecology | Franklin, 45005-2593, United States |
Completed | Continental Clinical Solutions | Towson, MD | Towson, 21204, United States |
Completed | Alabama Clinical Therapeutics | Birmingham, AL | Birmingham, 35205, United States |
Completed | Noble Clinical Research | Tucson, 85704, United States |
Completed | Women Partners in Health Obstetrics & Gynecology (OB/GYN) | Austin, 78705, United States |
Completed | Valley OB-GYN Clinic | Saginaw, 48602, United States |
Withdrawn | PharmaSite Research, Inc | Pikesville, MD | Pikesville, 21208, United States |
Completed | Office of Dr. James A. Simon, MD | Washington, 20036, United States |
Completed | Medical University of South Carolina | MUSC Center for Womens Health - Department of Obstetrics and Gynecology | Charleston, 29425, United States |
Completed | Bosque Womens Care | Albuquerque, 87109, United States |
Completed | Physician Care Clinical Research | Sarasota, 34239, United States |
Withdrawn | Houston Center for Clinical Research, LLC | Sugarland, 77479, United States |
Completed | Alliance Research Institute | Bell Gardens, CA | Tarzana, 91356, United States |
Completed | HWC Women's Research Center | Englewood, OH | Englewood, 45322, United States |
Completed | Rutgers Robert Wood Johnson Medical School | New Brunswick, 08901, United States |
Withdrawn | GYNERA | Praha 5, 156 00, Czechia |
Completed | MUDr. Stepan s.r.o. | Hradec Kralove, 500 02, Czechia |
Completed | Kestr-gyn s.r.o. | Nachod, 547 01, Czechia |
Completed | Del Sol Research Management LLC | Tucson, 85715, United States |
Completed | Wake Research - Clinical Research Center of Nevada, LLC | Las Vegas, 89123, United States |
Completed | MomDoc Women For Women | Scottsdale, 85251, United States |
Withdrawn | AMR Las Vegas | Las Vegas, 89119, United States |
Completed | A.O.U. Pisana | Pisa, 56126, Italy |
Completed | G-Centrum Olomouc s.r.o. Dr. Skrivanek | Olomouc, 772 00, Czechia |
Completed | Gynekologie Cheb s.r.o. | Cheb, 350 02, Czechia |
Completed | St. Antonius Ziekenhuis | Utrecht - R&D Interne Geneeskunde | Nieuwegein, 3435 CM, Netherlands |
Completed | Flevoziekenhuis | Almere, Netherlands |
Completed | Diakonessenhuis | UTRECHT, 3582 KE, Netherlands |
Withdrawn | Canisius Wilhelmina Ziekenhuis | NIJMEGEN, 6532 SZ, Netherlands |
Completed | Medisense, Inc. | Atlanta, 30363, United States |
Completed | Clinical Research Prime | Idaho Falls, 83404, United States |
Completed | Health Corporation of Galilee Medical Center | Nahariya, 2210001, Israel |
Withdrawn | Hillel Yaffe Medical Center | Hadera, 3810101, Israel |
Completed | Meir Medical Center | Kfar Saba, 4428164, Israel |
Withdrawn | HaEmek Medical Center | Internal Medicine C Department - Research Unit | Afula, 1834111, Israel |
Completed | Mayanei HaYeshua Medical Center | Bnei Brak, 5154475, Israel |
Completed | Hadassah Hebrew University Hospital Ein Kerem | Jerusalem, 9112001, Israel |
Completed | Jubilee Clinical Research, Inc | Las Vegas, 89106, United States |
Withdrawn | University General Hospital ATTIKON | Chaidari, 12462, Greece |
Completed | ARETAIEION University Hospital | Athens, 11528, Greece |
Completed | General Hospital of Thessaloniki Papageorgiou | Thessaloniki, 56403, Greece |
Withdrawn | University General Hospital of Patras | Univ Obs & Gynae Cli | Patra, 26504, Greece |
Withdrawn | Hippokration General Hospital of Thessaloniki | Thessaloniki, 54642, Greece |
Completed | Ioannina University General Hospital | Ioannina, 45500, Greece |
Completed | University General Hospital of Heraklion | Heraklion, 711 10, Greece |
Completed | Circuit Clinical OB/GYN Associates of WNY | West Seneca, 14224, United States |
Withdrawn | Pecsi Tudomanyegyetem Klinikai Kozpont | Pecs, 7624, Hungary |
Completed | NAP-MED Egeszsegugyi Szolgaltato Kft | Debrecen, 4028, Hungary |
Completed | Komaromi Selye Janos Korhaz | Komarom, 2900, Hungary |
Completed | TritonLife Medical Center, XIII.kerulet | Budapest, 1134, Hungary |
Completed | Rub-Int Noi Egeszsegcentrum | Szekesfehervar, 8000, Hungary |
Completed | Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary |
Completed | GYN-MIKA s.r.o. | Ceske Budejovice, 370 01, Czechia |
Completed | GYN-F s.r.o. | Hradec Kralove, 500 03, Czechia |
Completed | The Iowa Clinic - Ankeny | Ankeny, 50023, United States |
Completed | Revive Research Institute, Inc. - Women's Health | Dearborn Heights, 48127, United States |
Completed | Applied Research Center of Arkansas | Little Rock, 72212, United States |
Completed | OnSite Clinical Solutions, LLC | Charlotte, 28277, United States |
Completed | Axia Women's Health | Seven Hills Women's Health Centers - Montgomery | Cincinnati, 45242, United States |
Completed | Drug Studies America | Marietta, 30060, United States |
Withdrawn | SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont | Szeged, 6725, Hungary |
Completed | Paramount Research Solutions-College Park | College Park, 30349, United States |
Completed | Seattle Clinical Research Center | Seattle, 98105, United States |
Completed | Office of Dr. Edmond Pack | Las Vegas, 89113, United States |
Completed | Investigators Research Group, LLC | Brownsburg, 46112, United States |
Completed | Maximos Ob/Gyn | League City, 77573, United States |
Completed | Northern California Research | Sacramento | Sacramento, 95821, United States |
Completed | Central Research Associates | Birmingham, AL | Birmingham, 35205, United States |
Completed | Northeast Clinical Research of San Antonio, LLC | San Antonio, 78233, United States |
Completed | Women's Care Research Institute/Marion OBGYN, Inc. | Marion, 43302, United States |
Completed | Velocity Clinical Research - Albuquerque | Albuquerque, 87107, United States |
Primary Outcome
- Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])date_rangeTime Frame:Baseline to Week 4
- Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)date_rangeTime Frame:Baseline to Week 12
- Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD)date_rangeTime Frame:Baseline to Week 4
- Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)date_rangeTime Frame:Baseline to Week 12
Secondary Outcome
- Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)date_rangeTime Frame:Baseline to Week 1
- Mean change in frequency of moderate to severe HF from baseline over timedate_rangeTime Frame:Baseline to Week 26
- 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 12The 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.date_rangeTime Frame:Baseline to Week 12
- Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12The 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.date_rangeTime Frame:Baseline to Week 12
- Mean change in Beck depression inventory (BDI-II) total score from baseline to Week 12The 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).date_rangeTime Frame:Baseline to Week 12
- Mean change in BDI-II total score from baseline to Week 26The 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).date_rangeTime Frame:Baseline to Week 26
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2