check_circleStudy Completed

Vasomotor symptoms associated with menopause, Hot flashes

Bayer Identifier:

21651

ClinicalTrials.gov Identifier:

NCT05042362

EudraCT Number:

2020-004908-33

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.

Key Participants Requirements

Sex

Female

Age

40 - 65 Years
  • - Postmenopausal, defined as:
    a. at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or
    b. 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
    c. 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
    d. 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).
  • - 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.

Trial summary

Enrollment Goal
396
Trial Dates
August 2021 - November 2023
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Elinzanetant (BAY3427080)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Gynekologie MEDA s.r.o.Brno, 602 00, Czechia
Completed
AKH Wien | Allg. Gynaekologie & gynaekologische OnkologieWien, 1090, Austria
Completed
AKH Wien | Gyn. Endokrinologie & ReproduktionsmedizinWien, 1090, Austria
Completed
Medizinische Univ Graz | Frauenheilkunde & GeburtshilfeGraz, 8036, Austria
Withdrawn
Kepler Campus IV | Gyn, Gburtshilfe & gyn. EndokrinologieLinz, 4020, Austria
Completed
MedUni Innsbruck | Klinik fur Gyn Endo und ReproduktionsmedInnsbruck, 6020, Austria
Completed
Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Completed
A.O.U. Policlinico G.Rodolico-San MarcoCatania, 95123, Italy
Completed
Fondazione IRCCS Policlinico San MatteoPavia, 27100, Italy
Completed
Ospedale San Raffaele s.r.l.Milano, 20132, Italy
Completed
A.O.U. CareggiFirenze, 50134, Italy
Withdrawn
A.O.U. di FerraraFerrara, 44124, Italy
Completed
Clinical Research of Philadelphia, LLCPhiladelphia, 19114, United States
Completed
Wake Research, Inc.Raleigh, 27612, United States
Completed
Suncoast Clinical ResearchPalm Harbor, 34684, United States
Completed
Women's Clinic of Lincoln, PCLincoln, 68510, United States
Completed
Venus Gynecology, LLC former Magnolia OB/GYN Research CenterMyrtle Beach, 29572, United States
Completed
Mesa Obstetricians and GynecologistsMesa, 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 LLCMetairie, 70001, United States
Completed
Om Research, LLCLancaster, 93534, United States
Completed
Centricity Research formerly Aventiv - ColumbusColumbus, 43213, United States
Withdrawn
Advanced Clinical ResearchSalt Lake City, 84102, United States
Completed
Mount Vernon Clinical Research, LLCSandy Springs, 30126, United States
Completed
Chattanooga Medical Research, LLCChattanooga, 37404, United States
Completed
Cedar Health Research, LLCDallas, 75251, United States
Completed
Coastal Carolina Research Center | Mount Pleasant, SCMt. Pleasant, 29464, United States
Completed
The Center for Womens Health & Wellness, LLC | Lawrenceville, NJLawrenceville, 08648, United States
Completed
Diagnamics, Inc.Encinitas, 92024, United States
Completed
Alliance for Multispecialty Research, LLC - Fort MeyersFort Myers, 33912, United States
Completed
University Hospitals Landerbrook Health CenterMayfield Heights, 44124, United States
Completed
Soapstone Center for Clinical ResearchDecatur, 30034, United States
Completed
United Women's Clinical Research - LyndhurstWinston-Salem, 27103, United States
Completed
HillTop Obstetrics & GynecologyFranklin, 45005-2593, United States
Completed
Continental Clinical Solutions | Towson, MDTowson, 21204, United States
Completed
Alabama Clinical Therapeutics | Birmingham, ALBirmingham, 35205, United States
Completed
Noble Clinical ResearchTucson, 85704, United States
Completed
Women Partners in Health Obstetrics & Gynecology (OB/GYN)Austin, 78705, United States
Completed
Valley OB-GYN ClinicSaginaw, 48602, United States
Withdrawn
PharmaSite Research, Inc | Pikesville, MDPikesville, 21208, United States
Completed
Office of Dr. James A. Simon, MDWashington, 20036, United States
Completed
Medical University of South Carolina | MUSC Center for Womens Health - Department of Obstetrics and GynecologyCharleston, 29425, United States
Completed
Bosque Womens CareAlbuquerque, 87109, United States
Completed
Physician Care Clinical ResearchSarasota, 34239, United States
Withdrawn
Houston Center for Clinical Research, LLCSugarland, 77479, United States
Completed
Alliance Research Institute | Bell Gardens, CATarzana, 91356, United States
Completed
HWC Women's Research Center | Englewood, OHEnglewood, 45322, United States
Completed
Rutgers Robert Wood Johnson Medical SchoolNew Brunswick, 08901, United States
Withdrawn
GYNERAPraha 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 LLCTucson, 85715, United States
Completed
Wake Research - Clinical Research Center of Nevada, LLCLas Vegas, 89123, United States
Completed
MomDoc Women For WomenScottsdale, 85251, United States
Withdrawn
AMR Las VegasLas Vegas, 89119, United States
Completed
A.O.U. PisanaPisa, 56126, Italy
Completed
G-Centrum Olomouc s.r.o. Dr. SkrivanekOlomouc, 772 00, Czechia
Completed
Gynekologie Cheb s.r.o.Cheb, 350 02, Czechia
Completed
St. Antonius Ziekenhuis | Utrecht - R&D Interne GeneeskundeNieuwegein, 3435 CM, Netherlands
Completed
FlevoziekenhuisAlmere, Netherlands
Completed
DiakonessenhuisUTRECHT, 3582 KE, Netherlands
Withdrawn
Canisius Wilhelmina ZiekenhuisNIJMEGEN, 6532 SZ, Netherlands
Completed
Medisense, Inc.Atlanta, 30363, United States
Completed
Clinical Research PrimeIdaho Falls, 83404, United States
Completed
Health Corporation of Galilee Medical CenterNahariya, 2210001, Israel
Withdrawn
Hillel Yaffe Medical CenterHadera, 3810101, Israel
Completed
Meir Medical CenterKfar Saba, 4428164, Israel
Withdrawn
HaEmek Medical Center | Internal Medicine C Department - Research UnitAfula, 1834111, Israel
Completed
Mayanei HaYeshua Medical CenterBnei Brak, 5154475, Israel
Completed
Hadassah Hebrew University Hospital Ein KeremJerusalem, 9112001, Israel
Completed
Jubilee Clinical Research, IncLas Vegas, 89106, United States
Withdrawn
University General Hospital ATTIKONChaidari, 12462, Greece
Completed
ARETAIEION University HospitalAthens, 11528, Greece
Completed
General Hospital of Thessaloniki PapageorgiouThessaloniki, 56403, Greece
Withdrawn
University General Hospital of Patras | Univ Obs & Gynae CliPatra, 26504, Greece
Withdrawn
Hippokration General Hospital of ThessalonikiThessaloniki, 54642, Greece
Completed
Ioannina University General HospitalIoannina, 45500, Greece
Completed
University General Hospital of HeraklionHeraklion, 711 10, Greece
Completed
Circuit Clinical OB/GYN Associates of WNYWest Seneca, 14224, United States
Withdrawn
Pecsi Tudomanyegyetem Klinikai KozpontPecs, 7624, Hungary
Completed
NAP-MED Egeszsegugyi Szolgaltato KftDebrecen, 4028, Hungary
Completed
Komaromi Selye Janos KorhazKomarom, 2900, Hungary
Completed
TritonLife Medical Center, XIII.keruletBudapest, 1134, Hungary
Completed
Rub-Int Noi EgeszsegcentrumSzekesfehervar, 8000, Hungary
Completed
Debreceni Egyetem Klinikai KozpontDebrecen, 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 - AnkenyAnkeny, 50023, United States
Completed
Revive Research Institute, Inc. - Women's HealthDearborn Heights, 48127, United States
Completed
Applied Research Center of ArkansasLittle Rock, 72212, United States
Completed
OnSite Clinical Solutions, LLCCharlotte, 28277, United States
Completed
Axia Women's Health | Seven Hills Women's Health Centers - MontgomeryCincinnati, 45242, United States
Completed
Drug Studies AmericaMarietta, 30060, United States
Withdrawn
SZTE ÁOK Szent Györgyi Albert Klinikai KozpontSzeged, 6725, Hungary
Completed
Paramount Research Solutions-College ParkCollege Park, 30349, United States
Completed
Seattle Clinical Research CenterSeattle, 98105, United States
Completed
Office of Dr. Edmond PackLas Vegas, 89113, United States
Completed
Investigators Research Group, LLCBrownsburg, 46112, United States
Completed
Maximos Ob/GynLeague City, 77573, United States
Completed
Northern California Research | SacramentoSacramento, 95821, United States
Completed
Central Research Associates | Birmingham, ALBirmingham, 35205, United States
Completed
Northeast Clinical Research of San Antonio, LLCSan Antonio, 78233, United States
Completed
Women's Care Research Institute/Marion OBGYN, Inc.Marion, 43302, United States
Completed
Velocity Clinical Research - AlbuquerqueAlbuquerque, 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 time
    date_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 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.
    date_rangeTime Frame:
    Baseline to Week 12
  • Mean change in menopause specific quality of life scale (MENQOL) total score from 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.
    date_rangeTime Frame:
    Baseline to Week 12
  • Mean change in Beck depression inventory (BDI-II) total score from 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).
    date_rangeTime Frame:
    Baseline to Week 12
  • Mean change in BDI-II total score from 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).
    date_rangeTime Frame:
    Baseline to Week 26

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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