check_circleStudy Completed

Vasomotor symptoms associated with menopause, Hot flashes

Bayer Identifier:
21810
ClinicalTrials.gov Identifier:
NCT05030584
EudraCT Number:
2021-000059-38
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 52 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 they 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 is a treatment that looks like a medicine but does not have any medicine in it. To compare these study treatments, the participants will record information about their hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe they are. They will study the results from before treatment 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 will take the study treatments for 52 weeks.
During the study, the participants will visit their study site approximately 11 times and perform 2 visits by phone. Each participant will be in the study for approximately 62 weeks.
During the study, the participants will:
•   record information about their hot flashes in an electronic diary
•   answer questions about their symptoms
The doctors will:
•   check the participants’ health
•   take blood samples
•   ask the participants questions about what medicines they are taking and if they 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 they 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 is showing eligibility with respect to previous inclusion criterion during this time period.
  • - 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.

Trial summary

Enrollment Goal
628
Trial Dates
August 2021 - February 2024
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Lynkuet (Elinzanetant, BAY3427080)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Queen Charlottes & Chelseas HospitalLondon, W12 0NN, United Kingdom
Completed
Liverpool Womens HospitalLiverpool, L8 7SS, United Kingdom
Completed
Glasgow Royal Infirmary | HaematologyGlasgow, G4 0SF, United Kingdom
Completed
Southern Clinical Research Associates | Metairie, LAMetairie, 70001, United States
Completed
Advances in Health, INC. | Houston, TXHouston, 77030, United States
Completed
Suncoast Clinical Research Inc. | PascoTrinity, 34655, United States
Completed
Paramount Research Solutions | College Park LocationCollege Park, 30349, United States
Completed
Hospital de la Santa Creu i Sant Pau | Gynecology DepartmentBarcelona, 8041, Spain
Not yet recruiting
Hospital Clinico San Carlos | Women´s Health InstituteMadrid, 28040, Spain
Completed
Hospital Universitario La Zarzuela | Clinical Research UnitAravaca, 28023, Spain
Completed
Hospital Universitario 12 de Octubre | Department of Obstetrics and GynecologyMadrid, 28041, Spain
Completed
Sanos Clinic | Gandrup, DenmarkGandrup, 9362, Denmark
Completed
Sanos Clinic | Syddanmark, Vejle, DenmarkVejle, 7100, Denmark
Completed
Sanos Clinic | Herlev, DenmarkHerlev, 2730, Denmark
Completed
Medical Centre Asklepii OOD | Dupnitsa, BulgariaDupnitza, 2600, Bulgaria
Completed
Medical Center Panacea OOD | Sofia, BulgariaSofia, 1606, Bulgaria
Completed
Multiprofile Hospital for Active Treatment | Avis Medica - Obstetrics and GynecologyPleven, 5800, Bulgaria
Completed
Multiprofile Hospital for Active Treatment Niamed OOD | Department of Obstetrics and GynecologyStara Zagora, 6000, Bulgaria
Completed
Multiprofile Hospital for Active Treatment Plovdiv | Obstetrics and GynecologyPlovdiv, 4000, Bulgaria
Completed
SBAGAL Dr. Dimitar Stamatov | Varna, BulgariaVarna, 9000, Bulgaria
Completed
Multiprofile Hospital for Active Treatment Samokov | Gynecology DepartmentSamokov, 2000, Bulgaria
Completed
Diagnostic-Consultative Center Alexandrovska | Sofia, BulgariaSofia, 1431, Bulgaria
Completed
Helix Biomedics LLC | Boynton Beach, FLBoynton Beach, 33435, United States
Completed
University of Florida | OBGYN Research DepartmentJacksonville, 32207, United States
Completed
Tidewater Clinical Research | Virginia Beach, VANorfolk, 23502, United States
Completed
Affiliated Clinical Research, Inc. | Las Vegas, NVLas Vegas, 89113, United States
Completed
Physician Care Clinical Research LLC | Sarasota, FLSarasota, 34239, United States
Completed
Seattle Women's | Seattle, WASeattle, 98105, United States
Completed
Marvel Clinical Research | Huntington Beach, CAHuntington Beach, 92647, United States
Completed
Elite Clinical Network (ECN) | Las Vegas Clinical Trials, LLCNorth Las Vegas, 89030, United States
Completed
Suncoast Clinical Research Inc | PinellasPalm Harbor, 34684, United States
Completed
M3 Wake Research | Raleigh, NCRaleigh, 27612, United States
Completed
Mesa Obstetricians and Gynecologists | Research DepartmentMesa, 85206, United States
Completed
Venus Gynecology, LLC | Myrtle Beach, SCMyrtle Beach, 29572, United States
Completed
Clinical Research Philadelphia | Philadelphia, PAPhiladelphia, 19114, United States
Withdrawn
Conquest Clinical Research, LLCSanta Ana, 92701, United States
Completed
Elligo Health Research | Medical Colleagues of TexasHurst, 76054, United States
Completed
IntimMedicine | Washington, DCWashington, 20036, United States
Completed
Elligo Health Research | Protenium Clinical ResearchKaty, 77493, United States
Completed
Elligo Health Research | David I. Lubetkin, MD, LLC, Boca Raton, FLBoca Raton, 33486, United States
Completed
Mobile ObGyn, P.C. | Mobile, ALMobile, 36608-6703, United States
Completed
Eastern Virginia Medical School | OB/GYN Clinical Research CenterNorfolk, 23507, United States
Completed
UTHealth Womens Research Program | Memorial CityHouston, 77054, United States
Completed
ClinOhio Research Services, LLC. | Columbus, OHColumbus, 43213, United States
Completed
Empire Clinical Research | Pomona, CAPomona, 91767, United States
Completed
Coastal Connecticut Research | New London, CTNew London, 06320, United States
Completed
Johns Hopkins University School of Medicine | Johns Hopkins Hospital - Department of Gynecology and ObstetricsBaltimore, 21287, United States
Completed
Gabinet Ginekologiczny Janusz TomaszewskiBialystok, 15-224, Poland
Completed
Vita Longa Sp. z o.o.Katowice, 40-748, Poland
Completed
Centrum Medyczne Angelius ProvitaKatowice, 40-611, Poland
Completed
Twoja Przychodnia - Szczecinskie Centrum MedyczneSzczecin, 71-500, Poland
Completed
CLINICAL MEDICAL RESEARCH Sp. z o. o.Katowice, 40-156, Poland
Completed
Centrum Badawcze Wspolczesnej TerapiiWarszawa, 02-679, Poland
Completed
Hospital Clinico Universitario | Gynecology and Obstetrics DepartmentValencia, 46010, Spain
Completed
Instituto Palacios | Investigation Research Unit - Gynecology departmentMadrid, 28009, Spain
Completed
MAC Research Centre BlackpoolBlackpool, MISSING, United Kingdom
Completed
Alliance for Multispecialty Research, LLC. | Las Vegas, NVLas Vegas, 89119, United States
Completed
Ottawa Hospital-Riverside CampusOttawa, K1H 7W9, Canada
Withdrawn
IWK Health Centre | Department of Obstetrics and GynaecologyHalifax, B3K 6R8, Canada
Completed
Alpha Recherche Clinique | LebourgneufQuebec, G2J 0C4, Canada
Completed
Viable Clinical Research | Mississauga, CanadaScarborough, M1P 2T7, Canada
Completed
Manna Research (Ottawa)Nepean, K2J 4A7, Canada
Completed
Manna Research (Burlington North)Burlington, L7M 4Y1, Canada
Completed
Manna Research (Montreal)Pointe-Claire, H9R 4S3, Canada
Completed
Manna Research (Quebec)Levis, G6W 0M5, Canada
Completed
UZ GentGENT, 9000, Belgium
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
CHU de Liege | CHR Citadel - Department of Gyneacology and ObstetricsLIEGE, 4000, Belgium
Completed
CHU Saint-Pierre/UMC Sint-PieterBRUXELLES - BRUSSEL, 1000, Belgium
Completed
Femicare vzw | Tienen, BETienen, 3300, Belgium
Completed
Lääkärikeskus Gyneko, Gynaecological Medical Center | Oulu, FinlandOulu, 90100, Finland
Completed
HUS / NaistenklinikkaHelsinki, 29, Finland
Withdrawn
AuraklinikkaTurku, 20100, Finland
Completed
Mehilainen | Mehilainen KuopioKuopio, 70100, Finland
Completed
Terveystalo | Terveystalo Tampere Research UnitTampere, 33100, Finland
Completed
Virgen del Rocio University Hospital | Gynecology UnitSevilla, 41013, Spain
Completed
Pihlajalinna Lääkärikeskus Oy, Savo-KarjalaJoensuu, 80100, Finland
Completed
National Institute of Clinical Research - Garden GroveGarden Grove, 92844, United States
Completed
Southern Clinical Research, LLCZachary, 70791, United States
Withdrawn
Privia Medical Group NorthRowlett, 75088, United States
Completed
Investigators Research Group, LLCBrownsburg, 46112, United States
Completed
Boeson Research | Missoula, MTMissoula, 59804, United States
Completed
Multiprofile Hospital for Active Treatment for Women's Health Nadezhda | Department of Obstetrics and GynecologySofia, 1330, Bulgaria
Completed
Specialized Hospital for Active Treatment of Oncological Diseases Sofia Region | Oncological Gynecology DepartmentSofia, 1233, Bulgaria
Completed
Maximos Ob/GynLeague City, 77573, United States
Completed
MAC Research Centre - ManchesterManchester, MISSING, United Kingdom
Completed
Boeson Research | Great Falls, MTGreat Falls, 59405, United States
Withdrawn
Wasatch Clinical Research, LLCSalt Lake City, 84107, United States
Completed
HWC Women's Research Center | Englewood, OHEnglewood, 45322, United States
Not yet recruiting
Spec.Hospital for obstetrics and gynecology Selena OODPlovdiv, 4002, Bulgaria

Primary Outcome

  • Mean change in frequency of moderate to severe hot flashes (HFs) from baseline to Week 12 (assessed by hot flash daily diary [HFDD])
    The HFDD items assess the number of mild, moderate, and severe HF experienced during the day and during the night. In addition, the number of awakenings during the night and disturbance of sleep due to HF will be documented in the morning diary. Mild HF are defined as a “sensation of heat without sweating”, moderate HF are defined as a “sensation of heat with sweating, but able to continue activity”, and severe HF are defined as a “sensation of heat with sweating, causing cessation (stopping) of activity”.
    date_rangeTime Frame:
    Baseline to Week 12

Secondary Outcome

  • Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total T-score from baseline over time.
    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. The total raw scores were converted to total T-scores for analysis of this endpoint (range 28.9–76.5).
    date_rangeTime Frame:
    Baseline to Week 56
  • Mean change in menopause specific quality of life scale (MENQOL) total score from baseline over time
    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: Vasomotor functioning, psychosocial functioning, physical functioning, and sexual functioning. For each item, the participant indicates if they have experienced the symptom (yes/no). If they select yes, they 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 56

Trial design

A double-blind, randomized, placebo-controlled multicenter study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 52 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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