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
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 LLCMetairie, 70001, United States
Completed
Advances in Health, Inc.Houston, 77030, United States
Completed
Suncoast Clinical Research Center, Inc.New Port Richey, 34652, United States
Completed
Paramount Research Solutions-College ParkCollege Park, 30349, United States
Completed
Hospital de la Santa Creu i Sant Pau | Gynecology DepartmentBarcelona, 8041, Spain
Withdrawn
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Hospital Sanitas La ZarzuelaAravaca, 28023, Spain
Completed
H Univ. 12 de Octubre | Ginecología y ObstetriciaMadrid, 28041, Spain
Completed
Sanos Clinic - NordjyllandGandrup, 9362, Denmark
Completed
Sanos Clinic - SyddanmarkVejle, 7100, Denmark
Completed
Sanos Clinic - HerlevHerlev, 2730, Denmark
Completed
MC Asklepii OODDupnitza, 2600, Bulgaria
Completed
Medical Center PanaceyaSofia, 1606, Bulgaria
Completed
MHAT Avis MedikaPleven, 5800, Bulgaria
Completed
MHAT NiamedStara Zagora, 6000, Bulgaria
Completed
Multiprofile Hospital for Activ Treatment PlovdivPlovdiv, 4000, Bulgaria
Completed
SHOGAT Prof Dimitar StamatovVarna, 9000, Bulgaria
Completed
MHAT SamokovSamokov, 2000, Bulgaria
Completed
DCC AleksandrovskaSofia, 1431, Bulgaria
Completed
Helix Biomedics, LLCBoynton Beach, 33435, United States
Completed
University of Florida College of MedicineJacksonville, 32207, United States
Completed
Tidewater Physicians for WomenNorfolk, 23502, United States
Completed
Office of Dr. Edmond PackLas Vegas, 89113, United States
Completed
Physician Care Clinical ResearchSarasota, 34239, United States
Completed
Seattle Clinical Research CenterSeattle, 98105, United States
Completed
Marvel Clinical Research, LLCHuntington Beach, 92647, United States
Completed
Las Vegas Clinical Trials, LLCNorth Las Vegas, 89030, United States
Completed
Suncoast Clinical ResearchPalm Harbor, 34684, United States
Completed
Wake Research, Inc.Raleigh, 27612, United States
Completed
Mesa Obstetricians and GynecologistsMesa, 85206, United States
Completed
Venus Gynecology, LLC former Magnolia OB/GYN Research CenterMyrtle Beach, 29572, United States
Completed
Clinical Research of Philadelphia, LLCPhiladelphia, 19114, United States
Withdrawn
Conquest Clinical Research, LLCSanta Ana, 92701, United States
Completed
Women's Health TexasKaty, 77450, United States
Completed
Office of Dr. James A. Simon, MDWashington, 20036, United States
Completed
Women's Health TexasKaty, 77450, United States
Completed
David I Lubetkin, MD, LLCBoca Raton, 33486, United States
Completed
Mobile Ob-Gyn, PCMobile, 36608-6703, United States
Completed
Eastern Virginia Medical School | OB/GYN Clinical Research CenterNorfolk, 23507, United States
Completed
UT Health Women’s Research Center at Memorial CityHouston, 77024, United States
Completed
Columbus OB-GYN/Radiant ResearchColumbus, 43213, United States
Completed
Empire Clinical ResearchPomona, 91767, United States
Completed
Coastal Connecticut Research, LLCNew London, 06320, United States
Completed
Johns Hopkins Univ School Med|Johns Hopkins Hosp Dept Gyn/ObBaltimore, 21287, United States
Completed
Gabinet Ginekologiczny Janusz TomaszewskiBialystok, 15-244, 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, 71-434, 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 de Salud y Medicina de la MujerMadrid, 28009, Spain
Completed
MAC Research Centre BlackpoolBlackpool, United Kingdom
Completed
AMR Las VegasLas Vegas, 89119, United States
Completed
Ottawa Hospital-Riverside CampusOttawa, K1H 7W9, Canada
Withdrawn
IWK Health CentreHalifax, B3K 6R8, Canada
Completed
Alpha Recherche Clinique LB9Quebec, G2J 0C4, Canada
Completed
Viable Clinical Research CorporationScarborough, 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
CHR de la Citadelle - Department of Gynaecology & ObstetricsLIEGE, 4000, Belgium
Completed
CHU Saint-Pierre/UMC Sint-PieterBRUXELLES - BRUSSEL, 1000, Belgium
Completed
Femicare vzwTienen, 3300, Belgium
Completed
Lääkärikeskus GynekoOulu, 90100, Finland
Completed
HUS / NaistenklinikkaHelsinki, 00029, Finland
Withdrawn
AuraklinikkaTurku, 20100, Finland
Completed
Mehiläinen KuopioKuopio, 70100, Finland
Completed
Terveystalo TampereTampere, 33100, Finland
Completed
H Univ. Virgen Rocío | GinecologíaSevilla, 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 - MissoulaMissoula, 59804, United States
Completed
MHAT for Women's Health - Nadezhda OODSofia, 1330, Bulgaria
Completed
Spec. Hospital for Active Treatment of Oncological DiseasesSofia, 1233, Bulgaria
Completed
Maximos Ob/GynLeague City, 77573, United States
Completed
MAC Research Centre - ManchesterManchester, United Kingdom
Completed
Boeson Research - Great Falls OBGYNGreat Falls, 59405, United States
Withdrawn
Wasatch Clinical Research, LLCSalt Lake City, 84107, United States
Completed
HWC Women’s Research CenterEnglewood, 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])
    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 score 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.
    date_rangeTime Frame:
    Baseline to Week 56
  • Mean change in menopause specific quality of life scale (MENQOL) total score 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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