check_circleStudy Completed

Vasomotor symptoms associated with menopause, Hot flashes

Bayer Identifier:
21652
ClinicalTrials.gov Identifier:
NCT05099159
EudraCT Number:
2020-004855-34
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 (OASIS-2)

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 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
400
Trial Dates
October 2021 - October 2023
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Lynkuet (Elinzanetant, BAY3427080)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Praxis Hr. Dr. S. FiedlerAachen, 52074, Germany
Completed
emovis GmbHBerlin, 10629, Germany
Completed
Femme FrauenarztpraxisGera, 7545, Germany
Completed
Praxis f. Gynäkologie und GeburtshilfeBernburg, 6406, Germany
Completed
Frauenarztpraxis Dr. Inka KiescheHalle, 06110, Germany
Completed
Frauenärzte am Schloss BorbeckEssen, 45355, Germany
Completed
Helix Biomedics, LLCBoynton Beach, 33435, United States
Completed
Suncoast Clinical Research Inc. | PascoNew Port Richey, 34652, United States
Completed
Advances in Health, INC. | Houston, TXHouston, 77030, United States
Completed
Ocean Blue Medical Research Center, Inc | Miami Springs, FLMiami Springs, 33166, United States
Completed
Research Memphis Associates, LLC | Memphis, TNMemphis, 38120, United States
Completed
Unified Women's Clinical Research | Raleigh, NCRaleigh, 27607, United States
Completed
OHSU Hospital - OB-GYN - Women's Health Research UnitPortland, 97239, United States
Completed
Capital Health | Capital Health OBGYN LawrencevilleLawrenceville, 08648, United States
Completed
Clinical Research of West Florida | Clearwater, FLClearwater, 33765, United States
Completed
Medical Research Center of Memphis | Memphis, TNMemphis, 38120, United States
Completed
Accel Research Sites | Cahaba Medical Care - Birmingham, ALBirmingham, 35218, United States
Completed
Sweet Hope Research Specialty, Inc. - Miami LakesHialeah, 33016, United States
Completed
Columbia University Medical CenterNew York, 10032, United States
Not yet recruiting
R. Garn Mabey Jr. M.D. GynecologyLas Vegas, 89128, United States
Completed
Advanced Women's Health Institute | Denver Office, Greenwood Village, COGreenwood Village, 80111, United States
Completed
Sig Gyn Services (Dr. John A. Whitfield, MD) | Fort Worth, TXFort Worth, 76104-4145, United States
Completed
Clinical Research of West Florida | Tampa, FLTampa, 33606, United States
Completed
AMR - ChicagoOak Brook, 60523, United States
Completed
Fellows Research Alliance, Inc | Savannah, GASavannah, 31406, United States
Completed
The Woman's Place - Midlife HealthCharlottesville, 22903, United States
Not yet recruiting
Inselspital Universitätsspital BernBern, 3010, Switzerland
Completed
Kantonsspital BadenBaden, 5404, Switzerland
Completed
Tribe clinical Research LLC | Greenville, SCGreenville, 29607, United States
Not yet recruiting
Universitätsspital BaselBasel, 4056, Switzerland
Not yet recruiting
University of Chicago | Laboratory of Dr. Al-HendyChicago, 60637, 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
Not yet recruiting
Univerzitna nemocnica Bratislava, Nem. Sv. Cyrila a MetodaBratislava, 851 07, Slovakia
Completed
GA Lucenec s.r.oLucenec, 984 01, Slovakia
Withdrawn
BrenCare, s.r.o.Poprad, 058 01, Slovakia
Not yet recruiting
Virina sano, s.r.o. Gynekologicko porodnicka ambulanciaVelky Krtis, 990 01, Slovakia
Completed
GYNARIN, s.r.o.Filakovo, 986 01, Slovakia
Completed
ULMUS, s r.o.Hlohovec, 920 01, Slovakia
Withdrawn
Ottawa Hospital-Riverside CampusOttawa, K1H 7W9, Canada
Completed
Clinique Ovo | R&D DepartmentMontreal, H4P 2S4, Canada
Not yet recruiting
IWK Health Centre | Department of Obstetrics and GynaecologyHalifax, B3K 6R8, Canada
Completed
Alpha Recherche Clinique | LebourgneufQuebec, G2J 0C4, Canada
Completed
Alpha Recherche Clinique | Val-BelairVal-Bélair, G3K 2P8, Canada
Completed
Alta Clinical Research Inc | Edmonton, CanadaEdmonton, T5A 4L8, Canada
Withdrawn
Viable Clinical Research | Mississauga, CanadaScarborough, M1P 2T7, Canada
Completed
Kirkeparken SpesialistpraksisFredrikstad, 1605, Norway
Completed
Oslo University Hospital | Division of Obstetrics and Gynecology, Department of ResearchOslo, 450, Norway
Completed
Medicus ASTrondheim, 7014, Norway
Completed
Clinical Trials Management | Northshore OfficeCovington, 70433, United States
Completed
Centre Hospitalier Universitaire Vaudois (CHUV)Lausanne, 1011, Switzerland
Completed
Saginaw Valley Medical Research Group, LLC | Saginaw, MISaginaw, 48604, United States
Completed
Centro Hospitalar e Universitario de Coimbra, E.P.E. | Department of GynecologyCoimbra, 3000-075, Portugal
Completed
Hospital Santa Maria | Centro de Investigacao ClinicaMISSING, 1649-035, Portugal
Completed
Centro Hospitalar de Lisboa Ocidental | Clinical Research DepartmentLisboa, 1449-005, Portugal
Completed
Luz Saude | Hospital da Luz Setubal - Clinical Research DepartmentSetubal, 2900-722, Portugal
Completed
Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao ClinicaLoures, 2674-514, Portugal
Completed
Hospital Pedro Hispano | Clinical Research CenterMatosinhos, 4464-513, Portugal
Not yet recruiting
UPMC Magee-Women's Hospital - GynecologyPittsburgh, 15213, United States
Not yet recruiting
Lynn Institute of the OzarksLittle Rock, 72204, United States
Completed
DiscoveResearch, Inc.Bryan, 77802, United States
Completed
Family Care Research | Boise, IDBoise, 83713, United States
Completed
Diex Recherche Victoriaville Inc.Victoriaville, G6P 6P6, Canada
Not yet recruiting
Center of innovative medical technologies of NAS of UkraineKiev, 4053, Ukraine
Not yet recruiting
Instr. of Pediatrics, Obstetrics & GynecologyKiev, 4050, Ukraine
Not yet recruiting
CNE "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia regional councilZaporizhzhya, 69600, Ukraine
Not yet recruiting
Medical Center Motor SichZaporizhzhya, 69068, Ukraine
Not yet recruiting
Ivano-Frankivsk Regional Perinatal CenterIvano-Frankivsk, 76018, Ukraine
Not yet recruiting
Medical Center LLC "Verum Expert Clinic"Kyiv, 3039, Ukraine
Completed
UniversitätsSpital ZürichZürich, 8091, Switzerland
Completed
Medicus | Stavanger, NorwayStavanger, 4005, Norway
Completed
Medicus | Oslo, NorwayOslo, 161, Norway
Withdrawn
Endocrinology Research CenterMoscow, 117036, Russian Federation
Withdrawn
Smolensk State Medical UniversitySmolensk, 214019, Russian Federation
Withdrawn
Close Joint Stock Company "Medical Company IDK"Samara, 443072, Russian Federation
Not yet recruiting
RC MedicalNovosibirsk, 630091, Russia
Withdrawn
Siberian State Medical UniversityTomsk, 634050, Russian Federation
Withdrawn
Research Center for Obstetrics, Gynecology and PerinatologyMoscow, 177997, Russian Federation
Withdrawn
West Coast OB/GYN AssociatesSan Diego, 92123, United States
Not yet recruiting
Northwest Clinical Research Center | Bellevue, WABellvue, 98007, United States
Completed
Women's Health Care Research | San Diego, CASan Diego, 92111, United States
Completed
Austin Regional Clinic | ARC Kelly LaneAustin, 78731, United States
Withdrawn
Praxis Fr. Dr. F. GrevenHannover, 30459, Germany
Completed
Clinical Trials Research - LincolnLincoln, 95648, United States
Completed
Eastern Carolina Women's Center | New Bern, NCNew Bern, 28562, United States
Completed
Torrance Clinical Research Institute, Inc. | Lomita, CALomita, 90717, United States
Withdrawn
Physicians' Research Options, LLCDraper, 84020, United States
Not yet recruiting
Genesis Clinical Research and Consulting, LLCFall River, 02723, United States
Completed
Metro Jackson OBGYN | Jackson, MSJackson, 39202, United States
Completed
Physicians' Research Options, LLC | Red Rocks OBGYNLakewood, 80228, United States
Completed
Leavitt Clinical Research | Idaho Falls, IDIdaho Falls, 83404, United States
Withdrawn
Universitätsspital BaselBasel, 4056, Switzerland
Completed
Tandem Clinical Research | Marrero, LAMarrero, 70072, United States
Completed
Azienda Ospedaliera Universitaria Integrata Verona_Borgo Trento - Ostetricia e Ginecologia BVerona, 37126, Italy
Completed
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, 00168, Italy
Completed
Azienda Ospedaliera Ordine Mauriziano Di TorinoTorino, 10128, Italy
Completed
A.O.U. Policlinico Federico II NapoliNaples, 80131, Italy
Completed
Medplus NordrheinKrefeld, 47799, Germany
Completed
Gynekologie Studentsky dum s.r.o.Praha 6, 160 00, Czech Republic
Completed
GYNEVI s.r.o.Rokycany, 337 01, Czech Republic
Completed
GynPorCentrum s.r.o.Krnov, 794 01, Czech Republic
Completed
Gynpraxetabor s.r.o.Tábor, 390 03, Czech Republic
Completed
Synexus Frankfurt Clinical Research CentreFrankfurt, 60313, Germany
Completed
MUDr. Martina Maresova Rosenbergova, gynekologiePlzen, 301 00, Czech Republic
Completed
Synexus Leipzig Clinical Research CentreLeipzig, 04177, Germany
Completed
Centro Hospitalar Universitario do Porto | Servico de Investigacao ClinicaPorto, 4050-651, Portugal
Completed
Synexus Berlin Clinical Research CentreBerlin, 12627, Germany
Completed
Etyka Osrodek Badan KlinicznychOlsztyn, 10-117, Poland
Completed
Ob and Gyn Physicians MidAtlantic - SKYCRNGOxon Hill, 20705, United States
Completed
Sensible Healthcare, LLCOcoee, 34761, United States
Completed
ClinRx Research, LLCPlano, 75024, United States
Completed
South Texas Clinical ResearchCorpus Christi, 78404, United States
Completed
Onyx Clinical Research - PeoriaPeoria, 85381, United States
Completed
Ecogene 21Chicoutimi, G7H 0S7, Canada
Completed
Women's Health Alliance of MobileMobile, 36604, United States
Completed
Diex Recherche Quebec Inc.Quebec, G1V 4T3, Canada
Completed
Diex Recherche Sherbrooke Inc.Sherbrooke, J1L 0H8, Canada
Completed
GCP Research | Montreal, CanadaMontreal, H1M 1B1, Canada
Completed
UTHealth Womens Research Program | Memorial CityHouston, 77054, United States
Completed
National Institute of Clinical Research - Garden GroveGarden Grove, 92844, United States
Completed
Nemocnica AGEL Kocice-Saca a.s.Kosice - Saca, 040 15, Slovakia
Completed
Tidewater Clinical Research, Inc.Norfolk, 23456, 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 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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