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    Summary
    EudraCT Number:2021-000059-38
    Sponsor's Protocol Code Number:21810
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-08-31
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-000059-38
    A.3Full title of the trial
    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.
    Ensayo multicéntrico, doble ciego, aleatorizado y controlado con placebo para investigar la eficacia y la seguridad de elinzanetant para el tratamiento de los síntomas vasomotores en mujeres posmenopáusicas durante 52 semanas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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.
    Un estudio para obtener más información sobre como actúa elinzanetant y qué tan seguro es para el tratamiento de los síntomas vasomotores (sofocos) que son causados ​​por cambios hormonales durante 52 semanas en mujeres que han pasado por la menopausia
    A.3.2Name or abbreviated title of the trial where available
    OASIS 3
    A.4.1Sponsor's protocol code number21810
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBayer Consumer Care AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer Consumer Care AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team/ Ref:"EU CTR"/ Bayer AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930300139003
    B.5.6E-mailclinical-trials-contact@bayer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBAY 3427080 SOFT CAPS 60 MG 001
    D.3.2Product code BAY 3427080 (formerly NT-814)
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNElinzanetant
    D.3.9.1CAS number 929046-33-3
    D.3.9.2Current sponsor codeBAY 3427080
    D.3.9.3Other descriptive nameformerly used NT-814
    D.3.9.4EV Substance CodeSUB216548
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vasomotor symptoms associated with menopause
    Síntomas vasomotores asociados con la menopausia
    E.1.1.1Medical condition in easily understood language
    Vasomotor symptoms associated with the menopause, a condition of having hot flashes that are caused by hormonal changes in women who have been through the menopause.
    Síntomas vasomotores asociados con la menopausia, una condición de tener sofocos causados ​​por cambios hormonales en mujeres que han pasado por la menopausia.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10050903
    E.1.2Term Postmenopausal symptoms
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of elinzanetant for the treatment of vasomotor symptoms (VMS) associated with the menopause.
    Evaluar la eficacia de elinzanetant en el tratamiento de síntomas vasomotores (SVM) asociados con la menopausia
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of elinzanetant on: sleep quality; menopause related quality of life; weight and body composition in women being treated for relief of VMS associated with the menopause.
    2. To evaluate the safety of elinzanetant for the treatment of VMS associated with the menopause.
    1. Evaluar la eficacia de elinzanetant en: la calidad de sueño; la calidad de vida relacionada con la menopausia; el peso y composición corporal
    en mujeres que reciben tratamiento para el alivio de los SVM asociados con la menopausia
    2. Evaluar la seguridad de elinzanetant en el tratamiento de SVM asociados con la menopausia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Females aged 40 to 65 years, inclusive, at signing of informed consent.
    2. 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^2 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.
    3. Moderate to severe hot flash (HF) associated with the menopause and seeking treatment for this condition.
    4. Negative urine pregnancy test at Screening.
    5. In good general health, in the opinion of the investigator, based on the medical history, physical examination, 12-lead ECG, BMD, vital signs, gynecological ultrasound, endometrial biopsy, mammogram, clinical laboratory tests, eC-SSRS, and other assessments completed during screening.
    6. Normal or clinically insignificant cervical cytology not requiring further follow-up:
    a. A cervical cytology sample has to be obtained during screening, or
    b. A documented normal result has to be available from cervical cytology conducted within 12 months prior to signing of informed consent.
    c. HPV testing in participants with ASCUS will be used as an adjunctive test automatically. Participants with ASCUS can be included if they are negative for high-risk HPV strains.
    7. BMI between 18 and 38 kg/m2 at screening
    8. Participant has a screening mammogram performed, unless she is able to provide a written normal mammogram result obtained no more than 6 months prior to the start of screening.
    9. Participant has completed HFDD for at least 11 days during the two weeks preceding baseline visit.
    10. Capable of giving signed informed consent
    1. Mujeres de 40 a 65 años, inclusive, en el momento de la firma del consentimiento informado.
    2. Posmenopáusica, definida como:
    a. al menos 12 meses de amenorrea espontánea antes de la firma del consentimiento informado, o
    b. al menos 6 meses de amenorrea espontánea antes de la firma del consentimiento informado con concentraciones séricas de FSH >40 mUI/ml y concentración sérica de estradiol de <30 pg/ml, o
    c. al menos 6 meses después de la histerectomía en el momento de la firma del consentimiento informado con concentraciones séricas de FSH >40 mUI/ml y una concentración sérica de estradiol de <30 pg/ml, o
    d. ooforectomía bilateral quirúrgica con o sin histerectomía al menos 6 semanas antes de la firma del consentimiento informado.
    3. Sofocos moderados a intensos asociados a la menopausia para los que se ha buscado tratamiento.
    4. Prueba de embarazo en orina negativa en la selección.
    5. En buen estado de salud general, en opinión del investigador, según los antecedentes patológicos, la exploración física, el ECG de 12 derivaciones, la DMO, las constantes vitales, la ecografía ginecológica, la biopsia endometrial, la mamografía, las pruebas analíticas clínicas, la puntuación en la escala electrónica de valoración del riesgo de suicidio de la Universidad de Columbia (eC SSRS) y otras evaluaciones completadas durante la selección.
    6. Citología cervical normal o clínicamente insignificante que no requiere ningún seguimiento adicional:
    a. Debe obtenerse una muestra de citología cervical durante el examen, o
    b. Debe estar disponible un resultado normal documentado de la citología cervical realizada en los 12 meses anteriores a la firma del consentimiento informado.
    c. La prueba del virus del papiloma humano (VPH) en participantes con ASCUS (células escamosas atípicas de significado indeterminado) se utilizará automáticamente como prueba complementaria. Las participantes con ASCUS pueden ser incluidas si dan negativo para las cepas del VPH de alto riesgo
    7. IMC entre 18 y 38 kg / m2 en el screening
    8. A la participante se le realiza una mamografía en el screening, a menos que pueda proporcionar un resultado de mamografía normal por escrito obtenido no más de 6 meses antes del inicio del screening.
    9. La participante ha completado el HFDD durante al menos 11 días durante las dos semanas anteriores a la visita inicial
    10. Capaz de dar su consentimiento informado firmado
    E.4Principal exclusion criteria
    1. Any clinically significant prior or ongoing history of arrhythmias, heart block and QT prolongation either determined through clinical history or on ECG evaluation.
    2. Any clinically significant abnormal laboratory test result(s) measured during screening (single re-test allowed, except for tests listed in exclusion criteria 10).
    3. Any active ongoing condition that could cause difficulty in interpreting vasomotor symptoms (VMS) such as: infection that could cause pyrexia, pheochromocytoma, carcinoid syndrome.
    4. Current or previous history of any malignancy (except basal and squamous cell skin tumors).
    5. Uncontrolled or treatment-resistant hypertension. Women with mild hypertension can be included in the study if they are medically cleared prior to study participation.
    6. A history of untreated hyperthyroidism or hypothyroidism. 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.
    7. Any unexplained post-menopausal bleeding.
    8. Clinically relevant abnormal findings on mammogram.
    9. Renal impairment greater than moderate (i.e. estimated glomerular filtration rate
    < 30 mL/min) at screening
    10. Abnormal liver parameters.
    11. Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer diagnosed based on endometrial biopsy during screening.
    12. Any other history, condition, therapy, or uncontrolled intercurrent illness which could in the opinion of the investigator affect compliance with study requirements.
    13. Has used and is unwilling to wash-out use of any of the prohibited concomitant medications.
    14. Inability to comply with the use of prohibited medications.
    1. Antecedentes o presencia actual de arritmias, bloqueo cardíaco y prolongación del intervalo QT de importancia clínica, determinados por medio de la historia clínica o bien en la evaluación electrocardiográfica.
    2. Cualquier resultado anómalo en las pruebas analíticas que sea clínicamente significativo, medido durante la selección (se permite un único reanálisis, excepto para las pruebas enumeradas en el criterio de exclusión 9).
    3. Cualquier afección activa en curso que pueda causar dificultad en la interpretación de los SVM, como: infección que podría causar pirexia, feocromocitoma, síndrome carcinoide.
    4. Antecedentes o presencia actual de cualquier neoplasia maligna (excepto tumores de piel de células basales y escamosas).
    5. Hipertensión no controlada o resistente al tratamiento. Las mujeres con hipertensión leve pueden incluirse en el estudio si tienen autorización médica antes de participar en el estudio.
    6. Antecedentes de hipertiroidismo o hipotiroidismo no tratado. Es aceptable el hipotiroidismo tratado con resultados normales de las pruebas de función tiroidea durante la selección y una dosis estable (durante >3 meses antes de la firma del consentimiento informado) de tratamiento de reposición.
    7. Cualquier metrorragia posmenopáusica de causa desconocida.
    8. Hallazgos anómalos de interés clínico en la mamografía.
    9. Insuficiencia renal mayor que moderada (por ejemplo. tasa de filtración glomerular estimada <30 ml / min) en la selección.
    10. Parámetros hepáticos anómalos (presencia de al menos uno de los siguientes criterios):
    • AST >2 × LSN
    • ALT >2 × LSN
    • FA >2 × LSN
    • BRT >LSN
    • CIN >LSN a menos que se explique por la administración de anticoagulantes
    • Diagnóstico de infección por el virus de la hepatitis B, es decir, positividad para el antígeno Hbs en la selección
    • Diagnóstico de infección por el virus de la hepatitis C, es decir, anticuerpos contra la hepatitis C y positividad para el ARN del VHC en la selección.
    11. Endometrio proliferativo desordenado, hiperplasia endometrial, pólipo, o cáncer de endometrio diagnosticados a partir de una biopsia endometrial durante la selección (véase el apartado ‎8.2.10).
    12. Otros antecedentes, afecciones, tratamientos o enfermedades intercurrentes no controladas que, en opinión del investigador, podrían afectar al cumplimiento de los requisitos del estudio.
    13. Ha recibido y no está dispuesta a someterse a un período de reposo farmacológico de cualquiera de los medicamentos concomitantes prohibidos, como se especifica en el apartado ‎10.6.
    14. No puede dejar de utilizar medicamentos prohibidos como se describe en los apartados ‎6.8.1 y ‎10.6.
    15. Participación simultánea (o en los 2 meses anteriores a la firma del DCI) en un estudio clínico con un medicamento en investigación(incluyendo dispositivos médicos).
    16. En la selección, una ideación suicida en los últimos 6 meses (como se indica con «Sí» en el ítem 4 o el ítem 5 de la sección de ideación suicida de la eC-SSRS) o conducta suicida en los últimos 6 meses (indicado por «Sí» en cualquier ítem de la sección de conducta suicida de la eC-SSRS).
    17. Drogadicción o alcoholismo de interés clínico en los 12 meses posteriores a la firma del consentimiento informado .
    18. Dependiente del investigador, de la organización u organizaciones de investigación por contrato o del promotor, para educación o empleo( p.ej. familiares, empleados, personas que reciben becas / educación).
    19. Hipersensibilidad conocida al elinzanetant o a cualquiera de los excipientes de la formulación.
    20. Imposibilidad de cumplir los procedimientos del estudio por cualquier motivo, incluidos los siguientes ejemplos: falta de comprensión del idioma, enfermedad psiquiátrica, incapacidad general para acudir al centro del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in frequency of moderate to severe hot flashes (HFs) from baseline to Week 12 (assessed by hot flash daily diary [HFDD]).
    Variación media en la frecuencia sofocos moderados a intensos desde el valor inicial hasta la semana 12 (evaluada por el diario de sofocos [HFDD])
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 12.
    valor inicial hasta la semana 12
    E.5.2Secondary end point(s)
    1. Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline over time.
    2. Mean change in menopause specific quality of life scale (MENQOL) total score from baseline over time.
    1. Variación media en la puntuación total del cuestionario PROMIS SD SF 8b desde el valor inicial a lo largo del tiempo
    2. Variación media en la puntuación total del cuestionario MENQOL desde el valor inicial a lo largo del tiempo
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline to Week 56.
    2. Baseline to Week 56.
    1. Valor inicial a semana 56
    2. Valor inicial a semana 56
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The date of the last scheduled visit of the last subject in the study globally.
    La fecha de la última visita programada del último sujeto del estudio a nivel global
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 588
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 268
    F.4.2.2In the whole clinical trial 600
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None.
    ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-12
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