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    Summary
    EudraCT Number:2022-001045-21
    Sponsor's Protocol Code Number:FSD-MIC-2022-03
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-20
    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 number2022-001045-21
    A.3Full title of the trial
    A Phase III randomized controlled trial comparing the
    efficacy, safety and tolerability of two formulations of
    vaginal micronized progesterone.
    Estudio fase III aleatorizado para comarar la eficacia, seguridad y tolerabilidad de dos formulaciones de progesterona vaginal micronizada
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MIcronized PROgesterone in Frozen embryo transfer
    cycles
    Progesterona micronizada en ciclos con transferencia de embriones congelados
    A.3.2Name or abbreviated title of the trial where available
    MI-PROF
    MI-PROF
    A.4.1Sponsor's protocol code numberFSD-MIC-2022-03
    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 SponsorFUNDACION SANTIAGO DEXEUS FONT
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBESINS HEALTHCARE LTD
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCONSULTORIO DEXEUS
    B.5.2Functional name of contact pointHEAD RESEARCH UNIT
    B.5.3 Address:
    B.5.3.1Street AddressGRAN VIA CARLES III 71-75
    B.5.3.2Town/ cityBARCELONA
    B.5.3.3Post code08028
    B.5.3.4CountrySpain
    B.5.4Telephone number34932274700
    B.5.6E-mailNACROD@DEXEUS.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 Yes
    D.2.1.1.1Trade name LUGESTERON 400
    D.2.1.1.2Name of the Marketing Authorisation holderBESINS HEALTHCARE
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 namePROGESTERONE 400
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROGESTERONE, MICRONISED
    D.3.9.3Other descriptive namePROGESTERONE, MICRONISED
    D.3.9.4EV Substance CodeSUB45084
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name utrogestan 200 mg cápsulas blandas
    D.2.1.1.2Name of the Marketing Authorisation holderBESINS
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameUtrogestan 200
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROGESTERONE, MICRONISED
    D.3.9.3Other descriptive namePROGESTERONE, MICRONISED
    D.3.9.4EV Substance CodeSUB45084
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Utrogestan 300
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameUTROGESTAN 300
    D.3.4Pharmaceutical form
    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 INNPROGESTERONE, MICRONISED
    D.3.9.3Other descriptive namePROGESTERONE, MICRONISED
    D.3.9.4EV Substance CodeSUB45084
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Utrogestan 300
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameUTROGESTAN 300
    D.3.4Pharmaceutical form
    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 INNPROGESTERONE, MICRONISED
    D.3.9.3Other descriptive namePROGESTERONE, MICRONISED
    D.3.9.4EV Substance CodeSUB45084
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Estrogel® Estradiol Besins 0,75 mg/dose, gel transdermique
    D.2.1.1.2Name of the Marketing Authorisation holderBESINS HEALTHCARE
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameEstrogel
    D.3.4Pharmaceutical form Transdermal gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEstradiol hemihydrate
    D.3.9.3Other descriptive nameEstradiol Besins 0.75 mg
    D.3.9.4EV Substance CodeSUB11941MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    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.IMP: 6
    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 Yes
    D.2.1.1.1Trade name Estrogel® Estradiol Besins 0,75 mg/dose, gel transdermique
    D.2.1.1.2Name of the Marketing Authorisation holderBESINS HEALTHCARE
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameEstrogel
    D.3.4Pharmaceutical form Transdermal gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEstradiol hemihydrate
    D.3.9.3Other descriptive nameEstradiol Besins 0.75 mg
    D.3.9.4EV Substance CodeSUB11941MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Infertility
    Infertillidad
    E.1.1.1Medical condition in easily understood language
    Infertility
    Infertillidad
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the ongoing pregnancy rate, defined as a pregnancy ≥ 12 weeks, following luteal phase
    support with standard (200mg tid) and a new formulation (400mg bid) of vaginal micronized
    progesterone (VMP) in patients undergoing a FET cycle.
    Comparar la tasa de embarazo evolutivo por encima de 12 semanas tras tratamiento con sapoyo a la fase lutea con estandard 200mg tres veces al dia o una nueva formulación de 400 dos veces al día de progesterona vaginal micronizada en pacientes que realizan una transferenciade embriones congelados
    E.2.2Secondary objectives of the trial
    To compare the standard and the new formulations regarding:
    Prevalence of serum progesterone (P) levels <10 ng/ml before FET
    Implantation rate
    Biochemical pregnancy rate (defined as a pregnancy diagnosed only by the detection of
    bHCG in serum or urine)
    Clinical pregnancy rate (defined as the presence of at least one embryo with heartbeat on
    transvaginal ultrasound)
    Miscarriage rate
    Frequency of adverse events
    Comparar entre las dos formulaciones:
    Prevalencia de progesterona<10 ngml antes de la transferencia
    Tasa de implantación
    Embarazo bioquímico
    Embarazo Clínico
    Tasa de aborto
    Frecuencia de acontecimientos adversos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Endometrial preparation with hormone replacement therapy
    Age 18-43 years following an autologous IVF cycle (with or without preimplantation
    genetic testing for aneuploidy)
    Age < 50 years following an egg donation cycle
    BMI > 18 and < 30 kg/m2
    Blastocyst embryo transfer
    Able to come to the Center to comply with the procedures of the study: blood tests,
    appointments and drug dispensation.
    Proaración endometrial con terapia hormonal sustitutoria
    Edad entre 18-43 con un ciclo autologo de FIV con o sin diganóstico genético preimplantacional
    Edad <50 años en un ciclo con donación de ovocitos
    IMC> 18 and < 30 kg/m2
    Trnasferencia de Balstocistos
    Capaz de acudir al centro para realizar todos los procedimientos del estudio
    E.4Principal exclusion criteria
    • Uterine diseases (e.g. submucosal fibroids, polyps, previously diagnosed Müllerian
    abnormalities)
    • Hydrosalpinx
    • Recurrent pregnancy loss (≥ 3 previous miscarriages)
    • Recurrent implantation failure (≥ 3 previously failed embryo transfers of good-quality
    blastocysts)
    • Allergy to study medication
    • Pregnancy or lactation
    • Contraindication for hormonal treatment
    • Personalized initiation
    Recent history of severe disease requiring regular treatment (clinically significant concurrent
    medical condition that could compromise subject safety or interfere with the trial
    assessment).
    Patología uterina previa
    • Hydrosalpinx
    Abortadora de repatición (≥ 3 abortos previos)
    Fallo deimplantacion ((≥ 3 previos fallos de transferencias de embriones blastocisto de buena calidad)
    Alergia a la medicación del estudio
    Embarazo o lactancia
    Contraindicación para tratamiento hormonal
    Administración de progesterona de acuerdo a resultado previo de test de receptividad endometrial
    Antecedente reciente de patología grave que requiera tratamiento habitual que pueda interferir en el estudio o compremeter la seguridad del paciente

    Recent history of severe disease requiring regular treatment (clinically significant concurrent
    medical condition that could compromise subject safety or interfere with the trial
    assessment).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the comparison of ongoing pregnancy rate. The primary efficacy
    endpoint is related to the primary trial objective.
    La variable principal del estudio es la tasa de embarazo evolutivo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    the ongoing pregnancy rate, defined as a pregnancy ≥ 12 weeks
    La tasa de embarazo evolutivo se define como aquellas gestaciones confirmadas por encima de las 12 semanas
    E.5.2Secondary end point(s)
    Prevalence of serum progesterone (P) levels <10 ng/ml before FET
    Implantation rate
    Biochemical pregnancy rate (defined as a pregnancy diagnosed only by the detection of
    bHCG in serum or urine)
    Clinical pregnancy rate (defined as the presence of at least one embryo with heartbeat on
    transvaginal ultrasound)
    Miscarriage rate
    Frequency of adverse events
    Prevalencia de progesterona<10 ngml antes de la transferencia
    Tasa de implantación
    Embarazo bioquímico
    Embarazo Clínico
    Tasa de aborto
    Frecuencia de acontecimientos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Prevalence of serum progesterone (P) levels <10 ng/ml before FET:Day of transfer
    Implantation rate: After 6-7 weeks port transfer
    Biochemical pregnancy rate (defined as a pregnancy diagnosed only by the detection of
    bHCG in serum or urine): 14 days after transfer
    Clinical pregnancy rate (defined as the presence of at least one embryo with heartbeat on
    transvaginal ultrasound): 6-7 weeks after transfer
    Miscarriage rate: 10 weeks after transfer
    Frequency of adverse events: From the beginning of treatment until 10 weeks after transfer
    Prevalencia de progesterona<10 ngml antes de la transferencia: Dá de la transferencia
    Tasa de implantación: Despues de 6-7 semenas tras transferencia
    Embarazo bioquímico:14 días tras transferencia
    Embarazo Clínico: 6/7 semanas tras transferencia
    Tasa de aborto: 10 semanas tras transferencia
    Frecuencia de acontecimientos adversos: Desde el inicio del tratamiento hasta 10 semans tras transferencia
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 1020
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state1020
    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)
    Live birth rate
    Pregnancy complications:
    Preeclampsia
    Preterm birth
    Fetal growth restriction
    Tasa de nacido vivo
    Complicaciones en el embarazo:
    Preeclmpsia
    Parto prematuro
    Crecimiento intrauterino retardado
    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 Decision2023-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-27
    P. End of Trial
    P.End of Trial StatusOngoing
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