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    Summary
    EudraCT Number:2017-001878-42
    Sponsor's Protocol Code Number:viagra01
    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:2017-12-21
    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 number2017-001878-42
    A.3Full title of the trial
    Sildenafil Citrate effect on in vivo human trophoblast research.
    INVESTIGACIÓN SOBRE EL EFECTO DEL SILDENAFILO EN EL TROFOBLASTO HUMANO IN VIVO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sildenafil effect in placental vessels.
    Efecto del Sildenafilo en los vasos de la placenta.
    A.3.2Name or abbreviated title of the trial where available
    Sildenafil Citrate effect on in vivo human trophoblast research.
    INVESTIGACIÓN SOBRE EL EFECTO DEL SILDENAFILO EN EL TROFOBLASTO HUMANO IN VIVO.
    A.4.1Sponsor's protocol code numberviagra01
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00033863
    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 SponsorCONSORCIO HOSPITAL GENERAL UNIVERSITARIO DE VALENCIA
    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 supportFUNDACIÓN DE INVESTIGACIÓN HOSPITAL GENERAL DE VALENCIA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCONSORCIO HOSPITAL GENERAL UNIVERSITARIO
    B.5.2Functional name of contact pointSERVICIO DE GINECOLOGÍA
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Tres Cruces, 2,
    B.5.3.2Town/ cityValència
    B.5.3.3Post code46014
    B.5.3.4CountrySpain
    B.5.4Telephone number0034963 13 18 007127
    B.5.5Fax number0034963131973
    B.5.6E-mailpellicer_beg@gva.es
    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.2.5The 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.3.4Pharmaceutical form Capsule
    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 INNSILDENAFIL
    D.3.9.1CAS number 139755-83-2
    D.3.9.4EV Substance CodeSUB10517MIG
    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
    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
    This is a placebo – controlled longitudinal study to determine whether maternal administration of an unique oral dose of sildenafil citrate (50mg) improves placental flow in first trimester in healthy pregnancies. They are pregnant women before twelve weeks who comes to our hospital for legal medical abortion.
    Se trata de un estudio longitudinal con grupo control ( placebo) para determinar si la administración de una dosis única de 50mg de citrato de sildenafilo puede aumentar la vasscularización placentaria en el primer trimestre en embarazos sanos. Son mujeres embarazadas por debadjo de doce semana que acuden para solicitar la interrupción legal de su embarazo.
    E.1.1.1Medical condition in easily understood language
    The vascular effect of Sildenafil will be tested in early pregnancy.
    El efecto vascular del sildenafilo en la gestación temprana.
    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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10036585
    E.1.2Term Pregnancy, puerperium and perinatal conditions
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10036569
    E.1.2Term Pregnancy related circumstances
    E.1.2System Organ Class 100000004869
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether maternal administration of an unique oral dose of sildenafil citrate improves the placental flow. It will be measured by standard vascular indexes acquired with three dimensional angiopower doppler output.
    Determinar si una dosis única de citrato de sildenafilo aumenta el flujo placentario. Para ello se emplearán índices vasculares semicuantiativos estandarizados de angiopower 3D
    E.2.2Secondary objectives of the trial
    Uterine artery hemodynamic flow effect and maternal blood pressure and heart frequency variation.
    El efecto sobre las arterias uterinas, y la presión arterial y frecuencia cardíaca maternas.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    After abortion has been practised placental tissue samples (n= 10) from
    each studied group containing trophoblast tissue will be obtained they will be processed in
    order to examine angiogenic factors and its histologic structure.
    Tras el aborto legal las muestras de tejido placentario conteniendo trofoblasto (n:10) de cada grupo serán estudiadas buscando factores angiogénicos y/o estructura histológica.
    E.3Principal inclusion criteria
    1. Healthy women between 20-40 years old.
    2. Confirmed pregnant viability without any obstetric complication.
    3. First trimester gestational age.
    1. Mujeres sanas embarazadas entre 20-40 años.
    2. Embarazo confirmado sin complicaciones obstétricas.
    3. Edad gestacional de primer trimestre.
    E.4Principal exclusion criteria
    - Obstetric risk factors : recurrent miscarriage, previous preeclamsia and hematology disease.
    - Current use of vasoactive drugs. ( mainly related to hypertension treatment).
    - Toxic substances abuse.
    - Threatened abortion symptoms.
    - Sildenafil Citrate contraindications, as are described in the prescribing information formulary (
    exluding pregnancy).
    - Factores de riesgo obstétrico: Aborto recurrente, preclasia previa, o enfermedades hematológicas.
    - Uso de fármacos vasoactivos: Fundamentalmente relaionadas con la hipertensión
    - Abuso de sustancias tóxicas.
    - Síntomas de amenaza de aborto.
    - Contraindicaciones de Sildenafilo, tal como vienen descritos en ficha técnica ( excepto el embarazo).
    E.5 End points
    E.5.1Primary end point(s)
    Significant variation in the three values representing vascularity adquired automatically : VI as a vascularity index representing the proportion of blood vessels within the tissue, which is calculated as a percentage of colour voxels in the studied volume. FI representing the average power Doppler amplitude within blood
    vessels. It is calculated as the average value of all colour voxels and it is expressed as a scale of 0– 100. VFI, expressed as a scale of 0–100, is the average colour value of all grey and colour voxels, a product of the number of colour voxels represented as a percentage and the relative amplitude of these voxels.
    Una rvariación significativa de cualquiera de los siguientes índeces vasculares ecográficos otenidos automáticamnete: VI , indice de vascularización ( porcentaje de vasos en el volumen estudiado); FI, indice de fujo (porcentaje de amplitud del color en el volumen estudiado); VFI, que representa la densidad de vascularización, es la media de color respecto a la escala de grises.
    E.5.1.1Timepoint(s) of evaluation of this end point
    An initial scan is performed when the patient is admitted and another examination is done one
    hour later (following drug or placebo administration).
    Una evaluación ecográfica basal es realizada al ingreso y otro examen ecográfico se realiza pasada una hora de la administración ( del fármaco o el placebo).
    E.5.2Secondary end point(s)
    Significative variation of uterine artery hemodynamic flow and maternal blood pressure and heart frequency.
    Variaciones significativas en el flujo hemodinámico de la arteria uterina y en la presión arterial y frecuencia cardíaca maternas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood pressure and maternal heart rate every 15 minutes and side effects will be achieved. Patients are also contacted by telephone to detect side effects twelve hours later and seven days after legal abortion has been done.
    La presión arterial y la frecuencia cardíaca materna serán registardas cada 15 minutos tras la administración de sildenafilo. Los efectos secundarios se evaluarán telefónicamente a als 12 horas y a los siete dias de la administración.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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. Ultima visita de la ultima paciente.
    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 months0
    E.8.9.1In the Member State concerned 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: 66
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    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 Yes
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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
    NO
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-14
    P. End of Trial
    P.End of Trial StatusOngoing
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