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    The EU Clinical Trials Register currently displays   37537   clinical trials with a EudraCT protocol, of which   6155   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-000241-13
    Sponsor's Protocol Code Number:PESAPRO
    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:2012-02-10
    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 number2012-000241-13
    A.3Full title of the trial
    Prevention of preterm birth in women at risk identified by ultrasound: evaluation of two
    treatment strategies.
    Prevención de parto pretérmino en mujeres de riesgo identificadas por ecografía: evaluación de dos estrategias terapéuticas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevención de parto pretérmino en mujeres de riesgo identificadas por ecografía: evaluación de dos tratamientos.
    A.4.1Sponsor's protocol code numberPESAPRO
    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 SponsorDra. Martinez Payo-Hospital Universitario Puerta de Hierro
    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 supportMinisterio de Sanidad y politica social
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationServico de Farmacologia Clínica
    B.5.2Functional name of contact pointLourdes Caberera
    B.5.3 Address:
    B.5.3.1Street AddressManuel de Falla 1
    B.5.3.2Town/ cityMajadahonda
    B.5.3.3Post code28222
    B.5.3.4CountrySpain
    B.5.4Telephone number0034911917479
    B.5.5Fax number0034911917650
    B.5.6E-maillcabrera.hpth@salud.madrid.org
    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 PROGEFFIK
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios EFFIK, S.A
    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.3.4Pharmaceutical 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
    D.3.9.1CAS number 57-83-0
    D.3.9.2Current sponsor codepro
    D.3.9.4EV Substance CodeSUB10076MIG
    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.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
    Gestantes con cervix acortado (<de 25mm) en la ecografía de rutina de las 19-22 semanas.
    E.1.1.1Medical condition in easily understood language
    Mujeres embarazadas con cervix corto, diagnosticado en la ecografia de 2º trimestre. (19-22 semanas)
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    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
    Demostrar la eficacia de 2 estrategias terapéuticas, tratamiento con Progesterona Vaginal o colocación de Pesario Cervical frente al no tratamiento, en gestantes con cuello corto en términos de proporción de partos prematuros espontáneos antes de la 34 S de gestación.
    E.2.2Secondary objectives of the trial
    Comparar la eficacia de ambas intervenciones frente al no tratamiento en términos de:
    a. Peso del RN
    b. Nº de semanas de gestación al parto.
    c. Rotura espontánea de membranas antes de las 34S
    d. Morbi-mortalidad neonatal
    e. Necesidad de Hospitalización materna
    - Evaluar la seguridad de ambas estrategias.
    - Comparación entre los 2 grupos de tratamiento activo (Progesterona Vaginal vs Pesario Cervical).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Gestantes con cervix acortado (<de 25mm) en la ecografía de rutina de las 19-22 semanas.
    ? Gestaciones únicas.
    ? Edad mínima 18 años
    ? Aceptación del consentimiento informado escrito conforme a ICH/GCP y a la legislación local, obtenido antes de cualquier procedimiento de estudio.
    E.4Principal exclusion criteria
    ? Malformaciones fetales mayores.
    ? Malformaciones uterinas mayores.
    ? Presencia de cerclaje cervical in situ.
    ? Antecedente de conización cervical.
    ? Presencia de placenta previa en gestación actual.
    ? Presencia de sangrado vaginal o rotura prematura de membranas (RPM) en el momento de la randomización.
    ? Incapacidad para dar el consentimiento informado.
    ? Si en opinión del investigador existen hallazgos en la exploración física, anomalías en los resultados de los análisis clínicos u otros factores médicos, sociales o psicosociales que pudieran influir negativamente.
    E.5 End points
    E.5.1Primary end point(s)
    - Parto prematuro espontáneo antes de las 34 semanas de gestación.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Momento del parto
    E.5.2Secondary end point(s)
    - Parto prematuro espontáneo antes de las 37 S.
    - Parto prematuro espontáneo antes de las 28 S.
    - Rotura espontánea de membranas antes de las 34 S.
    - Incidencia de Corioamnionitis.
    - Hospitalización por amenaza de parto prematuro antes de 34 S, estancia media y necesidad de uso de tratamiento tocolítico (tipo, nº días y dosis)
    - Peso al nacer
    - Muerte fetal Intrauterina
    - Morbimortalidadlidad neonatal,
    - Seguridad y tolerancia
    E.5.2.1Timepoint(s) of evaluation of this end point
    Momento del parto y cuando ocurran desde el inicio del tratamiento.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Pesario cervical con marcado CE y brazo de no tratamiento.
    E.8.2.4Number of treatment arms in the trial3
    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
    4 semanas post-parto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    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: 600
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state600
    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)
    No aplica
    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 Decision2012-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
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