Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-005180-16
    Sponsor's Protocol Code Number:FFIS/2015/02/EV
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-03-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-005180-16
    A.3Full title of the trial
    Early vaginal progesterone for the prevention of spontaneous preterm birth in twins: A randomised, placebo controlled, double-blinded trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of preterm birth in twin pregnancies - “Randomised trial of progesterone versus placebo”
    A.3.2Name or abbreviated title of the trial where available
    EVENTS
    A.4.1Sponsor's protocol code numberFFIS/2015/02/EV
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN66445401
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1175-4589
    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 SponsorFundación para la Formación e Investigación Sanitaria
    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 supportFetal Medicine Foundation
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportLaboratoires Besins International
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFetal Medicine Foundation
    B.5.2Functional name of contact pointProfessor Kypros Nicolaides
    B.5.3 Address:
    B.5.3.1Street Address137 Harley Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1B 6BG
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailthanos@fetalmedicine.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 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 nameUtrogestan
    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.3.9.4EV Substance CodeAS1
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPessary
    D.8.4Route of administration of the placeboVaginal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Spontaneous preterm birth in twin pregnancies.
    Parto pretermine spontaneo
    E.1.1.1Medical condition in easily understood language
    Spontaneous preterm birth in twin pregnancies.
    Parto
    pretermine spontaneo nelle gravidanze gemellare
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10023555
    E.1.2Term Labour premature
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Does the use of high dose vaginal progesterone (Utrogestan) started in the first trimester reduce the chances of having a preterm birth before 34 weeks gestation in twin pregnancies?
    Nelle gravidanze gemellari, l’uso di alte dosi di
    progesterone intravaginale (Utrogestan) a partire dal primo trimestre, riduce
    le possibilità di avere un parto prematuro prima delle 34 settimane?
    E.2.2Secondary objectives of the trial
    Does the use of high dose vaginal progesterone from the first trimester of pregnancy reduce any of the following in twin pregnancies:
    1. The rate of preterm delivery before 37 weeks,
    2. The number of babies born that are low birthweight,
    3. The number of stillborn babies or babies that die soon after birth,
    4. The number of babies that are admitted to the neonatal intensive care unit or suffer from significant adverse outcomes that are associated with prematurity.
    Nelle gravidanze gemellari, l’uso di alte dosi di
    progesterone a partire dal primo trimestre, riduce alcune tra le seguenti
    complicanze?:
    - la percentuale di parti pretermine prima delle 37 settimane
    -il numero di nati con basso peso alla nascita
    -il numero morti endouterine o morti neonatali
    -il numero di bambini ricoverati in terapia intensiva neonatale o che
    presentano conseguenze associate alla prematurità
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age > 18 years;
    • DCDA or MCDA twin pregnancies;
    • Live fetuses at 11-13 weeks of gestation;
    • Fluent in local language (otherwise interpreters will be used);
    • Informed and written consent.
    -Età Q 18 anni
    -Gravidanza DCDA o MCDA
    -feto vivo fra 11-13 settimane di gestazione
    -buona comprensione della lingua (altrimenti presenza dell’interprete)
    -consenso informato firmato
    E.4Principal exclusion criteria
    • Pregnancies complicated by major fetal abnormality identified
    at the 11‐13 weeks assessment, including nuchal translucency
    thickness >3.5 mm;
    • MCDA twin pregnancies in which there are early signs of twinto‐
    twin transfusion syndrome (TTTS) (20% discordance in
    crown‐rump length [CRL]);
    • Women who are unconscious or severely ill, those with
    learning difficulties, or serious mental illness;
    • Hypersensitivity to progesterone;
    • Women taking progesterone regularly or at any time within
    the previous 7 days;
    • Concurrent participation in another drug trial or at any time
    within the previous 28 days;
    • Severe hepatic dysfunction [AST or ALT >3 times the upper limit
    of normal (ULN) or bilirubin >2 x ULN], mammary or genital tract
    carcinoma, thrombophlebitis or thromboembolic disorders
    • Porphyria
    • Cerebral haemorrhage
    • Allergy to sunflower oil, soy lethicin, gelatin, glycerol (E422),
    titanium dioxide (E171)
    -Malformazioni fetali maggiori, inclusa translucenza nucale Q 3,5 mm
    -MCDA in cui vi siano precoci segni di TTTS (20% di discrepanza fra i CRL)
    -incosciente o gravemente malata
    -malattie mentali gravi
    -difficoltà di comprensione
    -difficoltà nella comprensione linguistica e assenza di interprete
    -ipersensibilità al progesterone
    -donne in terapia regolare con progesterone fino a 7 giorni prima
    -partecipazione ad un altro studio che prevede l’utilizzo di farmaci fino a 28 giorni
    prima
    -Disfunzione epatica severa (AST o ALT Q 3 volte la norma o bilirubina Q 2 volte la
    norma), carcinoma alla mammella o del tratto genitale, tromboflebite o disordine
    tromboembolico
    -porfiria
    -emorragia cerebrale
    -allergia all’olio di semi di girasole, alla lecitina di soia, alla gelatina, al glicerolo (E422),
    diossido di titanio (E171)
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of spontaneous delivery before 34 weeks'.
    I dati relativi all’esito della
    gravidanza saranno raccolti dai registri ospedalieri o attraverso il medico di
    base. Verranno esaminati i casi di parti avvenuti F 34(F238 giorni) settimane,
    per stabilire se la natura sia iatrogena o spontanea. Questi ultimi includono
    quelli con inizio spontaneo del travaglio e con rottura prematura delle
    membrane. Saranno raccolti i dati relatini ai neonati, qualora siano ricoverati
    in terapia intensiva neonatale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Data on pregnancy outcome will be collected from hospital maternity records or general practitioners. The obstetric records of all patients delivered at <34 weeks' (<238 days) will be examined to determine if the preterm birth is iatrogenic or spontaneous. The latter includes those with spontaneous onset of labour and those with preterm pre-labour rupture of membranes. In the event when the neonates are admitted to Special Care Baby Unit (SCBU)/Neonatal Intensive Care Unit (NICU), additional neonatal outcomes will be collected from the discharge summary of SCBU/NICU.
    E.5.2Secondary end point(s)
    • The incidence of spontaneous preterm birth <37 weeks (259 days) of gestation;
    • Birthweight below the 3rd, 5th and 10th centile;
    • Stillbirth or neonatal death due to any cause;
    • Major adverse outcomes before discharge from the hospital (intraventricular haemorrhage, respiratory distress syndrome, retinopathy of prematurity, or necrotising entercolitis);
    • Need for neonatal special care (admission to a neonatal intensive care unit, ventilation, phototherapy, treatment for proven or suspected sepsis, or blood transfusion).
    -Incidenza di parti spontanei F 37
    settimane (259 giorni); - peso alla nascita inferiore al 3°, al 5°, al 10°
    percentile; -morte endouterina o morte neonantale dovuta a cause differenti;
    complicanze maggiori prima della dimissione ospedaliera (emorragia
    cerebrale, sindrome da distress resiratorio, retinopatia del prematuro oppure
    enterocolite necrotizzante); -necessità di cure neonatali speciali (terapia
    intensiva neonatale, ventilazione, fototerapia, trattamento per sepsi certa o
    sospetta, trasfusione di sangue.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Data on pregnancy outcome will be collected from hospital maternity records or general practitioners. The obstetric records of all patients delivered at <34 weeks' (<238 days) will be examined to determine if the preterm birth is iatrogenic or spontaneous. The latter includes those with spontaneous onset of labour and those with preterm pre-labour rupture of membranes. In the event when the neonates are admitted to Special Care Baby Unit (SCBU)/Neonatal Intensive Care Unit (NICU), additional neonatal outcomes will be collected from the discharge summary of SCBU/NICU.
    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 No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 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 end of the trial is defined as when the pregnancy outcome is complete for the last randomised trial patient and all oustanding data regarding the primary outcome measured is received.
    Lo studio terminerà quando sarà raccolto l’ultimo esito de gravidanza
    dell’ultima paziente randomizzata, insieme a tutti i dati relativi ai primi obiettivi
    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 months2
    E.8.9.1In the Member State concerned days31
    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 days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1180
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1180
    F.4.2.2In the whole clinical trial 1180
    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)
    As the patients will no longer be pregnant, this is not relevant.
    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 Decision2018-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-21
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 14:00:31 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA