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    Summary
    EudraCT Number:2016-002777-35
    Sponsor's Protocol Code Number:16I-Prg06
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-08-29
    Trial results View 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 number2016-002777-35
    A.3Full title of the trial
    Prospective, double-blind, randomised, placebo controlled, phase III clinical study assessing the efficacy of natural progesterone 25 mg/bid administered subcutaneously in the maintenance of early pregnancy in women with symptoms of threatened abortion.
    Studio prospettico, in doppio cieco, randomizzato, controllato verso placebo, di fase III per la valutazione dell’efficacia del progesterone naturale somministrato ad una dose di 25 mg/dì per via sottocutanea nel mantenimento di una gravidanza in donne con sintomi di minaccia d’aborto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective, double-blind, randomised, placebo controlled, phase III clinical study assessing the efficacy of natural progesterone 25 mg/bid administered subcutaneously in the maintenance of early pregnancy in women with symptoms of threatened abortion.
    Studio prospettico, in doppio cieco, randomizzato, controllato verso placebo, di fase III per la valutazione dell’efficacia del progesterone naturale somministrato ad una dose di 25 mg/dì per via sottocutanea nel mantenimento di una gravidanza in donne con sintomi di minaccia d’aborto
    A.3.2Name or abbreviated title of the trial where available
    Progesterone (Pleyrys)
    Progesterone (Pleyrys)
    A.4.1Sponsor's protocol code number16I-Prg06
    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 SponsorIBSA INSTITUT BIOCHIMIQUE SA
    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 supportIBSA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmaD&S
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressVia dei Pratoni 16
    B.5.3.2Town/ cityScandicci
    B.5.3.3Post code50018
    B.5.3.4CountryItaly
    B.5.4Telephone number0557224179
    B.5.5Fax number0557227014
    B.5.6E-mailedimartino@pharmades.it
    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 PROLUTEX - 25 MG/ML SOLUZIONE INIETTABILE 1 FLACONCINO IN VETRO
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA FARMACEUTICI ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNProgesterone
    D.3.9.2Current sponsor codeIBSA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Threatened abortion
    Minaccia di aborto
    E.1.1.1Medical condition in easily understood language
    Threatened abortion
    Minaccia di aborto
    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 PT
    E.1.2Classification code 10000242
    E.1.2Term Abortion threatened
    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 PT
    E.1.2Classification code 10063273
    E.1.2Term Progesterone normal
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10063291
    E.1.2Term Progesterone
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10063291
    E.1.2Term Progesterone
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg/bid in the maintenance of early pregnancy in women with symptoms of threatened abortion.
    L'obbiettivo principale sarà di valutare l'efficacia del progesterone naturale alla dose giornaliera di 25 mg/bid nel mantenimento della gravidanza in donne con minaccia di aborto.
    E.2.2Secondary objectives of the trial
    The secondary objectives will be the efficacy of progesterone in reducing both pain and uterine contractions.
    L'obbiettivo secondario è di valutare l'efficacia del progesterone nel ridurre il dolore addominale e le contrazioni uterine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pregnant women attending the emergency room of the study sites with the following characteristics:
    - Able and willing to sign the Subject Informed Consent Form and adhere to the study visit schedule;
    - Age: 18-37 years;
    - BMI: 18-28 kg/m2;
    - Symptoms of threatened abortion (vaginal bleeding, pelvic pain);
    - Ultrasound proof of viable singleton intrauterine pregnancy (positive foetal heart beat);
    - Gestation week ≥6 weeks (5 w +1d) and <12 weeks (11 w + 1d) according to ultrasound dating (CRL);
    - Closed uterine cervix;
    - Subchorionic haematoma with < 50% placental detachment;
    - At the first case of threatened abortion in the current pregnancy.
    Criteri di inclusione:
    - Donne in stato di gravidanza che arriveranno al pronto soccorso dei centri di studio con le seguenti caratteristiche:
    - Capaci e volontariamente in grado di firmare il -Consenso Informato e aderire al protocollo di studio.
    - Età compresa tra 18 e 37 anni;
    - BMI: 18-28 kg/m2;
    - Sintomi di minaccia di aborto con ( sangunamento vaginale, dolori addominali).
    - Prova ecografica di gravidanza intrauterine (presenza di battito cardiaco);
    - Settimana di gestazione compresa tra ≥6 settimane (5s+1g) e < di 12 settimane (11s + 1 g);
    - Cervice uterine chiusa;
    - Ematoma subcorionico con < 50% di distacco della placenta;
    - Alla prima esperienza di minaccia di aborto nella gravidanza corrente.
    E.4Principal exclusion criteria
    - Pregnancy obtained via ART treatment;
    - History of recurrent miscarriage;
    - Severe uterine malformations;
    - Known hypersensitivity to study medication;
    - Neoplasias (known or suspected breast or genital tract cancer);
    - Severe impairment of hepatic or renal function;
    - Use of concomitant medications that might interfere with study evaluations (other hormonal treatment or drugs affecting uterine contractility);
    - Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events;
    - Porphyria;
    - A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy;
    - Antiphospholipid syndrome;
    - Diabetes mellitus;
    - Known thyroid diseases or autoimmune conditions.
    Criteri di esclusione:
    - Gravidanza ottenuta via trattamento ART (Tecniche di riproduzione assistita)
    - Storia di aborti ricorrenti;
    - Severe malformazioni uterine
    - Ipersensitività conosciuta al Progesterone
    - Neoplasie (conosciute o cancro sospetto al seno o ai tratti genital);
    - Danni epatici severe o disfunzioni renali;
    - Uso di medicinali concomitanti che potrebbero interferire con la valutazione dello studio (altri trattamenti con ormoni o farmaci che potrebbero influenzare la contrattilità uterine);
    - Attivo tromboembolismo arterioso o venoso, o storie di questi eventi pregressi;
    - -Porfiria;
    - Storia di un ittero idiopatico, o di severo prurito o di pemphigoide durante la gestazione;
    - Syndrome antifosfolipidica;
    - Diabete mellito;
    - Patologie tiroidee o condizioni autoimmuni.
    E.5 End points
    E.5.1Primary end point(s)
    Ongoing pregnancy rate at 12 weeks of gestation
    Gravidanza alla 12ma settimana di gestazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks of gestation for the subject included in the study
    12ma settimana di gestazione del soggetto allo studio
    E.5.2Secondary end point(s)
    - Reduction of the frequency of uterine contractions;
    - Pain reduction (using a Numerical Rating Scale);
    - Reduction of subchorionic haematoma;
    - Number of subjects with onset of new threatened abortion symptoms after the treatment, but before the 12th week of pregnancy.
    - Riduzione delle contrazioni uterine;
    - Riduzione del dolore (valutato con la scala numerica del dolore)
    - Riduzione dell’ematoma subchorionico;
    -Numero di soggetti con inizio di una nuova minaccia di aborto dopo il trattamento con il progesterone, ma prima della 12ma settimana di gestazione.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    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 Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA2
    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 Information not present in EudraCT
    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
    Clinical Study Report
    Clinical Study Report
    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 months8
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days29
    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: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    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 state268
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 268
    F.4.2.2In the whole clinical trial 268
    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)
    Follow up on the delivery for the women that will continuous the pregnancy.
    Follow up sulla nascita del bambino per le donne che porteranno a termine la gravidanza
    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 Decision2017-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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