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    Summary
    EudraCT Number:2016-002731-14
    Sponsor's Protocol Code Number:16I-Prg05
    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:2018-02-27
    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 number2016-002731-14
    A.3Full title of the trial
    Prospective, randomised, double-blind, placebo controlled, phase III clinical study assessing the efficacy of 25 mg natural progesterone administered subcutaneously in restoring the normal luteal phase in women with previous diagnosis of luteal phase deficiency.
    Studio prospettico, randomizzato, in doppio cieco, 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 ripristino della normale fase luteale nelle donne con precedente diagnosi di deficit luteale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective, randomised, double-blind, placebo controlled, phase III clinical study assessing the efficacy of 25 mg natural progesterone administered subcutaneously in restoring the normal luteal phase in women with previous diagnosis of luteal phase deficiency.
    Studio prospettico, randomizzato, in doppio cieco, 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 ripristino della normale fase luteale nelle donne con precedente diagnosi di deficit luteale
    A.3.2Name or abbreviated title of the trial where available
    Progesterone (Pleyris)
    Progesterone (Pleyris)
    A.4.1Sponsor's protocol code number16I-Prg05
    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 INSTITUT BIOCHIMIQUE SA
    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 number055 7224179
    B.5.5Fax number055 7227014
    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 PLEYRIS - 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.3.9.3Other descriptive namePROGESTERONE
    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
    Women with diagnosis of luteal phase deficiency.
    Donne con diagnosi di deficit luteale
    E.1.1.1Medical condition in easily understood language
    Women with diagnosis of luteal phase deficiency.
    Donne con diagnosi di deficit luteale
    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 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 10036562
    E.1.2Term Pregnancy in habitual aborter
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    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 in restoring a normal luteal phase. The primary end-point will be the ongoing pregnancy rate.
    Valutare l’efficacia di una somministrazione giornaliera di 25mg/bid di progesterone naturale nel ristabilire la normale fase luteale, quindi la maggiore percentuale di gravidanze.
    E.2.2Secondary objectives of the trial
    The secondary objectives will be the rate of endometrial biopsy showing an in phase endometrium after 3 months of treatment.
    The length of the luteal phase of the menstrual cycle after treatment will also be assessed and compared with the initial duration (from LH peak to onset of menstruation).
    L’obbiettivo secondario sarà la percentuale di biopsie dell’endometrio che mostreranno di essere in fase dopo tre mesi di trattamento.
    Sarà valutata anche la lunghezza del ciclo mestruale dopo il trattamento paragonata con la durata iniziale (dal picco di LH all’arrivo della mestruazione).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women who wish to get pregnant with a previous diagnosis of luteal phase deficiency:
    - Able and willing to sign the Subject Consent Form and adhere to the study visit schedule;
    - Age: 20-35 years;
    - BMI: 18-28 kg/m2;
    - Menstrual period shorter than 25 days;
    - Sub-fertile couple: 12 months of trying to conceive without success;
    - Basal P4 level (day 3 of a previous cycle) ≤ 1.5 ng/ml;
    - Fertile male partner (normal sperm count);
    - Inadequate luteal phase (period between LH peak and onset of menstruation shorter than 9 days).
    Donne che desiderano rimanere incinta con una pregressa diagnosi di deficit luteale:
    - Capaci e intenzionate a firmare il Consenso Informato e aderire al protocollo di studio;
    - Età compresa tra 20 e 35 anni;
    - BMI: 18-28 kg/m2;
    - Durata del ciclo mestruale inferiore a 25 giorni;
    - Coppie Sub-fertili: 12 mesi di rapporti sessuali infruttuosi;
    - Livello basale P4 (giorno 3 del ciclo precedente) ≤ 1.5 ng/ml;
    - Partner maschile fertile (conta normale dello sperma);
    - Fase luteale inadeguata (periodo tra il picco LH e l’arrivo della mestruazione ≤9 giorni).
    E.4Principal exclusion criteria
    - History of recurrent miscarriage;
    - Severe uterine malformations (including submucosal fibroids, endometrial polyps, and intrauterine adhesions) ;
    - 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);
    - Current vaginal infection;
    - Endometriosis stage III or IV;
    - PCOS;
    - Partially or completed block of fallopian tubes;
    - Hydrosalpinx;
    - 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;
    - Thyroid diseases or autoimmune conditions;
    - Hypothalamic dysfunction;
    - Hyperprolactinaemia;
    - Infertility due to male factor;
    - Smokers.
    - Storia di aborti ricorrenti;
    - Malformazioni uterine severe (tra cui fibroma submucosale, polipi endometriali e adesioni intrauterine);
    - Ipersensibilità al Progesterone;
    - Neoplasie (conosciute o sospetto cancro al seno o agli organi genitali);
    - Danni epatici severi o disfunzioni renali;
    - Uso di medicinali concomitanti che potrebbero interferire con la valutazione dello studio (altri trattamenti con ormoni);
    - Infezioni vaginali ricorrenti;
    - Endometriosi di stadio III o IV;
    - PCOS;
    - Blocco parziale o completo delle tube di Faloppio;
    - Idrosalpinge;
    - Tromboembolismo arterioso o venoso attivo o severa tromboflebite, o storia pregressa di questi eventi;
    - Porfiria;
    - Storia di un ittero idiopatico, o di prurito severo o di pemfigoide gravidico, durante la gravidanza;
    - Sindrome antifosfolipidica;
    - Diabete mellito;
    - Patologie tiroidee o condizioni autoimmuni.
    - Disfunzione ipotalamica
    - Iperprolactinemia
    - Infertilità dovuta al partner maschio
    - Fumatori
    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
    12 settimana
    E.5.2Secondary end point(s)
    Rate of in phase endometrial biopsies 3 months after treatment start. Biopsies will be evaluated morphologically (according to Noyes criteria) with light microscopy and the presence of pinopodes will be further investigated with electron microscopy.
    Length of luteal phase (from LH peak to onset of menstruation).
    Percentuale di biopsie endometriali con risultato in fase dopo tre mesi di trattamento. Le biopsie saranno valutate morfologicamente (in accordo al criterio di Noyes) con microscopio ottico, la presenza di pinopodi, sarà ulteriormente valutata con microscopio elettronico.
    Lunghezza della fase luteale (dal picco LH all’arrivo della mestruazione).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Three months
    Tre mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    December 2019 (including Follow-up) Clinical Study Report
    Dicembre 2019 (Follow-up inclusi) 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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    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) Yes
    F.1.2.1Number of subjects for this age range: 60
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    Pregnant subjects will return at the clinic on the 12th week of gestation for a TVUS and clinical pregnancy confirmation. These subjects will be provided with a special follow-up form (pregnancy outcome form) to be filled in after delivery
    I soggetti in stato di gravidanza torneranno alla clinica alla 12esima settimana di gestazione per effettuare una ecografia transvaginale (TVUS) e confermare clinicamente la gravidanza. Questi soggetti riceveranno uno speciale modulo di follow-up (modulo di esito della gravidanza) da compilare dopo il parto.
    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 Decision2017-02-20
    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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    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
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