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    Summary
    EudraCT Number:2021-003027-15
    Sponsor's Protocol Code Number:EFFI2021/01
    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:2022-11-07
    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 number2021-003027-15
    A.3Full title of the trial
    A multicentre, prospective, open-label, non-comparative study to evaluate menstrual bleeding typology, tolerability, and compliance during a monophasic hormonal contraceptive treatment with norgestimate + ethinylestradiol in Italy.
    Studio clinico multicentrico, prospettico, in aperto, non comparativo per valutare la tipologia del sanguinamento mestruale, la tollerabilità e la aderenza terapeutica durante il trattamento contraccettivo ormonale monofasico con norgestimato + etinilestradiolo in Italia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a non-comparative study that aims to evaluate and confirm the effects of the Effimia® contraceptive pill on intermenstrual bleeding.
    Si tratta di uno studio non comparativo che valuta e conferma gli effetti della pillola contraccettiva Effimia® sul sanguinamento intermestruale.
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberEFFI2021/01
    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 SponsorITALFARMACO S.P.A.
    B.1.3.4CountryItaly
    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 supportITALFARMACO SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOPERA Contract Research Organization Srl
    B.5.2Functional name of contact pointStudy Management Division
    B.5.3 Address:
    B.5.3.1Street AddressVia Cozia 10
    B.5.3.2Town/ cityTimisoara
    B.5.3.3Post code300209
    B.5.3.4CountryRomania
    B.5.4Telephone number0040724345115
    B.5.5Fax number0040256200353
    B.5.6E-mailemanuel.dogaru@tigermedgrp.com
    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 EFFIMIA
    D.2.1.1.2Name of the Marketing Authorisation holderItalfarmaco SpA
    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.3.1Product nameEFFIMIA
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Tablet
    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 INNNorgestimate
    D.3.9.1CAS number 35189-28-7
    D.3.9.2Current sponsor code35189-28-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNethinylestradiol
    D.3.9.1CAS number 57-63-6
    D.3.9.2Current sponsor code57-63-6
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Combined Oral Contraceptives (COC)
    Contraccettivi orali combinati (COC)
    E.1.1.1Medical condition in easily understood language
    Combined Oral Contraceptives (COC)
    Contraccettivi orali combinati (COC)
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10014698
    E.1.2Term Endocrine disorders
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Evaluate the cycle control: breakthrough bleeding (bleeding and/or spotting between cyclically regular onset of menses) of monophasic oral contraceptive pill Effimia® (NGM250 + EE35) in a population of women residing in Italy.
    • Valutare in una popolazione di donne residenti in Italia, l'efficacia della pillola contraccettiva orale monofasica Effimia® (NGM250 + EE35) in termini di controllo del ciclo: sanguinamento intermestruale (sanguinamento tra l’inizio di 2 cicli mestruali regolari).
    E.2.2Secondary objectives of the trial
    • Evaluate the cycle control in terms of frequency, duration, regularity, flow volume (subject determined) and unscheduled bleeding and/or spotting.
    • Evaluate presence of possible correlations between cycle irregularities and age and / or condition of starter or switcher of contraception.
    • Evaluate impact on sexual life.
    • Evaluate impact in subjects affected by pre-treatment acne problems.
    • Evaluate impact in subjects with premenstrual syndrome (PMS).
    • Evaluate effects on lipid and glucose metabolism and on hormonal parameters related to hyperandrogenism (by means of calculus of Free Androgenicity Index - FAI) – only in a subgroup of 28 subjects recruited only in the centre of Genova.
    • Valutare l'efficacia in termini di controllo del ciclo: frequenza, durata, regolarità, volume del flusso (determinata dal soggetto stesso) e sanguinamento non atteso.
    • Valutare la presenza di possibili correlazioni tra irregolarità del ciclo ed età e/o condizione di “starter” o “switcher” della contraccezione.
    • Valutare l'impatto sulla vita sessuale.
    • Valutare l'impatto nei soggetti affetti da problemi di acne pre-trattamento.
    • Valutare l'impatto nei soggetti con sindrome premestruale (PMS).
    • Valutare gli effetti sul metabolismo lipidico e glucidico e sui parametri ormonali legati all'iperandrogenismo (mediante il calcolo dell'indice degli androgeni liberi
    - FAI) – solo in un sottogruppo di 28 soggetti reclutati solo nel centro di Genova.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All the following criteria must be met.
    • Healthy women aged from 18 and 35 years (inclusive) in need of contraception.
    • Subjects residing in Italy and having a good knowledge of the Italian language, such as to correctly understand the Informed Consent Form, the instructions for use, and to ensure potential adhesion to the study.
    • Subjects providing written Informed Consent Form.
    • Subjects willing to comply with the study protocol.
    Dovranno essere soddisfatti tutti i seguenti caratteri:
    • Donne sane di età compresa tra 18 e 35 anni (inclusi) che necessitano di contraccezione.
    • Soggetti residenti in Italia e in possesso di una buona conoscenza della lingua italiana, tale da comprendere correttamente il Modulo di Consenso Informato, le istruzioni per l'uso, e da garantire una potenziale adesione allo studio.
    • Soggetti che forniscono Modulo di Consenso Informato scritto.
    • Soggetti disposti a rispettare il protocollo.
    E.4Principal exclusion criteria
    Subjects who meet even one of the following criteria will be excluded from the study:
    • Subjects presenting any contraindications to the use of Combined Oral Contraceptives (COC) according to the current Summary of Product Characteristics (SmPC) of Effimia®, i.e. subjects presenting (or have ever presented) myocardial infarction, transient ischemic attack (TIA), stroke, angina pectoris, deep vein thrombosis (DVT), pulmonary embolism (PE) (or presence of blood clot in other organs than legs and lungs), any blood clotting disorder (such as protein C deficiency, protein S deficiency, antithrombin-III deficiency), or subjects that need to undergo surgery or that have to lie down for a long period of time.(including risk of previous deep vein thrombosis (DVT), arterial thromboembolism (ATE), hypertension in course of treatment, diabetes).
    • If any of the listed conditions should appear during the use of the tested COC, the product must be stopped immediately, and the subject withdrawn from the study.
    • Subjects presenting severe diabetes with blood vessel damages, heart valve disease whit complications, severe hypertension, severe hypercholesterolemia, or hypertriglyceridemia, hyperhomocysteinaemia, migraine with aura, hepatis C (and taking medications for this condition), endometrial hyperplasia, unexplained vaginal bleeding, that are pregnant or that are suspecting a pregnancy.
    • Subjects presenting (or have ever presented) any liver disease not yet recovered (liver function not yet normalized), any benign or malignant tumour of the liver, any breast or genital organs cancer (even suspected), jaundice during pregnancy or while using hormonal contraceptives.
    • Subjects presenting galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome.
    • Subjects presenting hypersensitivity to the active substances or to any excipients of the tested COC (e.g., norgestimate, ethinylstradiol or lactose).
    • Subjects using the following not allowed treatments during the whole study period (according to the SmPC of the Investigational Medicinal Product - IMP): treatments for tuberculosis (e.g. rifampicin), for epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine), for HIV and hepatitis C virus infection (protease inhibitor drugs and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz and also ombitasvir, paritaprevir, ritonavir and dasabuvir), for fungal infections (e.g. griseofulvin), for arthritis, for osteoarthritis (etoricoxib ), for pulmonary arterial hypertension (bosentan) and St. John's wort used as an antidepressant. Medicines containing cyclosporine, the antiepileptic lamotrigine, tranexamic acid, theophylline (used to treat respiratory problems) and tizanidine (used to treat muscle pain and / or cramps) should not be taken as well.
    • Subjects who have used hormonal contraceptives in the previous month.
    • Subjects presenting a Body Mass Index - BMI = 30 kg/m2 (class I obesity).
    • Subjects smoking > 15 cigarettes per day.
    • Subjects using COC off-label (e.g., for polycystic ovarian syndrome – PCOS, endometriosis, or recurrent menometrorrhagia).
    • Subjects currently taking part or who took part in clinical studies with experimental products in the previous month.
    • Subjects showing incapacity / inability to comply with the study protocol (unreliability in the intake of the product or in the completion of the diary) according to the Investigator’s opinion.
    Saranno esclusi dallo studio i soggetti che rientrino anche in uno solo dei seguenti criteri:

    • Soggetti che presentano controindicazioni all'uso di contraccettivi orali combinati (COC) secondo l'attuale Riassunto delle Caratteristiche del Prodotto (RCP) di Effimia®, ovvero soggetti che presentano (o che abbiano mai presentato) infarto del miocardio, attacco ischemico transitorio (TIA), ictus, angina pectoris, trombosi venosa profonda (TVP), embolia polmonare (EP) (o presenza di coaguli di sangue in organi diversi da gambe e polmoni), qualsiasi disturbo della coagulazione del sangue (come carenza di proteina C, carenza di proteina S, carenza di antitrombina-III) , o soggetti che devono sottoporsi ad un intervento chirurgico o che devono rimanere sdraiati per un lungo periodo di tempo (incluso rischio di pregressa trombosi venosa profonda (TVP), tromboembolia arteriosa (TEA), ipertensione in corso di trattamento, diabete).
    Se una delle condizioni elencate dovesse comparire durante l'uso del COC in studio, il prodotto deve essere interrotto immediatamente e il soggetto ritirato dallo studio.
    • Soggetti che presentano diabete grave con danni ai vasi sanguigni, malattia delle valvole cardiache con complicanze, ipertensione grave, ipercolesterolemia o ipertrigliceridemia grave, iperomocisteinemia, emicrania con aura, epatite C (e che assumono farmaci per questa condizione), iperplasia endometriale, sanguinamento vaginale di natura non chiara, che sono in gravidanza o che sospettano una gravidanza
    • Soggetti che presentano (o che abbiano mai presentato) qualsiasi malattia del fegato non ancora guarita (funzionalità epatica non ancora normalizzata), qualsiasi tumore epatico benigno o maligno, qualsiasi tumore alla mammella o agli organi genitali (anche solo sospetto), ittero durante la gravidanza o durante l'uso di contraccettivi ormonali.
    • Soggetti che presentano intolleranza al galattosio, deficit totale di lattasi o sindrome da malassorbimento di glucosio-galattosio.
    • Soggetti che presentano ipersensibilità ai principi attivi o ad eventuali eccipienti del COC testato (es. norgestimato, etinilstradiolo o lattosio).
    • Soggetti che utilizzano i seguenti trattamenti non ammessi durante l'intero periodo di studio (secondo l'RCP del medicinale sperimentale - IMP): trattamenti per la tubercolosi (es. rifampicina), per l'epilessia (es. primidone, fenitoina, barbiturici, carbamazepina, oxcarbazepina), per infezione da virus HIV ed epatite C (farmaci inibitori della proteasi e inibitori non nucleosidici della trascrittasi inversa come ritonavir, nevirapina, efavirenz e anche ombitasvir, paritaprevir, ritonavir e dasabuvir), per infezioni fungine (es. griseofulvina), per artrite, per osteoartrite (etoricoxib), per l'ipertensione arteriosa polmonare (bosentan) e l'erba di San Giovanni usata come antidepressivo. Inoltre medicinali contenenti ciclosporina, l’antiepilettico lamotrigina, acido tranexamico, teofillina (usata per trattare i problemi respiratori), e tizanidina (usata per trattare dolori muscolari e/ o crampi) non devono essere assunti.
    • Soggetti che hanno usato i contraccettivi ormonali nel mese precedente.
    • Soggetti che presentano un Indice di Massa Corporea - BMI = 30 kg/m2 (obesità di classe I).
    • Soggetti che fumano > 15 sigarette al giorno.
    • Soggetti che utilizzano della COC per indicazioni off-label (p. es., per sindrome dell'ovaio policistico – PCOS o endometriosi, menometrorragie ricorrenti.
    • Soggetti attualmente partecipanti o che hanno partecipato nel mese precedente a studi clinici con prodotti sperimentali.
    • Soggetti che mostrano incapacità di rispettare il protocollo di studio (inaffidabilità nell'assunzione del prodotto o nella compilazione del diario) secondo il parere dello Sperimentatore
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy outcome
    • Cycle control evaluation parameter: breakthrough bleeding (bleeding and/or spotting between cyclically regular onset of menses) by calculating the intermenstrual spotting occurrence rate at sixth cycle only (value to be intended as not cumulative with values from the other 5 cycles taking place during the whole study period). A comparison within group will be performed at V3 with respect to Baseline (V1).
    Outcome primario di efficacia
    • Valutazione di Parametri del controllo del ciclo: sanguinamento intermestruale (sanguinamento tra l’inizio di cicli mestruali) calcolando il tasso di incidenza dello spotting intermestruale solo al sesto ciclo (valore da intendersi come non cumulabile con i valori degli altri 5 cicli avvenuti durante l'intero periodo di studio). Verrà fatto un confronto all'interno del gruppo a V3 rispetto al Basale (V1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    LPLV
    LPLV
    E.5.2Secondary end point(s)
    Secondary efficacy outcomes
    • Cycle control evaluation parameters: frequency, duration, regularity, flow volume (subject determined), unscheduled bleeding. A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).
    • Global Acne Grading System (GAGS). A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).
    • Profile of Mood State (POMS). A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).
    • Female Sexual Function Index (FSFI). A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).
    • Dysmenorrhea - VAS scale. A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).
    • Compliance (adherence to treatment).
    • Metabolic and hormonal parameters: blood lipid and glucose parameters (total cholesterol, High Density Lipoprotein – Cholesterol HDL-C, Low Density Lipoprotein – Cholesterol LDL-C, triglycerides, total testosterone, dehydroepiandrosterone - DHEAS, androstenedione, glucose, insulin, Sex Hormone Binding Globulin - SHBG) and hyperandrogenism (Free Androgenicity Index – FAI) – only in a subgroup of 28 subjects recruited only in the centre of Genova. They will be evaluated in comparison with Baseline (V1).

    Safety outcomes
    • Adverse events and side effects occurrence assessments.
    Outcomes secondari di efficacia
    • Valutazione dei parametri di controllo del ciclo: frequenza, durata, regolarità, volume del flusso (determinata dal soggetto stesso), sanguinamento non atteso. Verrà eseguito un confronto all'interno del gruppo a V2 e V3 rispetto al Basale (V1).
    • Global Acne Grading System (GAGS). Verrà eseguito un confronto all'interno del gruppo a V2 e V3 rispetto al Basale (V1).
    • Profile of Mood State (POMS). Verrà eseguito un confronto all'interno del gruppo a V2 e V3 rispetto al Basale (V1).
    • Indice della funzione sessuale femminile (Female Sexual Function Index - FSFI). Verrà eseguito un confronto all'interno del gruppo a V2 e V3 rispetto al Basale (V1).
    • Dismenorrea valutata tramite scala VAS. Verrà eseguito un confronto all'interno del gruppo a V2 e V3 rispetto alBasale (V1).
    • Compliance (aderenza al trattamento).
    Parametri metabolici e ormonali: parametri ematici lipidici e glicemici (colesterolo totale, lipoproteine ad alta densità – colesterolo HDL-C, Lipoproteine a bassa densita – Colesterolo LDL-C, trigliceridi, testosterone totale, deidroepiandrosterone - DHEAS, androstenedione, glucosio, insulina, globulina leganti gli ormoni sessuali - SHBG) e iperandrogenismo (indice degli androgeni liberi– FAI) – solo in un sottogruppo di 28 soggetti reclutati nel centro di Genova. Questi parametri Saranno valutati rispetto al Basale (V1).

    Outcomes di sicurezza
    • Valutazioni di eventi avversi e degli effetti collaterali
    E.5.2.1Timepoint(s) of evaluation of this end point
    LPLV
    LPLV
    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 Yes
    E.6.13.1Other scope of the trial description
    Cycle control evaluation, Evaluate safety and tolerability
    Valutazione del controllo del ciclo, Valutare la sicurezza e la tollerabilità
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    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 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
    LVLS
    LVLS
    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 months1
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days10
    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: 228
    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 No
    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 state228
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 228
    F.4.2.2In the whole clinical trial 228
    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)
    NA
    NA
    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 Decision2023-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-20
    P. End of Trial
    P.End of Trial StatusOngoing
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