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    Summary
    EudraCT Number:2010-023534-23
    Sponsor's Protocol Code Number:EMR200061-504
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-24
    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 number2010-023534-23
    A.3Full title of the trial
    A phase IIIB, multicentre, multinational, randomized, open-label trial to compare the efficacy and safety of ovarian stimulation with GONAL-f day 1 to day 5 followed by Pergoveris starting day 6 to Pergoveris starting day 1 in women between 36 and 40 years of age undergoing assisted reproductive technique (ART)- (PERSIST)
    Studio di fase IIIB multicentrico, multinazionale, randomizzato, in aperto, per confrontare l’efficacia e la sicurezza della stimolazione ovarica con GONAL f dal giorno 1 al giorno 5, seguita da Pergoveris a partire dal giorno 6, rispetto al solo Pergoverisa partire dal giorno 1, in donne di eta' compresa tra 36 e 40 anni sottoposte a tecnica di riproduzione assistita (ART=assisted reproductive technique)-(PERSIST)
    A.3.2Name or abbreviated title of the trial where available
    PERSIST study (PERgoveriS In Stratified Treatment) for ART
    PERSIST
    A.4.1Sponsor's protocol code numberEMR200061-504
    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 SponsorMERCK SERONO 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 supportMERCK SERONO SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCOMMUNICATION CENTER MERCK KGAA
    B.5.2Functional name of contact pointCOMMUNICATION CENTER
    B.5.3 Address:
    B.5.3.1Street AddressFRANKFURTER STRASSE 250
    B.5.3.2Town/ cityDARMASTADT
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+496451725200
    B.5.5Fax number+496151722000
    B.5.6E-mailservice@merck.de
    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 PERGOVERIS
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SERONO 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.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLUTROPIN ALFA
    D.3.9.1CAS number 152923-57-4
    D.3.9.2Current sponsor codeLUTROPIN ALFA
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeormone follicolostimolante e ormone luteinizzante
    D.IMP: 2
    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 GONAL F*SC 1PEN 300UI/0,5ML+5A
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SERONO 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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFollitropin alfa
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeormone follicolostimolante ricombinante umano
    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
    FERTILITY DISORDERS
    INFERTILITA'
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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
    The overall objective of this trial is to generate data on the ovarian stimulation profile obtained when Pergoveris is started either on stimulation day 1 or stimulation day 6 in ART patients between 36 and 40 years of age (both inclusive).
    Obiettivo generale di questo studio e' generare dati sul profilo della stimolazione ovarica ottenuto iniziando la terapia con Pergoveris il giorno 1 della stimolazione o il giorno 6 della stimolazione in pazienti sottoposte a tecnica di riproduzione assistita (ART) di eta' compresa tra 36 e 40 anni (entrambe incluse).
    E.2.2Secondary objectives of the trial
    To further investigate the efficacy and safety profile of Pergoveris in ART patients between 36 and 40 years of age.
    Investigare ulteriormente il profilo di efficacia e sicurezza di Pergoveris in pazienti sottoposte a tecnica di riproduzione assistita (ART) di eta' compresa tra 36 e 40 anni.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Female subject justifying an IVF/ET treatment,  Between her 36th and 40th birthday (both Pergoveris phase IIIB at the time of the randomisation visit,  Early follicular phase (day 2-4) serum level of basal FSH ≤ 12 IU/L measured in the centre’s local laboratory during the screening period (i.e. within 2 months prior to down regulation start),  Body mass index (BMI) < 30 kg/m2,  Regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length,  Presence of both ovaries,  Normal uterine cavity, which in the Investigator’s opinion is compatible with pregnancy,  Negative cervical PAP test within the last 6 months prior to randomisation,  At least one wash-out cycle (defined as ≥ 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting GnRH agonist therapy,  Willing and able to comply with the protocol for the duration of the trial,  Having given written informed consent, prior to any trial-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care,  Having a male partner with semen analysis within the past 6 months prior to randomisation considered adequate to proceed with regular insemination or ICSI according to the centre’s standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used.
     Soggetto di sesso femminile che giustifichi un trattamento IVF/ET,  Soggetto di eta' compresa tra 36 e 40 anni (entrambe incluse) alla data della visita di randomizzazione,  Livello sierico della fase follicolare precoce (giorno 2-4) del FSH basale  12 UI/L, misurato nel laboratorio locale del centro durante il periodo di screening (vale a dire entro 2 mesi dall’inizio della down regulation),  Indice di massa corporea (BMI) &lt; 30 kg/m2,  Regolare ciclo mestruale ovulatorio spontaneo di durata compresa tra 21 e 35 giorni,  Presenza di entrambe le ovaie,  Cavita' uterina normale che, secondo il giudizio dello sperimentatore, sia compatibile con la gravidanza,  PAP test cervicale negativo entro gli ultimi 6 mesi prima della randomizzazione,  Almeno un ciclo di wash-out (definito come  30 giorni dall’ultima dose del trattamento con clomifene citrato e con gonadotropina) dall’ultimo ciclo di ART e/o di trattamento con clomifene citrato o con gonadotropina prima dell’inizio della terapia con l’agonista del GnRH,  Volonta' e capacita' di rispettare il protocollo per l’intera durata dello studio,  Consegna del consenso informato scritto, prima di qualsiasi procedura correlata allo studio non inclusa nella normale assistenza sanitaria, nonche' comprensione da parte della paziente che il consenso potra' essere ritirato da lei in qualsiasi momento senza alcun pregiudizio per la sua futura assistenza medica,  Esecuzione di analisi dello sperma di un partner di sesso maschile entro i 6 mesi precedenti alla randomizzazione, da cui risulti adeguato alla procedura di regolare inseminazione o ICSI (Inseminazione intracitoplasmatica dello spermatozoo) secondo la prassi standard del centro. Se tali criteri non vengono rispettati, la paziente potro' avere accesso allo studio soltanto utilizzando sperma di un donatore.
    E.4Principal exclusion criteria
     Had ≥ 2 previous ART cycles with a poor response to gonadotrophin stimulation defined as ≤ 6 mature follicles and/or ≤ 4 oocytes collected in any previous IVF cycle or previous cycles with a hyper response defined as ≥ 25 oocytes retrieved,  Had ≥ 3 previous ART cycles,  Any medical condition, which in the judgment of the Investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Merck Serono's Medical Responsible,  Previous severe OHSS,  Patients with primary ovarian failure,  Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS,  Presence of endometriosis requiring treatment,  Uterine myoma requiring treatment,  Any contraindication to being pregnant and/or carrying a pregnancy to term,  Extra-uterine pregnancy within the last 3 months prior to screening,  History of 3 or more miscarriages (early or late miscarriages) due to any cause,  Tumours of the hypothalamus and pituitary gland,  History or presence of ovarian enlargement or cyst of unknown aetiology,  Ovarian, uterine or mammary cancer,  A clinically significant systemic disease,  Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner,  Abnormal gynaecological bleeding of undetermined origin,  Known allergy or hypersensitivity to human
     La paziente e' stata sottoposta a ≥ 2 precedenti cicli ART con risposta insoddisfacente alla stimolazione con gonadotropina, definita come  6 follicoli maturi e/o  4 oociti prelevati in qualsiasi ciclo IVF precedente o cicli precedenti con iper-risposta definita come recupero di  25 oociti,  La paziente e' stata sottoposta a ≥ 3 precedenti cicli ART,  Qualsiasi condizione medica che, nel giudizio dello sperimentatore, possa interferire con l’assorbimento, la distribuzione, il metabolismo o l’eliminazione del farmaco. In caso di dubbio, si raccomanda di discutere il caso del soggetto in questione con il responsabile sanitario di Merck Serono,  Precedente grave sindrome da iperstimolazione ovarica (OHSS),  Pazienti con insufficienza ovarica primaria,  Sindrome ovarica policistica (PCOS; criteri di Rotterdam) per ridurre il rischio di comparsa di OHSS,  Presenza di endometriosi che necessita di trattamento,  Mioma uterino che necessita di trattamento,  Qualsiasi controindicazione ad avviare e/o a portare a termine una gravidanza,  Gravidanza extra-uterina entro gli ultimi 3 mesi dallo screening,  3 o piu' aborti in anamnesi (precoci o tardivi) dovuti a qualsiasi causa,  Tumori dell’ipotalamo o della ghiandola pituitaria,  Anamnesi o presenza di ingrossamento delle ovaie o cisti di eziologia sconosciuta,  Cancro all’ovaio, all’utero o alla mammella,  Malattia sistemica clinicamente significativa,  Infezione nota da virus di immunodeficienza umana (HIV), virus dell’epatite B o C nel soggetto dello studio o nel suo partner,  Emorragia ginecologica anomala di origine indeterminata,  Allergia nota o ipersensibilita' ai preparati a base di gonadotropina umana,  ≥ 10 sigarette al giorno,  Qualsiasi abuso di sostanze attive o trascorsi di abuso di droghe, farmaci o alcol negli ultimi 5 anni precedenti la visita di screening,  Precedente inclusione nel presente studio o partecipazione simultanea a un altro studio clinico,  Gravidanza e allattamento,  Partecipazione a un altro studio clinico negli ultimi 30 giorni
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be measured by the total number of oocytes retrieved per subject following ovarian stimulation.
    L’endpoint di efficacia primaria sara' calcolato dal numero totale di oociti recuperati per ogni soggetto a seguito di stimolazione ovarica.
    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 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 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) Yes
    E.8.2.2Placebo No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    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
    ND
    ULTIMA VISITA ULTIMA PAZIENTE ARRUOLATA LAST VISIT LAST PATIENT
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months15
    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: 0
    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.1.3Elderly (>=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 Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 208
    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 Decision2011-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-26
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