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    Summary
    EudraCT Number:2007-006595-11
    Sponsor's Protocol Code Number:07EU/Prg06
    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:2008-10-01
    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 number2007-006595-11
    A.3Full title of the trial
    Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) versus Vaginal Progesterone Gel (Crinone) for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF).
    Efficacia e tollerabilita` del Progesterone (IBSA) paragonato ad un Progesterone in gel per applicazione vaginale (Crinone) nel supporto della fase luteale in pazienti sottoposte a cicli di fertilizzazione in vitro (IVF)
    A.4.1Sponsor's protocol code number07EU/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
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 CRINONE 8
    D.2.1.1.2Name of the Marketing Authorisation holderIND.FARMACEUTICA 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 Vaginal gel
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number90
    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.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 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 nameProgesterone-IBSA
    D.3.2Product code NA
    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 INNProgesterone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Luteal phase support in patients undergoing Assisted Reproductive Technology (IVF).
    Supporto della fase luteale in pazienti sottoposte a trattamenti di procreazione medicalmente assistita (IVF.
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10021926
    E.1.2Term Infertility
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of a new progesterone formulation to be used for luteal support in IVF (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg, versus Crinone administered intravaginally at 90 mg daily.
    valutare l'efficacia della nuova formulazione di Progesterone (IBSA) somministrata tramite iniezione sottocutanea ad un dosaggio giornaliero di 25 mg, in confronto al Crinone somministrato per via vaginale al dosaggio di 90 mg al giorno nel supporto della fase luteale in pazienti sottoposte a cicli IVF.
    E.2.2Secondary objectives of the trial
    to evaluate the tolerability of the product
    valutare la tollerabilita' del prodotto
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18- 42 (upon starting COH); - BMI <30 kg/m2; - <3 prior ART cycles (IVF, ICSI and related procedures); - Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL; - Normal uterine cavity as per recent hysterosalpingogram, sonohystogram or hysteroscopic exam (i.e. no polyp or protruding sub-mucosal fibroid); - At least 3 retrieved oocytes; - Patient has given written informed consent.
    - Eta` compresa tra 18 42 anni (al momento dell inizio della stimolazione); - BMI &lt;30 kg/m2; - &lt;3 cicli ART precedenti allo studio (IVF, ICSI e procedure simili); - Livelli basali (al giorno 2-3 del ciclo) di FSH &#8804;15 IU/L e di E2 &lt;80 pg/mL; - Cavita` uterine normale dimostrata tramite isterosalpingografia, sonoisterografia o esame isteroscopico (i.e. assenza di polipi o fibroma sotto-mucoso sporgente); - Recupero di almeno 3 ovociti; - La paziente ha firmato il formulario di consenso informato.
    E.4Principal exclusion criteria
    Intramural uterine fibroids that distort the uterine cavity or polyps > 1 cm; Stage III or IV endometriosis (endometriomas); Hydrosalpinx; History of past poor response to COH resulting in cancelling ART; Use of thawed/donated oocytes; Use of thawed/donated embryos; Patients affected by pathologies associated with any contraindication of being pregnant; Hypersensitivity to study medication; Uncontrolled adrenal or thyroid dysfunction; Undiagnosed vaginal bleeding; History of arterial disease; Patients with hepatic impairment; Neoplasias (current) or history of neoplasia that may be responsive to progesterone; High grade cervical dysplasia; History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages wherein pregnancy developed to a minimum of a gestational sac on TVUS; Participation in a concurrent clinical trial or another trial within the past 2 months; Use of concomitant medications that might interfere with the study evaluation; Pre-implantation genetic diagnosis/screening. - Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders;
    - Presenza di un fibroma intramurale uterino deformante la cavita` uterina o presenza di polipi &gt;1 cm; - Endometriosi di stadio III o IV (presenza di endometriomi); - Idrosalpinge; - Precedenti esperienze di cancellazione del ciclo di stimolazione a causa di una debole risposta al trattamento; - Utilizzo di ovociti scongelati o donati; - Utilizzo di embrioni scongelati o donati; - Presenza di patologie controindicanti una gravidanza - Ipersensitivita` al farmaco in studio; - Disfunzione surrenale o tiroidea non controllata; - Sanguinamento vaginale anormale o di origine indeterminata; - Patologie arteriose pregresse; - Severa menomazione delle funzioni epatiche; - Neoplasia attuale o pregressa potenzialmente ricettiva al progesterone; - Grave displasia cervicale; - Soggetto ad aborto abituale ripetuto definito come interruzione spontanea di 3 o piu` gravidanze con presenza di sacco gestazionale dimostrata ecograficamente; - Attuale partecipazione in uno studio clinico o partecipazione in un altro studio clinico negli ultimi 2 mesi; - Utilizzo di medicamenti concomitanti che potrebbero interferire con la valutazione dello studio; - Diagnosi/screening genetico pre-impianto; - Tromboflebite attiva o problemi tromboembolici, o storia di pregresse tromboflebiti o pregressi fenomeni tromboembolici ormone- associati;
    E.5 End points
    E.5.1Primary end point(s)
    Ongoing pregnancy rate at the end of the study (10 weeks of luteal support).
    - Percentuale di gravidanze evolutive alla fine dello studio (alla 10a settimana di supporto luteale).
    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 concerned6
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    conclusione: ultima visita ultimo soggetto.
    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 months12
    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 months12
    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 Yes
    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 state260
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 572
    F.4.2.2In the whole clinical trial 672
    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 Decision2008-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-31
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