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    Summary
    EudraCT Number:2012-000269-19
    Sponsor's Protocol Code Number:11E/FSH03
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-29
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-000269-19
    A.3Full title of the trial
    Prospective, open-label, uncontrolled clinical trial evaluating multiple controlled ovarian hyperstimulation cycles in oocyte donor, to assess the immunogenicity of FSH-IBSA
    Estudio prospectivo, abierto, no controlado que analiza varios ciclos de hiperestimulación ovárica controlada en donante de ovocitos, para evaluar la inmunogenicidad de FSH-IBSA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate if the medication taken for inducing the production of eggs, Follicle Stimulating Hormone (FSH), may induce any kind of immune reaction.
    A.4.1Sponsor's protocol code number11E/FSH03
    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, Institute Biochimique S.A.
    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, Institute Biochimique S.A.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIBSA, Institute Biochimique
    B.5.2Functional name of contact pointClinical Research Manager
    B.5.3 Address:
    B.5.3.1Street AddressVia del Piano
    B.5.3.2Town/ cityPambio Noranco
    B.5.3.3Post code6915
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41583601000
    B.5.5Fax number+41583601655
    B.5.6E-mailbarbara.cometti@ibsa.ch
    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 Fostimon Fostipur
    D.2.1.1.2Name of the Marketing Authorisation holderANGELINI Farmaceutica S.A
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameFostipur/FSH IBSA
    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 INNUrofollitropin
    D.3.9.1CAS number 97048-13-0
    D.3.9.2Current sponsor codeFSH
    D.3.9.3Other descriptive nameUROFOLLITROPIN
    D.3.9.4EV Substance CodeSUB05053MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Yes
    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
    Female infertility
    Infertilidad femenina
    E.1.1.1Medical condition in easily understood language
    Female infertility
    Infertilidad femenina
    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 10053370
    E.1.2Term Oocyte donation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy volunteers undergoing COH in an oocyte donation program.
    El proposito del estudio es evaluar la potencial inmunogenicidad de FSH-IBSA en voluntarias sanas siguiendo Ciclos de Hiperestimulación Ovárica en un programa de donación de oocitos.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Able and willing to sign the Subject Consent Form and adhere to the study visitation schedule;
    ->=18 and <35 years old;
    -Regular menstrual cycle (26 ? 35 days);
    -BMI between 18 and 30 kg/m2;
    -First gonadotrophin treatment (i.e naïve Subjects with regard to exposure to human derived or recombinant gonadotrophins);
    -basal FSH <10 IU/L and E2 <80 pg/ml (~290 pmol/l);
    -normal TSH levels;
    -Willing to perform at least two consecutive oocyte retrieval cycles (with a wash out period of two months).
    -Capacidad y disposición para firmar el formulario de consentimiento del paciente y cumplir con el horario de visitas de estudio;
    -> = 18 y <35 años de edad;
    -Regular el ciclo menstrual (26 ? 35 días);
    -IMC entre 18 y 30 kg/m2;
    -Primer tratamiento con gonadotropinas (es decir, sujetos naïve con respecto a la exposición a los derivados de las gonadotropinas humanas o recombinantes);
    -Basal FSH <10 UI / L y E2 <80 pg / ml (~ 290 pmol / l);
    - Niveles normales de TSH;
    -Dispuesto a realizar al menos dos ciclos consecutivos de recuperación de ovocitos (con un período de lavado de dos meses).
    E.4Principal exclusion criteria
    -Age < 18 and >= 35 years;
    -PCOS;
    -Endometriosis;
    -Subjects with evidences of autoimmune or rheumatic diseases;
    -Hypersensitivity to the active substance or to any of the excipients (lactose);
    -Abnormal bleeding of undetermined origin;
    -Subject found to be positive to anti-TSH antibodies (i.e. suffering from thyroidal diseases);
    -Uncontrolled adrenal dysfunction;
    -Neoplasia;
    -Severe impairment of renal and/or hepatic function;
    -Use of concomitant medications that might interfere with study evaluations (e.g. immunosuppressant, non-study hormonal medications, therapeutics proteins like insulin, growth hormone?).
    -Edad <18 y> = 35 años;
    -PCOS;
    -Endometriosis;
    -Sujetos que presentaban evidencias de enfermedades autoinmunes o reumáticas;
    -Hipersensibilidad al principio activo o a cualquiera de los excipientes (lactosa);
    -Sangrado anormal de origen indeterminado;
    -Sujeto con resultado positivo a anticuerpos anti-TSH (es decir, sufren enfermedades tiroidea);
    -Disfunción adrenal controlada;
    -Neoplasia;
    -Severo deterioro de la función renal y / o hepática;
    -El uso de medicaciones concomitantes que puedan interferir con las evaluaciones del estudio (por ejemplo, inmunosupresores, no estudio de medicamentos hormonales, proteínas terapéuticas como insulina, hormona de crecimiento?).
    E.5 End points
    E.5.1Primary end point(s)
    To test the production of anti-FSH antibodies (IgG, IgM, and IgA) using a sensitive screening assay.
    Probar la producción de anticuerpos anti-FSH (IgG, IgM e IgA) usando un ensayo de detección sensible.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A serum sample will be collected for anti-FSH antibodies detection at visit 2, 3, 4, 5, 6, 7
    Una muestra de serum re recogerá para la detección de anticuerpos anti-FSH en la visit 2, 3, 4, 5, 6, 7
    E.5.2Secondary end point(s)
    In case anti-FSH antibodies are detected:
    - To determine whether the antibodies detected are neutralising in a bioassay.
    - To determine whether the antibodies that are induced by the product cross-react with their endogenous counterpart or with other hormones that share the common alpha chain with FSH (LH, TSH).
    En caso de detección de anticuerpos anti-FSH:
    - Determinar cuando los anticuerpos son neutralizados en un bioensayo
    - Determinar si los anticuerpos son inducidos por el producto de una reacción cruzada con su homólogo endógeno o con otras hormonas que comparten la cadena alfa común con FSH (LH, TSH).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At visit 2, 3, 4, 5, 6, 7 if anti-FSH are detected
    En visita 2, 3, 4, 5, 6, 7 si anti-FSH es detectado
    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 No
    E.6.5Efficacy No
    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
    Immunogenicity
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Prospective
    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.8.3 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.8.5The 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 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
    Last subject out: November 2013
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    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: 32
    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 state32
    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)
    None
    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 Decision2012-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
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