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    Summary
    EudraCT Number:2015-005762-28
    Sponsor's Protocol Code Number:1512-VLC-066-EB
    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:2016-02-24
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-005762-28
    A.3Full title of the trial
    Analysis of follicular steroid synthesis during controlled ovarian stimulation with recombinant FSH vs HMG in GnRH antagonist cycles
    Análisis de la esteroidogénesis folicular en estimulación ovárica controlada con FSH recombinante vs HMG en ciclos con antagonistas de la GnRH

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparative analysis of hormone variations during ovarian stimulation with two different stimulation drugs
    Análisis comparativo de los cambios hormonales durante la estimulación ovárica con dos medicaciones distintas
    A.3.2Name or abbreviated title of the trial where available
    Follicular steroid genesis in controlled ovarian stimulation
    Esteroidogénesis folicular en estimulación ovárica controlada
    A.4.1Sponsor's protocol code number1512-VLC-066-EB
    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 SponsorIVI Valencia
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRoche Diagnostics International Ltd
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportIVI Valencia
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIVI Valencia
    B.5.2Functional name of contact pointErnesto Bosch
    B.5.3 Address:
    B.5.3.1Street AddressPlaza Policia Local, 3
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46015
    B.5.3.4CountrySpain
    B.5.6E-mailErnesto.Bosch@ivi.es
    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 GONAL-f
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono Europe Ltd
    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.3.4Pharmaceutical form Powder and solution 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 INNFOLLITROPIN ALFA
    D.3.9.1CAS number 56832-30-5
    D.3.9.3Other descriptive nameFOLLITROPIN ALFA
    D.3.9.4EV Substance CodeSUB12426MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number225
    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 No
    D.IMP: 2
    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 MENOPUR
    D.2.1.1.2Name of the Marketing Authorisation holderFERRING, S.A.U
    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.3.4Pharmaceutical form Powder and solution 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 INNHUMAN MENOPAUSAL GONADOTROPHINS
    D.3.9.1CAS number 61489-71-2
    D.3.9.3Other descriptive nameHUMAN MENOPAUSAL GONADOTROPHINS
    D.3.9.4EV Substance CodeSUB22171
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number225
    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 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
    Women undergoing ovarian stimulation for oocyte donation
    Mujeres en tratamiento de estimulación ovárica para donación de ovocitos
    E.1.1.1Medical condition in easily understood language
    Oocyte donors
    Donantes de ovocitos
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    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
    To compare serum concentrations of the different hormones involved in follicular steroid genesis during a cycle of controlled ovarian stimulation with recombinant FSH or HMG
    Comparar las concentraciones en suero de las diferentes hormonas implicadas en la esteroidogénesis folicular durante un ciclo de EOC entre FSHr y hpHMG
    E.2.2Secondary objectives of the trial
    To define the area under the curve for each of the follicular steroids across the COS cycle with rFSH and HMG
    To adjust follicular steroid levels to ovarian response
    To identify the metabolic routes for follicular steroid genesis according to the gonadotropohin used.
    • Definir el área bajo la curva para cada uno de los esteroides foliculares a lo largo de la EOC en ciclos estimulados con FSHr y con hpHMG.
    • Ajustar los niveles de esteroides foliculares determinados a la respuesta folicular observada
    • Identificar las vías metabólicas de la esteroidogénesis folicular en función del tipo de gonadotrofina empleada para la EOC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    . Women aged 18-35
    . Good physical and psychological condition
    . Normal menstrual cycle (25-35 days)
    . Normal ovarian reserve defined by serum ANH010-30 pMol/L
    . All other criteria to fulfill by oocyte donors
    • Mujeres de 18 a 35 años
    • Buen estado de salud psico-física
    • Ciclo menstrual normal (duración de 25 a 35 días)
    • Reserva ovárica normal, determinada por una AMH=10-30 pMol/L)
    • IMC < 25.0
    • Resto de criterios a cumplir por las donantes de ovocitos
    E.4Principal exclusion criteria
    . Kidney failure
    . PCO
    . Any systemic or metabolic disfunction that counter indicates the use of gonadotrophins
    . Any other reason that involves exclusion of the oocyte donation program
    • Insuficiencia renal
    • Ovario poliquístico
    • Cualquier trastorno sistémico o metabólico que contraindique el uso de gonadotrofinas.
    • Cualquier motivo que implique exclusión del programa de donación de ovocitos
    E.5 End points
    E.5.1Primary end point(s)
    Area under the curve during ovarian stimulation of E2, P4, FSH, LH, 17-OH-P, Pregnenolone, Androstenodione, Dehidroepiandrostenodione, Testosterone and Estrone
    Area bajo la curca durante la estimulación ovárica para E2, P4, FSH, LH, 17-OH-P, Pregnenolona, Androstenodiona, Dehidroepiandrostenodiona, Testosterona y Estrona
    E.5.1.1Timepoint(s) of evaluation of this end point
    Stimulation days 1, 4, 6, 8 and triggering
    Días de estimulación 1, 4, 6, 8 y último día
    E.5.2Secondary end point(s)
    None
    Ninguno
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    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 Yes
    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
    Biological response
    Respuesta biológica
    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 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 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 day of ovarian stimulation of the last patient randomized
    El último día de estimulación ovárica de la última paciente randomizada
    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 months9
    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: 110
    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 state110
    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
    Ninguno
    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 Decision2016-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-29
    P. End of Trial
    P.End of Trial StatusCompleted
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