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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-002823-34
    Sponsor's Protocol Code Number:27818
    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:2007-10-29
    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 number2007-002823-34
    A.3Full title of the trial
    A phase II, multicentre, randomised, assessor.blinded, active-comparator, parallel-group dose finding trial to evaluate AS900672-Enriched versus follitropin alfa (GONAL-f) in oligo-anovulatory infertile women undergoing ovulation induction (OI)

    Estudio multicéntrico en Fase II, randomizado, con evaluador ciego, con comparador activo, con grupos en paralelo, de búsqueda de dosis para evaluar AS900672-enriquecida frente a folitropina alfa (GONAL-f®) en mujeres infértiles oligoanovuladoras sometidas a inducción de la ovulación (OI)
    A.3.2Name or abbreviated title of the trial where available
    AS900672-Enriquecida Fase II en OI
    A.4.1Sponsor's protocol code number27818
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Serono SA International
    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 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 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 nameAS900672-Enriched
    D.3.4Pharmaceutical form Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 typerecombinant biological
    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 GONAL-f
    D.2.1.1.2Name of the Marketing Authorisation holderSerono Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 typerecombinant biological
    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
    Mujeres infértiles y oligoanovuladoras que son candidatas para la inducción de la ovulación (OI).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10033312
    E.1.2Term Ovulation induction
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective:
    Identify the optimal effective dose of AS900672-
    Enriched to induce ovulation in oligo-anovulatory infertile women.

    El objetivo principal de este estudio clínico es identificar la dosis efectiva óptima de AS900672 enriquecida para inducir la ovulación en mujeres infértiles y oligoanovuladoras
    E.2.2Secondary objectives of the trial
    Secondary objectives:

    Demonstrate that the clinical pregnancy rate of the optimal effective dose of
    AS900672-Enriched is within the range of the clinical pregnancy rate obtained with
    follitropin alfa daily dosing, and

    Evaluate safety and tolerability of AS900672-Enriched in oligo-anovulatory infertile
    women undergoing OI.

    Other objectives:
    Further evaluate the pharmacokinetics and pharmacodynamics of AS900672-Enriched.

    Objectivos secundarios

    • Demostrar que la tasa de embarazo clínico de la dosis efectiva óptima de AS900672 enriquecida está dentro de los límites de la tasa de embarazo clínico obtenida con la administración diaria de folitropina alfa.
    • Evaluar la seguridad y la tolerabilidad de AS900672 enriquecida en mujeres infértiles y oligoanovuladoras sometidas a inducción de la ovulación (OI).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Oligoanovulación, definida por una duración del periodo menstrual de 35 días a seis meses.
    2.Menstruación espontánea o una respuesta positiva a la abstinencia a progestágenos o al citrato de clomifeno en los seis meses anteriores.
    3.Edad entre 18 y 36 años, inclusive, en el momento de la firma del consentimiento informado.
    4.Índice de masa corporal de 18 a 30 kg/m2, inclusive.
    5.Los valores séricos de TSH, DHEA-S, prolactina y FSH en la fase folicular temprana deben estar dentro de los límites de la normalidad para el laboratorio central.

    Excepción: Las pacientes con una concentración baja de TSH que reciben terapia de reemplazo pueden ser incluidas a discreción del investigador si los resultados del laboratorio local (T4) demuestran una función tiroidea satisfactoria.
    6.Glucosa en ayunas e insulina en ayunas dentro de los límites de la normalidad para el laboratorio central.
    7.Cavidad uterina normal y presencia de por lo menos un ovario con trompa de Falopio permeable ipsilateral, determinada mediante HSG, laparoscopia-histeroscopia o ambas en los tres años anteriores.
    8.Estudio citológico vaginal sin anomalías clínicamente significativas en los seis meses anteriores a la asignación aleatoria.
    9.Prueba de embarazo negativa antes de la asignación aleatoria.
    10.Pareja con análisis de semen que demuestre la idoneidad para la inseminación mediante relaciones sexuales, inseminación intrauterina o ambas en los seis meses anteriores a la asignación aleatoria.

    Nota: No se permite el uso de esperma de donante.
    11.Disposición y capacidad para cumplir el protocolo.
    12.Firma voluntaria del consentimiento informado escrito, antes de cualquier procedimiento relacionado con el estudio que no haya formado parte de la atención médica normal, con el entendimiento de que la paciente puede retirar su consentimiento en cualquier momento sin perjuicio de su atención médica en el futuro, incluida la disposición a proporcionar información de seguimiento a los niños nacidos como parte de este estudio.
    E.4Principal exclusion criteria
    1.Antecedente de ≥ 2 ciclos consecutivos de estimulación gonadotrófica que no produjeron ovulación.
    2.Antecedente de ciclos de estimulación con citrato de clomifeno, ninguno de los cuales produjo ovulación.
    3.Respuestas excesivas anteriores a la estimulación gonadotrófica, definidas como el desarrollo de ≥ 4 folículos maduros (> 17 mm) o cancelación del ciclo de inducción de la ovulación debido a respuesta folicular excesiva después del tratamiento con FSH a una dosis de ≤ 75 UI/día.
    4.Síndrome de hiperestimulación ovárica (SHEO) grave previo.
    5.Administración de cualquier gonadotrofina, citrato de clomifeno, análogo de la GnRH, tamoxifeno o inhibidores de la aromatasa en los 30 días anteriores.
    6.Perforación ovárica laparoscópica, cauterización ovárica o ambas en los seis meses anteriores.
    7.Cualquier contraindicación al embarazo o a llevar el embarazo a término.
    8.Un embarazo clínico que haya terminado en aborto espontáneo en los tres meses anteriores.
    9.Antecedente de ≥ 3 abortos espontáneos consecutivos, debidos a cualquier causa.
    10.Hemorragia ginecológica anormal de origen indeterminado.
    11.Resultados anormales, clínicamente significativos, de la cavidad uterina, evidentes en una ecografía pélvica transvaginal realizada durante la evaluación previa.
    12.Presencia de endometriosis de grado III o IV.
    13.Quiste de ovario con un diámetro medio de > 25 mm y E2 > 80 pg/ml en el día de la asignación aleatoria.
    14.Antecedentes de cáncer de ovario, útero o mama.
    15.Hiperplasia suprarrenal congénita, bloqueo enzimático parcial o completo.
    16.Uso de metformina en relación con la infertilidad en los dos meses anteriores.
    17.Alergia o hipersensibilidad conocida a preparaciones de gonadotrofina humana o a compuestos que sean estructuralmente similares a cualquiera de los otros medicamentos administrados durante el ensayo clínico.
    18.Cualquier contraindicación al tratamiento con gonadotrofina.
    19.Infección comprobada por el virus de la inmunodeficiencia humana (VIH), antígeno de superficie de la hepatitis B (HBsAg) positivo, o anticuerpos contra la hepatitis C en la paciente del estudio o en su pareja.
    20.Cualquier abuso activo de drogas o antecedentes de abuso de drogas, medicamentos o alcohol en los cinco años anteriores.
    21.Consumo de tabaco de más de cinco cigarrillos al día.
    22.Testosterona sérica (laboratorio central) que sugiera un tumor de ovario.
    23.Aleatorización previa en este estudio o participación en otro ensayo clínico en los tres meses anteriores.
    24.Cualquier enfermedad que, a juicio del Investigador, pueda interferir con la absorción, distribución, metabolismo o excreción de r-hFSH.
    25.Enfermedad sistémica clínicamente significativa, incluso diabetes mellitus, o resultado de laboratorio anormal clínicamente significativo.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is the ovulation rate.

    El criterio principal de valoración de este estudio es la tasa de ovulación.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Information not present in EudraCT
    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.8.2.3.1Comparator description
    GONAL-f
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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
    End of trial defined as final clinical database lock
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 420
    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 for subject. Baby follow up
    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 Decision2008-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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