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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2018-004400-19
    Sponsor's Protocol Code Number:1707-FIVI-084-MV
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-04-12
    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 number2018-004400-19
    A.3Full title of the trial
    Study of the effects of telomerase reactivation with Danazol on ovarian function. A Pilot Study.
    Estudio de los efectos de la reactivación de la telomerasa con Danazol en la función ovárica. Estudio piloto.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the effects of telomerase reactivation with Danazol on ovarian function. A Pilot Study.
    Estudio de los efectos de la reactivación de la telomerasa con Danazol en la función ovárica. Estudio piloto.
    A.3.2Name or abbreviated title of the trial where available
    Improve fertility in women with low ovarian reserve
    Mejorar la fertilidad en mujeres con baja reserva ovárica
    A.4.1Sponsor's protocol code number1707-FIVI-084-MV
    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 SponsorIVIRMA MADRID
    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 supportFINOX AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIVIRMA
    B.5.2Functional name of contact pointMaría Elisa Varela Sanz
    B.5.3 Address:
    B.5.3.1Street AddressAvenida del Talgo, 68
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28023
    B.5.3.4CountrySpain
    B.5.4Telephone number0034911802900
    B.5.5Fax number0034911802910
    B.5.6E-mailmariaelisa.varela@ivirma.com
    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 DANATROL
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDANAZOL
    D.3.9.1CAS number 17230-88-5
    D.3.9.3Other descriptive nameDANAZOL
    D.3.9.4EV Substance CodeSUB06897MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    low ovarian reserve
    Baja respuesta ovárica
    E.1.1.1Medical condition in easily understood language
    Premature ovarian aging
    Envejecimiento del ovario
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036602
    E.1.2Term Premature ovarian failure
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Define a pilot study to determine telomeric length distribution in granulosa cells to evaluate if telomerase reactivation via sexual steroids (DANAZOL), in patients with low ovarian reserve, is feasible.
    Estudio piloto para determinar la distribución de la longitud telomérica en las células de la granulosa para evaluar si la reactivación a través de esteroides sexuales (DANAZOL), en pacientes con baja reserva ovárica, es factible.
    E.2.2Secondary objectives of the trial
    -Describe telomere length and accumulation of short telomeres in blood.
    -Determine if there is a correlation between telomeric factors in blood and granulosa cells in order to find new biomarkers for early detection of premature low ovarian reserve.
    -Determination of the DNA damage inside the cell nucleus and the percentage of activation of proteins involved in senescence.
    -Study of the status of telomere protection by shelterins in blood and GC.
    -Study the beneficial effects of steroid treatment on fertilization parameters
    -Examination of the ovarian volume and reserve before and after treatment with sexual steroids and compared with normal ovarian reserve patients.
    -Analysis of the total number of oocytes retrieved (particularly MII oocytes) after induction of ovulation in all groups.
    -Analysis of the quality of embryos (morphology of embryos), the implantation rate and the clinical pregnancy rate .
    -Assessment and recording of adverse events
    -Describir longitud de los telómeros y acumulación de telómeros cortos en sangre.
    -Determinar si existe una correlación entre los factores teloméricos en las células de la sangre y la granulosa con el fin de encontrar nuevos biomarcadores para la detección temprana de baja reserva ovárica prematura.
    -Determinar el daño al ADN dentro del núcleo celular y el porcentaje de activación de proteínas involucradas en la senescencia.
    -Estudiar el estado de la protección de los telómeros en sangre y GC.
    -Estudiar los efectos beneficiosos del tratamiento con esteroides en los parámetros de fertilización.
    -Examinar volumen y reserva ovárica antes y después del tratamiento con esteroides sexuales y en comparación con pacientes normales con reserva ovárica.
    -Analizar el número total de ovocitos recuperados después de la inducción de la ovulación en todos los grupos.
    -Analizar calidad de los embriones, tasa de implantación y tasa de embarazo clínico.
    -Evaluar y registrar eventos adversos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Provide signed and dated informed consent form.
    -Willing to comply with all study procedures and be available for the duration of the study. This include the decision to use contraception methods different to sexual hormones, such as the use of condoms, during the treatment with Danazol.
    -female, aged 30 to 45 years old.
    -In good general health as evidenced by medical history or diagnosed with body mass index between 18 and 30Kg/m2.
    -Women with normal (AMH value must be equal or higher than 2ng/ml) or compromised ovarian reserve (defined as AMH <2ng/ml).
    -Not having had any steroid hormones for one month.
    -Proporcionar un formulario de consentimiento informado firmado y fechado.
    -Está dispuesto a cumplir con todos los procedimientos del estudio y estar disponible durante la duración del estudio. Esto incluye la decisión de usar métodos anticonceptivos diferentes a las hormonas sexuales, como el uso de condones, durante el tratamiento con Danazol.
    - Mujeres, de 30 a 45 años (ambas inclusive)
    -Buena salud general como lo demuestra la historia clínica o diagnosticado con un índice de masa corporal entre 18 y 30 Kg / m2.
    -Mujeres con reserva ovárica normal (el valor de AMH debe ser igual o superior a 2 ng / ml) o la reserva ovárica comprometida (definida como AMH <2 ng / ml).
    -No haber tomado hormonas esteroideas el mes previo.
     
    E.4Principal exclusion criteria
    -Pregnancy or lactation.
    -Taking other sexual hormones.
    -Women with diseases in heart, liver or kidney or tumors which depend on male sexual hormones or hormone-dependent tumour.
    -Women taking anticonvulsants, medicaments for diabetes, anticoagulants and anti-hypertension: Ciclosporin and tacrolimus and other steroids and statins.
    -Women suffering irregular genital bleeding or with thrombus or thromboembolic diseases.
    -Known allergic reactions to components of the study product (cornstarch and lactose).
    -Having received ovulation induction drugs within one month before the inclusion in the study.
    -Anything that would place the individual at increased risk or preclude the individual’s full compliance with or completion of the study.
    -Simultaneous participation in another clinical trial or previous participation in this study.
    -Participation in another clinical study 2 months before inclusion in the present study that could affect its objectives
    -Embarazo o lactancia.
    -Tomar otras hormonas sexuales.
    - Mujeres con enfermedades en el corazón, hígado o riñón o tumores que dependen de hormonas sexuales masculinas o tumores dependientes de hormonas.
    -Mujeres que toman anticonvulsivos, medicamentos para la diabetes, anticoagulantes y antihipertensores: ciclosporina y tacrolimus y otros esteroides y estatinas.
    -Mujeres con sangrado genital irregular o con trombo o enfermedades tromboembólicas.
    - Reacciones alérgicas conocidas a los componentes del producto del estudio (almidón de maíz y lactosa).
    -Haber recibido medicamentos de inducción a la ovulación dentro de un mes antes de la inclusión en el estudio.
    -Cualquier cosa que ponga a la persona en mayor riesgo o que impida su total cumplimiento o finalización del estudio.
    - Participación simultánea en otro ensayo clínico o participación previa en este estudio.
    -Participación en otro estudio clínico 2 meses antes de la inclusión en el presente estudio que podría afectar el cumplimiento de los objetivos
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in the percentage of dysfunctional telomeres in Granulosa Cells.
    Reducción en el porcentaje de telómeros disfuncionales en células de la granulosa
    E.5.1.1Timepoint(s) of evaluation of this end point
    After Eighth visit (36 h +/- 2h post induction) for women with low ovarian reserve and Fifth visit for woman with normal ovarian reserve
    Después de la visita octava ( 36 horas post inducción) para mujeres con baja reserva ovárica y después de la quinta visita para mujeres con reserva ovárica normal
    E.5.2Secondary end point(s)
    1-Accumulation of short telomeres,telomerase activity,DNA damage measurements, other telomeric factors,activation of factors.
    2-Ovarian reserve and volumen
    3- Oocytes collection
    4- Quality of the embryos obtained.
    5-Pregnancy results
    6- Safety assessment
    1-Acumulación de telómeros cortos, actividad de la telomerasa, mediciones de daños en el ADN, otros factores teloméricos, activación de factores.
    2- Reserva ovárica y volumen.
    3- Número de ovocitos .
    4- Calidad de los embriones obtenidos.
    5-Resultado de embarazo.
    6- Evaluación de la seguridad.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The evaluation will be done:
    1-Accumulation of short telomeres,telomerase activity,DNA damage measurements, other telomeric factors,activation of factors. After V5 and V10 for women with low ovarian reserve and V5 and V8 for woman with normal ovarian reserve.
    2-Ovarian reserve and volumen. V7 for women with low ovarian reserve and V4 for woman with normal ovarian reserve.
    3- Oocytes collection.V8 for women with low ovarian reserve and V5 for woman with normal ovarian reserve.
    4- Quality of the embryos obtained. V9 for women with low ovarian reserve and V6 for woman with normal ovarian reserve.
    5-Pregnancy results. V10 and V11 for women with low ovarian reserve and V7 and V8 for woman with normal ovarian reserve.
    6- Safety assessment, during all study.
    Tiempos de evaluación son:
    1-Acumulación de telómeros cortos, actividad de la telomerasa, mediciones de daños en el ADN, otros factores teloméricos, activación de factores. Después V5 y V10 mujeres con baja reserva ovárica y V5 y V8 para mujeres con reserva ovárica normal.
    2- Reserva ovárica y volumen. V7 mujeres con baja reserva ovárica y V4 para mujeres con reserva ovárica normal.
    3- Número de ovocitos. V8 mujeres con baja reserva ovárica y V5 para mujeres con reserva ovárica normal.
    4- Calidad de los embriones obtenidos. V9 mujeres con baja reserva ovárica y V6 para mujeres con reserva ovárica normal.
    5-Resultado de embarazo. V10 and V11 mujeres con baja reserva ovárica y V7 and V8 para mujeres con reserva ovárica normal.
    6- Evaluación de la seguridad. Durante todo el ensayo
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Estudio piloto con evaluador ciego
    Pilot study with blind evaluator
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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
    LVLS
    Última visita del último paciente
    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 months12
    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: 45
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    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 Decision2019-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-12-31
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