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    Summary
    EudraCT Number:2012-002215-26
    Sponsor's Protocol Code Number:M13-563
    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:2013-12-05
    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 number2012-002215-26
    A.3Full title of the trial
    A Double-Blind, Double-Dummy, Randomized, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg daily versus Intravaginal Micronized Progesterone Capsules 600 mg daily for Luteal Support in In-Vitro Fertilization
    Estudio multicéntrico, doble ciego, con doble simulación, aleatorizado, con dos grupos, para comparar la eficacia, seguridad y tolerabilidad de 30 mg diarios de didrogesterona oral frente a 600 mg diarios de progesterona micronizada intravaginal en cápsulas, como apoyo en la fase lútea de la fertilización in vitro (LOTUS I)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare if 30mg of oral Dydrogesterone is as good, tolerable and safe as 600mg of intravaginal capsules for luteal support in IVF pregnancies. This study will be conducted at several study sites and neither the patient or the doctor will know which of the two different treatments a patient will receive.
    Un estudio para comparar si 30 mg de didrogesterona oral es tan bueno, tolerable y seguro como 600 mg de cápsulas intravaginales para el apoyo en la fase lútea de embarazos de fecundación in vitro . Este estudio se llevará a cabo en varios centros del estudio, y ni el paciente ni el médico sabrán cual de los dos tratamientos diferentes recibirá el paciente.
    A.3.2Name or abbreviated title of the trial where available
    Lotus I
    A.4.1Sponsor's protocol code numberM13-563
    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 SponsorAbbott Laboratories GmbH
    B.1.3.4CountryGermany
    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 supportAbbott Laboratories GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles GmbH
    B.5.2Functional name of contact pointSimone Schicker
    B.5.3 Address:
    B.5.3.1Street AddressHugenottenallee 167
    B.5.3.2Town/ cityNeu-Isenburg
    B.5.3.3Post code63263
    B.5.3.4CountryGermany
    B.5.4Telephone number+496102 296 213
    B.5.5Fax number+496102296296
    B.5.6E-mailsimone.schicker@quintiles.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 Duphaston 10 mg comprimés pelliculés
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Products S.A.-N.V
    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 Tablet
    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 INNDYDROGESTERONE
    D.3.9.1CAS number 152-62-5
    D.3.9.4EV Substance CodeSUB06433MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 Utrogestan 200mg capsules
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires BESINS INTERNATIONAL
    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 Vaginal capsule, soft
    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 INNmicronised progesterone
    D.3.9.1CAS number 9002-68-0
    D.3.9.3Other descriptive namePROGESTERONE, MICRONISED
    D.3.9.4EV Substance CodeSUB45084
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboVaginal capsule, soft
    D.8.4Route of administration of the placeboVaginal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Female infertility
    Infertillidad femenina
    E.1.1.1Medical condition in easily understood language
    Female inability to conceive a child
    Incapacidad femenina para concebir un hijo
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10003540
    E.1.2Term Assisted fertilization
    E.1.2System Organ Class 100000004865
    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 is to demonstrate non-inferiority of oral dydrogesterone 10 mg TID versus micronized progesterone vaginal capsules 200 mg TID. The primary efficacy parameter is the presence of fetal heart beats at 12 weeks? gestation determined by transvaginal ultrasound.
    El objetivo principal es demostrar la no inferioridad de la dosis de 10 mg de didrogesterona suministrados por vía oral tres veces al día en comparación con cápsulas de 200 mg de progesterona micronizada intravaginal suministrados tres veces al día. El parámetro de eficacia principal es la presencia de latido fetal a las 12 semanas de gestación apreciado mediante ultrasonido transvaginal.
    E.2.2Secondary objectives of the trial
    The secondary objectives and parameters are a positive pregnancy test on Day 14 after embryo transfer, the incidence of live births and healthy newborns.
    The safety objective is to obtain safety and tolerability data by means of documentation of treatment emergent adverse events (TEAE) during the entire study period. In addition, data on vital signs, physical examination findings, and routine laboratory values will be obtained. Furthermore, signs and symptoms of threatened abortion, the rate of hypospadias and the rate of masculinization in female babies will be recorded. The time of delivery (pregnancy week) and the following parameters of the newborn will be obtained at delivery: gender, APGAR Score, weight, height, head circumference, abnormal findings of physical examination and any malformations.
    Los parámetros y objetivos secundarios son una prueba de embarazo positiva el día 14 después de haberse realizado la transferencia de embriones y la incidencia de nacidos vivos y recién nacidos sanos.
    El objetivo de seguridad es obtener datos sobre seguridad y tolerabilidad mediante la documentación de los acontecimientos adversos surgidos durante el tratamiento a lo largo de todo el período de estudio. Por otro lado, se obtendrán datos sobre las constantes vitales, los hallazgos realizados gracias a la exploración física y los valores rutinarios de laboratorio. Además, se registrarán los signos o síntomas en caso de amenaza de aborto, el índice de hipospadias y el índice de virilismo en bebés femeninos. La fecha del parto (semana de embarazo) y los siguientes parámetros del recién nacido se obtendrán en el parto: género, índice de Apgar, peso, altura, circunferencia de la cabeza, hallazgos inusuales durante la exploración física y cualquier malformación.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent;
    2. Premenopausal females, age > 18 years < 42 years
    3. Non-smokers. For females who were past smokers, they must have stopped tobacco usage for at least 3 months prior baseline visit
    4. Early follicular phase (Day 2-4) FSH (Follicle stimulating hormone) less than or equal to 15 IU/L and estradiol (E2)within normal limits
    5. LH (luteinizing hormone), PRL (prolactin), T (testosterone) and TSH (thyroid-stimulating hormone), within the normal limits for the clinical laboratory, or considered not clinically significant by the Investigator within 6 months prior to screening
    6. Documented history of infertility (e.g., unable to conceive for at least one year or for 6 months for women ? 38 years of age or bilateral tubal occlusion or absence)
    7. Normal transvaginal ultrasound at screening (or within 14 days of screening) without evidence of clinically significant abnormality consistent with finding adequate for ART with respect to uterus and adnexa (no hydrosalpinx or clinically relevant uterine fibroids)
    8. Negative pregnancy test on the day of pituitary down regulation (prior to administration of GnRH agonist or GnRH antagonist)
    9. Clinically indicated protocol for induction of IVF with a fresh embryo
    10. Single or dual embryo transfer
    11. BMI ? 18 and ? 30 kg/m2
    1. Firma del consentimiento informado.
    2. Mujeres premenopáusicas con edades comprendidas entre los 18 y los 42 años.
    3. No fumadoras. Aquellas mujeres que hayan sido fumadoras anteriormente deben haber dejado de fumar al menos 3 meses antes de la visita inicial.
    4. En la primera fase folicular (de los días 2 a 4) los niveles de hormona foliculoestimulante (FSH) deben ser menores o iguales a 15 UI/l y los niveles de estradiol (E2) deben estar dentro de los límites normales.
    5. Los niveles de hormona luteinizante (luteinizing hormone, LH), prolactina (PRL), testosterona (T) y tirotropina (thyroid-stimulating hormone, TSH) durante los 6 meses anteriores a la selección deben estar dentro de los límites que el laboratorio clínico considere normales o que el investigador no considere clínicamente importantes.
    6. Historial de infertilidad documentado (por ejemplo, casos de mujeres que no han podido concebir en el último año, o en los últimos 6 meses para mujeres de 38 años o más, o de mujeres con oclusión tubaria bilateral o ausencia de trompas).
    7. Ultrasonido transvaginal normal en el momento de la selección (o dentro de los 14 días antes de la selección) sin que exista ninguna evidencia de anomalías clínicas importantes consistentes con hallazgo suficiente para someterse a la tecnología de reproducción asistida con respecto al útero u otros órganos anexos (ausencia de hidrosalpinges o de miomas uterinos clínicamente relevantes).
    8. Prueba de embarazo negativa el día de la regulación descendente de la pituitaria (con anterioridad al suministro del fármaco agonista de GnRH y el antagonista de GnRH).
    9. Protocolo clínico indicado para la inducción de la FIV con un embrión fresco.
    10. Transferencia única o dual de embriones.
    11. IMC mayor o igual a 18 y menor o igual a 30 kg/m2.
    E.4Principal exclusion criteria
    1. Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurologic/psychiatric, allergy, recent major surgery (< 3 months), or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which could limit participation in or completion of the study;
    2. Acute urogenital disease
    3. Known allergic reactions to progesterone products
    4. Known allergic reactions to peanuts and peanut oil
    5. Intake of experimental drug or participation in any other clinical trial within 30 days prior to study start
    6. Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subjects to participate in or to complete the study
    7. Current or recent substance abuse, including alcohol and tobacco (Note: Patients who stopped tobacco usage at least 3 months prior to screening visit would be allowed)
    8. History of chemotherapy or radiotherapy
    9. Patients with more than 3 unsuccessful IVF attempts
    10. Contraindication for pregnancy
    11. Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests
    12. History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages
    1. Prueba de existencia de afecciones cardiovasculares, respiratorias, genitourinarias, gastrointestinales/hepáticas, hematológicas/inmunológicas, que afecten a la cabeza, oídos, ojos, nariz o garganta, afecciones dermatológicas o del tejido conectivo, musculoesqueléticas, metabólicas o nutricionales, endocrinas, neurológicas o psiquiátricas, alergias o cirugía mayor reciente (menos de 3 meses), así como otras enfermedades relevantes que se encuentren incluidas en la historia clínica, que se hallen durante la exploración física o en las evaluaciones de laboratorio que puedan limitar la participación de la paciente o evitar que esta complete el estudio.
    2. Enfermedad grave genitourinaria.
    3. Reacciones alérgicas conocidas a productos con progesterona.
    4. Reacciones alérgicas conocidas a cacahuetes o al aceite de cacahuete.
    5. Que haya ingerido algún medicamento experimental o participado en algún otro estudio clínico 30 días antes del inicio del estudio.
    6. Discapacidad mental o cualquier otro problema de salud, según la opinión del investigador, que impida la participación del sujeto o evitar que esta complete el estudio.
    7. Cualquier caso reciente de abuso de sustancias, incluyendo el tabaco y el alcohol (Nota: Se permitirá la participación de pacientes que hayan dejado de fumar al menos tres meses antes de la visita de selección).
    8. Pacientes que se hayan sometido a quimioterapia o radioterapia.
    9. Pacientes que se hayan sometido a la FIV más de 3 veces sin éxito.
    10. Pacientes a las que se haya contraindicado el embarazo.
    11. Rechazo o incapacidad de cumplir los requisitos establecidos por el protocolo del estudio debido a cualquier razón, incluyéndose incompatibilidad con los horarios de las visitas a la clínica o con las pruebas de laboratorio.
    12. Pacientes con historia de aborto recurrente, definido como 3 o más abortos espontáneos.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter is the pregnancy rate defined as the presence of fetal heart beats at 12 weeks? gestation determined by transvaginal ultrasound.
    El parámetro de eficacia principal es el embarazo definido por la presencia de latido fetal a las 12 semanas de gestación apreciado mediante ultrasonido transvaginal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks? gestation
    12 semanas de gestación
    E.5.2Secondary end point(s)
    The secondary parameters are a positive pregnancy test on Day 14 after embryo transfer, the incidence of live births and healthy newborns.
    Further secondary parameters are gender and APGAR score as well as the height, weight and head circumference of the newborn (s).
    In addition, a physical examination of the newborn will be performed and any malformations will be recorded.
    Los parámetros y objetivos secundarios son una prueba de embarazo positiva el día 14 después de haberse realizado la transferencia de embriones y la incidencia de nacidos vivos y recién nacidos sanos.
    Otros parámetros secundarios son el sexo y el índice de Apgar, así como la altura, el peso y el perímetro cefálico del recién nacido (s).
    Además, se realizará un exploración físico del recién nacido y se grabará cualquier malformación.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 14 after embryo transfer and birth
    Día 14 después de la transferencia de embriones y el nacimiento
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 EEA16
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    India
    Israel
    Russian Federation
    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
    End of Study is defined as Last Subject Last Visit
    Fin del estudio esta definido para la última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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.1.1.1In 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: 1066
    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 state590
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 705
    F.4.2.2In the whole clinical trial 1066
    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 Decision2014-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-06
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