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    The EU Clinical Trials Register currently displays   41231   clinical trials with a EudraCT protocol, of which   6758   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-004100-35
    Sponsor's Protocol Code Number:FSJD-PIOSPIMET-2012
    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
    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 number2012-004100-35
    A.3Full title of the trial
    A prospective, open-label, randomized, two-armed clinical trial to evaluate the efficacy and safety of a combination of ethinyl-estradiol and levonorgestrel versus a low-dose combination of pioglitazone + spironolactone + metformin in adolescents with ovarian hyperandrogenism and hyperinsulinemia: Effects on ovulatory function, parameters of chronic inflammation, on cardiovascular risk factors and on risk factors for the development of type 2 diabetes
    Ensayo clínico prospectivo, abierto, aleatorizado, con dos grupos de pacientes para evaluar la eficacia y la seguridad de la combinación de Etinil-estradiol y levonorgestrel versus la combinación de pioglitazona, espironolactona y metformina a dosis bajas en adolescentes con hiperandrogenismo ovárico e hiperinsulinismo: efectos sobre la función ovulatoria, parámetros de inflamación crónica, marcadores de riesgo cardiovascular y de desarrollo de diabetes tipo 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    clinical trial in adolescents with ovarian hyperandrogenism and hyperinsulinemia: Effects on ovulatory function, parameters of chronic inflammation, on cardiovascular risk factors and on risk factors for the development of type 2 diabetes
    Ensayo clínico en adolescentes con hiperandrogenismo ovárico e hiperinsulinismo: efectos sobre la función ovulatoria, parámetros de inflamación crónica, marcadores de riesgo cardiovascular y de desarrollo de diabetes tipo 2.
    A.4.1Sponsor's protocol code numberFSJD-PIOSPIMET-2012
    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 SponsorFundació per la Recerca i la Docència Sant Joan de Déu
    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 supportMinisterio de Sanidad y Política Social
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSERMES-CRO
    B.5.2Functional name of contact pointDña. Lena M. Erbiti León
    B.5.3 Address:
    B.5.3.1Street AddressC/ Rufino González 14 2º Dcha
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number3491375 69 30
    B.5.5Fax number3491754 27 21
    B.5.6E-maillena_erbiti@sermes.org
    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 Metformina Sandoz
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz Farmacéutica, 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 nameMetformina
    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 INNMetformina
    D.3.9.3Other descriptive nameMetformina
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    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 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 Aldactone Pfizer
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER, S.L.
    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 nameespironolactona
    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 INNEspironolactona
    D.3.9.3Other descriptive nameEspironolactona
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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: 3
    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 Aldactone Pfizer
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER, S.L.
    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 nameespironolactona
    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 INNEspironolactona
    D.3.9.3Other descriptive nameEspironolactona
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 4
    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 Actos®
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Takeda
    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 nameClorhidrato de pioglitazona
    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 INNPIOGLITAZONE
    D.3.9.3Other descriptive nameclorhidrato de pioglitazona
    D.3.9.4EV Substance CodeSUB09857MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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: 5
    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 LOETTE DIARIO
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Farma, 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 nameLOETTE DIARIO
    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 INNlevonorgestrel
    D.3.9.1CAS number 797-63-7
    D.3.9.3Other descriptive nameLEVONORGESTREL
    D.3.9.4EV Substance CodeSUB08483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNetinilestradiol
    D.3.9.3Other descriptive nameetinilestradiol.
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ovarian hyperandrogenism
    hiperandrogenismo ovárico
    E.1.1.1Medical condition in easily understood language
    Polycystic Ovary Syndrome
    Síndrome del ovario poliquístico
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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
    1)To study the efficacy and tolerability of low-dose combination treatment with pioglitazone, spironolactone and metformin (PioSpiMet) on endocrine-metabolic, vascular and inflammatory parameters, body composition (visceral and intrahepatic fat) and ovulatory function in adolescents with ovarian hyperandrogenism and hyperinsulinemia and without pregnancy risk;
    2)To compare the effects of the treatment with PioSpiMet to the effects of the treatment with an oral contraceptive containing ethinyl-estradiol and levonorgestrel, on endocrine-metabolic, vascular and inflammatory parameters and body composition in two groups of adolescents of a similar age and baseline characteristics;
    3)To compare the evolutionary changes of the endocrine-metabolic and vascular parameters and body composition in the 6 months after stopping treatment; to compare the effects of the two treatments on ovulatory function after stopping treatment. To assign the best treatment to the patients.
    1)Estudiar la eficacia y tolerancia del tratamto combinado con pioglitazona, espironolactona y metformina (PioSpiMet) a dosis bajas sobre parámetros endocrinometabólicos, vasculares,inflamatorios composición corporal (grasa visceral e intrahepática)función ovulatoria en adolescentes con hiperandrogenismo ováricoehiperinsulinismo sin riesgo de embarazo 2)Comparar los efectos del tratamto con PioSpiMet sobre los parámet. endocrino-metabólicos, vasculares, inflamatorios y de composición corporal con los obtenidos en un grupo de adolescentes con edad y características basales similares tratadas con aticonceptivo oral conteniendo etinil-estradiol + levonorgestre 3)Comparar los cambios evolutivos de los parámet. endocrinometabólicos, vasculares,de composición corporal en los 6 meses posteriores a la suspensión del tratamnto;comparar los efectos de las dos terapéuticas sobre la función ovulatoria posterior a la finalización del tratamiento.Adjudicación del mejor tratamiento a las pacientes.
    E.2.2Secondary objectives of the trial
    not applicable
    no aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age equal to or more than 14 years and less than 18 years
    2) Menarche at least two years before
    3) Body mass index (BMI) below 97th percentile and above the 10th percentile according to age (3)
    4) Clinical hyperandrogenism:
    a)Hirsutism and/or acne
    b)Oligomenorrhea or amenorrhea
    5) Biochemical hyperandrogenism:
    a)Total testosterone > 60 ng/dL and/or free androgen index > 5 (1.2)
    b)Androstenedione > 160 ng/dL
    6) Hyperinsulinemia:
    a)Basal insulin > 15 ?U/mL
    b)Glucose/insulin ratio < 7 or insulin peak in the oral glucose load > 100 ?UmL (1.2)
    1) Edad igual o superior a los 14 años e inferior a los 18 años
    2) Menarquia como mínimo 2 años antes
    3) Índice de masa corporal (IMC) inferior al percentil 97 y superior al percentil 10 para la edad (3)
    4) Hiperandrogenismo clínico:
    a)Hirsutismo y/o acné
    b)Oligomenorrea o amenorrea
    5) Hiperandrogenimmo bioquímico:
    a)Testosterona total > 60ng/dL y/o índice de andrógenos libres > 5 (1,2)
    b)Androstendiona > 160 ng/dL
    6) Hiperinsulinismo:
    a)Insulina basal > 15 mU/mL
    b)Cociente glucosa/insulina < 7 ó pico de insulina en la sobrecarga oral de glucosa > 100 mUmL (1,2)
    E.4Principal exclusion criteria
    1)Pregnancy or pregnancy risk: the patient must provide a written guarantee to abstain from intercourse during the study period or agree to use a barrier method of contraception.
    2)Congenital adrenal hyperplasia due to 21-hydroxylase deficiency
    3)Hyperprolactinemia
    4)Cushing's syndrome
    5)Uncontrolled hypothyroidism
    6)Liver or renal dysfunction of the CPK or the LDH
    7)Diabetes or glucose intolerance
    8)Known skin allergies
    9)Treatment during the previous six months with antiandrogens, estro-progestins, or drugs that interfere with the lipid and carbohydrate metabolism.
    10)The existence of known bacterial infections.
    11)Inflammatory bowel disease.
    12) Patient's with precedents allergy symptons, contraindications or intolerance to the used drugs.
    1)Embarazo o riesgo de embarazo: la paciente garantizara por escrito la ausencia de relaciones sexuales durante el período de estudio o la utilización de un método barrera en caso de que tenga intención de mantenerlas
    2)Hiperplasia suprarrenal congénita por déficit de 21-hidroxilasa
    3)Hiperprolactinemia
    4)Síndrome de Cushing
    5)Hipotiroidismo no controlado
    6)Alteraciones de la función hepática, renal, de las CPK o de la LDH
    7)Diabetes o intolerancia a la glucosa
    8)Alergias cutáneas conocidas
    9)Tratamiento con antiandrógenos, estro-progestágenos, o fármacos que interfieran con el metabolismo lipídico e hidrocarbonado en los 6 meses previos.
    10)Existencia de infecciones bacterianas conocidas.
    11)Enfermedad inflamatoria intestinal.
    12)Pacientes con historia de alergia, contraindicación o intolerancia a los fármacos utilizados.
    E.5 End points
    E.5.1Primary end point(s)
    Basal insulin, insulin sensitivity (HOMA), visceral abdominal fat, intrahepatic lipid content, IMT (carotid intima-media thickness). A reduction in HOMA equal to or more than 10%, accompanied by a decrease in basal insulin amounts by at least 10%, and two or more of the following changes: a decrease of visceral fat > 20%, a decrease of the intrahepatic lipid content > 30%, or a decrease of the IMT > 20% will be considered as a positive and discriminative response.
    nsulina basal, sensibilidad a la insulina (HOMA), grasa abdominal visceral, contenido de lípidos intrahepático, IMT. Se considerara una respuesta positiva y discriminativa una disminución del HOMA igual o superior al 10%, acompañada de una reducción de las cifras de insulina basal de la menos un 10%, y de dos o más de los cambios siguientes: disminución de la grasa visceral >20%, del contenido de lípidos intrahepático > 30%, o del IMT > 20%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months, 12 months and 6 months post treatment
    6 meses, 12 meses y 6 meses post tratamiento
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    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 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 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
    LVLS
    LPLV
    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 months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 40
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Under 18 years old.
    Menores de edad.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    not applicable
    no aplica
    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 Opinion2012-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
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