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    Summary
    EudraCT Number:2004-002076-42
    Sponsor's Protocol Code Number:KF5025/11
    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:2005-11-29
    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 number2004-002076-42
    A.3Full title of the trial
    Seguridad, efecto hemostático y metabólico y eficacia anticonceptiva de 2 posologías del anticonceptivo oral monofásico basado en la combinación etinilestradiol 0'03 mg/acetato de clormadinona 2 mg (CG5025).

    Safety, hemostatic and metabolic effects and contraceptive efficacy of an oral monophasic contraceptive containing 0.03 mg ethinylestradiol and 2 mg chlormadinone acetate (CG5025) used in two different regimens of intake
    A.4.1Sponsor's protocol code numberKF5025/11
    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 SponsorLaboratorios Andrómaco S.A.
    B.1.3.4CountrySpain
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Belara
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Andrómaco, 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 nameCG5025
    D.3.2Product code CG5025
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNEtinilestradiol
    D.3.9.1CAS number 57-63-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.03 mg
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAcetato de clormadinona
    D.3.9.1CAS number 302-22-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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
    Anticoncepción (Wish of contraception).
    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
    El objetivo de este estudio es mostrar que la seguridad y eficacia de un tratamiento anticonceptivo oral prolongado con Belara/CG5025 administrado durante dos ciclos de 196 días (189 días con administración de píldoras activas más 7 días de intervalo sin toma de píldoras) son comparables con la seguridad y eficacia del tratamiento convencional, es decir, con Belara/CG5025 administrado durante catorce ciclos de 28 días (21 días con administración de píldoras activas más 7 días de intervalo sin toma de píldoras), teniendo en cuenta que, en el grupo de CP, el número medio de días con sangrado intermenstrual relativo al número de días potenciales de sangrado intermenstrual no exceda del 16,0% durante dos ciclos prolongados

    E.2.2Secondary objectives of the trial
    No aplica.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Mujeres sanas en edad fértil con vida sexual activa y edad comprendida entre 18 y 40 años (no fumadoras) o entre 18 y 35 años (fumadoras) en el momento de la inclusión.
    - Ausencia de alteraciones en las pruebas de laboratorio que sean consideradas de relevancia clínica en el contexto del estudio por el investigador.
    - Compromiso para la toma de anticonceptivos durante al menos 392 días
    - IMC ≤30
    - SUBGRUPO HEMOSTÁTICO/METABÓLICO:
    - Mujeres sanas en edad fértil, no fumadoras, con vida sexual activa de edades comprendidas entre 18 y 40 años en el momento de la inclusión.
    - Compromiso para la toma de anticonceptivos durante al menos 392 días seguidos de aproximadamente dos meses con métodos de barrera, tales como preservativos.
    E.4Principal exclusion criteria
    Criterios Generales
    - Embarazo
    - Lactancia
    - Evidencia o antecedentes de adicción a alcohol, medicamentos o drogas
    - Enfermedad psiquiátrica severa, epilepsia o riesgo de suicidio.
    - Enfermedades crónicas (por ejemplo, hepáticas y/o renales) o seguimiento de una dieta que pueda afectar a la absorción, al metabolismo o la excreción del fármaco.


    Específicos del estudio
    - Cirugía programada que requiera la retirada de anticonceptivos orales dentro del periodo previsto de participación en el estudio.
    - Evidencia de neoplasia intraepitelial en citología de frotis cervical (por ejemplo. frotis de Papanicolau grado III a V).
    - Amenorrea o sangrado genital no filiados.
    -Diagnóstico de síndrome de ovario poliquístico, ciclos anovulatorios, histerectomía, oforectomía bilateral.
    - Administración de cualquier otro anticonceptivo hormonal incluidos parches y anillos vaginales durante los ciclos de medicación- Utilización de dispositivos intrauterinos (DIU) con o sin hormonas durante el ciclo de medicación
    - Uso de anticonceptivos implantables durante los ciclos de medicación
    - Uso de anticonceptivos inyectables durante los 6 meses (teniendo en cuenta la fecha de inyección) precedentes a la inclusión así como durante los ciclos de medicación.
    -Uso de medicación que contenga estrógeno o progesterona durante los ciclos de medicación
    - Uso regular concomitante de un método de barrera
    - Migraña con síntomas neurológicos focales (migraña con aura)
    - Necesidad de medicación concomitante (durante más de 5 días) con:
    •fármacos que incrementen la motilidad gastrointestinal (por ejemplo: metoclopramida) o que impidan la absorción (por ejemplo: carbón activado)
    •sustancias inductoras de las enzimas microsomales del hígado tales como rifampicina, rifabutina, barbituratos, antiepilépticos (por ejemplo fenitoína, carbamazepina, oxcarbazepina, topiramato, felbamato, primidona, barbexaclona), griseofulvina, modafinilo, inhibidores de la proteasa (por ejemplo ritonavir) y la Hierba de San Juan
    •antibióticos

    - Enfermedades hepáticas
    - Enfermedades metabólicas o que cursen con alteraciones circulatorias
    - Pancreatitis o antecedentes siempre y cuando esté asociada con hipertrigliceridemia severa
    - Tumores: presencia, antecedentes o sospecha de cualquier tumor maligno o sensible a hormonas.
    -Otras enfermedades
    •Porfiria (en particular porfiria hepática adquirida)
    •Otosclerosis degenerativa en embarazos previos
    •Alteraciones agudas de los sentidos; por ejemplo, alteraciones de la vista o la audición
    •Alteraciones motoras, en particular paresias
    •Dolor epigástrico severo, hepatomegalia o síntomas de hemorragia intraabdominal

    ESPECÍFICOS DEL ESTUDIO PARA LAS VOLUNTARIAS DEL SUBGRUPO HEMOSTÁTICO/METABÓLICO:
    -Uso de anticonceptivos orales, anillos vaginales anticonceptivos o parches anticonceptivos durante el ciclo anterior al ciclo de pre-medicación
    - Uso previo y concomitante de dispositivos intrauterinos (DIU) con o sin impregnación de hormonas durante el ciclo anterior al ciclo de pre-medicación
    - Uso de anticonceptivos implantables durante los dos ciclos previos al ciclo de pre-medicación
    - Parto o aborto natural o provocado durante los tres meses previos a la visita basal (visita 1B)
    - Uso concomitante de anticoagulantes, por ejemplo: heparinas y cumarinas
    - Medicación concomitante que afecte al metabolismo lipídico y/o de hidratos de carbono (por ejemplo: glucocorticoides por vía sistémica, ß-bloqueantes, diuréticos tiazídicos, agentes para la dislipemia).
    - Enfermedades concomitantes que afecten al metabolismo lipídico y/o de hidratos de carbono (por ejemplo: diabetes mellitus, hipotiroidismo, colestasis, síndrome nefrótico, insuficiencia renal que requiera hemodiálisis)
    - Nivel de colesterol en ayunas > 6’47 mmol/L (>250 mg/dl) y/o triglicéridos por encima del límite superior de la normalidad en la visita basal (visita 1B)
    -Uso concomitante de antiagregantes plaquetarios y/o antiinflamatorios no esteroideos (AINEs) durante los 7 días previos a la extracción de sangre bien en la visita basal (visita 1B), bien en las visitas 4, 6 y 7B
    E.5 End points
    E.5.1Primary end point(s)
    - Número de días con sangrado intermenstrual en relación con el número de días potenciales con sangrado intermenstrual durante 392 días,
    - Número total de días con sangrado durante 392 días y dentro de cada uno de los 4 períodos de referencia de 98 días,
    - Intensidad del sangrado
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    2 posologías distintas: dos ciclos prolongados en comparación con el la posología convencional
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Última visita del último sujeto en el ensayo.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-11-29. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 738
    F.4.2.2In the whole clinical trial 1012
    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)
    No se consideran tratamientos distintos del tratamiento habitual
    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 Decision2006-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2006-02-09
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