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    The EU Clinical Trials Register currently displays   36370   clinical trials with a EudraCT protocol, of which   5992   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-004214-27
    Sponsor's Protocol Code Number:91554
    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:2009-03-30
    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 number2008-004214-27
    A.3Full title of the trial
    Estudio multicéntrico, abierto, no controlado para investigar la eficacia y seguridad del parche anticonceptivo transdérmico que contiene 0,55 mg de etinilestradiol y 2,1 mg de gestodeno (n.º de material 80876395) en una pauta de 21 días durante 13 ciclos en 1650 mujeres sanas

    Multi-center, open-label, uncontrolled study to investigate the efficacy and safety of the transdermal contraceptive patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen for 13 cycles in 1650 healthy female subjects
    A.3.2Name or abbreviated title of the trial where available
    Estudio UE/LA/AUS Índice de Pearl - Parche anticonceptivo transdérmico
    A.4.1Sponsor's protocol code number91554
    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 SponsorBayer Healthcare AG
    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 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 nameParche de bajo CF
    D.3.2Product code material no. 80876395
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEtinilestradiol
    D.3.9.1CAS number 57-63-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.55
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGestodeno
    D.3.9.1CAS number 60282873
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.1
    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 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 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
    El objetivo principal de este estudio es investigar la eficacia anticonceptiva del parche anticonceptivo transdérmico (n.º de material 80876395).

    The primary objective of this study is to investigate the contraceptive efficacy of the transdermal contraceptive patch (material no. 80876395).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10060346
    E.1.2Term Transdermal contraception
    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 principal de este estudio es investigar la eficacia anticonceptiva del parche anticonceptivo transdérmico (n.º de material 80876395).
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios son investigar los perfiles de hemorragia, el control del ciclo y el perfil de seguridad. Como objetivos secundarios se evaluarán el cumplimiento y la valoración subjetiva de la satisfacción con el parche anticonceptivo transdérmico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Consentimiento informado firmado y fechado
    2. Mujeres sanas que requiere anticoncepción
    3. Edad: 18-35 años (ambas inclusive); las fumadoras no pueden ser mayores de 30 años en el momento de la obtención del consentimiento informado
    4. Frotis cervical normal que no requiere seguimiento (debe realizarse un frotis cervical en la visita de selección o se documentará un resultado normal en los previos 6 meses)
    5. Antecedentes de periodos menstruales cíclicos regulares
    E.4Principal exclusion criteria
    1. Embarazo o lactancia (menos de 3 ciclos menstruales desde el inicio del tratamiento)
    2. Obesidad (Índice de masa corporal > 30,0 kg/m2)
    3. Hipersensibilidad a cualquier componente del fármaco del estudio
    4. Reacción cutánea significativa a las preparaciones transdérmicas o sensibilidad al esparadrapo quirúrgico/médico
    5. Todas las enfermedades o afecciones que pueden comprometer la función de los sistemas corporales y que pudieran producir alteración de la absorción, acumulación excesiva, alteración del metabolismo o de la excreción del fármaco del estudio (p., ej., enfermedad cutánea conocida o posible alteración de la absorción dérmica o mala adherencia del parche como, por ejemplo, psoriasis).
    6. Todas las enfermedades o afecciones que podrían interferir en la realización del estudio o la interpretación de los resultados
    7. Todas las enfermedades o afecciones que podrían empeorar con la terapia hormonal tal como:
    - Presencia o antecedentes de episodios trombóticos/tromboembólicos venosos o arteriales (p. ej., trombosis venosa profunda, embolia pulmonar, infarto de miocardio) o de un accidente cerebrovascular, incluidos pródromos (p. ej., ataque isquémico transitorio, angina de pecho) y afecciones que pudieran incrementar el riesgo de sufrir cualquiera de los trastornos mencionados antes, por ejemplo un antecedente familiar indicativo de una predisposición hereditaria
    - Varias determinaciones de la presión arterial sistólica > 140 mmHg y/o presión arterial diastólica > 90 mmHg
    Hepáticas
    - Presencia o antecedentes de tumores hepáticos (benignos o malignos)
    - Presencia o antecedentes de hepatopatía grave, mientras los parámetros de función hepática no hayan retornado a la normalidad
    - Ictericia y/o prurito relacionado con colestasis (exceptuando el síndrome de Gilbert)
    - Antecedentes de ictericia colestásica asociada a embarazo o uso previo de AOC
    Enfermedades metabólicas
    - Diabetes mellitus no controlada y/o diabetes mellitus con afectación vascular
    - Dislipoproteinemia grave
    Otras enfermedades
    - Enfermedad maligna o premaligna
    - Trastorno tiroideo no controlado
    - Insuficiencia renal grave o insuficiencia renal aguda
    - Antecedentes de pancreatitis asociada a hipertrigliceridemia
    - Penfigoide gestacional durante un embarazo previo
    - Antecedentes de herpes gestacional
    - Hipoacusia relacionada con otosclerosis
    - Antecedentes de migraña con síntomas neurológicos focales
    - Epilepsia
    - Depresión clínicamente significativa
    - Angioedema hereditario

    8.Hemorragia genital anormal no diagnosticada
    9. Abuso de alcohol, fármacos o medicamentos (p. ej., laxantes)
    10.Otros métodos anticonceptivos:
    -Esterilización
    -Anticoncepción hormonal oral, vaginal o transdérmica durante el tratamiento
    -Dispositivos intrauterinos (DIU) con o sin liberación hormonal
    -Implantes
    -Preparaciones de acción prolongada (p. ej., MPA depot, inyección anticonceptiva mensual) en un plazo de 3 veces el intervalo de la inyección antes del inicio del tratamiento.
    11.Cualquier medicación que podría tener como resultado acumulación excesiva, alteración del metabolismo o de la excreción del fármaco del estudio o interferir en la realización del estudio o la interpretación de los resultados, tales como:

    - Productos que contienen hierba de San Juan (Hypericum perforatum)
    - Antibióticos
    - Anticoagulantes (p. ej., heparina, cumarina)
    - Antiepilépticos (derivados de hidantoína [p. ej., fenitoína] o derivados de carboxiamida [p. ej., carbamazepina, oxcarbamazepina], otros [p. ej., felbamato, topiramato])
    - Hipnóticos y sedantes (p. ej., derivados barbitúricos, primidona)
    - Tuberculostáticos (p. ej., rifampicina)
    - oral antimycotics (e.g., griseofulvin, ketoconazole, itraconazole, fluoconazole)
    (except for single shot treatment)
    -Antimicóticos orales (p. ej., griseofulvina, ketoconazol, itraconazol, fluconazol) en un plazo de 28 días antes de iniciar el tratamiento (excepto el tratamiento con una sola inyección)
    - Agentes virostáticos (excepto para uso tópico [p. ej., ritonavir])
    - Fenilbutazona
    - Esteroides sexuales adicionales y otros fármacos que alteran la función ovárica
    12. Participación simultánea en otro estudio clínico o participación en otro estudio clínico antes de la entrada en el estudio que pudiera afectar a los objetivos del estudio, según el criterio del investigador
    13. Cirugía mayor programada durante el periodo del estudio
    14. El sujeto es una persona dependiente (p. ej., un miembro de la familia o miembro del personal del investigador)
    15. Incapacidad para colaborar con los procedimientos del estudio por cualquier motivo, incluidos los siguientes ejemplos: falta de comprensión del idioma, enfermedad psiquiátrica, incapacidad para acudir al centro del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Embarazo (sí/no) durante el tratamiento hasta 7 días después de la retirada del último parche, evaluado mediante el índice de Pearl y análisis con tabla de vida
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned10
    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 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
    En cumplimiento con los reglamentos de la UE, el final del estudio (EOS) se define como la última visita del último paciente. Esto incluye todas las visitas no programadas, si procede.
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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 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 Yes
    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 2009-03-30. Yes
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1150
    F.4.2.2In the whole clinical trial 1650
    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 Decision2009-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-21
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