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    Summary
    EudraCT Number:2010-019902-17
    Sponsor's Protocol Code Number:BAY86-5300/14701
    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:2010-10-21
    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 number2010-019902-17
    A.3Full title of the trial
    Estudio multicéntrico, abierto, randomizado, controlado, dos grupos, para evaluar el cumplimiento de la toma diaria en mujeres usuarias de contracepción oral con SHT00186D/BAY 86-5300 (0.02 mg de etinilestradiol como clatrato de betadex, y 3 mg de Drospirenona) en un régimen extendido y flexible, con el apoyo de un dispensador (CADDY) con función de recordatorio, durante 12 meses.

    (A multicenter, open-label, randomized, controlled, two-arm study to assess compliance with daily tablet intake of women on treatment with the oral contraceptive SH T00186D/BAY 86-5300 (0.02 mg ethinyl estradiol as betadex clathrate and 3 mg drospirenone) in a flexible extended regimen supported by a dispenser (CADDY) with a reminder function over 12 months)
    A.3.2Name or abbreviated title of the trial where available
    EU-Compliance by buzzer study of YAZ Flex in the CADDY
    A.4.1Sponsor's protocol code numberBAY86-5300/14701
    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 Yes
    D.2.1.1.1Trade name YAZ 0,02 mg/3 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderQUIMICA FARMACEUTICA BAYER, 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 nameDRSP+EE tablets 3 mg + 20 µg
    D.3.2Product code SH T00186D/BAY 86-5300
    D.3.4Pharmaceutical form 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 57-63-6
    D.3.9.3Other descriptive nameETHINYLESTRADIOL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.02
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDROSPIRENONA
    D.3.9.1CAS number 67392-87-4
    D.3.9.3Other descriptive nameDROSPIRENONE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    Anticoncepción (Contraception)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10030970
    E.1.2Term Oral 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 del estudio es evaluar el efecto de la función de recordatorio del dispensador en el cumplimientode la toma diaria de comprimidos, durante 12 meses aproximadamente de tratamiento, en mujeres voluntarias sanas con edades comprendidas entre 18 y 35 años
    (ambos inclusive), que soliciten anticoncepción; las mujeres fumadoras no deberán ser mayores de 30 años en el momento de firmar el consentimiento informado.
    E.2.2Secondary objectives of the trial
    Además, se evaluará la eficacia y la seguridad del anticonceptivo oral SH T00186D/BAY 86-5300 (0,02 mg de EE como clatrato de betadex [Beta-CDC] y 3 mg de DRSP) en un régimen extendido flexible administrado utilizando un dispensador que facilita el cumplimiento (CADDY).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Las pacientes deben cumplir todos los siguientes criterios antes de ser incluidas en el estudio
    1. Consentimiento informado por escrito
    2. Mujeres sanas que solicitan anticoncepción.
    3. Edad entre 18 y 35 años (ambas inclusive), las mujeres fumadoras no deben ser mayores de 30 años en el momento de firmar el consentimiento informado
    4. Citología de cuello uterino normal o sin transcendencia clínica que no requiera más seguimiento (Debe obtenerse una muestra para citología de cuello uterino en la visita de selección ó disponer de la documentación pertinente del resultado de una citología obtenida durante los 6 meses previos a la visita). En pacientes con ASCUS, el análisis del VPH será utilizado como prueba completementaria. Se podrán incluir mujeres con ASCUS si el resultado de las cepas del VPH de alto riesgo es negativo.
    E.4Principal exclusion criteria
    - Embarazo o lactancia (parto, aborto o lactancia en los 3 meses previos al inicio del tratamiento)
    - Índice de masa corporal (IMC) 30.0 kg/m
    - Presencia o antecedentes de episodios de trombosis o tromboembolismo venoso o arterial
    - Mediciones repetidas de la presión sanguínea sistólica > 140 mmHg y/o presión sanguínea diastólica > 90 mmHg.
    - Presencia o antecedentes de tumores hepáticos (benignos o malignos), enfermedad hepática grave, Ictericia o prurito relacionados con colestasis, Antecedentes de ictericia colestásica asociada al embarazo o al uso previo de ACOC
    - Diabetes mellitus no controlada o diabetes mellitus con afectación vascular
    - Dislipoproteinemia grave
    - Enfermedad maligna o premaligna
    - Trastorno tiroideo no controlado
    - Enfermedad inflamatoria intestinal crónica
    - Insuficiencia renal grave o insuficiencia renal aguda
    - Antecedentes de migraña con síntomas neurológicos focales
    - Epilepsia
    E.5 End points
    E.5.1Primary end point(s)
    Media del retraso diario en la extracción del comprimido.

    (Mean daily delay of tablet release)
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Dos grupos de tratamiento (two treatment arms)
    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
    Grupo B con la función de recordatorio desactivada (Arm B - Group with inactivated CADDY buzzer)
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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 Information not present in EudraCT
    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
    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 months9
    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 months9
    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 2010-10-21. 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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 Decision2012-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-06
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