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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-004956-23
    Sponsor's Protocol Code Number:IIBSP-DIU-2015-85
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-01-13
    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 number2015-004956-23
    A.3Full title of the trial
    COLIBRI STUDY, Cooper and Levonorgestrel Intrauterine Device (IUD) Barcelona Research Initiative.
    A randomized controlled trial to compare the menstrual bleeding profile among cooper and 13,5mg levonorgestrel-releasing IUD (13,5 LNG-IUD) users.
    ESTUDIO COLIBRI (Cooper and Levonorgestrel IUD Barcelona Research Iniciative): Estudio comparativo del patrón de sangrado menstrual entre las usuarias del DIU Jaydess® y el DIU de cobre
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the menstrual bleeding profile among Jaydess® and Cooper IUD users
    Estudio comparativo del patrón de sangrado menstrual entre usuarias del DIU Jaydess® y el DIU de cobre
    A.3.2Name or abbreviated title of the trial where available
    COLIBRI STUDY
    ESTUDIO COLIBRI
    A.4.1Sponsor's protocol code numberIIBSP-DIU-2015-85
    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 SponsorInstitut de Recerca HSCSP
    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 supportBayer
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca HSCSP
    B.5.2Functional name of contact pointServicio Ginecología y Obstetricia
    B.5.3 Address:
    B.5.3.1Street AddressSant Antoni Maria Claret 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08026
    B.5.3.4CountrySpain
    B.5.6E-mailestudiocolibri2016@gmail.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 Jaydess
    D.2.1.1.2Name of the Marketing Authorisation holderBayer
    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.3.4Pharmaceutical form Intrauterine delivery system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrauterine use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVONORGESTREL
    D.3.9.1CAS number 17489-40-6
    D.3.9.4EV Substance CodeSUB08483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number13.5
    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
    Contraception
    Anticoncepción
    E.1.1.1Medical condition in easily understood language
    Contraception
    Anticoncepción
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    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
    To identify the menstrual bleeding profile among cooper and 13,5 LNG-IUD users.
    Hypothesis: 13,5 LNG-IUD users have less quantity and fewer days of menstrual bleeding that cooper IUD users. Among 13,5 LNG-IUD users the total blood loss per cycle progressively decreases with continued use. The number of spotting and menstrual bleeding days may initially increase but then decrease in the months that follow.
    El objetivo principal del estudio es evaluar las diferencias en el patrón de sangrado entre las usuarias del DIU-LNG 13,5mg y las del DIU-Cu de 380mm2.
    E.2.2Secondary objectives of the trial
    To evaluate:
    - Spotting pattern.
    - Satisfaction and quality of life.
    - Continuation rates after 1st, 2nd and 3rd year.
    - Pain profile and adverse events.
    Los objetivos secundarios son:
    Evaluar:
    - patrón de sangrado
    - satisfacción y calidad de vida
    - la presencia e intensidad de dismenorrea
    - tasas de continuación después del primers, segundo y tercer año
    - dolor y efectos secundarios relacionados con el uso de cada DIU;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Healthy female subject.
    - Parous or nulliparous women aged between 18 and 45 years who ask for an IUD as a contraceptive method.
    - History of regular cyclic menstrual periods ranged from 21 to 35 days with non-excessive menstrual blood loss.
    - Ser mujer en periodo fértil y edad comprendida entre 18 y 45 años.
    - Tener un ciclo menstrual normal. La menstruación se considerará normal cuando el sangrado uterino ocurra cada 28 +/- 7 días y la mujer refiera que no es excesivo.
    - Desear libremente un DIU como método contraceptivo.
    - Historial médico y examen físico que demuestre que no presente contraindicaciones para el uso de ninguno de los dos DIUs del estudio, teniendo en consideración los Criterios Médicos de Elegibilidad de la OMS del 2015.
    E.4Principal exclusion criteria
    - Absolute contraindications to IUD use, according to the World Health Organization Medical Eligibility Criteria.
    - Contraindications to use 13,5 LNG-IUD.
    - Anemia.
    - Use of short or long-acting preparations containing sex hormones within the 12 weeks before the IUD insertion.
    - Known bleeding irregularities.
    - Pregnancy or breast-feeding.
    - No ser capaz de entender la naturaleza del ensayo y los procedimientos que deberá seguir.
    - No firmar el consentimiento informado.
    - Haber utilizado un método contraceptivo hormonal durante los 3 meses previos al inicio del estudio.
    - Antecedente o evidencia clínica de trastornos psiquiátricos, alcoholismo, abuso de fármacos u otras drogas o consumo habitual de fármacos psicoactivos.
    - Presentar intolerancia o reacciones adversas graves al levonorgestrel o al cobre o a alguno de los componentes del dispositivo.
    - Historial médico y examen físico que demuestre que presente alguna contraindicación para el uso de cualquiera de los dos DIUs estudiados, teniendo en consideración los Criterios Médicos de Eligibilidad de la OMS del 2015 (categorías 3 y 4).
    - Tener sangrado menstrual abundante (SMA), considerado como una pérdida de sangre menstrual excesiva que interfiere con la actividad física, emocional o social normal de la mujer, afectando a su calidad de vida.
    - Haber presentado sangrado intermenstrual o coitorragia en los últimos 3 ciclos menstruales.
    - Referir dismenorrea severa previa a la colocación del DIU. Se establecen 4 grados de intensidad de dismenorrea: sin dolor, leve, moderado, severo.
    - Constancia de anomalías en la cavidad uterina o canal cervical que dificulten o imposibiliten la colocación de un DIU
    - Analítica que demuestre anemia en el momento del inicio del estudio (Hb < 12 g/L).
    - Mujeres en tratamiento con fármacos anticoagulantes o antiagregantes.
    - Mujeres en tratamiento crónico con AINEs o antifibrinolíticos (como los ácidos aminocaproico y tranexámico).
    - Estar embarazadas o en periodo de lactancia.
    - Pacientes que, a juicio del investigador, sean consideradas candidatas inadecuadas para participar en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Number of menstrual bleeding days. Time frame: daily recorded during 90 days treatment period.
    - Menstrual bleeding characterization (intensity, pattern). Time frame: for 90 days treatment period. Classified using a 5-item Likert-like scale from ?none? to ?heavy? and a pictorial blood loss assessment chart (PBAC).
    - Serum hemoglobin, hematocrit and ferritin levels.
    - Número de días de sangrado menstrual
    - Características del sangrado menstrual
    - Niveles de hemoglobina, hematocrito y ferritina
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily recorded during 90 days treatment period.
    Registro diario durante un periodo de 90 días
    E.5.2Secondary end point(s)
    - Number of spotting days. Time frame: daily recorded during 90 days treatment period.
    - Spotting bleeding characterization (intensity, pattern). Time frame: for 90 days treatment period. Classified using a 5-step scale from ?none? to ?heavy? and a pictorial blood loss assessment chart (PBAC).
    - Global satisfaction with 13,5 LNG-IUD using a 5-item Likert-like scale(from extremely unsatisfied to extremely satisfied). Time frame: at the single visit.
    - Quality of life after 1st, 2nd and 3rd year. Time framer: at the single visit
    - Continuation rate after 1st, 2nd and 3rd year. Time frame: at the single visit.
    - Adverse events as a measure of safety and tolerability.
    - Dolor percibido por la usuaria durante la inserción del dispositivo.
    - Facilidad de la inserción del dispositivo.
    - Días de sangrados irregulares.
    - Cantidad de sangrado irregular.
    - Días de dismenorrea.
    - Intensidad de dismenorrea.
    - Seguridad.
    - Satisfacción de la usuaria.
    - Calidad de vida.
    - Tasas de continuación al primer, segundo y tercer año.
    - Intención de continuar con el método a los 3 años.
    - Motivo de cambio/continuación del método.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Daily recorded during 90 days treatment period.
    Registro diario durante un periodo de 90 días
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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
    Producto sanitario
    Medical device
    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
    UVUS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    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: 106
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state106
    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 Decision2016-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-27
    P. End of Trial
    P.End of Trial StatusOngoing
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