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    Summary
    EudraCT Number:2014-000964-16
    Sponsor's Protocol Code Number:1311-BCN-138-DG
    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:2014-07-04
    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 number2014-000964-16
    A.3Full title of the trial
    Uterine fibroids: Impact of ulipristal acetate 10 mg on ART results.
    Miomas uterinos: Impacto del acetato de ulipristal 10 mg en los resultados
    de reproducción asistida
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Uterine fibroids: Impact of ulipristal acetate 10 mg on ART results
    Miomas uterinos: Impacto del acetato de ulipristal 10 mg en los resultados
    de reproducción asistida
    A.3.2Name or abbreviated title of the trial where available
    ulipristal acetate 10 mg and Asisted Reproduction
    acetato de ulipristal 10 mg y Reproduccion Asistida
    A.4.1Sponsor's protocol code number1311-BCN-138-DG
    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 SponsorIVI Valencia
    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 supportValencian Institute of Infertility
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIVI Valencia
    B.5.2Functional name of contact pointDaniela Galliano
    B.5.3 Address:
    B.5.3.1Street AddressPlaza Policia Local, 3
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46015
    B.5.3.4CountrySpain
    B.5.4Telephone number+34963050900
    B.5.5Fax number+34963050999
    B.5.6E-mailDaniela.Galliano@ivi.es
    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 Esmya
    D.2.1.1.2Name of the Marketing Authorisation holderGedeon Richter Plc
    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 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 INNUlipristal acetate
    D.3.9.1CAS number 126784-99-4
    D.3.9.3Other descriptive nameULIPRISTAL ACETATE
    D.3.9.4EV Substance CodeSUB30470
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/mg megabecquerel(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Uterine Fibroids and Assisted Reproduction
    Miomas uterinos y reproducción asistida
    E.1.1.1Medical condition in easily understood language
    Uterine Fibroids and Assisted Reproduction
    Miomas uterinos y reproducción asistida
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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
    Demonstrate an 15% increase in the rate of clinical pregnancy in women with inoperable intramural fibroids not distorting the uterine cavity within a program OVD, after administration of uPA in a dose of 10 mg orally daily for 12 weeks
    Demostrar un aumento del 15% en la tasa de gestación clínica en mujeres con miomas intramurales no operables que no distorsionan la cavidad uterina dentro de un programa de OVD, tras la administración de UPA en la dosis de 10 mg diarios por vía oral durante 12 semanas
    E.2.2Secondary objectives of the trial
    Check ifthere are significant differences in the proportions of evolutionary gestation rate of clinical and biochemical abortions and ectopic pregnancy rate due to treatment with Ulpristal.
    Assess volume reduction / fibroid (pre and post tto) for 3D / 3D ultrasound measuring 2D.
    Assess the change in the levels of E2, P4 and FSH (pre and post tto)
    Rate the change in pain reported by the patients in the study with VAS (pre and post tto)
    Assess and record the most common side effects of Esmya (see Side Effects section).
    Comprobar si existen diferencias significativas en las proporciones de gestación evolutiva, tasa de abortos clínico y bioquímico y tasa de embarazo ectópico, gracias al tratamiento con Ulpristal.
    Valorar la reducción del volumen del/de los miomas (pre y post tto) por ecografía 3D/ midiendo las 3 dimensiones en 2D.
    Valorar el cambio en los niveles de E2, P4 y FSH (pre y post tto)
    Valorar el cambio en el dolor reportado por las pacientes en el estudio con escala VAS (pre y post tto)
    Valorar y registrar los efectos secundarios más frecuentes del ESMYA (ver apartado efectos secundarios).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients> 18 and <50 years
    Patients who undergo a first / second cycle OVD
    Patients who present within 1-3 intramural myomas> 2 cm and <5 cm that do not distort the cavity, Type 3 and 4 of the FIGO classification (Figure 1).
    Miomas inoperable for medical judgment or patient desire, you want to avoid the post-surgical time waiting 6 months / 1 year before you can submit to TRA
    Patients who have undergone previous myomectomy who prefer to avoid having surgery again
    BMI 18-30 kg/m2
    Informed consent signed and dated
    Pacientes >18 años y < 50 años
    Pacientes que se someterán a un primer/segundo ciclo de OVD
    Pacientes que presentan entre 1-3 miomas intramurales de >2 cm y < 5 cm que no distorsionan la cavidad, Tipo 3 y 4 de la clasificación FIGO (figura 1).
    Miomas no operables por juicio médico o por deseo de la paciente, que quiere evitar el tiempo de espera post-quirúrgico de 6 meses/1 año antes de poder someterse a TRA
    Pacientes que han sido sometidas a miomectomías previas que prefieren evitar someterse a cirugía de nuevo
    BMI entre 18-30 kg/m2
    Consentimiento informado firmado y fechado
    E.4Principal exclusion criteria
    History of endometrial changes in patients (hyperplasia)
    Presence of other endometrial pathologies: polyps, scars of previous cesarean complicated adenomyosis foci, suspected adhesions
    Simultaneous participation in another clinical study
    Antecedentes de cambios endometriales en las pacientes (hiperplasia)
    Presencia de otras patologías endometriales: pólipos, cicatrices de cesárea anterior complicadas, focos de adenomiosis, sospecha de adherencias
    Participación simultánea en otro estudio clínico
    E.5 End points
    E.5.1Primary end point(s)
    Evolutionary gestation
    Gestación evolutiva
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be recruited for a year
    Se reclutarán pacientes durante un año
    E.5.2Secondary end point(s)
    biochemical pregnancy
    clinical pregnancy
    Implantation rate
    ectopic pregnancy
    Abortion biochemical
    Abortion clinic
    Gestación bioquímica
    Gestación clínica
    Tasa de implantación
    Embarazo ectópico
    Aborto bioquímico
    Aborto clínico
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be recruited for a year
    Se reclutarán pacientes durante un año
    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 Yes
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 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 concerned8
    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
    Última visita del último sujeto
    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
    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: 282
    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 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 state282
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 282
    F.4.2.2In the whole clinical trial 282
    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 Decision2015-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-31
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