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    Summary
    EudraCT Number:2012-001789-13
    Sponsor's Protocol Code Number:QUINA/2012
    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:2012-09-14
    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 number2012-001789-13
    A.3Full title of the trial
    Double-blind, randomized, controlled contraceptives, parallel group, to assess the effect on nerve fibers in patients diagnosed with endometriosis grade III / IV symptomatic ascending-dose oral quinagolide for 16 weeks
    Estudio doble ciego, aleatorizado, controlado con anticonceptivos, de grupos paralelos, para evaluar el efecto sobre las fibras nerviosas en pacientes diagnosticadas de endometriosis grado III/IV sintomática con quinagolida oral a dosis ascendentes durante 16 semanas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Contraceptive-controlled study to evaluate the effect on nerve fibers in patients diagnosed with endometriosis grade III / IV symptomatic ascending-dose oral quinagolide for 16 weeks
    Estudio controlado con anticonceptivos para evaluar el efecto sobre las fibras nerviosas en pacientes diagnosticadas de endometriosis grado III/IV sintomática con quinagolida oral a dosis ascendentes durante 16 semanas
    A.4.1Sponsor's protocol code numberQUINA/2012
    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 SponsorInstituto de Investigacion Sanitaria La e
    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 supportInstituto de Investigacion Sanitaria La e
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto de Investigacion Sanitaria La e
    B.5.2Functional name of contact pointUREC
    B.5.3 Address:
    B.5.3.1Street AddressAv. Campanar 21
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46009
    B.5.3.4CountrySpain
    B.5.4Telephone number34963862458
    B.5.5Fax number34963494416
    B.5.6E-mailinvestigacion_clinica@iislafe.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 Norprolac 25 microgramos y 50 microgramos comprimidos
    D.2.1.1.2Name of the Marketing Authorisation holderFERRING, S.A.U
    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 nameQUINAGOLIDE
    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 INNQUINAGOLIDE HYDROCHLORIDE
    D.3.9.1CAS number 94424-50-7
    D.3.9.4EV Substance CodeSUB04163MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 50
    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.IMP: 2
    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 Norprolac 75 microgramos
    D.2.1.1.2Name of the Marketing Authorisation holderFERRING, S.A.U
    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 nameQUINAGOLIDE
    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 INNQUINAGOLIDE HYDROCHLORIDE
    D.3.9.1CAS number 94424-50-7
    D.3.9.4EV Substance CodeSUB04163MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Liofora 0,02 mg / 3 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Hispania, 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 nameLIOFORA
    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 INNethinylestradiol as betadex clathrate
    D.3.9.1CAS number 256463-26-0
    D.3.9.2Current sponsor codeZK227269
    D.3.9.3Other descriptive nameETHINYLESTRADIOL BETADEX CLATHRATE
    D.3.9.4EV Substance CodeSUB25932
    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 INNDrospirenone
    D.3.9.1CAS number 67392-87-4
    D.3.9.2Current sponsor codeZK30595
    D.3.9.3Other descriptive nameDROSPIRENONE
    D.3.9.4EV Substance CodeSUB06413MIG
    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) 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
    D.8 Placebo: 2
    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
    Endometriosis grade III/IV
    Endometriosis grado III/IV
    E.1.1.1Medical condition in easily understood language
    Emergence and growth of endometrial tissue outside the uterus
    Aparición y crecimiento de tejido endometrial fuera del útero
    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
    To evaluate the efficacy of quinagolide on symptoms and nerve fiber density in patients with endometrial level endometriosis grade III / IV symptomatic as an alternative to surgery.
    Evaluar la eficacia de quinagolida sobre la sintomatología y densidad de fibras nerviosas a nivel endometrial en pacientes con endometriosis grado III/IV sintomática como alternativa a la cirugía.
    E.2.2Secondary objectives of the trial
    1) Evaluation by visual analogue scale the effect of quinagolide on pain in patients with endometriosis stage III / IV.
    2) evaluate through questionnaires on quality of life, the effect of quinagolide in patients with endometriosis stage III / IV.
    3) Determine the effect on peripheral blood of quinagolide on
    Profile of coagulation / fibrinolysis
    circulating prolactin levels
    1)Evaluar mediante escala analógica visual el efecto de la quinagolida sobre el dolor en pacientes con endometriosis grado III/IV.
    2) Evaluar mediante cuestionarios de calidad de vida, el efecto de la quinagolida en pacientes con endometriosis grado III/IV.
    3) Determinar en sangre periférica el efecto de la quinagolida sobre
    perfil de coagulación/fibrinolisis
    niveles de prolactina circulante
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with endometriosis grade III / IV diagnosed by history, physical examination and complementary examinations: ECO TV. ECO TR. RMN. Pain resistant to medical treatment: VAS greater than 50 Indication for surgery No immediate desire for pregnancy Women over 18 Washing period of hormone treatment
    Pacientes con endometriosis grado III/IV diagnosticada por anamnesis, exploración física, y exploraciones complementarias: ECO TV. ECO TR. RMN.
    Dolor resistente a tratamiento médico: VAS mayor de 50
    Indicación de cirugía
    No deseo inmediato de gestación
    Mujeres mayores de 18 años
    Periodo lavado de tratamiento hormonal
    E.4Principal exclusion criteria
    Be subjected to treatment with contraceptives, hormone replacement therapy or other treatment for endometriosis
    Tolerability and pharmacokinetics studies
    Intolerance or allergy to quinagolide or any of the excipients
    Rejection of barrier contraception during study
    Contraindication surgery
    History of surgery for endometriosis
    Estar sometidas a tratamientos con anticonceptivos, terapia hormonal sustitutiva o cualquier otro tratamiento para endometriosis
    Estudios tolerabilidad y farmacocinética
    Intolerancia o alergia a quinagolida o alguno de los excipientes
    No aceptación de anticoncepción de barrera durante estudio
    Contraindicación cirugía
    Antecedente de cirugía por endometriosis
    E.5 End points
    E.5.1Primary end point(s)
    Nerve fiber density
    Densidad de fibras nerviosas: antes de iniciar el tratamiento y al finalizar el mismo se evaluará la densidad de fibras nerviosas mediante imunohistoquímica y PCR q. Tras 16 semanas de tratamiento, se realizará un laparoscopia para resecar los implante, momento en que se establecerá la clasificación de la endometriosis según la ASRM.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Completion of the study
    Finalizacion del estudio.
    E.5.2Secondary end point(s)
    Pain- quality of life.
    Dolor-calidad de vida
    E.5.2.1Timepoint(s) of evaluation of this end point
    In each study visit.
    En cada visita del estudio.
    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 No
    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 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
    Last visit or at any of the patients in the study drug (quinagolide) suffer any major adverse effect
    Ultima visita o en el momento que alguna de las pacientes pertenecientes al fármaco a estudio (Quinagolida) sufra algún efecto adverso mayor
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 20
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 state20
    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)
    It is not different from the expected normal treatment of that condition
    El mismo tratamiento que en la práctica 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 Decision2012-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-24
    P. End of Trial
    P.End of Trial StatusOngoing
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