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    Summary
    EudraCT Number:2015-000290-12
    Sponsor's Protocol Code Number:1412-BCN-087-AB
    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:2015-04-14
    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 number2015-000290-12
    A.3Full title of the trial
    Randomized Clinical Trial comparing the endometrial transformation with 25 mg/day of subcutaneous progesterone (Prolutex) versus 50 mg/day intramuscular progesterone (Prontogest)
    Ensayo clínico randomizado comparando la transformación endometrial con 25 mg/día de progesterona subcutánea (Prolutex) versus 50 mg/día de progesterona intramuscular (Prontogest).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare the endometrial transformation with 25 mg / day of subcutaneous progesterone(Prolutex) versus 50 mg / day intramuscular progesterone (Prontogest)
    Ensayo clínico para comparar la transformación del endometrio con 25 mg/día de progesterona subcutánea (Prolutex) versus 50 mg/día de progesterona intramuscular (Prontogest).
    A.4.1Sponsor's protocol code number1412-BCN-087-AB
    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 SponsorClínica IVI Barcelona
    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 supportClínica IVI Barcelona
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClínica IVI Barcelona
    B.5.2Functional name of contact pointMedicina Reproductiva
    B.5.3 Address:
    B.5.3.1Street AddressRonda del General Mitre, 14
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08017
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932 063 000
    B.5.5Fax number0034932 053 428
    B.5.6E-mailagustin.ballesteros@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 Prolutex 25 mg solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA Farmaceutici Italia Srl
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROGESTERONE
    D.3.9.1CAS number 57-83-0
    D.3.9.2Current sponsor codeG03DA04
    D.3.9.3Other descriptive nameprogesterone
    D.3.9.4EV Substance CodeSUB10076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22.35
    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 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 PRONTOGEST 50 mg/ml soluzione iniettabile
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA Farmaceutini Italia Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROGESTERONE
    D.3.9.1CAS number 57-83-0
    D.3.9.2Current sponsor codeG03DA04
    D.3.9.3Other descriptive nameprogesterona
    D.3.9.4EV Substance CodeSUB10076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Infertility. Assisted Reproductive Techniques.
    Infertilidad. Técnica de Reproducción Asistida.
    E.1.1.1Medical condition in easily understood language
    Infertility. Assisted Reproductive Techniques
    Infertilidad. Técnica de Reproducción Asistida.
    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 study the predecidualización endometrial (ie, measuring the effects of progesterone in the endometrial glands and stroma in the luteal phase) and endometrial receptivity on Day 5 as gene expression, following daily administration of 25 mg / day of subcutaneous progesterone and 50 mg / day intramuscular progesterone, both for 5 days, to see if there are differences in the use of both progesterone.
    Estudiar la predecidualización del endometrio (es decir, medir los efectos de la progesterona en las glándulas endometriales y estroma en la fase lútea) y la receptividad endometrial en Día 5 según expresión génica tras la administración diaria de 25 mg/día de progesterona subcutánea y de 50 mg/día de progesterona intramuscular, ambas por un periodo de 5 días, para ver si existen diferencias con el uso de ambas progesteronas..
    E.2.2Secondary objectives of the trial
    To study plasma levels of progesterone, estradiol and LH on different days (Day programming follicular puncture Day follicular puncture and Day 5 of administration of progesterone / end of the study).
    Estudiar los niveles plasmáticos de progesterona, estradiol y LH en distintos días (Día de la programación de la punción folicular, Día de la punción folicular y Día 5 de la administración de progesterona / finalización del estudio).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Female age between 18 and 34 years (inclusive)
    BMI between 18 and 28 kg / m2 (inclusive)
    Endometrial thickness greater 7 mm on day of beginning progesterone treatment (day of follicular puncture)
    Follicular maturation with bolus GnRH agonist
    Egg donors who make a cycle of ovarian stimulation in the IVI Barcelona Centre
    Edad de la mujer entre 18 años y 34 años (ambos inclusive)
    IMC entre 18 y 28 Kg/m2 (ambos inclusive)
    Grosor endometrial mayor 7 mm el día del inicio del tratamiento con progesterona (día de la punción folicular)
    Maduración folicular con un bolo de agonista de la GnRH
    Donantes de óvulos que hacen un ciclo de estimulación ovárica en el Centro IVI Barcelona
    Donantes de óvulos seleccionadas de acuerdo con los requisitos de la Ley 14/2006 de 26 de mayo de 2006, sobre Técnicas de Reproducción Humana Asistida
    Consentimiento informado firmado y fechado
    E.4Principal exclusion criteria
    Known allergy to progesterone preparations or its excipients
    Known allergy to estrogens
    Known thrombophilia
    Dependence on alcohol, drugs or psychotropic
    Concurrent participation in another study
    Concomitant medications that may interfere with the study medication and ovarian stimulation
    Not complying the requirements for egg donors according to Law 14/2006 of 26 May 2006 on Assisted Human Reproduction Techniques
    Alergia conocida a los preparados de progesterona o sus excipientes
    Alergia conocida a estrógenos
    Trombofilias conocidas
    Dependencia de alcohol, drogas o psicofármacos
    Participación concurrente en otro estudio
    Medicación concomitante que pueda interferir con la medicación en estudio y la estimulación ovárica
    No cumplir con los requisitos para ser donantes de óvulos de acuerdo con la Ley 14/2006 de 26 de mayo de 2006, sobre Técnicas de Reproducción Humana Asistida
    E.5 End points
    E.5.1Primary end point(s)
    Endometrium predecidulacion: endometrial thickness (mm), endometrial transformation after treatment according to criteria of Noyes at al., endometrial receptivity on day 5 as gene expression profile (ERA)
    Predecidualización del endometrio: grosor endometrial (mm), transformación endometrial tras finalizar el tratamiento según Criterios de Noyes at al., receptividad endometrial en día 5 según perfil de expresión génica (ERA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 5
    día 5
    E.5.2Secondary end point(s)
    Plasmatic levels of progesterone
    Plasmatic levels of estradiol
    Plasmatic levels of LH
    Niveles plasmáticos de progesterona
    Niveles plasmáticos de estradiol
    Niveles plasmáticos de LH
    E.5.2.1Timepoint(s) of evaluation of this end point
    Plasmatic levels of hormones: before starting treatment with progesterone (Day -2), Day of the programming of the follicular puncture, Day of the follicular puncture and the 5 th Day of the progesterone administration / ending of the study
    Determinación en sangre de niveles de hormonas día de inicio del tratamiento con progesterona (Día 1) y el día que finaliza el estudio (Día 5) (ng/ml; pg/ml y UI/ml)
    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) 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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    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
    ultima visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 24
    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 state24
    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 Decision2015-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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