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    Summary
    EudraCT Number:2018-002897-27
    Sponsor's Protocol Code Number:18E-Prg06
    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:2019-01-18
    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 number2018-002897-27
    A.3Full title of the trial
    A proof of concept, randomized, controlled clinical trial to assess the efficacy of subcutaneous progesterone (Prolutex) versus vaginal proges-terone (Progeffik) for endometrial preparation in women undergoing Frozen Embryo Transfer (FET) cycles.
    Ensayo clínico demostrativo preliminar, aleatorizado y controlado para evaluar la eficacia de la progesterona subcutánea (Prolutex) frente a la progesterona vaginal (Progeffik) en la preparación endometrial de mujeres sometidas a ciclos de transferencia de embriones congelados (TEC).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of Prolutex in frozen embryo transfer cycles at the blastocyst stage.
    Uso de Prolutex en los ciclos de transferencia de embriones congelados en el estadio de blastocisto
    A.3.2Name or abbreviated title of the trial where available
    PROGEX Study
    Estudio PROGEX
    A.4.1Sponsor's protocol code number18E-Prg06
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03701490
    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 SponsorIBSA, Institut Biochimique, S.A.
    B.1.3.4CountrySwitzerland
    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 supportIBSA, Institut Biochimique S.A.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioclever 2005,S.L.
    B.5.2Functional name of contact pointPilar Delgado
    B.5.3 Address:
    B.5.3.1Street AddressBalmes, 151, 1
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08008
    B.5.3.4CountrySpain
    B.5.4Telephone number+34934086388
    B.5.5Fax number+34934672899
    B.5.6E-mailregulatory@bioclever.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 PROLUTEX 25MG SOLUTION FOR INJECTION
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA, Institut Biochimique S.A.
    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.3.9.4EV 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 number22.48
    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 PROGEFFIK 200 MG SOFT CAPSULES
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Effik, S.A.
    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 Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal 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.3.9.4EV Substance CodeSUB10076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Tecniques.
    Infertilidad. Técnica de Reprodución Asistida.
    E.1.1.1Medical condition in easily understood language
    Assisted Reproductive Tecniques.
    Técnica de Reprodución Asistida.
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10073184
    E.1.2Term Embryo transfer
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to evaluate the effect on the clinical pregnancy rate at 4-5 weeks of gestation, using one of the two progesterone treatments with a different route of administration, either vaginal (Progeffik, 200 mg/8 h), or subcutaneous (Prolutex 25 mg/12 h), to support the luteal phase in subjects submitted to a frozen blastocyst embryo transfer.
    El objetivo de este estudio es evaluar el efecto sobre la tasa de embarazo clínico a las 4-5 semanas de gestación, utilizando uno de los dos tratamientos con progesterona con una vía de administración diferente, ya sea vaginal (Progeffik, 200 mg / 8 h), o subcutánea (Prolutex 25 mg / 12 h), para apoyar la fase lútea en sujetos sometidos a una transferencia de embriones de blastocistos congelados
    E.2.2Secondary objectives of the trial
    Efficacy Assessments:
    •Serum progesterone levels in visits V2 and V3
    •Frequency of uterine contractions (n of uterine contractions/min) on the day of the embryo transfer V2
    •Positive serum β-hCG pregnancy test rate (V3)
    •Implantation rate (V4)
    •Ongoing pregnancy rate 9-11 weeks after progesterone treatment start (V5)
    Abortion rate.

    In addition:

    •Analyse if there is a relationship between serum progesterone levels on the day of em-bryo transfer and the ongoing pregnancy rate in each of the 2 groups.
    •Analyse if there is a relationship between serum progesterone levels on the day of em-bryo transfer and the frequency of uterine contractions before transfer.
    •Analyse if there is a relationship between the frequency of uterine contractions on the day of embryo transfer and the clinical and ongoing pregnancy rate.
    Evaluaciones de eficacia:
    •Niveles séricos de progesterona en las visitas V2 y V3.
    •Frecuencia de las contracciones uterinas (n de contracciones uterinas / min) en el día de la transferencia de embriones V2
    •Tasa de prueba de embarazo β-hCG sérica positiva (V3)
    •Tasa de implantación (V4)
    •Tasa de embarazo en curso 9-11 semanas después del inicio del tratamiento con progesterona (V5)
    •Tasa de abortos.
    Adicionalmente:
    •Analizar si existe una relación entre los niveles de progesterona en suero en el día de la transferencia de embrio y la tasa de embarazo en curso en cada uno de los 2 grupos.
    •Analizar si existe una relación entre los niveles de progesterona en suero en el día de la transferencia de embrio y la frecuencia de las contracciones uterinas antes de la transferencia.
    •Analizar si existe una relación entre la frecuencia de las contracciones uterinas en el día de la transferencia de embriones y la tasa clínica y de embarazo en curso.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •18-49 years of age for subjects undergoing ET with donated oocytes (both inclusive);
    •18-37 years of age for subjects undergoing ET with autologous oocytes (both inclu-sive);
    •BMI <32 kg/m2;
    •Adequate endometrium preparation (Endometrial thickness > 7 mm) and E2 levels (>100 pg/ml) on the day progesterone treatment is started;
    •P4 levels <1.5 ng/ml on the day progesterone treatment is started;
    •Transfer of 1 or 2 frozen embryos at blastocyst stage;
    •Transfer of frozen embryos of quality A and/or B according to Gardner criteria1;
    •Semen from ejaculation either from the partner or from a bank;
    •≤ 3 previous ET (frozen and fresh) with no pregnancy;
    •Normal uterine cavity (i.e. no polyp or protruding sub-mucosal fibroid).
    18-49 años de edad para sujetos sometidos a ET con ovocitos donados (ambos inclusive);
    •18-37 años de edad para sujetos sometidos a ET con ovocitos autólogos (ambos inclusive);
    •IMC <32 kg / m2;
    •Preparación adecuada del endometrio (grosor endometrial> 7 mm) y niveles de E2 (> 100 pg / ml) el día en que se inicia el tratamiento con progesterona;
    •Niveles de P4 <1.5 ng / ml el día en que se inicia el tratamiento con progesterona;
    •Transferencia de 1 o 2 embriones congelados en la etapa de blastocisto;
    •Transferencia de embriones congelados de calidad A y / o B según los criterios de Gardner1;
    •Semen de eyaculación ya sea de la pareja o de un banco;
    •≤ 3 ET anteriores (congeladas y frescas) sin embarazo;
    •Cavidad uterina normal (es decir, sin pólipo o fibroma sub-mucosa saliente).
    E.4Principal exclusion criteria
    •Presence of functional follicles > 10 mm of diameter on the day progesterone treatment is started;
    •Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
    •Stage III or IV endometriosis (endometriomas);
    •Hydrosalpinx;
    •Pregnancy or lactation;
    •Malformations of the sexual organs incompatible with pregnancy;
    •Subjects affected by pathologies associated with any contraindication of being preg-nant;
    •Known allergy to progesterone preparations or their excipients;
    •Uncontrolled adrenal or thyroid dysfunction;
    •Undiagnosed vaginal haemorrhage;
    •History of, or current arterial disease;
    •Subjects with hepatic impairment;
    •Human Immunodeficiency Virus, Hepatitis B Virus or Hepatitis C Virus seropositive;
    •Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
    •High grade cervical dysplasia;
    •Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders;
    •Currently dependent on alcohol, drugs or psychotropic drugs;
    •History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages wherein pregnancy developed to a minimum of a gestational sac on TVUS;
    •Participation in a concurrent clinical trial or another trial within the past 2 months;
    •Use of concomitant medications that might interfere with the study evaluation: hor-monal treatments other than those used in the study, except thyroid hormones.
    Presencia de folículos funcionales> 10 mm de diámetro en el día en que se inicia el tratamiento con progesterona;
    •Fibromas uterinos intramurales que distorsionan la cavidad uterina o los pólipos> 1 cm;
    •Endometriosis en etapa III o IV (endometriomas);
    •Hydrosalpinx;
    •Embarazo o lactancia;
    •Malformaciones de los órganos sexuales incompatibles con el embarazo;
    •Sujetos afectados por patologías asociadas a cualquier contraindicación de embarazo.
    •Alergia conocida a las preparaciones de progesterona o sus excipientes;
    •Disfunción suprarrenal o tiroidea no controlada;
    •Hemorragia vaginal no diagnosticada;
    •Historia de, o enfermedad arterial actual;
    •Sujetos con insuficiencia hepática;
    •Virus de inmunodeficiencia humana, virus de la hepatitis B o virus de la hepatitis C seropositivos;
    •Neoplasias (actuales) o antecedentes de neoplasia que pueden responder a la progesterona;
    •Displasia cervical de alto grado;
    •Tromboflebitis activa o trastornos tromboembólicos, o antecedentes de tromboflebitis asociada a hormonas o trastornos tromboembólicos;
    •Actualmente dependiente de alcohol, drogas o psicotrópicos;
    •Historial de pérdida recurrente de embarazo definida como 3 o más abortos espontáneos en los que el embarazo se desarrolló hasta un mínimo de un saco gestional en TVUS;
    •Participación en un ensayo clínico concurrente u otro ensayo en los últimos 2 meses;
    •Uso de medicamentos concomitantes que podrían interferir con la evaluación del estudio: tratamientos hormonales distintos a los utilizados en el estudio, excepto las hormonas tiroideas
    E.5 End points
    E.5.1Primary end point(s)
    Clinical pregnancy rate
    Tasa de embarazo clínico
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks of gestation
    6 semanas de gestación
    E.5.2Secondary end point(s)
    -Serum progesterone levels at visits V2 and V3
    -Frequency of uterine contractions (n of uterine contractions/min) on the day of the embryo transfer V2
    -Positive pregnancy (serum β-hCG) test rate (V3)
    -Implantation rate (V4)
    -Ongoing pregnancy rate 9-11 weeks after progesterone treatment start (V5)
    -Abortion rate
    -Niveles séricos de progesterona en las visitas V2 y V3.
    -Frecuencia de las contracciones uterinas (n de contracciones uterinas / min) en el día de la transferencia de embriones V2
    -Tasa de prueba positiva de embarazo (β-hCG) (V3)
    -Tasa de implantación (V4)
    -Tasa de embarazo en curso 9-11 semanas después del inicio del tratamiento con progesterona (V5)
    -Tasa de aborto
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 weeks of gestation
    6 semanas de gestación
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Estudio abierto de etiquetas. La evaluación de las contracciones uterinas se realizará a ciegas.
    Open label study. The assessment of the uterine contractions will be per-formed in a blind way
    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 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 concerned2
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 212
    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 state212
    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 Decision2018-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-19
    P. End of Trial
    P.End of Trial StatusOngoing
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