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    Summary
    EudraCT Number:2011-002173-33
    Sponsor's Protocol Code Number:CLOFA
    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:2012-03-06
    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 number2011-002173-33
    A.3Full title of the trial
    Impact of clomiphene citrate administration during the early luteal phase on endocrine profile in agonist triggered GnRH antagonist in vitro fertilization cycles
    Impacto de la administración de citrato de clomifeno al inicio de la fase lútea en el perfil endocrino de ciclos de fecundación in vitro frenados con antagonistas de la GnRH y maduración ovocitaria con bolus de agonista
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of the clomiphene citrate intake on blood test and endometrium of women undergoing an in vitro fertilization treatment.
    Impacto de la toma de citrato de clomifeno en la analítica y el endometrio de mujeres bajo tratamiento de fecundación in vitro
    A.3.2Name or abbreviated title of the trial where available
    CLOFA
    A.4.1Sponsor's protocol code numberCLOFA
    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 SponsorFundació Privada EUGIN
    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 supportFundació Privada EUGIN
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Privada EUGIN
    B.5.2Functional name of contact pointClinical Research Information
    B.5.3 Address:
    B.5.3.1Street AddressTravessera de les Corts 314
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08029
    B.5.3.4CountrySpain
    B.5.4Telephone number00349332211227344
    B.5.5Fax number0034933631118
    B.5.6E-maildgarcia@eugin.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 OMIFIN comprimidos
    D.2.1.1.2Name of the Marketing Authorisation holderEFFIK, 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 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 INNCLOMIFENO CITRATO
    D.3.9.1CAS number 50-41-9
    D.3.9.3Other descriptive nameCLOMIFENE CITRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    Female infertility
    Infertilidad femenina
    E.1.1.1Medical condition in easily understood language
    Problems to get pregnant
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10016398
    E.1.2Term Female infertility
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    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 effect of the 5-day CC administration during luteal phase on serum LH levels in oocyte donors.
    Evaluar el efecto de la administración de citrato de clomifeno en fase lútea en los niveles séricos de LH
    E.2.2Secondary objectives of the trial
    To evaluate the impact of the CC administration on the development of the endometrium.
    Evaluar el efecto de la administración de citrato de clomifeno en fase lútea en el desarrollo endometrial
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title of sub-study: Impact of clomiphene citrate administration during the early luteal phase on endocrine profile in agonist triggered GnRH antagonist in vitro fertilization cycles: a cross-over study.
    Date: 25-05-2011
    Objective: to get the data of a second donation cycle of donors having previously participated in the main study.
    Título del subestudio: Impacto de la administración de citrato de clomifeno al inicio de la fase lútea en el perfil endocrino de ciclos de fecundación in vitro frenados con antagonistas de la GnRH y maduración ovocitaria con bolus de agonista: un estudio cruzado.
    Fecha: 25-05-2011
    Objetivo: obtener información sobre un segundo ciclo de donación de las donantes que previamente hayan participado en el estudio principal.
    E.3Principal inclusion criteria
    - Oocyte donors
    - Age between 18 and 35 years.
    - BMI between 18 and 29 kg/m2
    - Presence of both ovaries
    - Caucasian phenotype
    - Basal level of E2 < 80 pg/ml.
    - Basal level P4 < 1.6 ng/ml
    - FSH levels <12 IU/l at initiation of stimulation
    - Not taking contraceptive pill
    - Standard ovarian stimulation treatment and dose
    - Donantes de ovocitos
    - Edad entre 18 y 35 años
    - BMI entre 18 y 29 kg/m2
    - Presencia de ambos ovarios
    - Fenotipo caucásico
    - Nivel basal de E2 < 80 pg/ml.
    - Nivel basal de P4 < 1.6 ng/ml
    - Nivel de <12 IU/l al inicio de la estimulación
    - No toma de píldora anticonceptiva
    - Tratamiento de estimulación ovárica y dosis estándard
    E.4Principal exclusion criteria
    - Polycystic ovarian syndrome
    - Previous participation in the study
    - Síndrome de ovarios policístico
    - Participación previa en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    - Serum LH levels measured in the luteal phase
    - Niveles séricos de LH medidos en fase lútea
    E.5.1.1Timepoint(s) of evaluation of this end point
    - 1st: Basal levels. (FSH, E2, and P4 required for inclusion).
    - 2nd: On the ovulation triggering day.
    - 3rd: On day 1 after OPU.
    - 4th: On day 5 after OPU.
    - 5th: On day 7 after OPU.
    - 6th: On day 10 after OPU.
    - 7th: On the first day of next period.
    E.5.2Secondary end point(s)
    - Endometrial development on day 5 after Oocyte Pick-Up (OPU) studied by histological dating criteria of Noyes
    - Desarrollo endometrial en día 5 después de la punción folicular según criterios de Noyes
    E.5.2.1Timepoint(s) of evaluation of this end point
    - day 5 after OPU
    - día 5 después de la punción folicular
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Main study has parallel groups design; substudy has cross over design
    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
    No treatment
    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 of the last participant: first day of next period after the stimulated cycle of the last participant
    Última visita de la última participante incluida en el ensayo: primer día de su siguiente periodo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial 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: 10
    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 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 state10
    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)
    Normal treatment
    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 Decision2012-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-13
    P. End of Trial
    P.End of Trial StatusOngoing
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