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    Summary
    EudraCT Number:2016-004302-33
    Sponsor's Protocol Code Number:TESTOPRIM
    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:2017-01-25
    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 number2016-004302-33
    A.3Full title of the trial
    Clinical effect of follicular preparation with testosterone in poor ovarian response: a randomized controlled clinical trial (TESTOPRIM)
    Efecto clínico de la preparación folicular con testosterona en baja respuesta ovárica: ensayo clínico randomizado y controlado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to assess de effect of testosterone in patients with poor ovarian response.
    Ensayo clínico para evaluar el efecto de la testosterona en pacientes con baja respuesta ovárica.
    A.4.1Sponsor's protocol code numberTESTOPRIM
    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 INVESTIGACIÓN SANITARIA LA FE
    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 supportIIS LA FE
    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 FE
    B.5.2Functional name of contact pointUREC
    B.5.3 Address:
    B.5.3.1Street AddressAV. FERNANDO ABRIL MARTORELL 106
    B.5.3.2Town/ cityVALENCIA
    B.5.3.3Post code46026
    B.5.3.4CountrySpain
    B.5.4Telephone number0034961246711
    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 Testim 50 mg
    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 nameTestim
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTESTOSTERONE
    D.3.9.1CAS number 58-22-0
    D.3.9.4EV Substance CodeSUB10937MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 with Poor Ovarian Response
    Infertilidad con Baja Respuesta Ovárica
    E.1.1.1Medical condition in easily understood language
    Infertility with Poor Ovarian Response
    Infertilidad con Baja Respuesta Ovárica
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10016398
    E.1.2Term Female infertility
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determining whether a Follicular preparation with transdermal testosterone increases the number of mature oocytes retrieved in patients diagnosed with Poor Ovarian Response and which testosterone administration regimen is more effective for this purpose.
    Determinar si la preparación folicular con testosterona transdérmica aumenta el número de ovocitos maduros recuperados en pacientes diagnosticadas de BRO y qué régimen de administración de testosterona es más efectivo para este fin.
    E.2.2Secondary objectives of the trial
    To assess the effect of testosterone in its different regimens on other cycle parameters such as the number of follicles on the day of HCG, number of good quality embryos obtained or duration of stimulation.
    To investigate the effect of testosterone on cycle outcome parameters, ie clinical gestation rate and evolutionary.
    To compare the hormonal profiles obtained between the different groups in the different moments of measurement throughout the treatment.
    Evaluar el efecto de la testosterona en sus distintos regímenes sobre otros parámetros de ciclo como el número de folículos el día de HCG, número de embriones de buena calidad obtenidos o duración de la estimulación.
    Investigar el efecto de la testosterona sobre parámetros de resultado de ciclo, es decir, tasa de gestación clínica y evolutiva.
    Comparar los perfiles hormonales obtenidos entre los distintos grupos en los distintos momentos de medición de los mismos a lo largo del tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed Informed consent prior to the completion of any procedure related to the clinical trial.
    - Female, between 18 and 40 years at the time of randomization (both ages included).
    -Prior diagnosis of poor ovarian response (POR) according to ESHRE Bologna criteria. Patients must meet at least 2 of the following:
    • Advanced maternal age (40 years or more) or any other risk factor for POR.
    • A previous POR (3 oocytes or less) with a conventional ovarian stimulation protocol.
    • Abnormal ovarian reserve test (RFA <5-7 or AMH 3.3-7.9 pmol / l).
    - Consentimiento informado firmado previamente a la realización de cualquier procedimiento relacionado con el ensayo clínico.
    - Mujer entre 18 y 40 años de edad en el momento de la aleatorización (ambas edades incluidas).
    - Diagnóstico previo de baja respuesta ovárica según criterios ESHRE Bologna, las pacientes deben cumplir al menos 2 de los siguientes:
    • Edad materna avanzada (40 años o más) o cualquier otro factor para baja reserva ovárica.
    • BRO previa (3 ovocitos o menos) con un protocolo de estimulación ovárica convencional.
    • Test de reserva ovárica anormal (RFA <5-7 o AMH 3.3-7.9 pmol/l).
    E.4Principal exclusion criteria
    Diagnosis of severe endometriosis (Grade III-IV).
    History of previous ovarian surgery.
    Presence of uterine malformations, corrected or not.
    Presence of uterine pathology defined as submucous myomas or endometrial polyps, documented by transvaginal ultrasound.
    Couples with severe male factor defined as REM <1 or azoospermia.
    Hydrosalpinx unilateral or bilateral uncorrected.
    Perimenopausal patients with irregular menstrual cycles.
    Concurrent untreated endocrine disorders.
    Patients who have participated in a clinical trial in a period of less than one month.
    Known allergy to the drug.
    Patients who have received androgen treatment within 3 months prior to inclusion in the study.
    BMI> 32 kg / m2
    Diagnóstico de endometriosis severa (Grado III-IV).
    Antecedentes de cirugía ovárica previa.
    Presencia de malformaciones uterinas corregidas o no.
    Presencia de patología uterina definida como miomas submucosos o pólipo endometrial, documentados por ecografía transvaginal.
    Parejas con factor masculino severo definido como REM< 1 o azoospermia.
    Hidrosálpinx unilateral o bilateral no corregido.
    Pacientes perimenopáusicas con ciclos menstruales irregulares.
    Alteraciones endocrinas concurrentes no tratadas.
    Haber participado en un ensayo clínico con medicamentos en un periodo inferior a un mes.
    Alergia conocida al fármaco.
    Haber recibido tratamiento con andrógenos en los 3 meses previos a la inclusión en el estudio.
    IMC >32 kg/m2
    E.5 End points
    E.5.1Primary end point(s)
    Total number of mature oocytes obtained at follicular puncture.
    Número total de ovocitos maduros obtenidos en la punción folicular.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 hours after induction of ovulation with recombinant HCG.
    36 horas después de la inducción de la ovulación con HCG recombinante.
    E.5.2Secondary end point(s)
    Number of obtained embryos
    Implantation rate
    Gestation Rate
    Número de embriones obtenidos
    Tasa de implantación
    Tasa de gestación
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 days after ovarian puncture.
    6 días después de la punción ovárica.
    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 No
    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 Yes
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Grupo control- sin tratamiento
    Control group- no treatment
    E.8.2.4Number of treatment arms in the trial3
    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 subject undergoing the trial
    Última visita del último paciente participando en el ensayo.
    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
    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: 63
    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 No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state63
    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 Decision2017-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-28
    P. End of Trial
    P.End of Trial StatusCompleted
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