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    Summary
    EudraCT Number:2014-001835-35
    Sponsor's Protocol Code Number:2014.TTRANSPORT
    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:2015-06-01
    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 number2014-001835-35
    A.3Full title of the trial
    Transdermal testosterone gel for poor ovarian responders. A multicenter double-blind placebo controlled randomized trial.
    Gel de testosterona transdérmico para pacientes con baja respuesta ovárica. Ensayo multicentrico, aleatorizado, doble ciego controlado con placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Transdermal testosterone gel for poor ovarian responders. A multicenter double-blind placebo controlled randomized trial.
    Gel de testosterona transdérmico para pacientes con baja respuesta ovárica. Ensayo multicentrico, aleatorizado, doble ciego controlado con placebo
    A.3.2Name or abbreviated title of the trial where available
    Testosterone TRANSdermal gel for Poor Ovarian Responders Trial (T-TRANSPORT)
    Gel de testosterona transdérmico para pacientes con baja respuesta ovárica. (T-TRANSPORT)
    A.4.1Sponsor's protocol code number2014.TTRANSPORT
    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 SponsorUniversitair Ziekenhuis Brussel
    B.1.3.4CountryBelgium
    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 supportUniversitair Ziekenhuis Brussel
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitair Ziekenhuis Brussel
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressLaarbeeklaan 101
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1090
    B.5.3.4CountryBelgium
    B.5.4Telephone number003224776648
    B.5.5Fax number003224776649
    B.5.6E-mailStudieverpleegkundigen_CRG@uzbrussel.be
    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 ANDROGEL
    D.2.1.1.2Name of the Marketing Authorisation holderBesins international
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameAndrogel
    D.3.4Pharmaceutical form Transdermal gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    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 number5.5
    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 placeboTransdermal gel
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Infertility in women with poor ovarian response to stimulation for IVF/ICSI
    Infertilidad en mujeres con baja respuesta a la estimulación ovárica con FIV/ICSI
    E.1.1.1Medical condition in easily understood language
    Poor ovarian responders are women undergoing infertility treatment who failed to produce adequate number of oocytes after ovarian stimulation treatment in previous treatment cycles for IVF/ICSI
    Mujeres con baja respuesta ovárica sometidas a tratamiento de infertilidad que no lograron producir un número adecuado de ovocitos trás tratamiento de estimulación ovárica en ciclos previos deFIV/ICSI
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10021928
    E.1.2Term Infertility female
    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
    The aim of the study is to determine whether pre-treatment with transdermal testosterone gel (TTG) results in significantly higher clinical pregnancy rates compared with placebo in poor ovarian responders fulfilling the Bologna criteria after treatment with HP-hMG in a long GnRH agonist protocol.
    El objetivo del estudio es determinar si el tratamiento previo con gel de testosterona transdérmico ( TTG ) se traduce en un mayor porcentaje de embarazo clínico en comparación con placebo, en pacientes con baja respuesta ovárica según los criterios de Bolonia después de tratamiento con HP- hMG en un protocolo largo con Agonista GnRH .
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate whether testosterone pretreatment may improve ovarian response and embryo quality in women undergoing ovarian stimulation for IVF/ICSI and whether it may have an impact on ovarian reserve markers such as antimullerian hormone and antral follicle count.
    Los objetivos secundarios son evaluar si el tratamiento previo con testosterona puede mejorar la respuesta ovárica y calidad embrionaria en mujeres sometidas a estimulación ovárica con FIV / ICSI y si puede tener un impacto en los marcadores de reserva ovárica , como la hormona antimülleriana y recuento de folículos antrales .
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Evaluation of endocrine profile during androgen supplementation
    Blood samples will be collected from each of the participating centres and will be kept frozen for analysis in the central lab in UZ Brussel. Endocrine profile analysis will be performed (Total testosterone (TT), DHEAS, Sex hormone-binding globulin (SHBG), IGF-1etc.) and will be compared between testosterone and placebo groups
    2. Differences in ovarian reserve markers
    Comparisons between AMH levels and AFC will be evaluated during testosterone and placebo supplementation and blood samples will be collected from each of the participating centres and will be kept frozen for analysis in the central lab in UZ Brussel. Analysis of AMH and AFC and will be compared between testosterone and placebo groups in order to evaluate the effect of testosterone ovarian reserve markers
    3. Follicular fluid analysis
    The participating centre and centres with expertise of collecting follicular fluid will collect follicular fluid samples from oocyte retrieval and separate analysis will be performed in order to evaluate concentration or testosterone, IGF1, FSH receptors etc. in the follicular fluid and correlate values with androgen levels in the blood.
    4 Use of Fertiqol questionnaire to evaluate quality of life for patients prior to initiating treatment and on the day of following termination of testosterone treatment.
    We will use the validated Fertiqol questionnaire (psych.af.ac.uk/fertiqol) to evaluate quality of life at the screening visit and on the day after the last testosterone dose in order to evaluate the effect of androgen supplementation on quality of life of individuals enrolled in the study ( find questionnaires attached)
    5. Use of FSFI and FSDS-R questionnaires to evaluate sexual function and sexual distress
    We will use the validated FSFI and FSDS-R questionnaires to evaluate sexual function and sexual distress at the screening visit and on the day of after the last testosterone dose in order to evaluate the effect of androgen supplementation on sexual life of individuals enrolled in the study
    1. Evaluación del perfil endocrino durante la suplementación de andrógenos.

    Las muestras de sangre se recogerán de cada uno de los centros participantes y se mantendrán congelados para su análisis en el laboratorio central en UZ Brussel . Se llevará a cabo el análisis del perfil de endocrino ( testosterona total ( TT ) , DHEAS , SHBG , IGF, - 1etc . ) y se comparara entre los grupos de testosterona y placebo

    2. Diferencias en los marcadores de reserva ovárica

    Las comparaciones entre los niveles de AMH y AFC serán evaluados durante la suplementación con testosterona y placebo, y se recogerán muestras de sangre de cada uno de los centros participantes y se mantendrán congeladas para su análisis en el laboratorio central en UZ Brussel . Los análisis de AMH y AFC se copararan entre los grupos placebo y testosterona con el fin de evaluar el efecto de los marcadores de reserva de testosterona ovárica


    3. Análisis del líquido folicular

    El centro participante y centros con experiencia en la recogida de líquido folicular recogerán muestras de líquido folicular de recuperación de los ovocitos, y se llevará a cabo un análisis separado con el fin de evaluar la concentración de la testosterona, IGF1 , receptores de FSH, etc. en el líquido folicular y de correlacionar los valores con los niveles de andrógenos en la sangre.

    4.Uso del cuestionario Fertiqol para evaluar la calidad de vida de los pacientes antes de iniciar el tratamiento y en el día de después de terminar el tratamiento con testosterona .
    Se utilizará el cuestionario validado Fertiqol ( psych.af.ac.uk/fertiqol ) para evaluar la calidad de vida en la visita de selección y en el día después de la última dosis de testosterona con el fin de evaluar el efecto de la suplementación de andrógenos en la calidad de vida de los individuos incluidos en el estudio ( ver cuestionarios adjuntos )

    5. Uso de los cuestionarios FSFI y SADA -R para evaluar la función sexual y disfunción sexual

    Se utilizará el cuestionario FSFI validado y el cuestionarios SADA -R para evaluar la función sexual y la disfunción sexual en la visita de selección y en el día de después de la última dosis de testosterona con el fin de evaluar el efecto de la suplementación de andrógenos en la vida sexual de las personas incluidas en el estudio
    E.3Principal inclusion criteria
    Patients participating in the TTRANSPORT study will be women who are considered poor ovarian responders according to the ?Bologna criteria? (Ferrarretti et al., 2011). Patients between 18-43 years old will be eligible.

    Patients should fulfill 2 out of 3 of the following criteira:
    1. Age >or =40 years
    2. At least 1 previous stimulated IVF/ICSI cycle with ?3 oocytes retrieved
    3. Low ovarian reserve markers (antral follicle count <7 or antimullerian hormone levels<1.1ng/ml)

    Women < 40 years old with normal AFC or AMH who underwent at least 2 previous stimulated IVF/ICSI cycles with ? 3 oocytes retrieved after maximum stimulation for IVF/ICSI, will also be considered eligible
    Los pacientes que participantes en el estudio TTRANSPORT serán mujeres con baja respuesta ovárica según los " criterios de Bolonia " ( Ferrarretti et al. , 2011 ) . Las pacientes entre 18-43 años de edad serán elegibles.

    Los pacientes deben cumplir 2 de cada 3 de los siguientes criterios :

    1. Edad > o = 40 años

    2. Al menos 1 ciclo de FIV/ICSI con 3 ovocitos recuperados
    3. Marcadores de reserva ovárica bajos (recuento de folículos antrales < 7 o niveles de hormona muleriana < 1.1ng / ml )

    Las mujeres <40 años de edad con AFC normal o AMH que se sometieron al menos a 2 ciclos de estimulación con FIV / ICSI y con 3 ovocitos recuperados después de la estimulación máxima con FIV / ICSI , también serán consideradas elegibles.
    E.4Principal exclusion criteria
    1.Perimenopausal women with amenorrhea not having a regular cycle
    2.Uterine abnormalities
    3.Recent history of any current untreated endocrine abnormality
    4.Unilateral or bilateral hydrosalpinx (visible on USS, unless clipped)
    5.Contraindications for the use of gonadotropins
    6.Recent history of severe disease requiring regular treatment
    7.Use of androgens during the last 3 months
    8.Patients with shBG values <20nmol/L or >160nmol/L
    9.Azoospermia ( sperm derived through TESE)
    1. Mujeres perimenopáusicas con amenorrea y sin ciclo regular

    2. Anomalias uterinas

    3. Historial reciente de cualquier anomalía endocrina sin tratar

    4. Hidrosalpinx unilateral o bilateral (visible en USS , excepto ligado )

    5. Contraindicaciones para el uso de gonadotropinas

    6. Historial reciente de enfermedad grave que requiere tratamiento regular

    7. Uso de andrógenos durante los últimos 3 meses

    8. Patients con valores de SHBG < 20nmol / L o > 160nmol / L

    9. Azoospermia ( espermatozoides obtenidos a través TESE )
    E.5 End points
    E.5.1Primary end point(s)
    Clinical pregnancy rate defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 7 weeks of gestation
    Tasa de embarazo clínico definida como la presencia de saco gestacional intrauterino con un polo embrionario que muestra actividad cardíaca a las 7 semanas de gestación
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 weeks of gestation
    7 semanas de gestación
    E.5.2Secondary end point(s)
    1. Ongoing pregnancy
    The presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9-10 weeks of gestation.

    2. Biochemical pregnancy
    Positive pregnancy test 2 weeks after embryo transfer

    3.Number of cumulus oocyte complexes (COCs) retrieved
    The outcome will be evaluated on the day of oocyte retrieval

    4.Number of MII oocytes retrieved
    The outcome will be evaluated on the day of oocyte retrieval

    5. Cycle cancellation due to poor ovarian response
    On stimulation day 10 (visit 8) the cycle will be cancelled in case of no follicular or monofollicular development

    6. Number of cycles reaching the stage of embryo transfer
    The outcome will be evaluated 2-3 days after oocyte retrieval

    7. Number and quality of embryos
    The outcome will be evaluated 2-3 days after oocyte retrieval

    8. Number of cycles with frozen supernumerary embryos
    The outcome will be evaluated 5 days after oocyte retrieval or 2-6 days after embryo transfer in case of an embryo transfer


    The pre-specified safety endpoint is the percentage of subjects with cycle cancellation due to serious adverse events (AE). Serious adverse events of medication are defined in accordance to FDA guidelines. http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm
    All other adverse vent s will be recorded in the CRF (case report form) in the following order:
    1.All adverse events
    2.Serious adverse event
    3.Adverse event prompting withdrawal
    4.Application-site reaction
    5.Androgenic events
    6.Hirsutism ( evaluation by the use of the Ferriman Gallwey Hirsutism Score- attached form)
    7. Other events
    1. embarazo en curso

    La presencia de saco gestacional intrauterino con un polo embrionario que muestra actividad cardíaca a los 9-10 semanas de gestación.

    2. embarazo bioquímico

    Prueba de embarazo positiva 2 semanas después de la transferencia de embriones

    3. Número de complejos de ovocitos cumulus (AOC) recuperados

    El resultado se evaluará el día de la obtención de ovocitos

    4. Número de ovocitos MII obtenidos

    El resultado se evaluará el día de la obtención de ovocitos



    5. Cancelación del ciclo por baja respuesta ovárica
    El décimo día de estimulación (visita 8) el ciclo se cancelará en caso de que no haya desarrollo folicular o desarrollo monofollicular

    6. Número de ciclos que alcanzan la etapa de transferencia de embriones
    El resultado se evaluará 2-3 días después de la obtención de ovocitos

    7. Número y calidad de los embriones
    El resultado se evaluará 2-3 días después de la obtención de ovocitos

    8. Número de ciclos con embriones congelados supernumerarios
    El resultado se evaluará 5 días después de la obtención de ovocitos o 2-6 días después de la transferencia de embriones en caso de transferencia de embriones


    El objetivo de seguridad pre-especificado es el porcentaje de sujetos con interrupción del ciclo debido a acontecimientos adversos graves (SAE). Los acontecimientos adversos graves de la medicación se definen de acuerdo a las directrices de la FDA. http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm

    El resto de acontecimientos adversos se registrará en el CRD (cuaderno de recogida de datos) en el siguiente orden:

    1. Todos los Acontecimientos adversos
    2. Acontecimientos adversos serios
    3. Acontecimiento adverso que provoca la retirada
    4. Reacción en el lugar de aplicación
    5. Acontecimiento androgenico
    6. Hirsutismo (evaluado según el Ferriman Gallwey Hirsutism Scorecard form-adjunto)
    7. Otros acontecimientos
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 9-10 weeks of gestation
    2. 2 weeks after embryo transfer
    3. 10 -20 days from initiation of ovarian stimulation
    4. 10-20 days from initiation of ovarian stimulation
    5. 10 days after initiation of daily injections of HP-hMG
    6. 10-20 days from initiation of ovarian stimulation
    7. 10-20 days from initiation of ovarian stimulation
    8. 10-20 days from initiation of ovarian stimulation
    1. 9-10 semanas de gestación
    2. 2 semanas después de la transferencia de embriones
    3. 10 -20 días desde el inicio de la estimulación ovárica
    4. 10-20 días desde el inicio de la estimulación ovárica
    5. 10 días después del inicio de las inyecciones diarias de HP- hMG
    6. 10-20 días desde el inicio de la estimulación ovárica
    7.10-20 días desde el inicio de la estimulación ovárica
    8. 10-20 días desde el inicio de la estimulación 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 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 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) 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Denmark
    Russian Federation
    Spain
    Sweden
    Switzerland
    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
    last visit of the last subject enter LVLS
    ultima visita del ultima sujeto incluido (UVUS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 400
    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 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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 400
    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 Decision2015-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-13
    P. End of Trial
    P.End of Trial StatusOngoing
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