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    Summary
    EudraCT Number:2014-001835-35
    Sponsor's Protocol Code Number:2014.TTRANSPORT
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-06-30
    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 ConcernedDenmark - DHMA
    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.
    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.
    A.3.2Name or abbreviated title of the trial where available
    Testosterone TRANSdermal gel for Poor Ovarian Responders Trial (T-TRANSPORT)
    A.4.1Sponsor's protocol code number2014.TTRANSPORT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02418572
    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 SponsorFundación Santiago Dexeus Font (Dexeus)
    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 supportUniversitair Ziekenhuis Brussel
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportFundación Santiago Dexeus Font (Dexeus)
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportBesins International
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportRoche Diagnostics
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportFerring Pharmaceuticals
    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.U.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressRambla Catalunya, 135, 3-1
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08008
    B.5.3.4CountrySpain
    B.5.4Telephone number034934086388
    B.5.5Fax number034934672899
    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 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
    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
    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 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
    Clinical pregnancy rate defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 7 weeks of gestation
    E.2.2Secondary objectives of the trial
    a.Ongoing pregnancy rate defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9-10 weeks of gestation
    b.Biochemical pregnancy defined as positive pregnancy test 2 weeks after embryo transfer
    c.Number of oocytes retrieved after oocyte retrieval before ICSI
    d.Cycle cancellation due to poor response
    e.Number of cycles reaching the stage of embryo transfer
    f.Number and quality of embryos
    g.Number of cycles with frozen supernumerary embryos
    h.Cycle cancellation due to adverse effects of medication
    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
    6. Use of Ferriman-Gallwey Hirsutism scoring system.
    Gallwey Hirsutism Score at the screening visit and on the day of after the last testosterone dose in order to evaluate the effect of androgen supplementation on hirsutism of individuals enrolled in the study.
    E.3Principal inclusion criteria
    Patients participating in the TTRANSPORT study will be women who are considered poor ovarian responders according to the “Bologna criteria” (Ferraretti et al., 2011).
    Subjects must fulfil the following criteria to be included in the study:
    1. All subjects must sign the Informed consent documents prior to screening evaluations.
    2.Age: between 18-43 years old.
    3.One of the features below:
    Infertile female <40 years old with
    i.≤ 3 oocytes in a previous cycle and AFC <7 OR
    ii.ovarian surgery/chemotherapy and AFC<7 OR
    iii.≤ 3 oocytes in at least 2 previous cycles with ≥300IU gonadotropins
    Infertile female ≥40 years old with
    i. ≤ 3 oocytes in a previous cycle OR
    ii. AFC <7.
    E.4Principal exclusion criteria
    1.Perimenopausal women with amenorrhea not having a regular cycle
    2.Basal FSH >20 IU/l
    3.Uterine malformations
    4.Recent history of any current untreated endocrine abnormality
    5.Unilateral or bilateral hydrosalpinx (visible on USS, unless clipped)
    6.Contraindications for the use of gonadotropins
    7.Recent history of severe disease requiring regular treatment
    8.Use of androgens during the last 3 months
    9.Patients with SHBG values <20nmol/L or >160nmol/L
    10.Azoospermia (sperm derived through FNA or TESE)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the clinical pregnancy rates, defined as defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 7 weeks of gestation. The primary efficacy endpoint is related to the primary trial objective.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 weeks of gestation
    E.5.2Secondary end point(s)
    The key secondary endpoints are:
    1.Cycle cancellation due to poor ovarian response
    2.Cycles with embryo transfer
    3.Ongoing pregnancy rate (the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9-10 weeks of gestation)
    4.Biochemical pregnancy (defined as positive pregnancy test 2 weeks after embryo transfer)
    5.Number of cumulus oocyte complexes (COCs) retrieved
    6.Number of MII oocytes retrieved
    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
    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 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 Yes
    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 EEA14
    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
    Spain
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months2
    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 state20
    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)
    In case of an ongoing pregnancy patients will be contacted ~9 months after the end of trial in order to report live birth and neonatal health data, including minor/major congenital anomalies, at birth and at 4 weeks after birth
    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 Decision2015-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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