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    Summary
    EudraCT Number:2012-002477-59
    Sponsor's Protocol Code Number:CDGP1
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-20
    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 ConcernedFinland - Fimea
    A.2EudraCT number2012-002477-59
    A.3Full title of the trial
    Constitutional Delay of Growth and Puberty: towards evidence-based treatment
    Viivästyneen puberteetin hoito aromataasin estäjällä: randomisoitu kontrolloitu kliininen lääketutkimus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Constitutional Delay of Growth and Puberty: towards evidence-based treatment
    Poikien viivästyneen murrosiän hoito naishormonin muodostumisen estäjällä: Satunnaistettu, kontrolloitu lääketutkimus
    A.4.1Sponsor's protocol code numberCDGP1
    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 SponsorTaneli Raivio, Helsingin yliopistollinen keskussairaala
    B.1.3.4CountryFinland
    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 supportLastentautien tutkimussäätiö
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsingin yliopistollinen keskussairaala
    B.5.2Functional name of contact pointLastenendokrinologian vastaanotto
    B.5.3 Address:
    B.5.3.1Street AddressStenbäckinkatu 11
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post codePL 281
    B.5.3.4CountryFinland
    B.5.6E-mailmatti.hero@hus.fi
    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 Letrozol Orion 2.5 mg tabletti
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 INNLETROZOLE
    D.3.9.1CAS number 112809-51-5
    D.3.9.4EV Substance CodeSUB08444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5
    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.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 Sustanon "250" injektioneste, liuos
    D.2.1.1.2Name of the Marketing Authorisation holderN.V.Organon, Oss, Alankomaat
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameSustanon "250"
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtestosteronipropionaatti
    D.3.9.3Other descriptive nameTESTOSTERONE PROPIONATE
    D.3.9.4EV Substance CodeSUB04743MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtestosteronifenyylipropionaatti
    D.3.9.3Other descriptive nameTESTOSTERONE PHENYLPROPIONATE
    D.3.9.4EV Substance CodeSUB04742MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtestosteroni-isokapronaatti
    D.3.9.3Other descriptive nameTESTOSTERONE ISOCAPROATE
    D.3.9.4EV Substance CodeSUB04740MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtestosteronidekanoaatti
    D.3.9.3Other descriptive nameTESTOSTERONE DECANOATE
    D.3.9.4EV Substance CodeSUB04735MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    constitutional delay of puberty
    viivästynyt puberteetti
    E.1.1.1Medical condition in easily understood language
    delayed puberty
    viivästynyt murrosikä
    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 PT
    E.1.2Classification code 10012205
    E.1.2Term Delayed puberty
    E.1.2System Organ Class 10014698 - Endocrine 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 study in boys with constitutional delay of puberty, showing very early signs of puberty, whether treatment with the aromatase inhibitor letrozole promotes the progression puberty more efficiently than the current standard of care, low-dose testosterone therapy.
    Tutkia jouduttaako hoito aromataasi-inhibiittori letrotsolilla poikien murrosiän kehitystä tehokkaammin kuin tavanomainen, pieniannoksinen testoteronihoito. Tutkimuspopulaatio koostuu pojista joilla murrosikä on selvästi viivästynyt, mutta aivan ensimmäiset murrosiän merkit on havaittavissa.
    E.2.2Secondary objectives of the trial
    To study whether aromatase inhibitor treatment also results in faster post-treatment progression of puberty, as compared with low-dose testosterone; to study treatment effect on several sex steroid-responsive tissues/pathways, such as bone mineralization, lipid profile, markers of maturing spermatogenesis; to study the treatment influence on measures psychological well-being
    Tutkia johtaako aromataasi-inhibiittorihoito myös hoidon päättymisen jälkeen nopeampaan puberteetin etenemiseen kuin annettu perinteinen, pieniannoksinen mieshormonihoito; verrata aromataasi-inhibiittorihoidon ja tavanomaisen mieshormonihoidon vaikutuksia prosesseihin, jotka ovat sukupuolihormonisäätelyn alkaisia, kuten luuston mineralisaatio ja kehitys, lipidiprofiili ja kypsyvä siittiön muodostus. Lisäksi vertaamme testosteroni- ja aromataasi-inhibiittorihoidon vaikutuksia psyykkiseen hyvinvointiin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Clinical and biochemical criteria: Age 14 yrs or more, mean testicular volume >2.5 mL and <4mL, serum testosterone <5 nM and the adolescent wants medical intervention. No signs of chronic diseases accounting for the delayed puberty.
    Biochemical criteria: As above, but serum testosterone >2 nM and normal serum DHEAS, even if the mean testicular volume is less than 2.5 ml.
    E.4Principal exclusion criteria
    Chronic diseases, primary hypogonadism, chromosomal anomalies, chronic medication that potentially adversely affects bone mineralization (excluding inhaled corticosteroid treatment).
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measures are: testicular volume, urinary LH levels, and circulating hormone values reflecting the activity of the hypothalamic-pituitary-gonadal axis (especially, basal and GnRH-induced LH, FSH, testosterone, inhibin B, AMH levels). Changes in these parameters during treatment are compared between the testosterone and letrozole groups
    E.5.1.1Timepoint(s) of evaluation of this end point
    After all patients in the randomized study have completed the 12 months of follow-up.
    E.5.2Secondary end point(s)
    The secondary end points are changes in
    bone mineral density and structure as evaluated by dual-energy x-ray absorptiometry and peripheral quantitative CT; measures of social functioning, body image and self esteem; lipid profile; markers of maturing spermatogenesis
    E.5.2.1Timepoint(s) of evaluation of this end point
    After all patients in the randomized study have completed the 12 months of follow-up.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 concerned3
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 50
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    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 state50
    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
    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 Decision2012-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-05
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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