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    The EU Clinical Trials Register currently displays   38927   clinical trials with a EudraCT protocol, of which   6396   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-004475-23
    Sponsor's Protocol Code Number:47410
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-12-08
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-004475-23
    A.3Full title of the trial
    Enhancement of exposure therapy for social anxiety disorder with testosterone: A randomized clinical trial
    De toegevoegde waarde van testosteron bij exposuretherapie voor sociale angststoornis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Testosterone and exposure therapy for SAD
    Testosteron en exposuretherapie voor sociale angststoornis
    A.4.1Sponsor's protocol code number47410
    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 SponsorRadboud University Nijmegen
    B.1.3.4CountryNetherlands
    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 supportRadboud University Nijmegen
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportPro Persona
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Nijmegen
    B.5.2Functional name of contact pointProfessor Roelofs
    B.5.3 Address:
    B.5.3.1Street AddressMontessorilaan 3
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525HR
    B.5.3.4CountryNetherlands
    B.5.6E-mailk.roelofs@psych.ru.nl
    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 No
    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 nameTestosterone
    D.3.4Pharmaceutical form Sublingual spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual 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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboSublingual spray, solution
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Social Anxiety Disorder (Social Phobia)
    Sociale Angststoornis (Social Phobia)
    E.1.1.1Medical condition in easily understood language
    Social Anxiety
    Sociale angst
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10041250
    E.1.2Term Social phobia
    E.1.2System Organ Class 10037175 - Psychiatric 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 investigate the efficacy of testosterone enhanced exposure therapy for social anxiety disorder.
    Primaire doelstelling is de toegevoegde waarde van testosteron bij exposuretherapie voor sociale angststooornis te onderzoeken.
    E.2.2Secondary objectives of the trial
    To assess which variables predict outcome.
    Predicerende factoren identificeren.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Woman, 18-45 years old
    - Social Anxiety Disorder (SAD) as established with a structured interview (MINI)
    - Self reported SAD symptoms of at least moderate severity (score > 30 on the Liebowitz Social Anxiety Scale)
    - Vrouw, tussen de 18 en 45 jaar
    - Diagnose sociale fobie, zoals vastgesteld met een gestructureerd klinisch interview (MINI)
    - Zelfgerapporteerde sociale angstsymptomen van minimaal matige ernst (score van >30 op de Liebowitz Social Anxiety Scale)
    E.4Principal exclusion criteria
    - Psychosis or delusion disorders (current or in the past)
    - Suicidality
    - Mental retardation
    - Substance abuse or dependence or alcohol abuse or dependence
    - Somatic illness
    - Women of childbearing potential that are not willing to use an active form of birth-control during the trial
    - Pregnancy or lactation
    - Infertility
    - Antipsychotic medication
    - Participants that use antidepressants or benzodiazepines will not be excluded, but have to be on a stable dose for at least 6 weeks prior to enrollment.
    - Insufficient ability to speak and write Dutch
    - Psychotische of waanstoornis (huidig of in de voorgeschiedenis)
    - Suicidaliteit
    - Zwakbegaafdheid
    - Middelen misbruik of afhankelijkheid of alcohol misbruik of afhankelijkheid
    - Somatische aandoeningen
    - Antipsychotische medicatie
    - Het gebruik van antidepressiva of benzodiazepines is geen exclusiecriterium, maar deelnemers moeten minimaal zes weken voor inclusie op een stabiele dosering zitten.
    - Vrouwen in de vruchtbare leeftijd die niet bereid zijn een actieve vorm van anticonceptie te gebruiken tijdens de trial
    - Zwangerschap of borstvoeding
    - Onvruchtbaarheid
    - Onvoldoende beheersing van de Nederlandse taal
    E.5 End points
    E.5.1Primary end point(s)
    Our main outcome is reduction of social anxiety disorder symptoms, as assessed by the Liebowitz Social Anxiety Scale (LSAS).
    Primaire uitkomstmaat is reductie van sociale angstklachten, zoals gemeten met de Liebowitz Sociale Anxiety Scale (LSAS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Posttreatment, 1 month FU
    Na de behandeling, en 1 maand follow-up
    E.5.2Secondary end point(s)
    Subsequently, outcome will be assessed by other self-report questionnaires (Social Phobia Anxiety Inventory (SPAI) and Beck Depression Inventory (BDI). In addition, we will assess automatic socio-anxiolytic behavior tendencies by means of implicit measures.
    Daarnaast zullen we de uitkomst evalueren aan de hand van andere zelfrapportage instrumenten (Social Phobia Anxiety Inventory (SPAI) and Beck Depression Inventory (BDI). Voorts bekijken we automatische sociaal-angstige gedragsneigingen aan de hand van impliciete maten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Posttreatment, 1 month FU
    Na de behandeling en 1 maand 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 No
    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 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 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
    The trial ends when the last subject finishes her follow-up assigment.
    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 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: 46
    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 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 state46
    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
    Geen bijzonderheden
    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 Decision2014-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-05
    P. End of Trial
    P.End of Trial StatusOngoing
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