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    Summary
    EudraCT Number:2015-003336-12
    Sponsor's Protocol Code Number:FatherTrials2015
    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:2016-01-11
    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 number2015-003336-12
    A.3Full title of the trial
    Father Trials: Hormonal Experiments on Prenatal and Postnatal Parenting
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Father Trials: Hormonal Experiments on Prenatal and Postnatal Parenting
    A.3.2Name or abbreviated title of the trial where available
    Father Trials
    A.4.1Sponsor's protocol code numberFatherTrials2015
    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 SponsorUniversiteit Leiden
    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 supportEuropean Research Council
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversiteit Leiden
    B.5.2Functional name of contact pointSecretary's Office
    B.5.3 Address:
    B.5.3.1Street AddressWassenaarseweg 52
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 AK
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715273434
    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 Syntocinon
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameSyntocinon
    D.3.2Product code RVG03716
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    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.IMP: 2
    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 Vasostrict
    D.2.1.1.2Name of the Marketing Authorisation holderPar Pharmaceutical Companies
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameVasostrict
    D.3.2Product code 42023-164-25
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNasal spray
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    There are no medical conditions or diseases under investigation
    E.1.1.1Medical condition in easily understood language
    There are no medical conditions or diseases under investigation
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10047146
    E.1.2Term Vasopressin
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10033329
    E.1.2Term Oxytocin
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In a series of randomized control trials (RCTs) the following hypothesis will be tested: Intranasal administration of oxytocin and vasopressin affect neural and behavioral responses to infant signals and threat to the infant.
    • Oxytocin and vasopressin modulate activation in the ‘parental brain’ systems related to arousal, reflexive care, and cognitive/empathic processing.
    • Oxytocin will increase connectivity of the amygdala with prefrontal regions, and vasopressin will increase amygdala connectivity with the brainstem.
    • Oxytocin will promote an affiliative response to threat to the infant, and vasopressin will promote an defensive response.
    E.2.2Secondary objectives of the trial
    This study has two secondary objectives. First, we will examine the extent to which effects of oxytocin and vasopressin are moderated by father’s ‘early childhood experiences’.
    Second, oxytocin, vasopressin, testosterone, and estradiol levels will be assessed in saliva and blood. Vasopressin and oxytocin levels will be measured to examine cross-reactions (oxytocin-vasopressin). Testosterone and estradiol levels will be measured to examine mechanisms (testosterone – estradiol – oxytocin; testosterone - vasopressin).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In each phase of parenthood (prenatal (child age = -3 months), early postnatal (child age = + 2 months), late postnatal (child age = + 7 months), 40 fathers having their first baby will be recruited to take part in the study.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:

    Not living in the same house as their partner
    Endocrine disorders
    Smoking
    Alcohol and drug abuse
    Use of medication potentially interfering with the endocrine system
    MRI contraindications, including metallic foreign objects, neurological disorder and claustrophobia
    Psychiatric disorder
    Cardiovascular disease
    Nose injuries and disorders
    E.5 End points
    E.5.1Primary end point(s)
    The first main study parameter is activity in brain areas associated with (1) arousal/salience (amygdala, ventral striatum), (2) reflexive care (hypothalamus), (3) emotion regulation (insula, medial prefrontal cortex, anterior cingulate cortex), and cognitive / empathic processing (insula, inferior frontal and orbitofrontal gyri, temporoparietal junction). We will examine the effects of oxytocin and vasopressin on activity in these areas in fathers during “processing infant signals” and “processing threat to infant” tasks designed to elicit protective responses (affiliative versus defensive response).
    The second main study parameter is parenting behavior, including “handgrip during infant cry”, (Bakermans-Kranenburg, van IJzendoorn, Riem, Tops, & Alink, 2012) sensitivity (“quality of care” task), involvement (“quantity of care task”), and protection (“Enthusiastic Stranger Paradigm”, (Mah, Bakermans-Kranenburg, Van, & Smith, 2015). We will examine the effects of oxytocin and vasopressin on these parenting behaviors.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Participants will come to the laboratory for three identical experimental
    sessions, seperated by 1 weeks.
    E.5.2Secondary end point(s)
    • We will examine the extent to which effects of oxytocin and vasopressin are moderated by father’s ‘early childhood experiences’.
    • Oxytocin, vasopressin, testosterone, and estradiol levels will be assessed in saliva and blood. Vasopressin and oxytocin levels will be measured to examine cross-reactions (oxytocin-vasopressin). Testosterone and estradiol levels will be measured to examine mechanisms (testosterone – estradiol – oxytocin; testosterone - vasopressin).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Participants will come to the laboratory for three identical experimental
    sessions, seperated by 1 weeks.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    With the proposed study we aim to gain insights into the effects of oxytocin and vasopressin on paternal quality of care, quantity of care, and offspring protection.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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 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
    LVLS
    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 months6
    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: 120
    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 Yes
    F.3.2Patients No
    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 state120
    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)
    There is no medical or other treatment of any clinical problem or
    disorder involved during or after the study.
    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 Decision2016-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-23
    P. End of Trial
    P.End of Trial StatusOngoing
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