Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44242   clinical trials with a EudraCT protocol, of which   7339   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-000790-24
    Sponsor's Protocol Code Number:BEC01
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-10
    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 ConcernedAustria - BASG
    A.2EudraCT number2020-000790-24
    A.3Full title of the trial
    BECONTRA - Effects of combined oral contraceptives on brain and behavior
    BECONTRA - Einfluss kombinierter oraler Kontrazeptiva auf Gehirn und Verhalten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BECONTRA - Effects of combined oral contraceptives on brain and behavior
    BECONTRA - Einfluss kombinierter oraler Kontrazeptiva auf Gehirn und Verhalten
    A.3.2Name or abbreviated title of the trial where available
    BECONTRA
    A.4.1Sponsor's protocol code numberBEC01
    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 SponsorUniversität Salzburg
    B.1.3.4CountryAustria
    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 (ERC)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversität Salzburg
    B.5.2Functional name of contact pointBelinda Pletzer
    B.5.3 Address:
    B.5.3.1Street AddressHellbrunnerstrasse 34
    B.5.3.2Town/ citySalzburg
    B.5.3.3Post code5020
    B.5.3.4CountryAustria
    B.5.4Telephone number004366280445184
    B.5.6E-mailBelinda.Pletzer@sbg.ac.at
    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 Selina Gynial
    D.2.1.1.2Name of the Marketing Authorisation holderGynial
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Coated 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 INNETHINYLESTRADIOL
    D.3.9.1CAS number 57-63-6
    D.3.9.4EV Substance CodeSUB07277MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.03
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVONORGESTREL
    D.3.9.1CAS number 797-63-7
    D.3.9.4EV Substance CodeSUB08483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.15
    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 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 Bilinda Gynial
    D.2.1.1.2Name of the Marketing Authorisation holderGynial
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Coated 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 INNETHINYLESTRADIOL
    D.3.9.1CAS number 57-63-6
    D.3.9.4EV Substance CodeSUB07277MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.03
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNChlormadinonacetat
    D.3.9.1CAS number 302-22-7
    D.3.9.3Other descriptive nameCHLORMADINONE ACETATE
    D.3.9.4EV Substance CodeSUB01219MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Girls and women 14 years - 35 years, considering the intake of COCs or under current use of EE/LNG or EE/CMA COCs
    Mädchen und Frauen im Alter von 14 bis 35 Jahren, die die Einnahme von kombinierten oralen Kontrazeptiva überlegen oder kombinierte orale Kontrazeptiva schon einnehmen
    E.1.1.1Medical condition in easily understood language
    Girls and women 14 years - 35 years, considering the intake of COCs or under current use of EE/LNG or EE/CMA COCs
    Mädchen und Frauen im Alter von 14 bis 35 Jahren, die die Einnahme von kombinierten oralen Kontrazeptiva überlegen oder kombinierte orale Kontrazeptiva schon einnehmen
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10030970
    E.1.2Term Oral contraception
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10010808
    E.1.2Term Contraception
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10073728
    E.1.2Term Hormonal contraception
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Drug trial on neurocognitive off-target effects of contraceptive drugs
    Charakterisierung neurokognitiver Off Target-Effekte von oralen Kontrazeptiva
    E.2.2Secondary objectives of the trial
    A secondary objective is to identify predictors of cognitive, emotional and neuronal off target effects of oral contraceptives, among:
    - Brain imaging parameters
    - Steroid hormone levels
    - Genes related to steroid hormone action and neurotransmission
    Identifizierung von Prädiktoren neurokognitiver Off Target-Effekte von oralen Kontrazeptiva aus
    - ZNS-Bildgebungsparametern
    - Steroidhormonkonzentrationnen
    - Genetischen Faktoren, die mit der Wirkung von Steroidhormonen und Neurotransmittern assoziiert sind
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Girls and women 14 years - 35 years,
    2. considering the intake of COCs or under current use of EE/LNG or EE/CMA COCs, with a
    3. regular menstrual cycle for at least 6 months according to the criteria of Fehring et al. (2006) and
    4. sufficient German language skills to follow task instructions
    1. Alter: 14 years - 35 years
    2. Geschlecht: weiblich
    3. Interesse an der Einnahme kombinierter oraler Kontrazeptiva
    4. Regelmäßiger Menstruationszyklus in den letzten 6 Monaten
    5. Ausreichende Deutschkenntnisse zum Verständnis der Aufgaben
    E.4Principal exclusion criteria
    Exclusion criteria:
    1. Known contra-indication to use of EE/LNG or EE/CMA COCs,
    2. diagnosed psychiatric disorder with known effects on cognition or brain structure/function (e.g. schizophrenia, etc.) with the exception of mood disorders
    3. diagnosed neurological disorder with known effects on cognition or brain structure/function (e.g. multiple sclerosis, epilepsy, etc.)
    4. diagnosed endocrinological disorder deemed clinically significant by the Investigator at screening (e.g. PCOS, Cushing's syndrome, congenital renal hyperplasia)
    5. regular intake of medication that might interfere with the conduct of the study or the interpretation of the results (defined below)
    6. current pregnancy or previous pregnancies
    7. for MR group: contra-indication for MRI
    8. for MR group: brain tissue abnormalities on structural MRI as screened by a neuro-radiologist
    1. Kontraindikation für die Einnahme der Prüfpräparate
    2. diagnostizierte psychiatrische Erkrankung mit bekannten Auswirkungen auf Kognition
    oder Gehirnfunktion (z.B. Schizophrenie) mit Ausnahme emotionaler Störungen
    3. diagnostizierte neurologische Erkrankung mit bekannten Auswirkungen auf Kognition
    oder Gehirnfunktion (z.B. Multiple Sclerose, Epilepsie)
    4. diagnostizierte endokrinologische Störung die vom Prüfarzt als klinisch signifikant
    eingestuft wird (PCOS, Cushing's Syndrome, Adrenogenitales Syndrom)
    5. regelmäßige Einnahme von Medikamenten, die die Studiendurchführung oder
    Ergebnisinterpretation beeinflussen könnten
    6. bestehende Schwangerschaft oder frühere Schwangerschaft
    7. bei MRT: Kontraindikation für eine MRT-Untersuchung
    8. bei MRT: Gehirnstrukturelle Auffälligkeiten
    E.5 End points
    E.5.1Primary end point(s)
    Cognitive, emotional and neuronal off target effects of COC treatment (maximum change from study visit 1 and timepoint of maximum Change)
    Kognitive, emotionale und neuronale Nebeneffekte der Einnahme von kombinierten oralen Kontrazeptiva (Maximale Veränderung ab Studienvisite 1 bis zum Zeitpunkt der maximalen Veränderung)
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months
    18 Monate
    E.5.2Secondary end point(s)
    Predictors of cognitive, emotional and neuronal off target effects of COC treatment, including
    - brain imaging parameters
    - steroid hormone levels
    - genes related to steroid actions or neurotransmissio
    Prädiktoren von kognitiven, emotionalen und neuronalen Nebeneffekten bei der Einnahme von kombinierten oralen Kontrazeptiva, einschließlich
    -
    -
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 months
    18 Monate
    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
    Drug trial on neurocognitive off-target effects of contraceptive drugs
    Charakterisierung neurokognitiver Off Target-Effekte von oralen Kontrazeptiva
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Prüfarzt und Auswerter sind verblindet
    investigator and rater-blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Keine Therapie
    no therapy
    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
    last Patient last visit
    letzter Patient, letzte Visite
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 Yes
    F.1.1Number of subjects for this age range: 350
    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: 350
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    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 Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-04-10. Yes
    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 state600
    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)
    normal treatment
    normale Behandlung
    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 Decision2020-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-14
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA