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    Summary
    EudraCT Number:2012-005640-14
    Sponsor's Protocol Code Number:42994
    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:2013-04-04
    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 number2012-005640-14
    A.3Full title of the trial
    The effects of hormonal contraception on the HPA-axis functioning
    De effecten van hormonal anticonceptie op het functioneren van de HPA-as
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Hormonal contraception and the HPA-axis
    Hormonale anticonceptie en de HPA-as
    A.4.1Sponsor's protocol code number42994
    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 SponsorErasmus MC
    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 supportErasmus MC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointtrial information
    B.5.3 Address:
    B.5.3.1Street Address's Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0107034969
    B.5.6E-mailj.aleknaviciute@erasmusmc.nl
    D. IMP Identification
    D.IMP: 1
    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 Synacthen 0,25 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderDefiante Farmaceutica, S.A.
    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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Ethinylestradiol/levonorgestrel 0,03/0,15 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer B.V.
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    healthy female volunteers; hormonal contraception method used: combined method (oestrogens en progestins) and progesterone-only method.
    Gezonde vrouwelijke vrijwilligers; gebruik van hormonale anticonceptie methoden:
    combinatie (oestrogeen en progesteron) methode en progesteron-alleen methode.
    E.1.1.1Medical condition in easily understood language
    hormonal contraception method
    Hormonale anticonceptie (de pil) methode
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10010812
    E.1.2Term Contraceptive methods female
    E.1.2System Organ Class 100000004865
    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 whether HPA-axis responses during an ACTH stimulation (Synacthen) test differ as a function of hormonal contraceptive method used, as compared to responses measured during the natural menstrual cycle (luteal phase) in healthy women.
    effecten van hormonale anticonceptie methode op HPA-as reacties tijdens een ACTH stimulatie (Synacthen) test, vergeleken met responsen van vrouwen met natuurlijke menstruatiecyclus (luteale fase).
    E.2.2Secondary objectives of the trial
    to assess a basal HPA-axis functioning over a period of several months using hair samples in order to determine if the contraceptive method used has an effect on tonic cortisol levels as compared to the natural menstrual cycle in healthy women.
    beoordelen van een basale HPA-as functioneren over een periode van enkele maanden in haar monsters. te beoordelen of de gebruikte anticonceptie methode invloed heeft op tonische cortisol niveaus in vergelijking met de vrouwen met natuurlijke cyclus.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy female participants using either a hormonal contraceptive combined method (Microgynon30, Stediril30, Marvelon) or a progesterone-only method (Mirena)
    Gezonde vrouwelijke deelnemers die een hormonale anticonceptie gebruiken: combinatie-methode (Microgynon30, Stediril30, Marvelon) of een progesteron-alleen-methode (Mirena)
    E.4Principal exclusion criteria
    Female subjects with a history of psychiatric illness and/or psychotherapeutic treatments; drug abuse; neurological, cardiovascular or respiratory diseases, allergies, asthma; pregnancy or lactation.
    Vrouwelijke proefpersonen met een voorgeschiedenis van psychiatrische ziekte en/of psychotherapeutische behandelingen; drugsmisbruik; neurologische, cardiovasculaire of ademhalingsaandoeningen, allergieën, astma, zwangerschap en/of borstvoeding.
    E.5 End points
    E.5.1Primary end point(s)
    - The levels of ACHT, cortisol, cortisol binding globuline (CBG), progesterone, and estradiol in serum.
    - The levels of free cortisol in saliva before and during a Synacthen test.
    - De niveaus van ACHT, cortisol, cortisol bindend globulin (CBG), progesteron en estradiol in het serum.
    - De niveaus van vrije cortisol in het speeksel voor en tijdens een Synacthen test.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The levels of ACTH, cortisol, CBG, progesterone, estradiol in serum, levels of salivary cortisol will be measured just before the injection and at the three time point after synacthen injection every 30 minutes.
    De niveaus van ACTH, cortisol, CBG, progesteron, estradiol in het serum, de niveaus van vrije cortisol in speeksel worden gemeten vlak voor de injectie en op de drie tijdstippen na de Synacthen injectie om de 30 minuten.
    E.5.2Secondary end point(s)
    - Basal cortisol levels as measured in hair strands
    - Basale cortisol niveuas gemeten in haarlokken
    E.5.2.1Timepoint(s) of evaluation of this end point
    Basal cortisol levels in hair strands will be evaluated once.
    Basale cortisol niveaus in de haarlokken zal een keer worden geëvalueerd.
    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
    the effect of hormonal contraception method used on HPA-axis reactivity to Synacthen test.
    de effecten van hormonale anticonceptie methoden op HPA-as reactiviteit op Synacthen test.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    When all included participants finished all assessments or have dropped out.
    Wanneer alle geincludeerde patienten alle metingen hebben afgerond of niet meer deelnemen aan de studie
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 60
    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 2013-04-04. 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 state60
    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
    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 Decision2013-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-15
    P. End of Trial
    P.End of Trial StatusOngoing
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