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    Summary
    EudraCT Number:2008-002142-38
    Sponsor's Protocol Code Number:292008
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-002142-38
    A.3Full title of the trial
    A phase I, single center, open-label parallel group trial to compare the pharmacokinetics of NOMAC between healthy female adolescents (aged 14-17 years) and healthy female adults (aged 18-50 years) after single dose administration of NOMAC-E2 tablets
    A.4.1Sponsor's protocol code number292008
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNV Organon
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameNOMAC-E2
    D.3.2Product code Org 10486-0 + Org 2317
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNNomegestrol
    D.3.9.1CAS number 58652-20-3
    D.3.9.2Current sponsor codeOrg 10486-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEstradiol
    D.3.9.1CAS number 50-28-2
    D.3.9.2Current sponsor codeOrg 2317
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Hormonal oral contraception in healthy women
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To compare the pharmacokinetics of NOMAC between female adolescents (aged 14-17 years) and female adults (aged 18-50 years) after single dose administration of NOMAC- E2.
    E.2.2Secondary objectives of the trial
    • To explore the pharmacokinetics of E2 and estrone (E1) of both female populations after single dose administration of NOMAC-E2.
    • To explore the safety and tolerability of NOMAC-E2 after single dose administration of NOMAC-E2 and to compare this between the age groups.
    • To explore and, if possible, identify the major metabolites of NOMAC in plasma and urine of the female adults.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female subjects between 18 and 50 years of age (extremes included) which have a normal menstrual cycle as judged by the investigator or female subjects between 14 and 17 years of age (extremes included) after menarche, which have a history of at least six months of normal menstrual cycles, which is in accordance with the age of the subjects, as judged by the investigator.
    2. A body mass index (BMI) between 17 and 29 kg/m2 (extremes included).
    3. Able and willing to sign the Informed Consent Form prior to screening evaluations. For the subjects between 12 and 17 years of age a parental informed consent is needed in addition.
    4. (History of) good physical and mental health as determined by history taking, physical and laboratory examinations, ECG and vital signs recordings as judged by the investigator and taken into account the age of the subjects.
    5. Able and willing to stop their own hormonal contraceptive, if used, one month before drug administration.
    6. Able and willing to use non-hormonal contraceptives during the trial from screening up to and including follow-up. E.g. condoms with spermicide, diaphragm with spermicide, non-hormonal intra-uterine device (IUD), a vasectomized (> 6 months) partner or previous tubal ligation.
    7. Subject smokes less than 5 cigarettes or equivalent per day and is capable of not smoking from 48 hours prior to drug administration until the last pharmacokinetic blood sample has been taken.
    8. Able to refrain from all use of (methyl)xanthines (e.g. coffee, tea, cola, chocolate, red bull and other energy drinks) and alcohol from 48 hours prior to drug administration until the last pharmacokinetic blood sample has been taken.
    9. Able to refrain from all use of grapefruit containing products from 7 days prior to drug administration until the last pharmacokinetic blood sample has been withdrawn.
    E.4Principal exclusion criteria
    1. Clinically relevant history or presence of any medical disorder, potentially interfering with this pharmacokinetic trial.
    2. Contraindications for the use of contraceptive steroids.
    a. Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident;
    b. Presence or history of prodromi of a thrombosis (e.g. transient ischemic attack, angina pectoris);
    c. History of migraine with focal neurological symptoms;
    d. Diabetes mellitus with vascular involvement;
    e. The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (to be judged by the(sub)-investigator). e.g. increasing age; smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age); a positive family history (i.e. venous or arterial thromboembolism ever in a sibling or parent at a relatively early age); dyslipoproteinaemia; hypertension, migraine, valvular heart disease, atrial fibrillation; prolonged immobilization, major surgery or any surgery to the legs or major trauma of which the remobilization had not fully resumed within 2 weeks prior to screening. In these situations it is advisable to discontinue the COC use and not to resume until two weeks after full remobilization; systemic lupus erythematosus; hemolytic uremic syndrome; chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis); sickle cell disease;
    f. Severe dyslipoproteinaemia
    g. Severe hypertension
    h. Hereditary or acquired predisposition for venous or arterial thrombosis, such as APC resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia, and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant)
    i. Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia;
    j. Presence or history of severe hepatic disease as long as liver function values have not returned to normal;
    k. Presence or history of liver tumors (benign or malignant);
    l. Known or suspected sex steroid-influenced malignancies (e.g. of the genital organs or the breasts);
    m. Undiagnosed vaginal bleeding;
    3. History of sensitivity/idiosyncrasy to NOMAC-E2 or chemically related compounds or excipients which may be employed in the study or to any other unknown drug used in the past.
    4. Use of any drug or substance that is known to induce drug-metabolizing enzymes within two months prior to drug administration.
    5. Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration before screening.
    6. Use of any drug or substance within one week prior to drug administration, except for paracetamol or topical medication without systemic exposure.
    7. Known or suspected pregnancy.
    8. Breastfeeding or within 2 months after stopping breastfeeding prior to drug administration.
    9. Before spontaneous menstruation has occurred following a delivery or abortion.
    10. History of or current abuse of drugs or alcohol or solvents.
    11. Positive drug or alcohol screen at screening or admission (day -1).
    12. Participation in an investigational drug study within 90 days prior to drug administration.
    13. Donation of blood within 90 days prior to drug administration.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetics of NOMAC
    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 Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) Yes
    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) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.2Adults (18-64 years) Yes
    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 2008-05-28. 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 state30
    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)
    No treatment with the trial medication will be allowed under the current protocol beyond the final scheduled visit.
    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 Decision2008-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-18
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