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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

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    Summary
    EudraCT Number:2005-005304-16
    Sponsor's Protocol Code Number:292001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-04-20
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-005304-16
    A.3Full title of the trial
    A randomized, open-label, comparative, multi-center trial to evaluate contraceptive efficacy, cycle control, safety and acceptability of a monophasic combined oral contraceptive (COC) containing 2.5 mg nomegestrol acetate (NOMAC) and 1.5 mg estradiol (E2), compared to a monophasic COC containing 3 mg drospirenone (DRSP) and 30 µg ethinyl estradiol (EE).
    A.3.2Name or abbreviated title of the trial where available
    Samba
    A.4.1Sponsor's protocol code number292001
    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 Information not present in EudraCT
    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 Acetate
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typea medicinal product with an active substance of chemical origin
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Yasmin 28
    D.2.1.1.2Name of the Marketing Authorisation holderSchering AG
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameYasmin 28
    D.3.2Product code Yasmin 28
    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 INNDrospirenone
    D.3.9.1CAS number 67392-87-4
    D.3.9.2Current sponsor codeOrg 36674
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEthinyl estradiol
    D.3.9.1CAS number 57-63-6
    D.3.9.2Current sponsor codeOrg 224
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typea medicinal product with an active substance of chemical origin
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    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 assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the NOMAC-E2 COC in a large group of women aged 18-50 years.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of the NOMAC-E2 COC on satisfaction and health related
    quality of life, libido, acne, menstrual symptoms, and body weight;
    - To explore the aforementioned characteristics of the NOMAC-E2 COC in comparison
    with the DRSP-EE COC.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Sexually active women, at risk for pregnancy and not planning to use condoms;
    - Women in need for contraception and willing to use an OC for 12 months
    (13 cycles);
    - At least 18 but not older than 50 years of age at the time of screening;
    - Body mass index ≥17 and ≤35;
    - Good physical and mental health;
    - Willing to give informed consent in writing.
    E.4Principal exclusion criteria
    - Contraindications for contraceptive steroids:
    • 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;
    • Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack,
    angina pectoris);
    • History of migraine with focal neurological symptoms;
    • Diabetes mellitus with vascular involvement;
    • 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); obesity (body mass index over 30 kg/m2);
    dyslipoproteinaemia; hypertension, migraine, valvular heart disease, atrial
    fibrillation; prolonged immobilization, major surgery any surgery to the legs, or
    major trauma until two weeks after full remobilization; systemic lupus
    erythematosus; haemolytic uraemic syndrome; chronic inflammatory bowel disease
    (Crohn’s disease or ulcerative colitis); sickle cell disease; known predisposition for
    venous or arterial thrombosis, with or without hereditary involvement (e.g.
    Activated Protein C (APC) resistance; hyperhomocysteinaemia; deficiencies in
    ATIII, protein C, protein S; antiphospholipid antibodies (anticardiolipin antibodies,
    lupus anticoagulant);
    • Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia;
    • Presence or history of severe hepatic disease as long as liver function values have not returned to normal;
    • Presence or history of liver tumors (benign or malignant);
    • Known or suspected sex steroid-influenced malignancies (e.g. of the genital
    organs or the breasts);
    • Undiagnosed vaginal bleeding;
    • Known or suspected pregnancy;
    • Hypersensitivity to the active substances or to any of the excipients of the
    investigational product.
    - In accordance with the SmPC/Package Insert of DRSP-EE, additional
    contraindications related to the antimineralocorticoid activity of drospirenone
    (conditions that predipose to hyperkalemia):
    • Renal insufficiency;
    • Hepatic dysfunction;
    • Adrenal insufficiency.
    - An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia (CIN),
    SIL, carcinoma in situ, invasive carcinoma) at screening;
    - Clinically relevant abnormal laboratory result at screening as judged by the
    investigator;
    - 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 spontaneous menstruation has occurred following a delivery or abortion;
    - Breastfeeding or within 2 months after stopping breastfeeding prior to the start of
    trial medication;
    - Present use or use within 2 months prior to the start of the trial medication of the
    following drugs: phenytoin, barbiturates, primidone, carbamazapine,
    oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin,
    ketoconazole, sex steroids (other than pre- and posttreatment contraceptive
    method) and herbal remedies containing Hypericum perforatum (St John’s Wort);
    - Administration of investigational drugs and/or participation in another clinical trial
    within 2 months prior to the start of the trial medication or during the trial period.
    E.5 End points
    E.5.1Primary end point(s)
    Pearl Index (PI), i.e. the number of pregnancies per 100 woman years of exposure for the restricted ITT analysis set;
    Vaginal bleeding (most relevant parameters: breakthrough bleeding/spotting and absence of withdrawal bleeding)
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    satisfaction and health related quality of life
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    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 2006-04-20. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2036
    F.4.2.2In the whole clinical trial 2080
    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 after the last tablet intake will be allowed under the current protocol. Post-treatment contraceptive counseling should be given to each subject at the visit after Cycle 9. The post-treatment contraceptive treatment should be started no later than on the day following the last tablet intake of the trial medication.
    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 Decision2006-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-04-10
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