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    Summary
    EudraCT Number:2013-005234-37
    Sponsor's Protocol Code Number:CF111/304
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Not Authorised
    Date on which this record was first entered in the EudraCT database:2014-02-10
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-005234-37
    A.3Full title of the trial
    Multicentre, Open-Label Trial to Assess the Safety and Tolerability of LF111 (Drospirenone 4.0 mg) Over 6 Cycles in Female Adolescents, With a 7-Cycle Extension Phase
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study for testing safety and tolerability of 4.0 mg Drospirenone (LF111) during 6 cycles at several study sites with the possibility of a trial extension for further 7 cycles
    A.4.1Sponsor's protocol code numberCF111/304
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLaboratorios León Farma S.A.
    B.1.3.4CountrySpain
    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 supportLaboratorios León Farma S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHEMO France
    B.5.2Functional name of contact pointDirector of Clinical Development
    B.5.3 Address:
    B.5.3.1Street Address7 rue Victor Hugo
    B.5.3.2Town/ citySèvres
    B.5.3.3Post code92310
    B.5.3.4CountryFrance
    B.5.4Telephone number0033149662 226
    B.5.5Fax number0033141149917
    B.5.6E-maildominique.drouin@chemofrance.com
    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 nameDrospirenone
    D.3.2Product code LF111
    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 INN-
    D.3.9.1CAS number 67392-87-4
    D.3.9.2Current sponsor codeLF111
    D.3.9.3Other descriptive nameDROSPIRENONE
    D.3.9.4EV Substance CodeSUB06413MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    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
    Oral contraception for postmenarcheal female adolescents, with or without intact hymen, aged 12-17 and without uncontrolled concomitant disease.
    E.1.1.1Medical condition in easily understood language
    Oral contraception for healthy young postmenarcheal females, with or without intact hymen, aged 12-17.
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate safety and tolerability including bleeding pattern.
    E.2.2Secondary objectives of the trial
    Not applicable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female adolescents aged 12-17 years, with or without intact hymen. (In some countries the lower age limit may be higher due to national legislation.)
    2. Subject is postmenarcheal for at least six months.
    3. For starters: At least four menstrual cycles during the last six months before Visit 1a were regular.
    4. Menstruation restarted since last pregnancy (only applicable for subjects who were pregnant within the last six months), i.e. at least one menstrual cycle after delivery.
    5. Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg, in sitting position, after 5 minutes of rest.
    6. Laboratory values with no deviations of any clinical relevance for the course of the study in the opinion of the investigator.
    7. Legal representatives willing to provide written informed consent, and subject able and willing to provide written assent prior to undergoing any trial-related procedures.
    8. Subject willing to use an oral contraceptive for at least six cycles.
    E.4Principal exclusion criteria
    1. Body-mass-index (BMI) below the 5th percentile or above the 95th percentile (girls’ BMI-for-age percentiles).
    2. Breastfeeding.
    3. Subject with uncontrolled concomitant disease.
    4. Subject is known to or suspected of not being able to comply with the trial protocol, the use of the IMP or the use of the diary.
    5. Abnormal finding on gynaecological examination that in the investigator’s opinion contraindicates participation in the trial.
    6. Unexplained amenorrhea.
    7. Known polycystic ovary syndrome.
    8. Known contraindication or hypersensitivity to ingredients or excipients of IMP:
    Renal insufficiency, hepatic dysfunction, adrenal insufficiency, thrombophlebitis, current thrombophlebitis or thromboembolic disorders, cerebral-vascular or coronary-artery disease (current or history), valvular heart disease with thrombogenic complications, severe hypertension, diabetes mellitus with vascular involvement, headaches with focal neurological symptoms, major surgery with prolonged immobilisation, known or suspected carcinoma of the breast, carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, cholestatic jaundice of pregnancy or jaundice with prior pill use, known or suspected pregnancy, liver tumor (benign or malignant) or active liver disease.
    9. Uncontrolled thyroid disorder (i.e. on stable dose of thyroid hormone replacement therapy for less than two months).
    10. Evidence or history of alcohol, medication or drug abuse (within the last 12 months).
    11. Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a.
    12. Prohibited previous medication / contraceptives, i.e. injectable hormonal methods of contraception within the last six months, progestin-releasing IUD or contraceptive implant within the last two months or anti-retroviral therapy within the last six months.
    13. Regular administration of prohibited co-medication, i.e. estrogens, progestogens, activated charcoal, anticonvulsants (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, primidone), barbiturates, rifampicin, atorvastatin, bosentan, griseofulvin, phenylbutazon, St. John’s wort (hypericum perforatum), medications that may increase serum potassium (ACE inhibitors, angiotensin – II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists and NSAIDs).
    14. Planned surgery during the anticipated time of participation in this trial requiring withdrawal of an oral contraceptive.
    15. Evidence or history of neurotic personality, psychiatric illness or suicide risk.
    16. Participation in another trial of investigational drugs or devices parallel to, or less than 30 days before trial entry.
    17. Previous participation in this trial.
    18. Subject is a dependent person, e.g. a relative, family member, or member of the investigator’s or sponsor’s staff.
    19. Any condition that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    1. Treatment-emergent adverse events (TEAEs)
    2. Vital signs
    3. Clinical laboratory parameters
    4. Vaginal bleeding pattern during treatment cycles 1-6 (subject diaries)
    5. IMP acceptability
    E.5.1.1Timepoint(s) of evaluation of this end point
    After trial termination.
    E.5.2Secondary end point(s)
    Not applicable.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable.
    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 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 No
    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 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) 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 Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Netherlands
    Finland
    Germany
    Ukraine
    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 subject last visit = end of 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 months7
    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 months7
    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 Yes
    F.1.1Number of subjects for this age range: 130
    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: 130
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 2014-02-10. 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 130
    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)
    For subjects participating only in the first treatment phase: At V6/EDV (or already at V5) the investigator will arrange for the subsequent contraceptive to be used by the subject only after last IMP intake.

    For subjects participating in the extension phase: At V8/EDV (or already at V7) the investigator will arrange for the subsequent contraceptive to be used by the subject only after last IMP intake.
    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 Decision2014-02-07
    N.Ethics Committee Opinion of the trial applicationNot-Favourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-14
    P. End of Trial
    P.End of Trial StatusNot Authorised
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