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    Summary
    EudraCT Number:2011-002065-37
    Sponsor's Protocol Code Number:BAY86-5028 / 14371
    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:2011-08-17
    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 number2011-002065-37
    A.3Full title of the trial
    Multi-center, single-arm study to assess the safety, efficacy, discontinuation rate and pharmacokinetics of the low-dose levonorgestrel intrauterine contraceptive system (LCS12) in post-menarcheal female adolescents under 18 years of age for 1 year, and an optional 2-year extension phase
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    LCS12 adolescent study
    A.4.1Sponsor's protocol code numberBAY86-5028 / 14371
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/606/2009
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 supportBayer Healthcare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer Healthcare AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team / Ref: „EU CTR“ / S102 – Room 156, Müllerstrasse 170-178
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 nameLCS12
    D.3.4Pharmaceutical form Intrauterine delivery system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrauterine use
    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.3.9.3Other descriptive nameLEVONORGESTREL
    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 number13.5
    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) 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
    Contraception
    E.1.1.1Medical condition in easily understood language
    Prevention of pregnancy
    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 14.0
    E.1.2Level PT
    E.1.2Classification code 10010808
    E.1.2Term Contraception
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the safety of low-dose levonorgestrel (LNG) (12μg/24h, initial in vitro
    release rate), delivered locally by an intrauterine contraceptive system in adolescents
    over 1 year of treatment, including insertion and removal procedures.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate efficacy, discontinuation rate and pharmacokinetics in adolescents.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject has signed and dated the informed consent form or given assent.

    2. The subject is a female adolescent, age 12 to under 18 years of age at the Screening visit, is generally healthy, post-menarcheal, nulliparous or parous, and requires contraception.

    3. The subject has regular menstrual cycles without hormonal contraceptive use (at regular intervals of 21-35 days). In the opinion of the investigator, the subject has general and uterine conditions suitable for the insertion of LCS12 (uterine sound depth 6-10 cm).

    5. The subject has clinically normal safety laboratory results inside the specified range for inclusion.

    6. The subject has a normal or clinically insignificant cervical smear (i.e. one that does not require further follow up according to Bethesda or a comparable system). A cervical smear must be taken at the Screening Visit or a documented normal result must have been obtained not more than 6 months before the Screening Visit. Subjects with atypical squamous cells of undetermined significance (ASCUS) can be included in the study if they have a Human Papilloma Virus (HPV) DNA test that, according to the standards of the central laboratory, is negative for high-risk HPV.

    7. The subject is willing and able to attend the scheduled study visits and to comply with
    E.4Principal exclusion criteria
    1. Known or suspected pregnancy or is lactating.

    2. Vaginal delivery, cesarean delivery, or abortion less than 6 weeks before Visit 1. Note: Postpartum insertions should be postponed until uterus is fully involuted, however not earlier than 6 weeks after delivery. If involution is substantially delayed,
    consider waiting until 12 weeks postpartum. In the event of a difficult insertion and/or exceptional pain or bleeding during or after insertion, physical examination and ultrasound should be performed immediately to exclude perforation.

    3. History of ectopic pregnancies.

    4. Infected abortion or postpartum endometritis less 3 months before Visit 1.

    5. Abnormal uterine bleeding of unknown origin.

    6. Any lower genital tract infection (until successfully treated).

    7. Acute or history of recurrent pelvic inflammatory disease.

    8. Congenital or acquired uterine anomaly.

    9. Submucous uterine fibroids

    10. Any other distortion of the uterine cavity (by e.g. larger intramural or subserousal fibroids) likely to cause problems (in the opinion of the investigator) during insertion, retention or removal of LCS12.

    11. History of, diagnosed or suspected genital malignancy, and untreated cervical dysplasia.

    12. Current deep venous thrombosis or thrombophlebitis; history of deep venous thrombosis.

    13. Clinically significant endometrial polyp(s), which, in the opinion of the investigator, will interfere with the assessment of the bleeding profile during the study.

    14. Clinically significant ovarian cyst(s).

    15. Concomitant use of other sex-hormone containing preparations or an IUD after the insertion of LCS12

    16. Use of any long-acting injectable sex-hormone preparations less than 12 months before start of study medication.

    17. Established immunodeficiency.

    18. Any known hypersensitivity to the constituents of the LCS, or any health problems caused by previous use of an IUS.

    19. Diagnosed or suspected malignant or premalignant disease at the screening

    20. Arterial hypertension (as defined by systolic and diastolic values relevant for age) not responding to appropriate treatment.

    21. Current (or history of) severe hepatic diseases including benign or malignant tumors. There should be an interval of at least 3 months between the start of study treatment (i.e., LCS12 insertion) and the return of liver function values to normal

    22. History of chronic alcoholism, drug dependence or abuse, psychotic states or severe neurosis or any other condition that, in the opinion of the investigator, might impair a subject’s ability to cooperate
    23. Known or suspected HIV infection or high risk for Sextually Transmitted Disease.

    24. Any clinically significant condition or laboratory result that, in the opinion of the investigator, compromises the subject’s safety, might interfere with the evaluations or prevents the completion of the study.

    25. Participated in another clinical study or consumed another experimental drug less than 30 days before Visit 1

    26. Previous participation in this study

    27. A person with close affiliation with the investigational site; e.g., close relative of the investigator, dependent person, employee or student of the investigational site
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable is the incidence of adverse events over the first 12-month treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    First 12-months
    E.5.2Secondary end point(s)
    The secondary variables are:

    For efficacy
    - Overall satisfaction rating
    - Pregnancies (Pearl index)
    - Bleeding patterns
    - Pharmacokinetics
    For population pharmacokinetics:
    - Safety
    - LCS12 insertion ease and pain assessments
    - LCS12 removal ease and pain assessments
    For other:
    - Discontinuation rate
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 3 years
    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 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) 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 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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    For each participating European Union (EU) country, the end of the study according to the EU Clinical Trial Directive will be reached when the last visit of the last subject in all centers in the respective country has occurred.
    The end of the study as a whole will be reached as soon as the end of the study according to the above definition has been reached in all participating countries (EU and non-EU).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 Yes
    F.1.1Number of subjects for this age range: 360
    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: 360
    F.1.2Adults (18-64 years) No
    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 No
    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 Yes
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 360
    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)
    All subjects will receive a follow-up telephone call from the study site 3 months after removal of LCS12 to assess the return to fertility.
    Subjects who discontinue treatment because they wish to get pregnant will also receive a telephone call 12 months after removal of LCS12 if they are not pregnant at the time of the 3-month follow-up.
    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 Decision2011-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-28
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