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    Summary
    EudraCT Number:2010-023911-32
    Sponsor's Protocol Code Number:BAY86-5028 / 13363
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-03-14
    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 ConcernedSweden - MPA
    A.2EudraCT number2010-023911-32
    A.3Full title of the trial
    Multicenter, open-label, randomized, controlled parallel-group study to assess discontinuation rates, bleeding patterns, user satisfaction and adverse event profile of LCS12 in comparison to etonogestrel subdermal implant over 12 months of use in women 18 to 35 years of age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To examine the discontinuation rates in women 18 to 35 years of age using LCS12 compared with discontinuation rates in women using the etonogestrel subdermal implant over 12 months. Additionally bleeding patterns, user satisfaction and adverse event profile will be assessed.
    A.3.2Name or abbreviated title of the trial where available
    LCS12 vs. ENG subdermal implant (Nexplanon) discontinuation rate study
    A.4.1Sponsor's protocol code numberBAY86-5028 / 13363
    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 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
    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 pointCTP team / Ref: "EU CTR" / S102
    B.5.3 Address:
    B.5.3.1Street AddressMüllerstrasse 170-178
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post codeD-13342
    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.3.9.1CAS number 797-63-7
    D.3.9.3Other descriptive nameLEVONORGESTREL
    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 Yes
    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 Nexplanon
    D.2.1.1.2Name of the Marketing Authorisation holderOrganon Laboratories Limited, UK
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETONOGESTREL
    D.3.9.1CAS number 54048101
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number68
    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
    The aim of the present study is to examine the discontinuation rates in women (ages 18-35, inclusive) using LCS12 compared with the discontinuation rates in women using the ENG subdermal contraceptive implant over 12 months.
    E.1.1.1Medical condition in easily understood language
    Contraception
    E.1.1.2Therapeutic area Health Care [N] - Population Characteristics [N01]
    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 demonstrate that discontinuation rates in women (ages 18-35 years inclusive) using LCS12 are not higher than those seen in women using ENG subdermal implant over a period of 12 months.

    E.2.2Secondary objectives of the trial
    Secondary objectives are to observe the bleeding patterns, adverse event profiles, and the occurrence of unintended pregnancies. Additionally, data on user satisfaction, IUS expulsions and implant site complications will be collected.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed and dated the informed consent
    - Healthy female subjects in need of contraception
    - Age: between 18 and 35 years (inclusive) at Screening visit
    - Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous six months). HPV testing in subjects with ASCUS can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains.
    - History of regular cyclic menstrual periods as determined by subject’s history, subject has regular menstrual cycles (length of cycle 21 – 35 days). (Subject’s history while not using hormonal contraceptives is sufficient, no washout period is required).
    - Subject is willing and able to attend the scheduled study visits and to comply with the study procedures.
    E.4Principal exclusion criteria
    - Pregnancy or currently lactating
    - Vaginal delivery, cesarean delivery or abortion within 6 weeks prior to Screening visit. Note: Postpartum LCS12 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.
    - Infected abortion or postpartum endometritis within 3 months prior to the Screening visit.
    - Undiagnosed abnormal genital bleeding.
    - Acute lower genital tract infection (until successfully treated)
    - Acute, or history of recurrent, pelvic inflammatory disease.
    - Congenital or acquired uterine anomaly or any distortion of the uterine cavity (e.g. by fibroids) that, in the opinion of the investigator or designee, would cause problems during insertion, retention, or removal of LCS12.
    - History of, diagnosed, or suspected genital malignancy, and untreated cervical dysplasia.
    - Clinically significant endometrial polyp(s) that, in the opinion of the investigator or designee, may interfere with the assessment of the bleeding profile during the study.
    - Clinically significant ovarian cyst (defined as abnormal non-functional cysts).
    - Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
    - Has previously failed screening for this study.
    - Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
    - Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator. The following are examples of such conditions or diseases:
    Cardiovascular
    • 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, including prodromi (e.g. transient ischemic attack, angina pectoris)
    • Repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.
    Liver
    • Presence or history of liver tumors (benign or malignant)
    • Presence or history of severe hepatic disease as long as liver function values have not returned to normal
    • Jaundice and/or pruritus related to cholestasis (Gilbert’s syndrome excepted)
    • History of cholestatic jaundice associated with pregnancy or previous COC use
    Other diseases
    • Malignant or premalignant disease (excluding melanoma)
    • History of migraine with focal neurologic symptoms
    - Other contraceptive methods:
    •Sterilization
    •Use of any long-acting injectable sex-hormone preparations within 10 months prior to the Randomization visit. The use of non study oral, vaginal, or transdermal hormonal contraception, intrauterine devices (IUDs) with or without hormonal release, and implants is prohibited during treatment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be discontinuation rate, by treatment group, at month 12. Discontinuations of study medication for any reason will count towards the discontinuation rate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 12 months
    E.5.2Secondary end point(s)
    Discontinuation rates, by treatment group, Overall satisfaction rating and questionnaires on User satisfaction and bleeding and Contraceptive tolerability and Pregnancy rate, as determined by Pearl index
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 6 and 12 months and 12 months
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Contraception
    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.8.2.4Number of treatment arms in the trial2
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Australia
    Finland
    France
    Norway
    Sweden
    United Kingdom
    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 years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 760
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state246
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 760
    F.4.2.2In the whole clinical trial 760
    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 be contacted by phone at 3 months after the study drug removal to assess return to fertility. At this time, subjects will be asked whether a pregnancy has occurred. All pregnancies identified at 3 month follow-up call must be reported to the sponsor. All pregnancies identified at 12 month follow up contact in case of discontinuation due to wish for pregnancy will also be reported to the sponsor. All pregnancy outcomes both after 3 and 12 months should reported to sponsor.
    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 Decision2011-05-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-30
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