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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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:2010-020181-21
    Sponsor's Protocol Code Number:BAY86-5028/13362
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-03
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-020181-21
    A.3Full title of the trial
    Multicenter, randomized, open-label, parallel-group study to evaluate user satisfaction with and tolerability of the low-dose levonorgestrel (LNG) intrauterine delivery system (IUS) with 12 µg LNG/day initial in vitro release rate (LCS12) in comparison to a combined oral contraceptive containing 30 µg ethinyl estradiol and 3 mg drospirenone (Yasmin®) in young nulliparous and parous women (18-29 years) over 18 months of use
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To examine the user satisfaction and tolerability in women 18 to 29 years of age using LCS12 compared to women using Yasmin® over 18 months. Additionally bleeding patterns and adverse event profile will be assessed.
    A.3.2Name or abbreviated title of the trial where available
    LCS12 vs COC user satisfaction study
    A.4.1Sponsor's protocol code numberBAY86-5028/13362
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01254292
    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 sponsor
    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 pointCTP team/Ref: "EU CTR"/S102-Room 15
    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 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.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 Yasmin 28
    D.2.1.1.2Name of the Marketing Authorisation holderBayer B.V.
    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 Film-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 INNETHINYLESTRADIOL
    D.3.9.1CAS number 57-63-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.030
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 67392-87-4
    D.3.9.3Other descriptive nameDROSPIRENONE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.00
    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 overall satisfaction with and tolerability of LCS12 compared with a standard combined oral contraceptive (COC; Yasmin; 30 µg ethinyl estradiol and 3 mg drospirenone) regimen in young nulliparous and parous women aged 18-29 years.
    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 of this study is to evaluate user satisfaction in young nulliparous and parous women (18-29 years of age) using LCS12 compared with young nulliparous and parous women using a COC over a period of 18 months.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to determine the tolerability, discontinuation rates, AE profiles, occurrences of unintended pregnancies (including calculation of PI), and bleeding profiles.
    Additionally, data on missed tablets in the COC group, and IUS expulsions in the LCS12 group will be recorded.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject has signed and dated the Informed Consent Form (ICF).
    - The subject is generally healthy, requesting contraception, and is between 18 and 29 years of age (inclusive) at Screening.
    - In the opinion of the investigator, the subject is
    -- in good health;
    -- without uterine conditions that would preempt insertion of LCS12;
    -- without conditions/history that would contraindicate the use of oral contraceptives.
    - Subject has normal or clinically insignificant cervical smear (ie, one that does not require further follow up). A cervical smear must be taken at the Screening Visit or a documented normal result has to have been obtained within 6 months of Screening. Subjects with atypical squamous cells of undetermined significance (ASCUS) can be included in the study if they have a Human Papilloma Virus (HPV) deoxyribonucleic acid (DNA) test that, according to the standards of the local laboratory, is negative for high-risk HPV.
    - As determined by subject’s history, subject has regular (ie, endogenous cyclicity without hormonal contraceptive use) menstrual cycles (length of cycle 21-35 days).
    - Subject is willing and able to attend the scheduled study visits and to comply with the study procedures.
    E.4Principal exclusion criteria
    - Pregnancy or current lactation (less than 6 weeks since vaginal or Cesarean delivery or abortion). Postpartum LCS12 insertions should be postponed until the uterus is fully involuted, and not earlier than 6 weeks after delivery. If involution is substantially delayed, the investigator should consider waiting until 12 weeks postpartum.
    - Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit (Visit 1).
    - Chronic, daily use of drugs that may increase serum potassium levels, such as nonsteroidal anti-inflammatory drugs (NSAIDs, eg. ibuprofen and naproxen), potassium-sparing diuretics (eg. spironolactone), potassium supplementation, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, aldosterone antagonists, and heparin.
    - Abnormal uterine bleeding of unknown origin/undiagnosed abnormal genital bleeding
    - Any genital infection (until successfully treated).
    - Abnormal cervical smear result (see inclusion criterion 4)
    - Acute, current, or history of recurrent pelvic inflammatory disease.
    - Congenital or acquired uterine anomaly or any distortion of the uterine cavity (eg, by fibroids) that, in the opinion of the investigator, would cause problems during insertion, retention, or removal of LCS12.
    -History of diagnosed,or suspected genital malignancy, and untreated cervical dysplasia.
    -History of migraine with focal neurological symptoms.
    -Vascular diseases and coagulation disorders, including presence or history of venous thromboembolic diseases (eg, deep vein thrombosis, pulmonary embolism), presence or history of arterial thromboembolic diseases (eg, myocardial infarction, stroke), and any condition that could increased increase the risk of suffering from any of the above mentioned disorders (eg, a positive family history [event that occurred in a sibling or parent at an early age] or a known or suspected hereditary predisposition).
    -Clinically significant endometrial polyp(s) that, in the opinion of the investigator, may interfere with the assessment of the bleeding profile during the study.
    -Clinically significant ovarian cyst (defined as abnormal non-functional cysts) based on the investigator’s clinical judgment.
    -Established immunodeficiency.
    -Diabetes mellitus with vascular involvement.
    -Severe renal insufficiency or acute renal failure.
    -Any known hypersensitivity to the constituents of LCS12 or COC (Yasmin).
    -Diagnosed or suspected malignant or premalignant disease at the Screening Visit (Visit 1).
    -Arterial hypertension not responding to treatment, with systolic pressure >140 mm Hg or diastolic pressure >90 mm Hg.
    -History of or current severe hepatic diseases, including benign or malignant tumors. An interval of at least 3 months between the return to normal liver function values and the start of study treatment (ie, LCS12 insertion or ingestion of first COC pill) should be observed.
    -History of chronic alcoholism, drug dependence or abuse, psychotic states, severe neurosis, or any other condition that, in the judgment of the investigator, may impair the subject's ability to cooperate with the conditions of this protocol.
    -Known or suspected infection with the human immunodeficiency virus or, in the investigator’s judgment, is at high risk for sexually transmitted diseases (STDs).


    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the overall satisfaction rate, by treatment group, at the end of the comparative phase of the study (or at early termination for those subjects discontinuing the study before completion of the 18-month comparative phase).
    Satisfaction will be assessed by the subject based on a 5-point Likert item, using the following question:
    o How satisfied are you with the birth control method used during the study?
    1. Very satisfied
    2. Satisfied
    3. Neither satisfied nor dissatisfied
    4. Dissatisfied
    5. Very dissatisfied
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the comparative phase of the study (or at the early termination for those subjects discontinuing the study before completion of the 18-month comparative phase).
    E.5.2Secondary end point(s)
    Secondary efficacy variables will include:
    o Frequency of each possible answer (1 to 5) on the Likert item at 6, 12, and 18 months.
    o Overall satisfaction rates, by treatment group, at 6 and 12 months.
    o Pearl index
    o Modified EVAPIL scale at Baseline, 6, 12, and 18 months.
    o User satisfaction and bleeding questionnaire at 6, 12 and 18 months.
    o Discontinuation rates, by treatment group at 6, 12, and 18 months.
    o Diary data for pill intake
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 6, 12 and 18 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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    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 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
    Austria
    Belgium
    Germany
    United States
    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
    LVLS (Last visit last subject)
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    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: 550
    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 state115
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 550
    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 last dose of study drug to assess return to fertility. At this time, subjects will be asked whether a pregnancy has occurred. All pregnancies identified at the 3-month follow-up contact must be reported to the sponsor. All pregnancies identified at the 12-month follow-up contact must also be reported to the 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 Decision2010-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-23
    P. End of Trial
    P.End of Trial StatusCompleted
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