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    Summary
    EudraCT Number:2010-020922-16
    Sponsor's Protocol Code Number:BAY 86-5028/15105
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-01-11
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2010-020922-16
    A.3Full title of the trial
    International, prospective, double-blind, 3-arm comparative, randomized, placebo controlled phase IV study on the effect of counseling and either tranexamic acid or
    mefenamic acid or placebo, on the management of bleeding/spotting in women using
    the levonorgestrel-releasing intrauterine system (MIRENA) for contraception
    A.3.2Name or abbreviated title of the trial where available
    Management of initial bleeding/spotting associated with levonorgestrel-intrauterine system Mirena
    A.4.1Sponsor's protocol code numberBAY 86-5028/15105
    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 SponsorBayer Healthcare AG
    B.1.3.4CountryFinland
    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 Yes
    D.2.1.1.1Trade name Cyklokapron
    D.2.1.1.2Name of the Marketing Authorisation holderMeda Pharma GmbH, 8602 Wangen-Brüttisellen, Schweiz
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameTranexamic acid
    D.3.4Pharmaceutical form Capsule, hard
    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 INNTranexamic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number to 500
    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 No
    D.3.11.8Extractive medicinal product No
    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 No
    D.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Mefenacid
    D.2.1.1.2Name of the Marketing Authorisation holderStreuli Pharma AG, 8730 Uznach, Switzerland
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameMefenamic acid
    D.3.4Pharmaceutical form Capsule, hard
    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 INNMefenamic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number to 500
    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 No
    D.3.11.8Extractive medicinal product No
    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 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 placeboCapsule, hard
    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
    Management of bleeding/spotting in women using the levonorgestrel-releasing intrauterine system (Mirena) for contraception.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10046883
    E.1.2Term Vaginal bleeding
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate if tranexamic acid and/or mefenamic acid are superior
    to placebo in the management of bleeding/spotting during the first
    90 days of levonorgestrel-releasing intrauterine system use.
    E.2.2Secondary objectives of the trial
    -To compare the number of bleeding/spotting (B/S) days during the 30-day follow-up period in the 3 treatment groups, and the change in the number of B/S days between Day 60 and Day 90 of levonorgestrel-releasing intrauterine system use and the 30-day follow-up period in the 3 treatment groups.
    -To investigate subject satisfaction and continuation rate with tranexamic acid, mefenamic acid, or placebo treatment for B/S.
    -To investigate subject satisfaction and continuation rate with the
    levonorgestrel-releasing intrauterine system in women treated with tranexamic acid, mefenamic acid, or placebo.
    -To investigate the safety of tranexamic acid and mefenamic acid in the management of B/s during the first 90 days of levonorgestrel-releasing intrauterine system use.
    -To investigate the occurrence of dysmenorrhea before and after
    levonorgestrel-releasing intrauterine system insertion and the effect blinded study drug treatment for B/S on the need of pain medication for
    dysmenorrhea.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Signed and dated informed consent
    -Healthy female subjects requesting contraception
    -Age: 18 - 45 years inclusive
    -Successful interval insertion of MIRENA
    -History of regular cyclic menstrual periods (length of cycle 21 - 35 days, i.e. endogenous cyclicity without hormonal contraceptive use)
    -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 12 months)
    E.4Principal exclusion criteria
    -Pregnancy or lactation
    -Immediate switch from a previous MIRENA to a new MIRENA (subject is not eligible
    before she has had at least 2 complete menstrual cycles after removal of a previous
    MIRENA).
    -Vaginal delivery, Cesarean delivery, or abortion within 6 weeks prior to the screening visit (Visit 1).
    -Infected abortion or postpartum endometritis within 3 months prior to the screening visit (Visit 1)
    -Predominant indication for MIRENA use is idiopathic menorrhagia/HMB or
    endometrial protection during estrogen replacement therapy
    -Climacteric symptoms prior to the screening visit (Visit 1)
    -Known or suspected congenital or acquired uterine anomaly including fibroids if they
    distort the uterine cavity
    -Current or recurrent pelvic inflammatory disease
    -Known or suspected genital or other malignancy or untreated cervical dysplasia
    -Undiagnosed abnormal genital bleeding
    -Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower
    genital tract infections until infection is controlled
    -Conditions associated with increased susceptibility to pelvic infections
    -Active liver disease or liver tumor
    -Current or history of thrombembolic disease, or established risk factors for venous
    thromboembolism
    -Current migraine, focal migraine with asymmetrical visual loss or other symptoms
    indicating transient cerebral ischemia, or exceptionally severe headaches
    -Uncontrolled hypertension
    -Current or history of severe arterial disease such as stroke or myocardial infarction
    -Known or suspected clinically significant ovarian cysts, endometrial polyps, fibroids, or
    other genital organ pathology, that, in the opinion of the investigator, may interfere with the assessment of the bleeding profile during the study
    -Disturbances of color vision
    -Inflammatory bowel disease
    -History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
    -Active or history of peptic ulcer/hemorrhage
    -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 investigational medicinal products (e.g. severe renal, liver or heart failure)
    -Hypersensitivity to any ingredient of the investigational medicinal products (TXA,
    MFA, and placebo) or the non-investigational medicinal product (MIRENA)
    -Previous hypersensitivity reaction (e.g. asthma, bronchospasm, rhinitis, angioedema, or urticaria) to aspirin, ibuprofen, or other NSAIDs
    -Daily or frequent use of NSAIDs for any condition
    -Not willing to use non-NSAID medication as pain medication during the double-blind
    treatment period
    -Other medication known to affect vaginal bleeding pattern (including, but not limited
    to, TXA, daily use of NSAIDs, gonadotropin-releasing hormone (GnRH) analogues,
    danazol, progestins, estrogens, anticoagulants) is prohibited during the whole study
    -Long-acting preparations (e.g. DMPA, monthly contraceptive injection, contraceptive
    implant) within 3 months before start of treatment
    -The use of oral, vaginal, injectable, or transdermal hormonal contraception, Copper
    IUDs, and implants is prohibited during the whole study
    -Abuse of alcohol, drugs, or medicine (e.g. laxatives)
    -Simultaneous participation in another clinical study. Participation in another clinical
    study prior to study entry that might have an impact on the study objectives, at the
    discretion of the investigator.
    -Major surgery scheduled for the study period
    -Any diseases or conditions that might interfere with the conduct of the study or the
    interpretation of the results
    -Close affiliation with the investigational site; e.g. a close relative of the investigator,
    dependent person.
    -Inability to cooperate with the study procedures for any reason, including the following examples: language comprehension, psychiatric illness, inability to get to the study site
    -Previous assignment to treatment (e.g. randomization) during this study (allowing
    previously randomized subjects to be re-included into the study may lead to bias)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be the cumulative number of B/S days during the 90-day double-blind treatment period.

    Secondary efficacy variables:
    -Number of bleeding-only days
    -Number of spotting-only days
    -Number of B/S episodes
    -Length of B/S episodes
    -Number of bleeding days with heavy intensity
    -Number of days and number and length of episodes of oral blinded study drug treatment during the 90-day treatment period
    -Number of B/S days, number of bleeding-only days, number of spotting-only days,
    number of B/S episodes, and number of bleeding days with heavy intensity, during the 30-day follow-up period
    -Change in the number of B/S days between Day 60 and Day 90 of MIRENA use (last
    30 days on oral blinded study drug) and the 30-day follow-up period
    -Satisfaction with oral blinded study drug treatment for B/S
    -Continuation rate with the oral blinded study drug treatment during the 90-day treatment
    period
    -Continuation rate with MIRENA including the 30-day follow-up period
    -Satisfaction with MIRENA
    -Occurrence of dysmenorrhea before and after MIRENA insertion
    -Number of days of pain medication for dysmenorrhea during the 90-day treatment
    period
    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 Yes
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo Yes
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 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 years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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 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 state83
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 93
    F.4.2.2In the whole clinical trial 186
    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 Decision2011-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-22
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