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    Summary
    EudraCT Number:2020-002271-36
    Sponsor's Protocol Code Number:MEPIC
    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:2020-12-07
    Trial 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 number2020-002271-36
    A.3Full title of the trial
    Mepivacaine for pain relief at insertion of intrauterine contraception (MEPIC) – a triple-blind randomized controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mepivacaine for pain relief at insertion of intrauterine contraception (MEPIC) – a randomized controlled trial.
    A.4.1Sponsor's protocol code numberMEPIC
    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 SponsorDanderyd Hospital
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKarolinska Institutet/Stockholm Region
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska Institutet
    B.5.2Functional name of contact pointHelena Kopp Kallner
    B.5.3 Address:
    B.5.3.1Street AddressDanderyd Hospital, Dept of Obstetrics and Gynecology
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code182 88
    B.5.3.4CountrySweden
    B.5.5Fax number704402070
    B.5.6E-mailhelena.kopp-kallner@ki.se
    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 Carbocain, Mepivacaine Accord
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Nordic, Accord Healthcare AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Injection
    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 INNmepivacaine
    D.3.9.3Other descriptive nameMEPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03158MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboInjection
    D.8.4Route of administration of the placeboIntrauterine use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Insertion of intrauterine contraception
    E.1.1.1Medical condition in easily understood language
    Insertion of intrauterine contraception
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective: To evaluate the difference in pain score at the time of the insertion of the IUC between treatment and control group.
    E.2.2Secondary objectives of the trial
    Secondary outcomes include overall experience of the procedure and pain score measured 10 minutes after insertion (efficacy), proportion of adverse events in each group (safety), and method recommendation to a friend (acceptability). Method acceptability among health care providers measured as ease to use, willing to include intrauterine instillation as standard routine for pain relief with IUD insertion, and recommendation to a fellow provider (acceptability).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients ≥ 18 years of age at risk of pregnancy
    • nulliparous
    • opting for intrauterine contraception
    • negative pregnancy test
    • willing to participate in the study after it has been explained orally and in written
    E.4Principal exclusion criteria
    • previous conisation
    • known cervical stenosis
    • signs of ongoing genital infection
    • known uterine abnormality
    • conditions resulting in bleeding disorder
    • contraindication to any local anaesthetic
    • Body weight below 40 kilograms
    • IUC replacement
    • Use of other analgesia prior to or during insertion
    E.5 End points
    E.5.1Primary end point(s)
    • Pain score on a 100 mm VAS-scale measured immediately after IUC insertion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    immediately after insertion
    E.5.2Secondary end point(s)
    Efficacy variables
    1. Overall experience of the procedure rated as “easier than expected”, “as expected” and “worse than expected”
    2. Pain score on a 100 mm VAS-scale

    Safety variables
    3. Allergic reaction related to the study drug (number of patients in group allocated to active study drug)
    4. Vasovagal reactions (proportion in each group)
    5. Failed insertion (proportion in each group)
    6. Other side effects measured at follow up (in each group respectively)
    - IUC expulsion
    - Infections
    - Hospital admission or contact with healthcare system

    Acceptability variables
    Patients
    7. Would you recommend this method for pain relief to a friend? (yes/no).
    8. Would you opt for an IUD again if the procedure was like this?” (yes/no).
    9. “Was the pain at insertion worth having the IUD inserted” (yes/no).
    10. “The pain you felt during the insertion was…?” tolerable/not tolerable.
    Healthcare provider:
    11. “Rate how easy it was to perform the 10 ml instillation from a technical perspective? Numerical rating scale evaluated after each instillation. 1 very easy, 2 easy, 3 neither easy nor difficult, 4 difficult, 5 very difficult. Analyzed as difference in proportion of instillations receiving each rating.
    12. Are you willing to include intrauterine instillation as standard routine for pain relief with IUD insertion (yes/no)
    13. Would you recommend this method to a fellow provider (yes/no). Number of respondents in each group will be presented.


    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy variables:
    Patient 10 minutes after insertion: 1 and 2

    safety variables
    evaluated during study visit: 3, 4, 5

    From first study visit until End of trial: 6

    Acceptability variables:
    Assessment at 10 minutes after insertion: 7, 8, 10,
    Rated after instillation prior to insertion: 11

    3 months post insertion: 9.


    Rate how easy it was to perform the10 ml instillation. After each instillation.

    After last instillation at each clinic: 12, 13
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    blinded end point
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned6
    E.8.5The trial involves multiple Member States No
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days
    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: 520
    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 No
    F.3.2Patients Yes
    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 state520
    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)
    None
    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 Decision2021-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-10-31
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