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    The EU Clinical Trials Register currently displays   37979   clinical trials with a EudraCT protocol, of which   6230   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-005610-37
    Sponsor's Protocol Code Number:PROTEC1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-005610-37
    A.3Full title of the trial
    PROgesterone Therapy for Endometrial Cancer prevention in obese women (PROTEC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mirena IUS for Womb Cancer Protection
    A.3.2Name or abbreviated title of the trial where available
    PROTEC1
    A.4.1Sponsor's protocol code numberPROTEC1
    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 SponsorCentral Manchester University Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Manchester
    B.5.2Functional name of contact pointDr Emma Crosbie
    B.5.3 Address:
    B.5.3.1Street AddressSt Mary's Hospital
    B.5.3.2Town/ cityOxford Road
    B.5.3.3Post codeM13 9WL
    B.5.4Telephone number0161 701 6912
    B.5.6E-mailemma.crosbie@manchester.ac.uk
    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 Mirena Intra Uterine System
    D.2.1.1.2Name of the Marketing Authorisation holderBayer plc
    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.3.1Product nameMirena 20micrograms/24hours intrauterine delivery system
    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.3.9.3Other descriptive nameMirena
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Proliferation of the endometrium.
    E.1.1.1Medical condition in easily understood language
    Prevention of endometrial cancer and pre-cancer in women with a high BMI.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    To determine whether the Mirena coil is effective at interrupting pathways in the womb associated with increased risk of developing cancer.
    E.2.2Secondary objectives of the trial
    1) To assess if the Mirena IUS is acceptable to women as a preventative treatment for endometrial cancer.
    2) To assess the effects the Mirena IUS on physical and mental wellbeing.
    3) To see what effects (if any) the Mirena IUS has on hormone levels in the blood in obese women
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Women seen in the Sleep Apnoea Clinic at Salford Royal Hospital
    2 BMI >40
    3 Informed consent
    4 Aged 18 or over
    5 Normal up to date smear
    6 Normal endometrial sample at screening
    E.4Principal exclusion criteria
    1) Previous hysterectomy
    2) LNG-IUS or IUD in situ or in previous 6 months
    3) Pregnant or breast feeding
    4) Previous endometrial ablation
    5) Breast cancer
    6) Congenital/acquired uterine anomaly
    7) Pelvic inflammatory disease, current STI or genital actinomycosis
    8) Immunodeficiency
    9) Progestin IUS contraindicated (coagulopathy, liver disease, migraine, raised blood pressure, arterial disease)
    E.5 End points
    E.5.1Primary end point(s)
    1) Ki 67 expression in the endometrium (a marker of proliferation).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Serial endometrial biopsies and fasting study bloods will be taken at the screening appointment, at Mirena insertion and 6-9 months following Mirena insertion. The questionnaire will be completed at the screening appointment and at the 9-12 month follow-up appointment.
    E.5.2Secondary end point(s)
    3) Endocrine markers including but not limited to:
    a. Fasting serum glucose & insulin, HbA1c, IGFBP-1 and C-peptide levels
    b. SHBG, oestrogen, progesterone, free androgen index, FSH, LH, testosterone, CRP
    c. Leptin, adiponectin
    4) Changes in menstrual function, physical and mental wellbeing
    E.5.2.1Timepoint(s) of evaluation of this end point
    We will take a detailed medical and gynaecological history, including a history of menstrual abnormalities, hormonal and contraceptive use and baseline observations at all three appointments (screening, Mirena insertion and 6-9 month follow up).
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    The 12 month follow up of the last patient taking part in the study. A further 9 months will be needed for investigational work and writing up the results for publication. N.B we may offer extended follow up at the 12 month appointment for annual biopsy and review up to 5 years, after substantial amendment agreement by the REC.
    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 months4
    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 months4
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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)
    At their 6-9 month follow up appointment we will offer to remove the Mirena IUS or for the patient to keep it. We may re-apply for a substantial amendment to the REC for extended annual follow up and biopsies up to 5 years post insertion of the Mirena IUS. The patients will be aware we may contact them for future studies.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-01
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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