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    Summary
    EudraCT Number:2004-001552-37
    Sponsor's Protocol Code Number:RG07-066(FormerlyHTA02/06/02)
    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:2005-02-08
    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 number2004-001552-37
    A.3Full title of the trial
    Effectiveness and Cost-effectiveness of Levonorgestrel containing Intrauterine system in Primary care against Standard Treatment for menorrhagia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomised controlled trial of LNG-IUS (coil) against standard treatment (medical management) for patients suffering with Heavy Menstrual Bleeding
    A.3.2Name or abbreviated title of the trial where available
    ECLIPSE
    A.4.1Sponsor's protocol code numberRG07-066(FormerlyHTA02/06/02)
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN86566246
    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 SponsorUniversity of Birmingham
    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 supportNIHR Health Technology Assessment Programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBirmingham Clinical Trials Unit
    B.5.2Functional name of contact pointTrial Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressUniversity of Birmingham
    B.5.3.2Town/ cityEdgbaston, Birmingham
    B.5.3.3Post codeB15 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01214159109
    B.5.5Fax number01214159136
    B.5.6E-maileclipse-trial@bham.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
    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
    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.3.9.2Current sponsor codeRG 07-066
    D.3.9.3Other descriptive nameLEVONORGESTREL
    D.3.9.4EV Substance CodeSUB08483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number276
    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 Yes
    D.3.11.13.1Other medicinal product typeLevonorgestrel containing intrauterine system
    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
    Menorrhagia
    E.1.1.1Medical condition in easily understood language
    Heavy Menstrual Periods
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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
    The ECLIPSE Trial is a large, pragmatic, “real-life” community based trial that will determine reliably whether a (Levonorgestrel-releasing intrauterine system) LNG-IUS is preferable to standard medical treatments (i.e. tranexamic acid, mefenamic acid or contraceptive pill as per Royal College of Obstetrics and Gynaecology guidelines) for menorrhagia
    E.2.2Secondary objectives of the trial
    The cost-effectiveness and acceptability of treatment policies.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Further Information relating to ECLIPSE Protocol Version 5 dated 12/09/07
    Section 9.2 Patient Satisfaction with Treatment
    E.3Principal inclusion criteria
    Women between the ages of 25-50 presenting to General Practitioners with menorrhagia (see Section 3.2 of protocol for specific definition).
    Not intending to become pregnant in the next 5 years.
    E.4Principal exclusion criteria
    Women taking HRT
    Women with contraindications to IUD use, with or without Levonorgestrel
    Women with contraindications to all medical treatments for menorrhagia
    Women with abdominally palpable enlarged fibroid uteri (10-12 weeks size)
    Women to whom the contraceptive effect of LNG-IUS would be unacceptable
    Women with symptoms suggestive of other pathology:
    Women with risk factors for endometrial cancer:
    E.5 End points
    E.5.1Primary end point(s)
    The Shaw Menorrhagia Questionnaire is the primary outcome measure. Menorrhagia is a subjective problem and quality of life is affected by practical difficulties and the impact on social life, psychological wellbeing, physical health, work routine and family life. The Shaw questionnaire attempts to capture the consequences of menorrhagia on these domains with 6 questions each with 4 levels of response.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 6months, 1year, 2year and 5year
    E.5.2Secondary end point(s)
    Short Form-36
    The SF-36 v2 is a 36-item short-form survey that measures general health-related quality of life (HRQOL) and can be used to obtain utilities.39 The SF-36 is a practical and reliable way to obtain important health outcomes data in a variety of settings, measuring eight domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and mental health. The standard format with 4-week recall period will be used to capture the average quality of life over a menstrual cycle.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 6months, 1year, 2year and 5year
    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 No
    E.6.5Efficacy No
    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
    clinical and cost effectivenes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Treatment algorithms involving medical products
    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 concerned120
    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 Yes
    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 trial aims to follow-up participants for 10 years. The trial will be analysed after 5 years of follow-up and a final decision on whether the 10 year folllow-up is desirable.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years12
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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: 570
    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 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 state570
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 570
    F.4.2.2In the whole clinical trial 570
    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)
    Normal clinical management
    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 Decision2004-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-15
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