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    Summary
    EudraCT Number:2004-000053-34
    Sponsor's Protocol Code Number:0473081
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-10-11
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2004-000053-34
    A.3Full title of the trial
    Comparison of continuous combined estrogen-progestin regimen in alleviation of estrogen deficiency symptoms of postmenopausal women. A randomized, double-blind, fixed dose, multicentre phase IIIb study of 12 month
    A.4.1Sponsor's protocol code number0473081
    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 SponsorOrion Corporation, Orion Pharma, Orionintie,
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Indivina 1.0 mg/ 2.5 mg Indivina 1.0 mg/ 5.0 mg Indivina 2.0 mg/ 5.0 mg
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Pharma
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 nameIndivina
    D.3.4Pharmaceutical form Tablet
    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.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0, 2.0 E2V to 2.5, 5.0 MPA
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Postmenopausal estrogen replacement regimen is the therapy of choice for the alleviation of climacteric symptoms.
    During the past few years, continuous-combined hormone replacement therapy (HRT) have become increasingly popular. Lower dose estrogen-progestogen combinations are likely to induce less bleeding disturbances and other adverse effects (AEs) and may therefore improve compliance and allow long-term treatment, necessary, e.g. for the prevention of postmenopausal bone loss.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10027304
    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 the study is to investigate efficacy and safety of 3 continuous combined regimens of Indivina in alleviation of vasomotor (estrogen deficiency) symptoms in women who are more than 1 year menopausal, by measuring the change in frequency and severity of moderate to severe vasomotor symptoms from baseline to Week 12 vasomotor (estrogen deficiency) symptoms using a self-assessed symptoms diary.
    E.2.2Secondary objectives of the trial
    The secondary objectives include investigations of bleeding days, vasomotor symptoms, alleviation of other estrogen deficiency symptoms, and quality of life (QoL).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    • signed and dated IC
    • Postmenopausal women: ≥ 12 months of spontaneous amenorrhoea or ≥ 6 weeks post-surgical bilateral oophorectomy without hysterectomy at screening
    • ≥ 30 moderate to severe hot flushes per week at baseline and/or vasomotor symptoms requiring treatment according to clinical judgement of the investigator
    • Wash-out period
    - is not needed or
    - of 1 wk or longer for prior vaginal hormonal products (rings, creams, gels)
    - of 4 wks or longer for prior transdermal estrogen alone or estrogen/progestin products
    - of 4 wks or longer for prior oral estrogen and/or estrogen/progestin therapy
    - of 8 wks or longer for prior intrauterine progestin therapy
    - of 3 months or longer for prior progestin implants and estrogen alone injectable drug therapy
    - of 6 months or longer for prior estrogen pellet therapy or progestin injectable drug therapy
    • no pathological findings in mammogram obtained within 6 months of screening visit
    E.4Principal exclusion criteria
    • 36 months of spontaneous amenorrhea at screening
    • pregnancy or breastfeeding
    • known or past endometrial hyperplasia or cancer
    • known, past, or suspected estrogen-dependent malignant tumours (e.g. breast cancer)
    • cervical smear class III-IV according to the Bethesda classification
    • undiagnosed uterine bleedings
    • previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)
    • active or recent arterial thromboembolic disease (e.g. angina pectoris, myocardial infarction)
    • personal or strong family history of thromboembolism or recurrent (≥ 3) spontaneous abortions
    • heart failure (NYHA class III-IV)
    • cerebrovascular accidents, stroke or transient ischemic attacks in the subject history
    • serious disorders of blood coagulation system
    • acute liver disease or a history of liver disease (including cholelithiasis) with clinically significant abnormalities in liver function tests at baseline
    • porphyria
    • uterine fibroids
    • endometriosis
    • known hypersensitivity to any component of the preparations
    • uncontrolled or poorly controlled hypertension (diastolic BP > 95 mmHg and/or systolic BP > 160 mmHg) despite of antihypertensive treatment
    • severe or uncontrolled thyroid disease, e.g. thyreotoxicosis
    • impaired renal function with clinically significant elevated serum creatinine concentration
    • insulin-dependent diabetes mellitus
    • diagnosed psychiatric disorders (e.g. schizophrenia, depression)
    • systemic lupus erythematosus (SLE)
    • any other treatment for climacteric symptoms
    • any treatment for hyperlipidemias
    • any treatment affecting sex hormone system (e.g. phytoestrogens like soya)
    • suspected alcohol or drug abuse
    • suspected poor compliance
    • participation in another clinical study within the previous 60 days or during the study
    • clinically significant abnormalities in the laboratory assessments at baseline
    E.5 End points
    E.5.1Primary end point(s)
    The change in frequency and severity of moderate to severe vasomotor symptoms from baseline to Week 12 vasomotor (estrogen deficiency) symptoms using a self-assessed symptoms diary.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 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 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 Yes
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Study subjects are free to withdraw from the study at any time without providing a reason, a study subject needs to discontinue the study, if the investigator considers the discontinuation to be medically necessary.
    Meeting any of the exclusion criteria during the study is also a criterion for discontinuation ,
    Hyperplasia in histological evaluation of endometrial biopsy at Week 24 will be considered as a treatment failure and will lead to discontinuation in the study.
    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 months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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 Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state108
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 675
    F.4.2.2In the whole clinical trial 675
    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 Decision2004-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-06-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-11-22
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