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    Summary
    EudraCT Number:2004-000811-24
    Sponsor's Protocol Code Number:308260
    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:2004-12-07
    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 number2004-000811-24
    A.3Full title of the trial
    Multicenter, double-blind, randomized, pleacebo-controlled study to evaluate the oral low-dose estradiol preparations SH T 04170 E (100 µg estradiol) and SH T 04170 F (190 µg estradiol) in postmenopausal women for the prevention of osteoporosis over two years
    A.3.2Name or abbreviated title of the trial where available
    Oral Low Dose Estradiol
    A.4.1Sponsor's protocol code number308260
    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 SponsorSchering AG
    B.1.3.4CountryGermany
    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.2.5The 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 nameSH T 04170 E
    D.3.2Product code DE-04170
    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.3.8INN - Proposed INNestradiol
    D.3.9.1CAS number 35380-71-3
    D.3.9.2Current sponsor codeZK 5018
    D.3.9.3Other descriptive nameb-Estradiol hemihydrate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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.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 Information not present in EudraCT
    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 nameSH T 04170 F
    D.3.2Product code DE-04170
    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.3.8INN - Proposed INNestradiol
    D.3.9.1CAS number 35380-71-3
    D.3.9.2Current sponsor codeZK 5018
    D.3.9.3Other descriptive nameb-Estradiol hemihydrate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number190
    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) Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    postmenopausal women with high risk for osteoporosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10050213
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to evaluate the efficacy and safety of 2 different low-dose E2 preparations (SHT04170E – 100 µg E2; SHT04170F – 190 µg E2) for the prevention of postmenopausal osteoporosis in women who are at least 5 years postmenopausal over a treatment period of 2 years (26 cycles of 28 days) compared to placebo. Efficacy will be assessed by BMD measurements of the lumbar spine (L1-L4), femoral neck, and total hip.
    E.2.2Secondary objectives of the trial
    A secondary objective will be endometrial safety and the evaluation of differences in E2 and E1 exposure between the treatment groups. This evaluation will be based on population pharmacokinetic analyses of E2 and E1 concentrations in the targeted patient population. The relationship of E2 and E1 with SHBG will be studied in an explorative way. Additionally, the influence of covariates (i.e., age, weight, race, and concomitant medication) on pharmacokinetic parameters of E2 and E1, like clearance (CL) and volume of distribution (V), will be explored.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Age ≥ 55 years and ≤ 80 years (at visit 1)
    2. Last (regular) menstrual period ≥ 5 years ago (at visit 2)
    3. Intact, normal uterus and an endometrial biopsy result confirming absence of hyperplasia or any relevant pathology
    4. Evaluable BMD by DXA of the lumbar spine (AP view, L1-L4; at least 2 vertebrae should be evaluable), femoral neck, and total hip
    5. Mean pretreatment BMD T score ≤-1 and ≥-2.5 at the lumbar spine (L1-L4)
    6. Presence of at least one additional risk factor to develop osteoporosis as listed below:
    - Mother, father or sister with history of low trauma fracture or osteoporosis
    - Body mass index (BMI) < 19 kg / m2, or weight less than 58 kg
    - Previous low trauma fracture
    - Menopause before age 45 years
    - Current smoking
    - Alcohol intake of more than 3 units per day (e.g. 1 unit = 1 glass of beer or 1 small glass of wine or 1 shot (25ml) of spirit)
    - Little or no (less than 1 hour per day) weight bearing exercise (e.g., sport activity, speedy gardening, heavy shopping)
    - Inadequate intake of calcium (less than 750 mg per day as estimated by the intake of milk, milk products and cheese)
    - History of use of corticosteroid therapy for more that 3 months
    - Hyperthyroidism (medicinally controlled)
    7. Signed informed consent form.
    E.4Principal exclusion criteria
    1. Current bone and musculoskeletal diseases, e.g., Morbus Scheuermann, osteogenesis imperfecta, hypo- or hyper-parathyroidism, Paget’s disease, osteomalacia, or other metabolic disease of bone; hypo- or hypercalcemia, vitamin D deficiencies
    2. History of immobilization > 2 months in the last 6 months before visit 1
    3. History of clinically significant vertebral fracture within the last 12 months before visit 1
    4. Patients requiring specific anti-osteoporotic treatment according to the investigator’s judgement
    5. Any uterine bleeding within the last year before visit 1
    6. Cervical smear with abnormal result (Pap: C III or worse)
    7. Pre-existing cardiovascular disease
    - Uncontrolled hypertension; sitting systolic blood pressure ≥ 180 mm Hg or sitting diastolic blood pressure ≥ 105 mm Hg after at least 10 minutes rest (at either visits 1 or 2)
    - History of stroke, transient ischemic attacks and myocardial infarction, or angiographic evidence of 50% narrowing of one or more coronary arteries, or heart disease requiring anti-arrhythmic or anti-anginal drug treatment, or congestive heart failure
    - History or planned coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty, coronary stenting
    - Existing or history of venous thromboembolic event (including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis) at any time and any condition which might increase the risk to suffer from any of the mentioned disorders, or known or suspected genetical component thereof (e.g., positive family history, event that occurred in a sibling or a parent at an early age), or current treatment with anticoagulants
    8. Laboratory values as defined as clinically significant by the sponsor (see 7.5.1.3.10 and protocol attachment 3) and/or assessed as significantly abnormal by the investigator
    9. Uncontrolled diabetes mellitus or diabetes mellitus currently treated with insulin
    10. Uncontrolled thyroid disorders, or initiation or change in dose of thyroid replacement therapy within 6 months
    11. Relevant renal disorder or significant liver dysfunction (including cholestasis and porphyria)
    12. Current or past history of clinically significant depression
    13. Malignant or premalignant disease within the last 5 years (except for superficial skin cancer)
    14. Sex steroid (hormone)-dependent malignant disease at any time
    15. Any other systemic or gynecologic disorder, laboratory finding, or ultrasound finding which might worsen under study drug treatment, might interfere with the conduct of the study or the interpretation of the results
    16. Any disease or condition that compromises the function of the body system and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
    17. Intake or use of the following medications (before visit 1 or during the study)
    - Within 4 weeks before visit 1: estrogen or progestin therapy (oral, transdermal, intrauterine or intravaginal administration, or estrogen implants), for intramuscular depot injections wash-out phase of 6 months
    - Within 3 months before visit 1: raloxifene, fluoride, or calcitonin
    - If taken for a duration > 3 months within the past 2 years: bisphosphonates, parathyroid hormone
    - Currently taking GnRH agonists or antagonists, therapeutic vitamin D analogues
    - Currently taking: systemic corticosteroids, high dose multivitamins, or other agents which are known or suspected to affect bone metabolism
    - Currently taking: medication which may alter the plasma concentration of estrogen, e.g., St. John’s Wort (Hypericum perforatum), phenobarbital, carbamazepine, rifampicin, erythromycin, clarithromycin, ketoconazole, itraconazole, and ritonavir
    18. History of alcohol or drug abuse (within the last 2 years)
    19. Known allergic reaction or hypersensitivity to any components of the study drugs
    20. Participation in another clinical study within 1 month or use / administration of an investigational drug within the last 3 months before visit 1
    21. Patient is a dependent person, e.g., a relative / family member and / or is a member of the investigator’s staff.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the percent change in the BMD at the lumbar spine (L1-L4) from pretreatment to the final visit (visit 7). With respect to the 2 pretreatment measurements, the arithmetic mean of the BMD measurements by DXA from screening (visit 1) will be used. With respect to the 2 final visit measurements, the arithmetic mean of the BMD measurements by DXA after 2 years of treatment at the final visit (visit 7) will be used.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) Yes
    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 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 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 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 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
    End of study is defined to be last patient last visit (LPLV) according to protocol. It is expected that LPLV is in July 2007.
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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) Yes
    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 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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 700
    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 Decision2004-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-01-06
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