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    Summary
    EudraCT Number:2011-005518-12
    Sponsor's Protocol Code Number:2
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-02-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-005518-12
    A.3Full title of the trial
    effect of oral administration of red clover on menopausal symptoms of the syndrome induced by adjuvant hormonal treatment in women diagnosed with breast cancer
    effetto dell'assunzione orale di trifoglio rosso sui sintomi della sindrome menopausale indotta dal trattamento ormonale adiuvante nelle donne con diagnosi di carcinoma mammario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    effect of a herbal product made ​​from red clover on the symptoms of menopause caused by adjuvant therapy in women who were diagnosed with breast cancer
    effetto di un prodotto fitoterapico a base di trifoglio rosso sui sintomi della menopausa causati dalla terapia adiuvante nelle donne alle quali e' stato diagnosticato carcinoma mammario
    A.4.1Sponsor's protocol code number2
    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 SponsorNAMED SRL
    B.1.3.4CountryItaly
    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 supportNamed Srl
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNamed Srl
    B.5.2Functional name of contact pointResponsabile scientifico
    B.5.3 Address:
    B.5.3.1Street AddressVia Lega Lombarda 33
    B.5.3.2Town/ cityLesmo
    B.5.3.3Post code20855
    B.5.3.4CountryItaly
    B.5.4Telephone number039-698501
    B.5.5Fax number039-6985030
    B.5.6E-mailalessandro.orlandini@named.it
    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 No
    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 namePromensil
    D.3.2Product code NA
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNSOY ISOFLAVONES
    D.3.9.1CAS number 8000055-25-6
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namered clover isoflavones
    D.3.9.4EV Substance CodeSUB15343MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Yes
    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 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
    - Patients who have undergone surgery for breast cancer: he chose T1-2NO-1MO treated with tamoxifen more or less the same, adjuvant or pre-operative chemotherapy
    - Premenopausal patients at the time of histological diagnosis
    - pazienti che hanno subito intervento chirurgico per carcinoma mammario: DICIS T1-2NO-1MO in terapia con Tamoxifene più o meno analoghi, , più o meno chemioterapia adiuvante o pre-operatoria
    - pazienti in premenopausa al momento della diagnosi istologica
    E.1.1.1Medical condition in easily understood language
    - Patients who have undergone surgery for breast cancer and are treated with tamoxifen
    - Patients who are premenopausal at the time of histological diagnosis
    - pazienti che hanno subito intervento per carcinoma mammario e che sono in terapia con Tamoxifene
    - pazienti che sono in premenopausa al momento della diagnosi istologica
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10006232
    E.1.2Term Breast disorders
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    decrease of menapausal symptoms in women treated with tamoxifen for breast cancer after surgery
    diminuzione dei sintomi della menopausa nelle donne trattate con Tamoxifene per carcinoma mammario dopo intervento chirurgico
    E.2.2Secondary objectives of the trial
    To evaluate the ability of serum of treated patients compared to patients not treated with phytoestrogens to alter the migratory ability of tumor cells in the presence of estradiol.
    Valutare la capacità del siero delle pazienti trattate rispetto alle pazienti non trattate con fitoestrogeni di modificare la capacità migratoria delle cellule tumorali in presenza di estradiolo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients who have undergone surgery for breast cancer: he chose
    - T1-2N0-1M0 treated with tamoxifen more or less the same, more or less pre-operative adjuvant chemotherapy or
    - Patients who are premenopausal at the time of histological diagnosis
    - No cancer arising in pregnancy
    - Renal function, normal cardiac and respiratory
    - Complete blood count to normal
    - Adherence to the study with informed consent
    - People can take part in the study for the expected time
    - Score rating scale (MRS Menopausal Rating Scale) ≥ 8
    - pazienti che hanno subito intervento chirurgico per carcinoma mammario: DICIS
    - T1-2N0-1M0 in terapia con Tamoxifene più o meno analoghi, più o meno chemioterapia adiuvante o pre-operatoria
    - Pazienti in premenopausa al momento della diagnosi istologica
    - Carcinoma non insorto in gravidanza
    - Funzionalità renale, cardiaca e respiratoria nella norma
    - Emocromo nella norma
    - Adesione allo studio con consenso informato
    - Persone in grado di prendere parte allo studio per il tempo previsto
    - score della scala di valutazione MRS (Menopausal Rating Scale) ≥ 8
    E.4Principal exclusion criteria
    - Score rating scale (MRS Menopausal Rating Scale) ≤ 8
    - Women after natural menopause or induced at the time of surgery
    - A history of or concurrence of other primary malignancies except carcinoma in situ of the cervix and basal-cell carcinoma of the skin
    - Recurrence of breast cancer
    - Presence of distant metastases
    - Histology different from breast cancer epithelial
    - Lobular carcinoma in situ of the breast
    - Participating in other clinical trials, controlled trials that could interfere with the evaluation of the results of this study
    - Geographical inaccessibility
    - score della scala di valutazione MRS (Menopausal Rating Scale) ≤ 8
    - donne in post-menopausa naturale o indotta al momento della chirurgia
    - anamnesi positiva o concomitanza di altri tumori maligni primitivi ad eccezione del carcinoma in situ della cervice e carcinoma baso-cellulare della cute
    - recidive di carcinoma mammario
    - presenza di metastasi a distanza
    - istologia diversa dal carcinoma epiteliale della mammella
    - carcinoma lobulare in situ della mammella
    - partecipazioni ad altri trial clinici controllati, randomizzati che possano interferire con la valutazione dei risultati di questo studio
    - inaccessibilità geografica
    E.5 End points
    E.5.1Primary end point(s)
    1) Improving the quality of life by reducing symptoms of menopausal syndrome induced by antineoplastic treatment
    2) Demonstration of toxicity and no additional treatment-related interference in the studio
    1) Miglioramento della qualità della vita mediante la riduzione dei sintomi della Sindrome menopausale indotta dal trattamento antineoplastico
    2) Dimostrazione della non tossicità e dell’interferenza aggiuntiva legata al trattamento in studio
    E.5.1.1Timepoint(s) of evaluation of this end point
    total study duration: 2 years, 3 months after first detection
    durata totale dello studio: 2 anni; prima rilevazione dopo 3 mesi
    E.5.2Secondary end point(s)
    - Evaluation of estrogen on the serum of patients
    - Evaluating changes of migration of cell lines
    - valutazione dell'attività estrogenica su siero delle pazienti
    - valutazione delle modificazioni dell'attività migratoria di linee cellulari
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months from start of therapy
    a tre mesi dall'inizio della terapia
    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 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 Yes
    E.6.13.1Other scope of the trial description
    improvement in quality of life
    milgioramento della qualità di vita
    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 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 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.8.2.4Number of treatment arms in the trial2
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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.1.1.2Preterm 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: 80
    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 state80
    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)
    routine clinical practice
    come da consiglio medico
    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 Decision2012-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-24
    P. End of Trial
    P.End of Trial StatusOngoing
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