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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-024603-26
    Sponsor's Protocol Code Number:IEOS583/111
    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:2012-03-01
    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 number2010-024603-26
    A.3Full title of the trial
    A phase II study of low-dose vaginal estrogens in pre and postmenopausal breast cancer patients with urogenital atrophy
    Studio di fase II con estrogeno topico a basse dosi in pazienti con carcinoma mammario in pre e post menopausa con atrofia urogenitale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The fase II study evaluates the safety and efficacy of treatment with low doses of topical vaginal estrogen in pre- and postmenopausal patients with breast cancer and urogenital symptoms related to adjuvant hormone therapy
    Studio clinico di fase II che valuta la sicurezza e l’efficacia del trattamento con basse dosi di estrogeno topico in pazienti con una pregressa diagnosi di carcinoma della mammella in pre- e postmenopausa e con sintomi urogenitali correlati alla terapia endocrina adiuvante
    A.4.1Sponsor's protocol code numberIEOS583/111
    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 SponsorISTITUTO EUROPEO DI ONCOLOGIA
    B.1.3.4CountryItaly
    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 supportFondazione Istituto Europeo Oncologia
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportFondazione Veronesi
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Europeo Oncologia
    B.5.2Functional name of contact pointUfficio studi clinici
    B.5.3 Address:
    B.5.3.1Street Addressvia Ramusio 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20141
    B.5.3.4CountryItaly
    B.5.4Telephone number02 57 48 98 48
    B.5.5Fax number02 57 48 97 81
    B.5.6E-mailufficio.studiclinici@ieo.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 Yes
    D.2.1.1.1Trade name VAGIFEM*15CPR VAG 25MCG
    D.2.1.1.2Name of the Marketing Authorisation holderNOVO NORDISK FARMACEUTICI SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Vaginal tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNESTRADIOL HYDRATE
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 No
    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
    Pre- and postmenopausal women who are receiving adjuvant endocrine treatment (LH-RH analogue plus Tamoxifene or Aromatase Inhibitor, Tamoxifene alone, Aromatase Inhibitor alone) for early breast cancer.
    Pazienti in pre- e postmenopausa in trattamento endocrino per carcinoma della mammella, sintomatiche per disturbi uro-genitali refrattari a trattamento con lubrificanti topici.
    E.1.1.1Medical condition in easily understood language
    Endocrine treatments for breast cancer therapy determine a drastic reduction of estrogens that leads to, in many women, a progressive urogenital atrophy.
    I trattamenti endocrini per carcinoma della mammella causano una riduzione drastica degli estrogeni con atrofia urogenitale in molte pazienti.
    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 LLT
    E.1.2Classification code 10006283
    E.1.2Term Breast neoplasm malignant female
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 safety and the efficacy of treatment with low doses of vaginal estrogens in pre and post menopausal patients with previous diagnosis of breast cancer and urogenital symptoms related to the adjuvant hormonal therapy
    Lo scopo di questo studio è di valutare la sicurezza e l'efficacia del trattamento con basse dosi di estrogeni vaginali nelle pazienti in pre-e post-menopausa con precedente diagnosi di carcinoma della mammella e sintomi urogenitali correlati alla terapia ormonale adiuvante
    E.2.2Secondary objectives of the trial
    The evaluation of quality of life and the Efficacy of Vagifem in terms of vulvovaginal epithelial maturation during treatment
    La valutazione della Qualità della vita e l’efficacia del trattamento sperimentale sulla maturazione dell’epitelio vulvovaginale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients mast have histologically proven primary breast cancer;
    • Age 18-70 years;
    • Immunohistochemical evaluation of ER, PgR, HER2, is mandatory;
    • ER and/or PgR must be ≥ 10%
    • Postmenopausal level of serum estrogen (< 5 – 30 pg/ml );
    • Patients must have had proper surgery for primary breast cancer;
    • Patients should be treated with hormone therapy (Tamoxifene, letrozole, anastrozole, exemestane and/or LH-RH analogue);
    • Urogenital symptoms (Vaginal dryness, Vaginal atrophy, Dyspareunia, Decreased libido, Urinary urgency/frequency ); patients must be refractory to local non-hormonal treatments for urogenital symptoms;
    • No evidence of distant metastatic disease;
    • ECOG performance status <2;
    • No significant co-morbidities ( > grade 2);
    Signed informed consent.
    • Pazienti con diagnosi istologica di carcinoma mammario;
    • Età tra i 18 e i 70 anni;
    • E’ obbligatoria la valutazione immunoistochimica di ER, PgR, HER2;
    • ER e/o PgR ≥ 10%;
    • Le pazienti devono avere dei livelli sierici di estrogeno compatibili con menopausa (&lt; 5 – 30 pg/ml);
    • Le pazienti devono essere state sottoposte a chirurgia adeguata;
    • Le pazienti devono essere in trattamento adiuvante endocrino (Tamoxifene, letrozole, anastrozole, exemestane e/o LH-RH analogue);
    • Le pazienti devono lamentare sintomi urogenitali (secchezza vaginale, atrofia, dispareunia, riduzione della libido) refrattari a trattamenti non-ormonali per sintomi urogenitali;
    • Nessuna evidenza di metastasi;
    • ECOG performance status&lt;2;
    • Nessuna comorbidità significativa (grado&gt;2);
    • Le pazienti devono firmare il Consenso Informato ai fini della partecipazione allo studio.
    E.4Principal exclusion criteria
    • Patients with previous or concomitant malignancy;
    • Patients who exceed the postmenopausal estradiol serum level of 30 pg/ml at baseline;
    • Uncontrolled undercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
    • Patients who have received prior therapy for breast cancer;
    • Patients who have received endometrial biopsy;
    • Pazienti con altre neoplasie precedenti o concomitanti;
    • Pazienti con valori basali di estradiolo superiori o uguali a 30 pg/ml;
    • Patologie scompensate come scompenso cardiaco, angina pectoris, aritmie cardiache, patologie psichiatriche che limitino la compliance al trattamento, infezioni attive in atto;
    • Pazienti che hanno già ricevuto trattamenti per un precedente carcinoma mammario;
    • Pazienti già sottoposte a biopsie endometriali;
    E.5 End points
    E.5.1Primary end point(s)
    maintenance of serum estradiol levels in postmenopausal range.
    mantenimento di livelli sierici di estradiolo in range postmenopausali.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the baseline, at the 8th day of treatment and at the 28th day
    al basale, al giorno 8 di trattamento e al giorno 28 di trattamento
    E.5.2Secondary end point(s)
    Targeted Quality of Life (sexual functioning) of patients during treatment.
    - Efficacy of Vagifem in terms of vulvovaginal epithelial maturation during treatment.
    - Estradiol serum levels during the study period and follow up.
    Qualità della vita delle pazienti durante il trattamento.
    - Efficacia di Vagifem in termini di maturazione dell’epitelio vulvovaginale durante il trattamento.
    - Livello di estradiolo sierico durante il periodo di studio e follow up
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline, Day 28, 6th month, yearly (from year 1 to year 5)
    Al basale, giorno 28, 6 mese, annualmente fino a 5 anni
    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 No
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 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 years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    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.1.1Number 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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state67
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 67
    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)
    TRERE ARE NO SPECIFIC TREATMENT PROGRAMS OTHER THAN STANDARD TREATMENT
    NON SONO PREVISTI PROGRAMMI SPECIFICI ALTRI CHE IL TRATTAMENTO STANDARD
    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 Decision2011-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-22
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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