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    Summary
    EudraCT Number:2010-023918-30
    Sponsor's Protocol Code Number:SOMA-001-2010
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-05
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-023918-30
    A.3Full title of the trial
    Pilot clinical study on the systemic bioavailability of l-thyroxine in healthy female volunteers after four weeks of topical treatment with a new formulation based on l-thyroxine
    Studio clinico pilota sulla biodisponibilita' sistemica della l-tiroxina in donne volontarie sane dopo quattro settimane di trattamento topico con una nuova formulazione a base di l-tiroxina
    A.3.2Name or abbreviated title of the trial where available
    SOMA-001-2010
    SOMA-001-2010
    A.4.1Sponsor's protocol code numberSOMA-001-2010
    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 SponsorSOCIETA' ITALO BRITANNICA L. MANETTI - H.ROBERTS & C. PER AZIONI
    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 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 Yes
    D.2.1.1.1Trade name SOMATOLINE*EMULS 30BUST 10G
    D.2.1.1.2Name of the Marketing Authorisation holderL.MANETTI-H.ROBERTS & C. 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 Cutaneous emulsion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOther dermatologicals
    D.3.9.1CAS number 51489
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.3Concentration number.1
    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
    treatment of localized fat, accompanied by cellulite
    trattamento di adiposita' localizzate, accompagnate da cellulite.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10065339
    E.1.2Term Cellulite
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the systemic bioavailability of l-thyroxine (FT4) in healthy women after application of a new formulation of Somatoline dosing schedules provided by the AIC
    Valutazione della biodisponibilita' sistemica della l-tiroxina libera (FT4) in donne sane dopo applicazione di una nuova formulazione di Somatoline secondo la posologia prevista dalla AIC
    E.2.2Secondary objectives of the trial
    Evaluation of the systemic bioavailability of T3, rT3 and TSH under the same conditions specified in the primary endpoint.
    Evaluation of the safety and tolerability of systemic and local product.
    Valutazione della biodisponibilita' sistemica di T3, rT3 e TSH nelle medesime condizioni sperimentali indicate per l’obiettivo primario.
    Valutazione della sicurezza e della tollerabilita' locale e sistemica del prodotto.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult women aged between 18 and 50 years.
    2. Caucasians.
    3. BMI (Body Mass Index) <30.
    4. Blood pressure, measured in the supine position after 5 minutes rest, less than or equal to 90 mm / Hg and 140 mm / Hg respectively for systolic and diastolic.
    5. Heart rate measured in the supine position after 5 minutes of rest between 50 and 90 beats / minute.
    6. Signing the informed consent form.
    1. Donne adulte di eta' compresa tra 18 e 50 anni.
    2. Razza caucasica.
    3. BMI (Body Mass Index) &lt;30.
    4. Pressione arteriosa, rilevata in clinostatismo dopo 5 minuti di riposo, inferiore o uguale a 90 mm/Hg ed a 140 mm/Hg rispettivamente per la diastolica e la sistolica.
    5. Frequenza cardiaca rilevata in clinostatismo, dopo 5 minuti di riposo, compresa tra 50 e 90 battiti minuto.
    6. Firma del modulo del consenso informato.
    E.4Principal exclusion criteria
    1. Pregnancy or breast-feeding in place.
    2. Changes (early or suspension) of the use of contraceptive estrogen-progestin in the last 4 weeks.
    3. Inability to take adequate contraception during the study.
    4. Any disease or dysfunction, even asymptomatic, significant endocrine disruption and thyroid in particular.
    5. Any acute or chronic detectable load of any device on history.
    6. Any clinically significant abnormality detected on examination.
    7. Any clinically significant abnormality detectable on ECG.
    8. Any clinically significant abnormal laboratory values.
    9. History of allergy or intolerance to study the products and / or excipients.
    10. Over the past 6 months, treatment or therapeutic use of iodine or iodine-containing medications (eg amiodarone, Somatoline).
    11. Over the past 6 months, treatment with antithyroid drugs.
    12. Over the past 6 months, diagnostic tests that led to the use of tracers, contrast agents containing iodine or iodine isotopes.
    13. During the past 4 weeks, changes in diet of foods containing iodine (eg iodized salt), or use disinfectants (eg Betadine), detergents or any systemic or topical product containing iodine, including mouthwashes (eg Iodosan), toothpaste iodinated, douches, Lugol's solution.
    14. Alcohol abuse (over 75 g / day of ethanol), xanthine (over 5 cups / day), tobacco (over 10 cigarettes / day) or use of psychotropic drugs (except for occasional use as ipnoinuttori) or any drug.
    15. Donate blood or bleeding in the previous three months, or intentions to donate blood during the study and 4 weeks later.
    16. Persons unable to psychological or linguistic reasons, to understand the information given to obtain the consent or who refuse to give consent in writing.
    17. Another clinical study in the four weeks prior to or during this study or are planning to take part in a study with experimental drugs during the current surve
    1. Gravidanza o allattamento al seno in atto.
    2. Modifiche (inizio o sospensione) dell’uso di contraccettivi estro-progestinici nelle ultime 4 settimane.
    3. Impossibilita' di adottare una contraccezione adeguata durante la fase di studio.
    4. Qualsiasi malattia o disfunzione, anche asintomatica, di rilievo endocrinologico e tiroideo in particolare.
    5. Qualsiasi malattia acuta o cronica a carico di qualsiasi apparato rilevabile all’anamnesi.
    6. Qualsiasi anomalia clinicamente significativa rilevabile all’esame obiettivo.
    7. Qualsiasi anomalia clinicamente significativa rilevabile al ECG.
    8. Qualsiasi anomalia clinicamente significativa dei valori di laboratorio.
    9. Storia di allergia o intolleranza ai prodotti in studio e/o agli eccipienti.
    10. Negli ultimi 6 mesi, trattamenti o terapie a base di iodio o uso di farmaci contenenti iodio (es. amiodarone, Somatoline).
    11. Negli ultimi 6 mesi, trattamenti con farmaci antitiroidei.
    12. Negli ultimi 6 mesi, indagini diagnostiche che abbiano comportato l’impiego di traccianti o mezzi di contrasto contenenti iodio o suoi isotopi.
    13. Nelle ultime 4 settimane, modifiche nel regime dietetico di alimenti contenenti iodio (es. sale iodato) oppure uso di disinfettanti (es. Betadine), detergenti o qualsiasi prodotto per uso sistemico o topico contenente iodio, compresi colluttori (es. Iodosan), dentifrici iodati, lavande vaginali, soluzioni di Lugol.
    14. Abuso di alcool (oltre 75 g/die di etanolo), xantine (oltre 5 tazze/die), tabacco (oltre 10 sigarette/die) oppure uso di psicofarmaci (tranne che per occasionale impiego come ipnoinuttori) o di qualsiasi droga.
    15. Donazioni di sangue o emorragie nei tre mesi precedenti oppure intenzioni di donare sangue durante lo studio e nelle 4 settimane successive.
    16. Soggetti impossibilitati, per motivi linguistici o psicologici, di comprendere le informazioni date per l’ottenimento del consenso o che rifiutino di dare il proprio consenso in forma scritta.
    17. Altro studio clinico nelle quattro settimane precedenti o durante questo studio o intenzione di prendere parte ad uno studio con farmaci sperimentali durante la presente indagine.
    E.5 End points
    E.5.1Primary end point(s)
    evaluation on healthy adult women of the stability compared to pre-treatment plasma concentrations of l-thyroxine (FT4) observed 5:24 hours and after 14 days and 28 days after the first use of a new formulation of Somatoline applied in accordance SmPC the terms of the product
    valutazione su donne adulte sane, la stabilita' rispetto ai livelli pre-trattamento, delle concentrazioni plasmatiche di l-tiroxina libera (FT4) osservata 5 e 24 ore e dopo 14 giorni e 28 giorni dal primo impiego di una nuova formulazione di Somatoline applicato secondo le modalita' previste dal SmPC del prodotto.
    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 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
    biodisponibilita' sistemica del FT4
    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 No
    E.8.1.1Randomised No
    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 No
    E.8.1.6Cross over No
    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 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
    ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    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.1.1Number 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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-01-05. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Decision2011-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-16
    P. End of Trial
    P.End of Trial StatusCompleted
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