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    Summary
    EudraCT Number:2011-000677-31
    Sponsor's Protocol Code Number:STH15216
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-08-08
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-000677-31
    A.3Full title of the trial
    Testosterone Replacement in Young Male cancer Survivors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Testosterone replacement in young male cancer survivors
    A.3.2Name or abbreviated title of the trial where available
    TRYMS
    A.4.1Sponsor's protocol code numberSTH15216
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN70274195
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT99999999
    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 SponsorSheffield Teaching Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportCancer Research UK
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportProStrakan Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Leeds
    B.5.2Functional name of contact pointCTRU
    B.5.3 Address:
    B.5.3.1Street AddressUniversity of Leeds
    B.5.3.2Town/ cityLeeds
    B.5.3.3Post codeLS2 9JT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01133431477
    B.5.5Fax number01133431471
    B.5.6E-maila.m.chalmers@leeds.ac.uk
    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 Tostran 2% Gel
    D.2.1.1.2Name of the Marketing Authorisation holderProStrakan Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameTostran 2% Gel
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Gel
    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 INNTestosterone
    D.3.9.1CAS number 58-22-0
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGel
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Borderline low levels of testosterone in male cancer survivors who have previously had leukaemia, lymphoma or testicular cancer.
    E.1.1.1Medical condition in easily understood language
    Borderline low levels of testosterone in male cancer survivors who have previously had leukaemia, lymphoma or testicular cancer.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10047900
    E.1.2Term Weight loss
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal research question is to find out whether testosterone replacement therapy can reduce body fat and improve quality of life in young male cancer survivors who have a borderline low level of testosterone. This question is split in to two principal research objectives which are: • To assess the effect of 26 weeks of testosterone treatment on levels of fat within the body • To assess the effect of 26 weeks of testosterone treatment on the participants' physical functioning. This information is collected using questionnaires that are completed by the participant.
    E.2.2Secondary objectives of the trial
    • To assess the effect of 26 weeks of treatment with testosterone gel on lean body mass, whole body fat mass, BMI, waist circumference, blood insulin, glucose, lipid and LH levels and bone density in hypogonadal cancer survivors • To assess the effect of 26 weeks of treatment with testosterone gel on participant self-reported quality of life, fatigue, self-esteem and sexual function scores in hypogonadal cancer survivors
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Able and willing to provide written informed consent • Able and willing to comply with all study procedures • Male • Aged between 25 and 50 years • Post-pubertal • Previous testicular cancer, lymphoma or leukaemia • At least 12 months from completion of curative treatment for testicular cancer, lymphoma or leukaemia • A serum testosterone level ≥7nmol/l and ≤12nmol/l • If taking any hormone replacement, on stable doses for the last 6 months
    E.4Principal exclusion criteria
    • Body Mass Index (BMI) of more than 35 kg/m2 • Currently receiving corticosteroid therapy or likely to receive corticosteroids during the trial • Previous testosterone treatment within 12 months of entering the trial • Previous allogeneic bone marrow transplant • A history of hormone-dependent cancer (e.g. prostate or breast cancer) • A history of primary liver tumour • Previous history of hypercalcaemia • Nephrotic syndrome • Diabetes mellitus (type 1 or type 2) • Hypertension • Heart failure • Liver disease • Renal failure • Deep vein thrombosis • Systolic blood pressure > 100 mmHg diastolic or > 160 mmHg systolic after resting and three measurements - Clinically significant abnormal PSA or FBC • Other severe concurrent disease or mental disorder which would affect the collection of study measurements
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are truncal fat mass and the patient-reported SF36™ physical functioning scale at 26 weeks. Truncal fat mass will be measured by whole body dual energy X-ray absorptiometry (DXA). Local quality assurance data and quality of scan images will be centrally reviewed. The SF-36™ is a well validated, multi-purpose standard health-related quality of life (QoL) evaluation questionnaire which will be used to assess generic, self reported QoL. It generates an 8-scale profile of functional health and well-being scores including a physical functioning scale, as well as summary measures of physical and mental health. This information relates to the previous 4 week time period.
    E.5.2Secondary end point(s)
    The secondary research objectives are: • To assess the effect of 26 weeks of testosterone treatment on Body Mass Index, waist circumference, blood insulin, glucose and lipid levels and bone density • To assess the effect of 26 weeks of treatment with testosterone gel on participant self-reported quality of life, fatigue, self-esteem and sexual function scores
    E.5.2.1Timepoint(s) of evaluation of this end point
    26 weeks after randomisation
    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 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 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) 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 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.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned10
    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 Yes
    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
    The end of the trial is defined as the date of the last participant's last treatment visit. Long term follow up for the purposes of the Main REC and Research Governance to one month after the last participant's last trial follow up visit constitutes the non-interventional phase of the trial.
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 268
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    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 state268
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 268
    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)
    Ongoing treatment would be provided via participants’ GP if it was felt to be appropriate. The GP will be sent a letter when the participant is due to stop treatment to explain that they may want to continue their treatment through them. It is acknowledged that continued treatment may not be possible for all participants and that this is a local decision made on a per patient basis by the GP.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-06
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