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    Summary
    EudraCT Number:2019-000315-91
    Sponsor's Protocol Code Number:RG_18-236
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-07-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-000315-91
    A.3Full title of the trial
    The pAToMiUM Trial: pilot trial of Antioxidant Therapy of Men in Unexplained Miscarriage
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The pAToMiUM Trial: testing a dietary supplement for men aimed at reducing unexplained miscarriage
    A.3.2Name or abbreviated title of the trial where available
    pAToMiUM - pilot Antioxidant Therapy of Men in Unexplained Miscarriage
    A.4.1Sponsor's protocol code numberRG_18-236
    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 SponsorUniversity of Birmingham
    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 supportNIHR Academy
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportBAYER Healthcare
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Birmingham
    B.5.2Functional name of contact pointKirkman-Brown
    B.5.3 Address:
    B.5.3.1Street AddressCentre for Human Reproductive Science
    B.5.3.2Town/ cityIBR West, The Medical School,
    B.5.3.3Post codeB15 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number 0121 414 5867
    B.5.6E-mailJ.Kirkman-Brown@nhs.net
    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 nameMenevit
    D.3.4Pharmaceutical form Film-coated 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 INNVitamin E
    D.3.9.1CAS number 7695-91-2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVitamin B6
    D.3.9.1CAS number 58-56-0
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFolic acid
    D.3.9.1CAS number 59-30-3
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVitamin B12
    D.3.9.1CAS number 68-19-9
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVitamin C
    D.3.9.1CAS number 50-81-7
    D.3.9.4EV Substance CodeAS5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZinc
    D.3.9.1CAS number 546-46-3
    D.3.9.4EV Substance CodeAS6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSelenium
    D.3.9.1CAS number 471-34-1
    D.3.9.4EV Substance CodeAS7
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCarnitine
    D.3.9.1CAS number 36687-82-8
    D.3.9.4EV Substance CodeAS8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLycopene
    D.3.9.1CAS number 502-65-8
    D.3.9.4EV Substance CodeAS9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Yes
    D.3.11.13.1Other medicinal product typeDietary Food Supplement
    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 placeboFilm-coated tablet
    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
    Unexplained miscarriage and how this may relate to the quality of the sperm DNA at conception, with particular emphasis on chromatin structure and DNA fragmentation and whether this may be improved by male dietary supplementation.
    E.1.1.1Medical condition in easily understood language
    Whether some unexplained miscarriage is caused by reversible problems with the man's sperm that can simply be corrected by taking a food supplement.
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10065877
    E.1.2Term Dietary and nutritional therapies
    E.1.2System Organ Class 100000004865
    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 question in this research is to study the feasibility, compliance and tolerance of recruiting the male partner, in couples with recurrent unexplained pregnancy loss, to a trial of dietary supplementation.

    The overarching aim our research is to improve sperm DNA quality in men of couples that have suffered recurrent, unexplained pregnancy loss. This will be achieved using a dietary supplement of minerals and antioxidants given to the men, which we hypothesise should improve sperm DNA quality, this in turn may result in a reduction in the number of miscarriages and thus an increase in successful live births.

    E.2.2Secondary objectives of the trial
    Secondary questions relate to the subsequent trial should the pilot be successful, but we would be interested to observe changes in a number of observed measures that we could examine in a later trial. These include sperm parameters; ongoing clinical pregnancy at 12 weeks and other details related to the couple's baseline health.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    >2 Unexplained miscarriages

    In order to determine whether a male patient is eligible for the study sperm DNA damage will be assessed by the TUNEL assay from the baseline semen sample they provide. If the patient sample has elevated DNA damage they will be considered eligible from a baseline semen sample perspective.
    E.4Principal exclusion criteria
    Couple not naturally conceiving
    Couple have a diagnosed cause of repetitive miscarriage
    Male partner is a smoker
    E.5 End points
    E.5.1Primary end point(s)
    The success of the feasibility study will be assessed by criteria related to the feasibility measurements to ascertain if a larger study is feasible in its current format, needs modification or is unfeasible, and includes recruitment, adherence, follow-up and withdrawal measures.

    Feasibility outcomes
    Proportion of screened men that are eligible for the trial on the basis of their baseline sperm sample
    Proportion of eligible couples randomised
    Proportion of potentially eligible men who consent to baseline sperm sample provision
    Proportion of randomised men that return for their 1 month and 3 month follow-up visits for additional sperm sample provision
    Men’s compliance to taking the daily nutritional supplement and reasons for stopping taking the trial intervention early
    Proportion of couples that withdraw from the trial, and the reasons for this
    Proportion of couple that are lost to follow-up
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months post-randomisation
    E.5.2Secondary end point(s)
    Mechanistic monitoring
    Amount of sperm DNA damage relative to baseline after 1 month on the trial intervention
    Changes in conventional sperm parameters after 1 month on the trial intervention
    Amount of sperm DNA damage relative to baseline after 3 months on the trial intervention
    Changes in conventional sperm parameters after 3 months on the trial intervention
    Clinical monitoring
    Ongoing pregnancy at 12 completed weeks of gestation
    Spontaneous conception rates whilst man is taking the treatment
    Adverse events related to the trial intervention
    Acceptability and impact on patients (outcome)
    All men will be requested to complete a short questionnaire at their 3 month follow-up visit to assess:
    How the trial impacted on their day-to-day life, including the attendance of follow-up visits.
    The acceptability of taking the daily nutritional supplement.
    Suggestions for making improvements to the recruitment processes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 completed weeks of gestation for those couples that achieve pregnancy.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    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 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 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 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 trial will be four weeks after the last data capture. This will allow sufficient time for the completion of protocol procedures, data collection and data input. The BCTU trial team will notify the main REC, and RGT within 90 days of the end of trial. Where the trial has terminated early, the Trials Office will inform REC and MHRA within 15 days of the end of trial. The Trials Office will provide them with a summary of the clinical trial report within 12 months of the end of trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days28
    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: 30
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    The intervention is unproven. It is envisaged that towards the end of the study it will be available in certain countries globally, at this stage participants would, if they so wished, be ale to source it via the internet. We know that this already occurs in the patient population from our PPI.
    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 Decision2019-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-09
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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