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    Clinical Trial Results:
    Pharmacokinetics of intravenous, rectal, intravesical, vaginal, and transdermal administration of exogenous melatonin in healthy female volunteers: a crossover study

    Summary
    EudraCT number
    		 2017-000997-13
    Trial protocol
    		 DK  
    Global end of trial date
    01 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Feb 2021
    First version publication date
    17 Feb 2021
    Other versions
    Summary report(s)
    		 Summary attachment

    Trial information

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    Trial identification
    Sponsor protocol code
    HEHDZ01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03519750
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Center for Perioperative Optimization, Department of Surgery
    Sponsor organisation address
    Borgmester Ib Juuls Vej 1, Herlev, Denmark, 2730
    Public contact
    Dennis Zetner, Center for Perioperative Optimization, Gastroenheden D, Herlev Hospital, dennis.zetner@gmail.com
    Scientific contact
    Dennis Zetner, Center for Perioperative Optimization, Gastroenheden D, Herlev Hospital, dennis.zetner@gmail.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the study is to determine the pharmacokinetic properties, and possible adverse reactions of melatonin when administered rectally, intravesically, vaginally, transdermally and intravenously, in healthy female volunteers.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited by an ad for medical students of the University of Copenhagen. All 10 participants were recruited in November/December 2018.

    Pre-assignment
    Screening details
    		 After contacting the primary investigator, possible participants showed up at the hospital. All participants were screened for eligibility criteria. All 10 volunteers were deemed eligible by the primary investigator.

    Pre-assignment period milestones
    Number of subjects started
    		 10
    Number of subjects completed
    		 10

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Arm 1
    Arm description
    		 Intravenous administration
    Arm type
    		 Experimental

    Investigational medicinal product name
    Intravenous Melatonin
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    25 mg

    Investigational medicinal product name
    Intravesical Melatonin
    Investigational medicinal product code
    PR2
    Other name
    Pharmaceutical forms
    Intravesical suspension
    Routes of administration
    Intravesical use
    Dosage and administration details
    25 mg

    Investigational medicinal product name
    Vaginal Melatonin
    Investigational medicinal product code
    PR3
    Other name
    Pharmaceutical forms
    Vaginal capsule, soft
    Routes of administration
    Vaginal use
    Dosage and administration details
    25 mg

    Investigational medicinal product name
    Rectal melatonin
    Investigational medicinal product code
    PR4
    Other name
    Pharmaceutical forms
    Rectal emulsion
    Routes of administration
    Rectal use
    Dosage and administration details
    25 mg

    Investigational medicinal product name
    Transdermal melatonin
    Investigational medicinal product code
    PR5
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    25 mg/g, 1 g applied

    Number of subjects in period 1
    		Arm 1
    Started
    10
    Completed
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 23 (22 to 27) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 0 0
    Ethnicity
    Units: Subjects
        Caucasian
    		 9 9
        Asian
    		 1 1
    Height
    Units: cm
        median (full range (min-max))
    		 172 (163 to 184) -
    Weight
    Units: kg
        median (full range (min-max))
    		 64 (54 to 71) -
    BMI
    Units: kg/m2
        median (full range (min-max))
    		 21.1 (18.7 to 23.1) -

    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Intravenous administration

    Primary: Pharmacokinetic Properties

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    End point title
    		 Pharmacokinetic Properties [1]
    End point description
    End point type
    Primary
    End point timeframe
    Over 48 hours.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical tests have been performed, only pharmacokinetic calculations. I am unable to enter these, as I have not calculated any p-values.
    End point values
    		 Arm 1
    Number of subjects analysed
    10
    Units: variable
        number (not applicable)
    10
    Attachments
    		 Untitled (Filename: Table 3.docx)
    No statistical analyses for this end point

    Secondary: SRT and KSS

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    End point title
    		 SRT and KSS
    End point description
    End point type
    Secondary
    End point timeframe
    48 hours
    End point values
    		 Arm 1
    Number of subjects analysed
    10
    Units: variable
        number (not applicable)
    10
    Attachments
    		 Untitled (Filename: Table 4.docx)
    No statistical analyses for this end point

    Secondary: Adverse reactions

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    End point title
    		 Adverse reactions
    End point description
    End point type
    Secondary
    End point timeframe
    24-48 hours after administration.
    End point values
    		 Arm 1
    Number of subjects analysed
    10
    Units: n
    10
    Attachments
    		 Untitled (Filename: Table 5.docx)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    24-48 hours after administration of melatonin
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: These are reported under secondary outcomes.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32937627
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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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