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    Clinical Trial Results:
    A pharmacokinetic study of vaginally and intravenously administered oxytocin in postmenopausal women with vaginal atrophy

    Summary
    EudraCT number
    		 2013-002690-22
    Trial protocol
    		 SE  
    Global end of trial date
    30 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Jul 2020
    First version publication date
    17 Jul 2020
    Other versions
    Summary report(s)
    		 Summary of study OXYPEP003
    Report of study OXYPEP003

    Trial information

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    Trial identification
    Sponsor protocol code
    OXYPEP003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Peptonic Medical AB
    Sponsor organisation address
    Gustavslundsvagen 143, Bromma, Sweden, 167 51
    Public contact
    Dan Markusson, PeP-Tonic Medical AB, +46 768550200, info@peptonicmedical.se
    Scientific contact
    Dan Markusson, PeP-Tonic Medical AB, +46 768550200, dan.markusson@peptonicmedical.se
    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
    26 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the uptake of oxytocin following intravaginal administration of Vagitocin 400IU over a period of 14 days and also to compare oxytocin bioavailability after vaginal and intravenous administration
    Protection of trial subjects
    In connection with nurses during the hole treatment period
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Aug 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    6
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 12 healthy postmenopausal female volunteers, 40 to 70 years old, who were judged to be healthy on the basis of a pre-study physical examination.

    Pre-assignment
    Screening details
    		 1. Postmenopausal women with vaginal atrophy 2. Subjects who are willing to participate in the study as indicated by signing the informed consent 3. Subjects who are healthy post-menopausal women between the ages of 40 and 70 years, inclusive

    Period 1
    Period 1 title
    25 days (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    It is pharmacokinetic study

    Arms
    Arm title
    		 Intravaginally use and intravenous
    Arm description
    		 Each eligible subject will be administered intravaginally with Vagitocin 400IU [PeP-Tonic Medical AB] once daily for 15 days and a single intravenous dose of oxytocin 10 IU Syntocinon®. There will be a minimum of 7 days washout between the two dosing periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxytocin 400 IU + Syntocinon
    Investigational medicinal product code
    Oxytocin
    Other name
    Pharmaceutical forms
    Gel, Concentrate for suspension for injection
    Routes of administration
    Vaginal use, Intravenous use
    Dosage and administration details
    Each eligible subject will be administered intravaginally with Vagitocin 400IU [PeP-Tonic Medical AB] once daily for 15 days (Period I) and a single intravenous dose of oxytocin 10 IU Syntocinon® (Period II). There will be a minimum of 7 days washout between the two dosing periods.

    Number of subjects in period 1
    		Intravaginally use and intravenous
    Started
    12
    Completed
    12

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Intravaginally use and intravenous
    Reporting group description
    		 Each eligible subject will be administered intravaginally with Vagitocin 400IU [PeP-Tonic Medical AB] once daily for 15 days and a single intravenous dose of oxytocin 10 IU Syntocinon®. There will be a minimum of 7 days washout between the two dosing periods.

    Primary: Oxytocin Plasma

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    End point title
    		 Oxytocin Plasma [1]
    End point description
    Primary Endpoints - To determine the oxytocin plasma levels after intravaginal and intravenous administration and also pharmacokinetic parameters
    End point type
    Primary
    End point timeframe
    On Day 1, Day 15 (Period I) and Day 22 (Period II) of the study serial blood samples will be collected at the following times relative to dosing: -1.0, -0.5, 0, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 and 8.0 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: Only following the pmol/L of oxytocin
    End point values
    		 Intravaginally use and intravenous
    Number of subjects analysed
    12
    Units: pmol/L
        number (not applicable)
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Recording of Adverse Events (AE/SAE) throughout the study
    Adverse event reporting additional description
    Questions at each visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8
    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: No SAE have been found

    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
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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