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    Clinical Trial Results:
    A Phase I, Open-Label Study to Investigate the Pharmacokinetics and Pharmacodynamics of Etonogestrel (ENG) and 17ß-Estradiol (E2) in Healthy female Postmenarcheal Adolescents and Healthy Female Adults Following Administration of MK-8342B (ENG-E2, 125/300 μg/day) Vaginal Ring

    Summary
    EudraCT number
    		 2015-005284-16
    Trial protocol
    		 AT  
    Global end of trial date
    14 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Aug 2020
    First version publication date
    06 Aug 2020
    Other versions
    Summary report(s)
    		 EudraCT Summary Results

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-8342B-072
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    14 Jul 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jul 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Objective 1: To investigate the pharmacokinetics of ENG, E2 and E1 (estrone) following administration of MK-8342B (ENGE2,125/300 μg/day) vaginal ring in healthy female postmenarcheal adolescents (≥12 to <18 years of age) and in healthy female adults (≥18 to ≤36 years of age). Objective 2: To evaluate the pharmacodynamic effects (on progesterone (P), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and sex hormonal binding globulin (SHBG) following administration of MK-8342B (ENG-E2, 125/300 μg/day) vaginal ring in healthy female postmenarcheal adolescents (≥12 to <18 years of age) and in healthy female adults (≥18 to ≤36 years of age). Objective 3: To investigate the safety and tolerability following administration of MK-8342B (ENG-E2, 125/300 μg/day) vaginal ring in healthy female postmenarcheal adolescents (≥12 to <18 years of age) and in healthy female adults (≥18 to ≤36 years of age). NOTE: This study was terminated early. No participants were ever enrolled in
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jul 2016
    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
    Austria: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial

    Pre-assignment
    Screening details
    		 N/A

    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
    		 ENG-E2 125 μg/300 μg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etonogestrel + 17β-Estradiol Vaginal Ring
    Investigational medicinal product code
    Other name
    MK-8342B
    Pharmaceutical forms
    Buccal film, Vaginal delivery system
    Routes of administration
    Vaginal use
    Dosage and administration details
    ENG-E2 125 μg/300 μg

    Number of subjects in period 1
    		ENG-E2 125 μg/300 μg
    Started
    99999
    Completed
    99999

    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
    		 99999 99999
    Age Categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 99999 99999
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 0 ± 0 -
    Gender Categorical
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    ENG-E2 125 μg/300 μg
    Reporting group description
    		 -

    Primary: Time to maximum observed serum drug concentration (Tmax)

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    End point title
    		 Time to maximum observed serum drug concentration (Tmax) [1]
    End point description
    99999 is a "Not applicable" value. There were 0 participants. This study was terminated early. No participants were ever enrolled in it. y on 14-July-2016.
    End point type
    Primary
    End point timeframe
    Day 1-22 and Day 1-29 of Cycle 2
    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: This study was terminated early. No participants were ever enrolled in it.
    End point values
    		 ENG-E2 125 μg/300 μg
    Number of subjects analysed
    99999
    Units: Hours
        median (full range (min-max))
    0 (0 to 0)
    No statistical analyses for this end point

    Primary: Maximum observed serum concentration (Cmax)

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    End point title
    		 Maximum observed serum concentration (Cmax) [2]
    End point description
    99999 is a "Not applicable" value. There were 0 participants. This study was terminated early. No participants were ever enrolled in it.
    End point type
    Primary
    End point timeframe
    Day 1-22 and Day 1-29 of Cycle 2
    Notes
    [2] - 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: This study was terminated early. No participants were ever enrolled in it.
    End point values
    		 ENG-E2 125 μg/300 μg
    Number of subjects analysed
    99999
    Units: nM
        geometric mean (geometric coefficient of variation)
    0 ± 0
    No statistical analyses for this end point

    Primary: Area under the concentration versus time curve from Day 1 to Day 29 (AUC1-29)

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    End point title
    		 Area under the concentration versus time curve from Day 1 to Day 29 (AUC1-29) [3]
    End point description
    99999 is a "Not applicable" value. There were 0 participants. This study was terminated early. No participants were ever enrolled in it.
    End point type
    Primary
    End point timeframe
    Up to 672 hours after vaginal ring insertion
    Notes
    [3] - 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: This study was terminated early. No participants were ever enrolled in it.
    End point values
    		 ENG-E2 125 μg/300 μg
    Number of subjects analysed
    99999 [4]
    Units: nM*hr
        geometric mean (geometric coefficient of variation)
    0 ± 0
    Notes
    [4] - This study was terminated early. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Primary: Area under the concentration versus time curve from Day 1 to Day 22 (AUC1-22)

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    End point title
    		 Area under the concentration versus time curve from Day 1 to Day 22 (AUC1-22) [5]
    End point description
    99999 is a "Not applicable" value. There were 0 participants. This study was terminated early. No participants were ever enrolled in it.
    End point type
    Primary
    End point timeframe
    Up to 504 hours after vaginal ring insertion
    Notes
    [5] - 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: This study was terminated early. No participants were ever enrolled in it.
    End point values
    		 ENG-E2 125 μg/300 μg
    Number of subjects analysed
    99999 [6]
    Units: nM*hr
        geometric mean (geometric coefficient of variation)
    0 ± 0
    Notes
    [6] - This study was terminated early. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Primary: Minimum observed/measured non-zero concentration (Cmin)

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    End point title
    		 Minimum observed/measured non-zero concentration (Cmin) [7]
    End point description
    99999 is a "Not applicable" value. There were 0 participants. This study was terminated early. No participants were ever enrolled in it.
    End point type
    Primary
    End point timeframe
    Day 1-22 and Day 1-29 of Cycle 2
    Notes
    [7] - 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: This study was terminated early. No participants were ever enrolled in it.
    End point values
    		 ENG-E2 125 μg/300 μg
    Number of subjects analysed
    99999 [8]
    Units: mcg/mL
        arithmetic mean (standard error)
    0 ± 0
    Notes
    [8] - This study was terminated early. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Primary: Ratio of AUC1-29 to the corresponding time interval Day 1 to Day 29

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    End point title
    		 Ratio of AUC1-29 to the corresponding time interval Day 1 to Day 29 [9]
    End point description
    99999 is a "Not applicable" value. There were 0 participants. This study was terminated early. No participants were ever enrolled in it.
    End point type
    Primary
    End point timeframe
    Up to 672 hours after vaginal ring insertion
    Notes
    [9] - 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: This study was terminated early. No participants were ever enrolled in it.
    End point values
    		 ENG-E2 125 μg/300 μg
    Number of subjects analysed
    99999 [10]
    Units: Number
    99999
    Notes
    [10] - This study was terminated early. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Primary: Ratio of AUC1-22 to the corresponding time interval Day 1 to Day 22

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    End point title
    		 Ratio of AUC1-22 to the corresponding time interval Day 1 to Day 22 [11]
    End point description
    99999 is a "Not applicable" value. There were 0 participants. This study was terminated early. No participants were ever enrolled in it.
    End point type
    Primary
    End point timeframe
    Up to 504 hours
    Notes
    [11] - 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: This study was terminated early. No participants were ever enrolled in it.
    End point values
    		 ENG-E2 125 μg/300 μg
    Number of subjects analysed
    99999 [12]
    Units: Number
    99999
    Notes
    [12] - This study was terminated early. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Primary: Apparent terminal half life (t1/2)

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    End point title
    		 Apparent terminal half life (t1/2) [13]
    End point description
    99999 is a "Not applicable" value. There were 0 participants. This study was terminated early. No participants were ever enrolled in it.
    End point type
    Primary
    End point timeframe
    Day 1-22 and Day 1-29 of Cycle 2
    Notes
    [13] - 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: This study was terminated early. No participants were ever enrolled in it.
    End point values
    		 ENG-E2 125 μg/300 μg
    Number of subjects analysed
    99999 [14]
    Units: Hours
    99999
    Notes
    [14] - This study was terminated early. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Primary: Percent change from baseline in serum hormone concentrations of progesterone (P)

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    End point title
    		 Percent change from baseline in serum hormone concentrations of progesterone (P) [15]
    End point description
    99999 is a "Not applicable" value. There were 0 participants. This study was terminated early. No participants were ever enrolled in it.
    End point type
    Primary
    End point timeframe
    Up to Day 29 of Cycle 2
    Notes
    [15] - 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: This study was terminated early. No participants were ever enrolled in it.
    End point values
    		 ENG-E2 125 μg/300 μg
    Number of subjects analysed
    99999 [16]
    Units: Number
    99999
    Notes
    [16] - This study was terminated early. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Primary: Percent change from baseline in serum hormone concentrations of luteinizing hormone (LH)

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    End point title
    		 Percent change from baseline in serum hormone concentrations of luteinizing hormone (LH) [17]
    End point description
    99999 is a "Not applicable" value. There were 0 participants. This study was terminated early. No participants were ever enrolled in it.
    End point type
    Primary
    End point timeframe
    Up to Day 29 of Cycle 2
    Notes
    [17] - 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: This study was terminated early. No participants were ever enrolled in it.
    End point values
    		 ENG-E2 125 μg/300 μg
    Number of subjects analysed
    99999 [18]
    Units: Number
    99999
    Notes
    [18] - This study was terminated early. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Primary: Percent change from baseline in serum hormone concentrations of follicle-stimulating hormone (FSH)

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    End point title
    		 Percent change from baseline in serum hormone concentrations of follicle-stimulating hormone (FSH) [19]
    End point description
    99999 is a "Not applicable" value. There were 0 participants. This study was terminated early. No participants were ever enrolled in it.
    End point type
    Primary
    End point timeframe
    Up to Day 29 of Cycle 2
    Notes
    [19] - 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: This study was terminated early. No participants were ever enrolled in it.
    End point values
    		 ENG-E2 125 μg/300 μg
    Number of subjects analysed
    99999 [20]
    Units: Number
    99999
    Notes
    [20] - This study was terminated early. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Primary: Percent change from baseline in serum hormone concentrations of sex hormonal binding globulin (SHBG)

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    End point title
    		 Percent change from baseline in serum hormone concentrations of sex hormonal binding globulin (SHBG) [21]
    End point description
    99999 is a "Not applicable" value. There were 0 participants. This study was terminated early. No participants were ever enrolled in it.
    End point type
    Primary
    End point timeframe
    Up to Day 29 of Cycle 2
    Notes
    [21] - 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: This study was terminated early. No participants were ever enrolled in it.
    End point values
    		 ENG-E2 125 μg/300 μg
    Number of subjects analysed
    99999 [22]
    Units: Number
    99999
    Notes
    [22] - This study was terminated early. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Primary: Percentage of participants who experienced one or more adverse events

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    End point title
    		 Percentage of participants who experienced one or more adverse events [23]
    End point description
    99999 is a "Not applicable" value. There were 0 participants. This study was terminated early. No participants were ever enrolled in it.
    End point type
    Primary
    End point timeframe
    Up to approximately 72 days
    Notes
    [23] - 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: This study was terminated early. No participants were ever enrolled in it.
    End point values
    		 ENG-E2 125 μg/300 μg
    Number of subjects analysed
    99999 [24]
    Units: Percentage of participants
    99999
    Notes
    [24] - This study was terminated early. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Primary: Percentage of participants who discontinued treatment due to an adverse event

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    End point title
    		 Percentage of participants who discontinued treatment due to an adverse event [25]
    End point description
    99999 is a "Not applicable" value. There were 0 participants. This study was terminated early. No participants were ever enrolled in it.
    End point type
    Primary
    End point timeframe
    Up to Day 58
    Notes
    [25] - 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: This study was terminated early. No participants were ever enrolled in it.
    End point values
    		 ENG-E2 125 μg/300 μg
    Number of subjects analysed
    99999 [26]
    Units: Percentage of participants
    99999
    Notes
    [26] - This study was terminated early. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All adverse events occurring during the course of the clinical trial were to be collected.
    Adverse event reporting additional description
    99999 is a "Not applicable" value. There were 0 participants. This study was terminated early. No participants were ever enrolled in it.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    ENG-E2 125 μg/300 μg
    Reporting group description
    		 This study was terminated early. No participants were ever enrolled in it.

    Serious adverse events
    		 ENG-E2 125 μg/300 μg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ENG-E2 125 μg/300 μg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
    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: This study was terminated early. No participants were ever enrolled in it.

    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.
    This study was terminated early on 14-July-2016. No participants were ever enrolled in it.
    For support, Contact us.
    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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