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    Clinical Trial Results:
    A Phase 2a Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Parallel Group, Dose-Range Finding Study of MVT-602 in Healthy Premenopausal Women Undergoing Controlled Ovarian Stimulation (COS) Using a Minimal Stimulation Protocol.

    Summary
    EudraCT number
    		 2018-001379-20
    Trial protocol
    		 NL  
    Global end of trial date
    11 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Aug 2021
    First version publication date
    25 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MVT-602-009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Myovant Sciences GmbH
    Sponsor organisation address
    Viaduktstrasse 8, Basel, Switzerland, 4051
    Public contact
    Clinical Trials, Myovant Sciences GmbH, clinicaltrials@myovant.com
    Scientific contact
    Elizabeth Migoya, PharmD, Myovant Sciences Inc., elizabeth.migoya@myovant.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
    22 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To characterize the exposure-response relationship of MVT-602 effects on luteinizing hormone (LH) concentrations after subcutaneous administration of single 0.1 to 3 micrograms (µg) doses of MVT-602, placebo, or active comparator (0.2 milligrams [mg] triptorelin) in healthy premenopausal women undergoing COS to inform dose selection of MVT-602 for subsequent studies.
    Protection of trial subjects
    This study was conducted in accordance with The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which the study was conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 May 2018
    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
    Netherlands: 75
    Worldwide total number of subjects
    75
    EEA total number of subjects
    75
    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)
    75
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Healthy adult premenopausal women were included in this study, as defined by the inclusion and exclusion criteria.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Participants, Principal Investigator and sub-investigators, including the reproductive medicine specialist and study site staff were blinded to study treatment. Only the pharmacist and independent clinician at the study site responsible for study drug administration were unblinded. Because the injection of triptorelin (comparator) required 2 separate injections, a placebo injection was administered along with MVT-602 to keep the blind.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MVT-602 0.1 μg
    Arm description
    		 Participants received a single 0.1 μg dose of MVT-602. To maintain blind, participants in the MVT-602 group also received 1 subcutaneous injection of placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVT-602
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Injected subcutaneously as a single bolus dose.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo (glucose 5%) was administered subcutaneously.

    Arm title
    		 MVT-602 0.3 μg
    Arm description
    		 Participants received a single 0.3 μg dose of MVT-602. To maintain blind, participants in the MVT-602 group also received 1 subcutaneous injection of placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVT-602
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Injected subcutaneously as a single bolus dose.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo (glucose 5%) was administered subcutaneously.

    Arm title
    		 MVT-602 1 μg
    Arm description
    		 Participants received a single 1 μg dose of MVT-602. To maintain blind, participants in the MVT-602 group also received 1 subcutaneous injection of placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVT-602
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Injected subcutaneously as a single bolus dose.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo (glucose 5%) was administered subcutaneously.

    Arm title
    		 MVT-602 3 μg
    Arm description
    		 Participants received a single 3 μg dose of MVT-602. To maintain blind, participants in the MVT-602 group also received 1 subcutaneous injection placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVT-602
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Injected subcutaneously as a single bolus dose.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo (glucose 5%) was administered subcutaneously.

    Arm title
    		 Triptorelin
    Arm description
    		 Participants received a GnRH agonist, triptorelin 0.2 mg.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Triptorelin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Triptorelin was administered as 2 separate subcutaneous injections.

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo (glucose 5%) was administered subcutaneously.

    Number of subjects in period 1
    		MVT-602 0.1 μg MVT-602 0.3 μg MVT-602 1 μg MVT-602 3 μg Triptorelin Placebo
    Started
    16
    17
    16
    16
    5
    5
    Received at least 1 dose of study drug
    16
    17
    16
    16
    5
    5
    Completed
    16
    17
    14
    16
    5
    5
    Not completed
    0
    0
    2
    0
    0
    0
         Failure to meet the discharge criteria
    -
    -
    1
    -
    -
    -
         Did not follow the dietary restrictions
    -
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 All participants who received at least 1 dose of study treatment.

    Reporting group values
    		 Overall Total
    Number of subjects
    		 75 75
    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)
    		 0 0
        Adults (18-64 years)
    		 75 75
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 25.8 ± 4.44 -
    Gender categorical
    Units: Subjects
        Female
    		 75 75
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    MVT-602 0.1 μg
    Reporting group description
    		 Participants received a single 0.1 μg dose of MVT-602. To maintain blind, participants in the MVT-602 group also received 1 subcutaneous injection of placebo.

    Reporting group title
    MVT-602 0.3 μg
    Reporting group description
    		 Participants received a single 0.3 μg dose of MVT-602. To maintain blind, participants in the MVT-602 group also received 1 subcutaneous injection of placebo.

    Reporting group title
    MVT-602 1 μg
    Reporting group description
    		 Participants received a single 1 μg dose of MVT-602. To maintain blind, participants in the MVT-602 group also received 1 subcutaneous injection of placebo.

    Reporting group title
    MVT-602 3 μg
    Reporting group description
    		 Participants received a single 3 μg dose of MVT-602. To maintain blind, participants in the MVT-602 group also received 1 subcutaneous injection placebo.

    Reporting group title
    Triptorelin
    Reporting group description
    		 Participants received a GnRH agonist, triptorelin 0.2 mg.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo.

    Subject analysis set title
    Overall
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who received at least 1 dose/injection of study treatment.

    Primary: Maximum Change From Pre-trigger LH Concentration

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    End point title
    		 Maximum Change From Pre-trigger LH Concentration [1]
    End point description
    Blood samples for determination of LH concentrations were collected prior to administration of study drug and for up to 48 hours thereafter. Pre-trigger was defined as the last assessment prior to study drug administration.
    End point type
    Primary
    End point timeframe
    Up to 48 hours post-trigger (study treatment)
    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: Descriptive statistics are included as per protocol.
    End point values
    		 MVT-602 0.1 μg MVT-602 0.3 μg MVT-602 1 μg MVT-602 3 μg Triptorelin Placebo
    Number of subjects analysed
    16
    17
    16
    16
    5
    5
    Units: U/L
        arithmetic mean (standard deviation)
    62.53 ± 33.443
    76.45 ± 39.783
    70.16 ± 42.807
    82.41 ± 49.662
    184.18 ± 25.138
    34.70 ± 18.877
    No statistical analyses for this end point

    Secondary: Change From Baseline In LH Concentrations

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    End point title
    		 Change From Baseline In LH Concentrations
    End point description
    Blood samples for determination of pharmacodynamic endpoints were collected for up to 48 hours post-trigger administration. Baseline was defined as the assessment prior to administration of COS medication. Assessments after study treatment administration at 12, 24, 36, and 48 hours pre-discharge are presented.
    End point type
    Secondary
    End point timeframe
    12, 24, 36, and 48 hours
    End point values
    		 MVT-602 0.1 μg MVT-602 0.3 μg MVT-602 1 μg MVT-602 3 μg Triptorelin Placebo
    Number of subjects analysed
    16
    17
    16
    16
    5
    5
    Units: IU/L
    arithmetic mean (standard deviation)
        12 hour
    25.04 ± 27.782
    41.29 ± 41.995
    36.41 ± 45.360
    60.41 ± 61.839
    176.28 ± 26.532
    4.84 ± 7.151
        24 hour
    41.03 ± 35.003
    48.29 ± 32.426
    44.95 ± 36.955
    51.31 ± 27.953
    40.06 ± 8.784
    4.70 ± 9.640
        36 hour
    19.81 ± 18.407
    26.34 ± 22.606
    32.74 ± 15.882
    38.72 ± 19.772
    17.92 ± 3.318
    20.64 ± 26.331
        48 hour
    9.74 ± 8.584
    10.45 ± 11.261
    16.96 ± 13.136
    15.43 ± 10.278
    10.98 ± 2.523
    20.82 ± 21.861
    No statistical analyses for this end point

    Secondary: Change From Baseline In Follicle Stimulating Hormone Concentrations

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    End point title
    		 Change From Baseline In Follicle Stimulating Hormone Concentrations
    End point description
    Blood samples for determination of follicle stimulating hormone concentrations were collected prior to administration of study drug and for up to 48 hours thereafter. Baseline was defined as the assessment prior to administration of COS medication. Assessments after study treatment administration at 12, 24, 36, and 48 hours pre-discharge are presented.
    End point type
    Secondary
    End point timeframe
    12, 24, 36, and 48 hours
    End point values
    		 MVT-602 0.1 μg MVT-602 0.3 μg MVT-602 1 μg MVT-602 3 μg Triptorelin Placebo
    Number of subjects analysed
    16
    17
    16
    16
    5
    5
    Units: IU/L
    arithmetic mean (standard deviation)
        12 hours
    3.50 ± 6.576
    6.19 ± 7.522
    3.78 ± 7.227
    8.28 ± 8.949
    34.00 ± 8.845
    -0.96 ± 1.504
        24 hours
    7.60 ± 7.858
    9.66 ± 7.241
    6.40 ± 7.778
    10.45 ± 6.927
    12.10 ± 3.893
    -1.14 ± 2.349
        36 hours
    3.09 ± 5.189
    4.92 ± 4.580
    4.38 ± 4.338
    7.49 ± 5.461
    3.32 ± 2.461
    0.64 ± 5.740
        48 hours
    0.26 ± 3.509
    1.72 ± 3.28
    1.50 ± 3.93
    2.19 ± 3.972
    0.68 ± 2.460
    0.38 ± 5.378
    No statistical analyses for this end point

    Secondary: Change From Baseline In Estradiol Concentrations

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    End point title
    		 Change From Baseline In Estradiol Concentrations
    End point description
    Blood samples for determination of estradiol concentrations were collected prior to administration of study drug and for up to 48 hours thereafter. Baseline was defined as the assessment prior to administration of COS medication. Assessments after study treatment administration at 12, 24, 36, and 48 hours pre-discharge are presented.
    End point type
    Secondary
    End point timeframe
    12, 24, 36, and 48 hours
    End point values
    		 MVT-602 0.1 μg MVT-602 0.3 μg MVT-602 1 μg MVT-602 3 μg Triptorelin Placebo
    Number of subjects analysed
    16
    17
    16
    16
    5
    5
    Units: pmol/L
    arithmetic mean (standard deviation)
        12 hours
    1478.7 ± 988.65
    1778.4 ± 1592.41
    1260.1 ± 630.01
    1177.8 ± 550.82
    1581.2 ± 843.53
    1437.8 ± 1001.96
        24 hours
    1431.6 ± 1105.76
    1600.6 ± 1375.02
    1363.4 ± 693.53
    1024.8 ± 439.13
    1127.2 ± 793.99
    1825.8 ± 1444.41
        36 hours
    1198.6 ± 1021.52
    1289.9 ± 1178.50
    1265.4 ± 940.60
    835.2 ± 698.81
    583.0 ± 423.07
    1998.0 ± 1545.44
        48 hours
    886.3 ± 766.76
    859.5 ± 879.66
    1007.5 ± 806.05
    514.9 ± 640.53
    217.0 ± 165.60
    1891.6 ± 1509.07
    No statistical analyses for this end point

    Secondary: Change From Baseline In Progesterone Concentrations

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    End point title
    		 Change From Baseline In Progesterone Concentrations
    End point description
    Blood samples for determination of progesterone concentrations were collected prior to administration of study drug and for up to 48 hours thereafter. Baseline was defined as the assessment prior to administration of COS medication. Assessments after study treatment administration at 12, 24, 36, and 48 hours pre-discharge are presented.
    End point type
    Secondary
    End point timeframe
    12, 24, 36, and 48 hours
    End point values
    		 MVT-602 0.1 μg MVT-602 0.3 μg MVT-602 1 μg MVT-602 3 μg Triptorelin Placebo
    Number of subjects analysed
    16
    17
    16
    16
    5
    5
    Units: nmol/L
    arithmetic mean (standard deviation)
        12 hours
    0.981 ± 0.5696
    1.121 ± 0.8379
    0.956 ± 0.7962
    0.877 ± 0.5295
    1.650 ± 0.6078
    0.594 ± 0.3576
        24 hours
    1.578 ± 1.3124
    2.483 ± 2.1247
    1.604 ± 1.4307
    1.339 ± 0.7816
    1.330 ± 0.6061
    0.398 ± 0.4525
        36 hours
    2.154 ± 1.6344
    2.416 ± 1.2955
    2.353 ± 1.2510
    1.817 ± 0.5711
    1.530 ± 0.9041
    1.210 ± 0.9244
        48 hours
    2.193 ± 1.6848
    2.718 ± 2.0775
    2.389 ± 1.0842
    2.039 ± 1.1927
    2.410 ± 0.4036
    1.340 ± 1.2646
    No statistical analyses for this end point

    Secondary: Time To Ovulation After Trigger Administration (Study Treatment)

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    End point title
    		 Time To Ovulation After Trigger Administration (Study Treatment)
    End point description
    Time ovulation (follicular rupture) as determined by transvaginal ultrasound (TVUS). Transvaginal ultrasound scans for the determination of ovulation were performed once daily (in the morning) until follicular rupture was observed or the participant met discharge criteria, which was based on initiation of menses, or estradiol or progesterone concentrations within the post-ovulatory range. Time to ovulation was defined as the time interval (in days) from the date of pre-trigger until the first date of ovulation; the censored time was the last TVUS assessment time. Time to event was analyzed using Kaplan-Meier method.
    End point type
    Secondary
    End point timeframe
    Day 1 (after study treatment) through 13 days post discharge (-1/+3 days)
    End point values
    		 MVT-602 0.1 μg MVT-602 0.3 μg MVT-602 1 μg MVT-602 3 μg Triptorelin Placebo
    Number of subjects analysed
    16
    17
    16
    16
    5
    5
    Units: days
        median (confidence interval 95%)
    4.0 (4.00 to 5.00)
    4.0 (4 to 4)
    3.5 (3.00 to 4.00)
    4 (4 to 4)
    4.0 (2.00 to 4.00)
    5.0 (4.00 to 9.00)
    No statistical analyses for this end point

    Secondary: Area Under The Concentration-time Curve Extrapolated To Infinity (AUC0-inf)

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    End point title
    		 Area Under The Concentration-time Curve Extrapolated To Infinity (AUC0-inf) [2]
    End point description
    Blood samples for pharmacokinetic (PK) analysis of MVT-602 were collected up to 24 hours after administration of study treatment.
    End point type
    Secondary
    End point timeframe
    Pre-trigger, 15 and 30 min, and 1, 2, 4, 6, 8, 12, and 24 hours post-trigger (study treatment)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only MVT-602 groups were analyzed for PK assessments.
    End point values
    		 MVT-602 0.1 μg MVT-602 0.3 μg MVT-602 1 μg MVT-602 3 μg
    Number of subjects analysed
    1 [3]
    16
    16
    16
    Units: pg*h/mL
        geometric mean (geometric coefficient of variation)
    4.29 ± 0
    14.4 ± 18
    48.9 ± 19
    137 ± 20
    Notes
    [3] - Geometric coefficient of variation is not available since only 1 participant was analyzed.
    No statistical analyses for this end point

    Secondary: Area Under The Concentration-time Curve From Time Zero To Last Quantifiable Time Point (AUC0-t)

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    End point title
    		 Area Under The Concentration-time Curve From Time Zero To Last Quantifiable Time Point (AUC0-t) [4]
    End point description
    Blood samples for pharmacokinetic analysis of MVT-602 were collected up to 24 hours after administration of study treatment.
    End point type
    Secondary
    End point timeframe
    Pre-trigger, 15 and 30 min, and 1, 2, 4, 6, 8, 12, and 24 hours post-trigger (study treatment)
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only MVT-602 groups were analyzed for PK assessments.
    End point values
    		 MVT-602 0.1 μg MVT-602 0.3 μg MVT-602 1 μg MVT-602 3 μg
    Number of subjects analysed
    16
    17
    16
    16
    Units: pg*h/mL
        geometric mean (geometric coefficient of variation)
    3.69 ± 12
    12.7 ± 19
    46.9 ± 19
    134 ± 20
    No statistical analyses for this end point

    Secondary: Maximum Concentration (Cmax)

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    End point title
    		 Maximum Concentration (Cmax) [5]
    End point description
    Blood samples for pharmacokinetic analysis of MVT-602 were collected up to 24 hours after administration of study treatment.
    End point type
    Secondary
    End point timeframe
    Pre-trigger, 15 and 30 min, and 1, 2, 4, 6, 8, 12, and 24 hours post-trigger (study treatment)
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only MVT-602 groups were analyzed for PK assessments.
    End point values
    		 MVT-602 0.1 μg MVT-602 0.3 μg MVT-602 1 μg MVT-602 3 μg
    Number of subjects analysed
    16
    17
    16
    16
    Units: pg/mL
        geometric mean (geometric coefficient of variation)
    3.03 ± 21
    6.86 ± 34
    22.9 ± 24
    63.1 ± 32
    No statistical analyses for this end point

    Secondary: Time To Maximum Concentration (tmax)

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    End point title
    		 Time To Maximum Concentration (tmax) [6]
    End point description
    Blood samples for pharmacokinetic analysis of MVT-602 were collected up to 24 hours after administration of study treatment.
    End point type
    Secondary
    End point timeframe
    Pre-trigger, 15 and 30 min, and 1, 2, 4, 6, 8, 12, and 24 hours post-trigger (study treatment)
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only MVT-602 groups were analyzed for PK assessments.
    End point values
    		 MVT-602 0.1 μg MVT-602 0.3 μg MVT-602 1 μg MVT-602 3 μg
    Number of subjects analysed
    16
    17
    16
    16
    Units: hour
        median (full range (min-max))
    0.26 (0.25 to 1.00)
    0.50 (0.25 to 1.00)
    0.50 (0.25 to 1.00)
    0.50 (0.25 to 1.03)
    No statistical analyses for this end point

    Secondary: Elimination Half-life (t1/2)

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    End point title
    		 Elimination Half-life (t1/2) [7]
    End point description
    Blood samples for pharmacokinetic analysis of MVT-602 were collected up to 24 hours after administration of study treatment.
    End point type
    Secondary
    End point timeframe
    Pre-trigger, 15 and 30 min, and 1, 2, 4, 6, 8, 12, and 24 hours post-trigger (study treatment)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only MVT-602 groups were analyzed for PK assessments.
    End point values
    		 MVT-602 0.1 μg MVT-602 0.3 μg MVT-602 1 μg MVT-602 3 μg
    Number of subjects analysed
    1 [8]
    16
    16
    16
    Units: hour
        geometric mean (geometric coefficient of variation)
    0.602 ± 0
    1.26 ± 19
    1.85 ± 23
    2.03 ± 26
    Notes
    [8] - Geometric coefficient of variation is not available since only 1 participant was analyzed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 (after study treatment) through 13 days post discharge (-1/+3 days).
    Adverse event reporting additional description
    All participants who received at least 1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    MVT-602 0.1 μg
    Reporting group description
    		 Participants received a single 0.1 μg dose of MVT-602.

    Reporting group title
    MVT-602 0.3 μg
    Reporting group description
    		 Participants received a single 0.3 μg dose of MVT-602.

    Reporting group title
    MVT-602 1 μg
    Reporting group description
    		 Participants received a single 1 μg dose of MVT-602.

    Reporting group title
    MVT-602 3 μg
    Reporting group description
    		 Participants received a single 3 μg dose of MVT-602.

    Reporting group title
    Triptorelin
    Reporting group description
    		 Participants received a GnRH agonist, triptorelin 0.2 mg.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo.

    Reporting group title
    Overall
    Reporting group description
    		 All participants who received at least 1 dose/injection of study treatment.

    Serious adverse events
    		 MVT-602 0.1 μg MVT-602 0.3 μg MVT-602 1 μg MVT-602 3 μg Triptorelin Placebo Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 75 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 MVT-602 0.1 μg MVT-602 0.3 μg MVT-602 1 μg MVT-602 3 μg Triptorelin Placebo Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 16 (93.75%)
    17 / 17 (100.00%)
    15 / 16 (93.75%)
    15 / 16 (93.75%)
    2 / 5 (40.00%)
    5 / 5 (100.00%)
    69 / 75 (92.00%)
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Administration site discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Catheter site pain
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    3 / 75 (4.00%)
         occurrences all number
    2
    0
    0
    0
    0
    1
    3
    Catheter site related reaction
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Chest discomfort
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    2
    Chest pain
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    3 / 16 (18.75%)
    2 / 17 (11.76%)
    1 / 16 (6.25%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    8 / 75 (10.67%)
         occurrences all number
    3
    3
    1
    3
    0
    0
    10
    Feeling hot
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    2
    Injection site bruising
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Injection site hypersensitivity
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Injection site pain
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Injection site pruritus
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Injection site reaction
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 17 (11.76%)
    2 / 16 (12.50%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    7 / 75 (9.33%)
         occurrences all number
    1
    2
    2
    2
    0
    0
    7
    Pain
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Reproductive system and breast disorders
    Breast tenderness
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Dysmenorrhoea
         subjects affected / exposed
    2 / 16 (12.50%)
    2 / 17 (11.76%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    4 / 75 (5.33%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    4
    Menorrhagia
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    3 / 75 (4.00%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    3
    Nipple pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    2
    Ovarian cyst
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    2
    Pelvic discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    3
    Polycystic ovaries
         subjects affected / exposed
    0 / 16 (0.00%)
    3 / 17 (17.65%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    4 / 75 (5.33%)
         occurrences all number
    0
    3
    0
    0
    0
    1
    4
    Vaginal discharge
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    3 / 75 (4.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    3
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 17 (11.76%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    3 / 75 (4.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    2
    Epistaxis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    3 / 16 (18.75%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    4 / 75 (5.33%)
         occurrences all number
    1
    0
    0
    3
    0
    0
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Mood altered
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 17 (11.76%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    4 / 75 (5.33%)
         occurrences all number
    0
    2
    1
    1
    0
    0
    4
    Nightmare
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    3
    Oestradiol increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 16 (25.00%)
    3 / 17 (17.65%)
    3 / 16 (18.75%)
    4 / 16 (25.00%)
    2 / 5 (40.00%)
    1 / 5 (20.00%)
    17 / 75 (22.67%)
         occurrences all number
    4
    3
    6
    4
    6
    1
    24
    Dizziness postural
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 17 (0.00%)
    2 / 16 (12.50%)
    3 / 16 (18.75%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    7 / 75 (9.33%)
         occurrences all number
    3
    0
    2
    3
    0
    0
    8
    Dysgeusia
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 17 (11.76%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    3 / 75 (4.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    3
    Head discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    3
    Hypoaesthesia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    2
    Restless legs syndrome
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Sensory disturbance
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    5 / 16 (31.25%)
    9 / 17 (52.94%)
    7 / 16 (43.75%)
    7 / 16 (43.75%)
    1 / 5 (20.00%)
    2 / 5 (40.00%)
    31 / 75 (41.33%)
         occurrences all number
    13
    14
    11
    10
    1
    2
    51
    Ear and labyrinth disorders
    Excessive cerumen production
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Motion sickness
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Eye disorders
    Eye allergy
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Eye irritation
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Eyelid irritation
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    3 / 16 (18.75%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    4 / 75 (5.33%)
         occurrences all number
    1
    0
    3
    0
    0
    0
    4
    Abdominal distension
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 16 (12.50%)
    3 / 16 (18.75%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    5 / 75 (6.67%)
         occurrences all number
    0
    0
    2
    5
    0
    0
    7
    Abdominal pain
         subjects affected / exposed
    2 / 16 (12.50%)
    5 / 17 (29.41%)
    4 / 16 (25.00%)
    3 / 16 (18.75%)
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    16 / 75 (21.33%)
         occurrences all number
    2
    6
    4
    4
    0
    3
    19
    Abdominal pain lower
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    5 / 75 (6.67%)
         occurrences all number
    1
    1
    1
    1
    1
    0
    5
    Abdominal pain upper
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 17 (5.88%)
    2 / 16 (12.50%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    6 / 75 (8.00%)
         occurrences all number
    1
    1
    2
    2
    0
    0
    6
    Nausea
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 17 (11.76%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    6 / 75 (8.00%)
         occurrences all number
    1
    2
    3
    1
    0
    0
    7
    Vomiting
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Renal and urinary disorders
    Bladder pain
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    2
    Dysuria
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    3 / 16 (18.75%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    6 / 75 (8.00%)
         occurrences all number
    1
    1
    0
    3
    1
    0
    6
    Myalgia
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 17 (11.76%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    2
    Neck pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    2
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    3 / 75 (4.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    3
    Oral herpes
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    3 / 75 (4.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    3
    Otitis externa
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Apr 2018
    - Exclusion Criteria # 14 was amended to include the use of an injectable hormonal method of contraception within 6 months prior to Day 1 in the Run-in Period. - Clarified Section 5.6.1 Synchronization Screen Failure. - Clarified Section 5.6.2 Run-in Screen Failure. - Revised the risk assessment and mitigation strategy for MVT-602 to include all monitoring timepoints for Reproductive Toxicity.

    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
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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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