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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VT-1161 Oral Capsules in the Treatment of Subjects with Recurrent Vulvovaginal Candidiasis

    Summary
    EudraCT number
    2018-001270-26
    Trial protocol
    CZ   BE   HU  
    Global end of trial date
    13 Oct 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Sep 2021
    First version publication date
    09 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VMT-VT-1161-CL-012
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03561701
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Mycovia Pharmaceuticals, Inc.
    Sponsor organisation address
    4721 Emperor Blvd., Suite 220, Durham, United States, 27703
    Public contact
    Clinical Trial Administration, Mycovia Pharmaceuticals, Inc., +011 9194678539, adminops@mycovia.com
    Scientific contact
    Chief Development Officer, Mycovia Pharmaceuticals, Inc., +011 9194678539,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-002392-PIP01-18
    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
    13 Oct 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of oral oteseconazole (VT-1161) in the treatment of recurrent vulvovaginal candidiasis (RVVC) through Week 48 of the study.
    Protection of trial subjects
    The study was conducted in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (GCP), all applicable subject privacy requirements, the guiding principles of the current version of the Declaration of Helsinki, and applicable country-specific regulatory requirements.
    Background therapy
    Prior to randomization, subjects completed an Induction Phase where all subjects received 3 sequential 150 milligram (mg) doses of fluconazole that were administered 72 hours apart. After the Induction Phase, if subjects were still eligible for randomization, fluconazole was used as a rescue medication to treat an acute vulvovaginal candidiasis (VVC) infection during the remainder of the study.
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Oct 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
    Belgium: 26
    Country: Number of subjects enrolled
    Czechia: 73
    Country: Number of subjects enrolled
    Hungary: 11
    Country: Number of subjects enrolled
    Romania: 72
    Country: Number of subjects enrolled
    Ukraine: 26
    Country: Number of subjects enrolled
    United States: 122
    Worldwide total number of subjects
    330
    EEA total number of subjects
    182
    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)
    329
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted in generally healthy non-pregnant females aged ≥12 years (aged ≥18 years in Hungary, Romania, Ukraine and Czech Republic) with a history of RVVC and with a clinical diagnosis of symptomatic acute VVC. Subjects were randomized in a 2:1 ratio to receive either oteseconazole or a matching placebo regimen.

    Pre-assignment
    Screening details
    The study consisted of a 2-week Induction Phase (screening to Day 1 pre-randomization) and 48-week Maintenance Phase (comprising a 12-week treatment period and 36 weeks follow up). As a result of multiple GCP violations, a site was terminated from the study; 4 subjects enrolled at this site were excluded from the Intent-to-Treat (ITT) population.

    Period 1
    Period 1 title
    Randomized
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Oteseconazole
    Arm description
    Subjects received loading doses of 150 mg oteseconazole once daily on Days 1 to 7, followed by maintenance doses of 150 mg oteseconazole once weekly starting at Week 2 (7 days after the completion of daily dosing) through Week 12 of the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Oteseconazole
    Investigational medicinal product code
    Other name
    VT-1161
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oteseconazole was administered as 150 mg oral capsules. Subjects were instructed to take the doses of investigational product (IP) within 30 minutes after ingestion of their main meal, at approximately the same time of the day consistently throughout the study.

    Arm title
    Placebo
    Arm description
    Subjects received matching placebo regimen once daily on Days 1 to 7, followed by placebo once weekly starting at Week 2 (7 days after the completion of daily dosing) through Week 12 of the study.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was administered as oral capsules to match oteseconazole. Subjects were instructed to take the doses of IP within 30 minutes after ingestion of their main meal, at approximately the same time of the day consistently throughout the study.

    Number of subjects in period 1
    Oteseconazole Placebo
    Started
    220
    110
    Completed
    218
    108
    Not completed
    2
    2
         Excluded from ITT population
    2
    2
    Period 2
    Period 2 title
    Included in ITT Population
    Is this the baseline period?
    Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Oteseconazole
    Arm description
    Subjects received loading doses of 150 mg oteseconazole once daily on Days 1 to 7, followed by maintenance doses of 150 mg oteseconazole once weekly starting at Week 2 (7 days after the completion of daily dosing) through Week 12 of the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Oteseconazole
    Investigational medicinal product code
    Other name
    VT-1161
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oteseconazole was administered as 150 mg oral capsules. Subjects were instructed to take the doses of IP within 30 minutes after ingestion of their main meal, at approximately the same time of the day consistently throughout the study.

    Arm title
    Placebo
    Arm description
    Subjects received matching placebo regimen once daily on Days 1 to 7, followed by placebo once weekly starting at Week 2 (7 days after the completion of daily dosing) through Week 12 of the study.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was administered as oral capsules to match oteseconazole. Subjects were instructed to take the doses of IP within 30 minutes after ingestion of their main meal, at approximately the same time of the day consistently throughout the study.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 1 presents data for all subjects randomized and Period 2 presents data for all subjects included in the ITT population. 4 subjects were excluded from the ITT population due to GCP non-compliance at a site. The analysis population for baseline characteristics was the ITT population; Period 2 is therefore the baseline period.
    Number of subjects in period 2 [2]
    Oteseconazole Placebo
    Started
    218
    108
    Completed
    190
    91
    Not completed
    28
    17
         Consent withdrawn by subject
    16
    8
         Physician decision
    2
    3
         Adverse event, non-fatal
    1
    1
         Sponsor request
    1
    -
         Pregnancy
    1
    -
         Non-compliance
    -
    2
         Subject relocated
    -
    1
         Lab assessment; clinically significant changes
    1
    -
         Lost to follow-up
    6
    2
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The analysis population for baseline characteristics was the ITT population which excluded 4 randomized subjects due to GCP non-compliance at a site.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Oteseconazole
    Reporting group description
    Subjects received loading doses of 150 mg oteseconazole once daily on Days 1 to 7, followed by maintenance doses of 150 mg oteseconazole once weekly starting at Week 2 (7 days after the completion of daily dosing) through Week 12 of the study.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo regimen once daily on Days 1 to 7, followed by placebo once weekly starting at Week 2 (7 days after the completion of daily dosing) through Week 12 of the study.

    Reporting group values
    Oteseconazole Placebo Total
    Number of subjects
    218 108 326
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    218 107 325
        From 65-84 years
    0 1 1
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    34 ( 9.4 ) 36 ( 10.8 ) -
    Gender categorical
    Units: Subjects
        Female
    218 108 326
        Male
    0 0 0
    Race
    Units: Subjects
        White
    193 96 289
        Black or African American
    23 8 31
        Asian
    0 3 3
        American Indian or Alaska Native
    0 0 0
        Native Hawaiian or Other Pacific Islander
    0 0 0
        Other
    2 1 3
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    30 18 48
        Not Hispanic or Latino
    187 90 277
        Unknown/Not Reported
    1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Oteseconazole
    Reporting group description
    Subjects received loading doses of 150 mg oteseconazole once daily on Days 1 to 7, followed by maintenance doses of 150 mg oteseconazole once weekly starting at Week 2 (7 days after the completion of daily dosing) through Week 12 of the study.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo regimen once daily on Days 1 to 7, followed by placebo once weekly starting at Week 2 (7 days after the completion of daily dosing) through Week 12 of the study.
    Reporting group title
    Oteseconazole
    Reporting group description
    Subjects received loading doses of 150 mg oteseconazole once daily on Days 1 to 7, followed by maintenance doses of 150 mg oteseconazole once weekly starting at Week 2 (7 days after the completion of daily dosing) through Week 12 of the study.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo regimen once daily on Days 1 to 7, followed by placebo once weekly starting at Week 2 (7 days after the completion of daily dosing) through Week 12 of the study.

    Primary: Percentage of Subjects with 1 or More Culture-verified Acute VVC Episodes during the Maintenance Phase

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    End point title
    Percentage of Subjects with 1 or More Culture-verified Acute VVC Episodes during the Maintenance Phase
    End point description
    The primary efficacy outcome measure was the proportion of subjects with 1 or more culture-verified acute VVC episodes during the Maintenance Phase in the ITT population. The Maintenance Phase was defined as post-randomization through Week 48 of the study. An acute VVC episode during the Maintenance Phase (considered a recurrent episode) was defined as a positive culture for Candida species and a clinical signs and symptoms score of ≥3. Missing values were imputed with multiple imputation using the following auxiliary information: region, treatment, baseline body mass index, baseline age, ethnicity, and visit. Analysis was performed on the ITT population which included all randomized subjects (except those specifically excluded from the analysis).
    End point type
    Primary
    End point timeframe
    48 weeks
    End point values
    Oteseconazole Placebo
    Number of subjects analysed
    218
    108
    Units: percentage of subjects
        number (not applicable)
    3.9
    39.4
    Statistical analysis title
    Comparison of oteseconazole to placebo
    Comparison groups
    Oteseconazole v Placebo
    Number of subjects included in analysis
    326
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Chi-squared
    Confidence interval

    Secondary: Time to First Recurrence of a Culture-verified Acute VVC Episode during the Maintenance Phase

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    End point title
    Time to First Recurrence of a Culture-verified Acute VVC Episode during the Maintenance Phase
    End point description
    The Maintenance Phase was defined as post-randomization through Week 48 of the study. An acute VVC episode during the Maintenance Phase was defined as a positive culture for Candida species and a clinical signs and symptoms score of ≥3. Time to recurrence of acute VVC was estimated using the method of Kaplan-Meier and was calculated as: Date of first culture-verified acute VVC episode – date of randomization+1 Subjects with no recurrence were censored at their last non-missing assessment. Analysis was performed on the ITT population which included all randomized subjects (except those specifically excluded from the analysis).
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    Oteseconazole Placebo
    Number of subjects analysed
    213 [1]
    107 [2]
    Units: weeks
        median (confidence interval 95%)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    Notes
    [1] - 999999 denotes that the value was not estimable
    [2] - 999999 denotes that the value was not estimable
    Statistical analysis title
    Comparison of oteseconazole to placebo
    Statistical analysis description
    The Cox regression model included factors for treatment, region, baseline body mass index, baseline age, ethnicity and screening signs and symptoms score.
    Comparison groups
    Oteseconazole v Placebo
    Number of subjects included in analysis
    320
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.04
         upper limit
    0.17

    Secondary: Percentage of Subjects with at Least 1 Positive Culture for Candida Species during the Maintenance Phase

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    End point title
    Percentage of Subjects with at Least 1 Positive Culture for Candida Species during the Maintenance Phase
    End point description
    The percentage of subjects with ≥1 positive culture for Candida species during the Maintenance Phase is reported. Missing values were imputed with multiple imputation using the following auxiliary information: region, treatment, baseline body mass index, baseline age, ethnicity, and visit. Analysis was performed on the ITT population which included all randomized subjects (except those specifically excluded from the analysis).
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    Oteseconazole Placebo
    Number of subjects analysed
    218
    108
    Units: percentage of subjects
        number (not applicable)
    27.6
    84.0
    Statistical analysis title
    Comparison of oteseconazole to placebo
    Comparison groups
    Oteseconazole v Placebo
    Number of subjects included in analysis
    326
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Chi-squared
    Confidence interval

    Secondary: Percentage of Subjects with at Least 1 Culture-verified Acute VVC Episode through Week 24

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    End point title
    Percentage of Subjects with at Least 1 Culture-verified Acute VVC Episode through Week 24
    End point description
    The percentage of subjects with ≥1 positive culture for Candida species during post-randomization through Week 24 is reported. Missing values were imputed with multiple imputation using the following auxiliary information: region, treatment, baseline body mass index, baseline age, ethnicity, and visit. Analysis was performed on the ITT population which included all randomized subjects (except those specifically excluded from the analysis).
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    Oteseconazole Placebo
    Number of subjects analysed
    218
    108
    Units: percentage of subjects
        number (not applicable)
    2.8
    31.9
    Statistical analysis title
    Comparison of oteseconazole to placebo
    Comparison groups
    Oteseconazole v Placebo
    Number of subjects included in analysis
    326
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Chi-squared
    Confidence interval

    Secondary: Change from Screening through Week 48 in the 36-item Short Form Survey (SF-36) Mental Component Score (MCS)

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    End point title
    Change from Screening through Week 48 in the 36-item Short Form Survey (SF-36) Mental Component Score (MCS)
    End point description
    The least squares (LS) mean change from Screening through Week 48 for SF-36 MCS is reported. The SF-36 questionnaire consists of 36 items which are used to calculate 8 scaled scores for the following domains: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. Scores for the SF-36 scales range from 0 to 100, with higher scores denoting less disability. The MCS was derived as the average of the following 4 domain scores: vitality, social role functioning, emotional role functioning, and mental health. If 2 or more of the domain scores were missing, the MCS was missing. Missing values after applying the imputations according to the SF-36 scoring algorithm were imputed using last observation carried forward (LOCF). Analysis was performed on the ITT population which included all randomized subjects (except those specifically excluded from the analysis).
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    Oteseconazole Placebo
    Number of subjects analysed
    194
    101
    Units: scores on a scale
        least squares mean (confidence interval 95%)
    14.19 (11.91 to 16.46)
    11.69 (8.53 to 14.86)
    Statistical analysis title
    Comparison of oteseconazole to placebo
    Statistical analysis description
    The LS mean, 95% confidence interval (CI) for LS mean, difference in LS mean, 95% CI for the difference, and the p-value for the difference came from a repeated measures analysis of covariance (ANCOVA) model with a random effect for subject and fixed effects for treatment group, time point, treatment by time point interaction, and baseline value. A compound symmetry covariance structure was used.
    Comparison groups
    Oteseconazole v Placebo
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.21
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    2.49
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.41
         upper limit
    6.4

    Secondary: Change from Screening through Week 48 in the SF-36 Total Score

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    End point title
    Change from Screening through Week 48 in the SF-36 Total Score
    End point description
    The LS mean change from Screening through Week 48 for SF-36 total score is reported. The SF-36 questionnaire consists of 36 items which are used to calculate 8 scaled scores for the following domains: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. Scores for the SF-36 scales range between 0 and 100, with higher scores denoting less disability. The SF-36 total score was derived as the average of the 8 domain scores. If 3 or more of the domain scores were missing, the total score was missing. Missing values after applying the imputations according to the SF-36 scoring algorithm were imputed using LOCF. Analysis was performed on the ITT population which included all randomized subjects (except those specifically excluded from the analysis).
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    Oteseconazole Placebo
    Number of subjects analysed
    194
    101
    Units: scores on a scale
        least squares mean (confidence interval 95%)
    13.69 (11.75 to 15.63)
    11.45 (8.76 to 14.14)
    Statistical analysis title
    Comparison of oteseconazole to placebo
    Statistical analysis description
    The LS mean, 95% CI for LS mean, difference in LS mean, 95% CI for the difference, and the p-value for the difference came from a repeated measures ANCOVA model with a random effect for subject and fixed effects for treatment group, time point, treatment by time point interaction, and baseline value. A compound symmetry covariance structure was used.
    Comparison groups
    Oteseconazole v Placebo
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.186
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    2.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.08
         upper limit
    5.56

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 through Week 48 of the study.
    Adverse event reporting additional description
    Treatment-emergent adverse events were defined as adverse events that occurred on or after the initiation of IP. The safety population was defined as all randomized subjects who received at least 1 dose of the IP.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Oteseconazole
    Reporting group description
    Subjects received loading doses of 150 mg oteseconazole once daily on Days 1 to 7, followed by maintenance doses of 150 mg oteseconazole once weekly starting at Week 2 (7 days after the completion of daily dosing) through Week 12 of the study.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo regimen once daily on Days 1 to 7, followed by placebo once weekly starting at Week 2 (7 days after the completion of daily dosing) through Week 12 of the study.

    Serious adverse events
    Oteseconazole Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 217 (3.23%)
    5 / 110 (4.55%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer female
         subjects affected / exposed
    0 / 217 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocarditis
         subjects affected / exposed
    0 / 217 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Motor dysfunction
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine polyp
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 217 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cholecystitis infective
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 217 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Severe acute respiratory syndrome
         subjects affected / exposed
    0 / 217 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Oteseconazole Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 217 (27.65%)
    37 / 110 (33.64%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    18 / 217 (8.29%)
    7 / 110 (6.36%)
         occurrences all number
    27
    7
    Reproductive system and breast disorders
    Vulvovaginal pruritus
         subjects affected / exposed
    4 / 217 (1.84%)
    6 / 110 (5.45%)
         occurrences all number
    6
    8
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    6 / 217 (2.76%)
    2 / 110 (1.82%)
         occurrences all number
    6
    2
    Vomiting
         subjects affected / exposed
    6 / 217 (2.76%)
    2 / 110 (1.82%)
         occurrences all number
    6
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 217 (0.92%)
    3 / 110 (2.73%)
         occurrences all number
    2
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 217 (1.84%)
    3 / 110 (2.73%)
         occurrences all number
    4
    3
    Infections and infestations
    Bacterial vaginosis
         subjects affected / exposed
    14 / 217 (6.45%)
    6 / 110 (5.45%)
         occurrences all number
    23
    7
    Nasopharyngitis
         subjects affected / exposed
    11 / 217 (5.07%)
    7 / 110 (6.36%)
         occurrences all number
    14
    9
    Urinary tract infection
         subjects affected / exposed
    12 / 217 (5.53%)
    4 / 110 (3.64%)
         occurrences all number
    16
    6
    Influenza
         subjects affected / exposed
    6 / 217 (2.76%)
    3 / 110 (2.73%)
         occurrences all number
    7
    3
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 217 (0.92%)
    7 / 110 (6.36%)
         occurrences all number
    2
    7
    Cystitis
         subjects affected / exposed
    5 / 217 (2.30%)
    3 / 110 (2.73%)
         occurrences all number
    6
    6
    Herpes simplex
         subjects affected / exposed
    0 / 217 (0.00%)
    3 / 110 (2.73%)
         occurrences all number
    0
    3

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Feb 2019
    Changes included the following: • Expanded the description of Maintenance Phase dosing for IP to prevent confusion of the dosing regimens. • Updated details of collection of RVVC history for subjects in the United States only. • Clarified that the countries of Romania and Ukraine would not enroll subjects <18 years of age. • Added Romania and Ukraine to list of countries where subjects <18 years of age could not be enrolled. • Clarified subject population eligible for enrollment as post-menarcheal (this was previously assumed). • Established RVVC history to be based on locally approved testing, as outlined in the study design. • Improved clarity on timelines for Papanicolaou test requirement. • Clarified definition of abstinence and restricted contraceptive methods to only highly effective methods during repeat dosing of fluconazole. • Added a cross-reference to allowed treatment plan should a subject fail to respond to fluconazole treatment for an acute VVC episode. • Added collunarium/nasal to list of concomitant steroids permitted and to Exclusion Criterion #5. • Reduced potential confounding factors for efficacy assessments. • Improved clarity for which pregnancy testing (central serum or local urine) would be performed at each visit. • Implemented testing request to evaluate cholesterol and triglycerides across all subject populations. • Clarified Informed Consent Form and included assent for subjects aged 12 to 17 years. • Clarified which bacterial testing would be performed locally and centrally. • Provided clarification on capsule formulation of oteseconazole. • Clarified subjects can be eligible for re-screening once. • Modified the protocol deviation criterion for IP compliance. • Implemented changes made during European Union Voluntary Harmonisation Procedure review as they were beneficial to subject safety and data quality from a global perspective.

    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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