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

    Summary
    EudraCT number
    		 2018-001269-18
    Trial protocol
    		 BG   PL   GB  
    Global end of trial date
    21 Oct 2020

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

    Trial information

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    Trial identification
    Sponsor protocol code
    VMT-VT-1161-CL-011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03562156
    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
    21 Oct 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 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 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
    20 Aug 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
    United States: 124
    Country: Number of subjects enrolled
    Bulgaria: 73
    Country: Number of subjects enrolled
    Canada: 16
    Country: Number of subjects enrolled
    Japan: 44
    Country: Number of subjects enrolled
    Poland: 57
    Country: Number of subjects enrolled
    United Kingdom: 12
    Worldwide total number of subjects
    326
    EEA total number of subjects
    130
    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)
    1
    Adults (18-64 years)
    323
    From 65 to 84 years
    2
    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 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). All randomized subjects were included in the Intent-to-Treat (ITT) population.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    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
    217
    109
    Completed
    182
    91
    Not completed
    35
    18
         Consent withdrawn by subject
    18
    9
         Physician decision
    1
    1
         Missed study visit(s)
    1
    1
         Adverse event, non-fatal
    1
    -
         Subject decision
    -
    1
         Sponsor request
    2
    -
         Pregnancy
    2
    1
         Non-compliance
    1
    -
         Subject relocated
    1
    -
         Lab assessment; clinically significant changes
    -
    1
         Lost to follow-up
    8
    4

    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
    		 217 109 326
    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)
    		 1 0 1
        Adults (18-64 years)
    		 214 109 323
        From 65-84 years
    		 2 0 2
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34 ( 10.3 ) 34 ( 9.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 217 109 326
        Male
    		 0 0 0
    Race
    Units: Subjects
        White
    		 156 80 236
        Black or African American
    		 26 17 43
        Asian
    		 33 12 45
        American Indian or Alaska Native
    		 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Other
    		 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 19 6 25
        Not Hispanic or Latino
    		 198 103 301
        Unknown/Not Reported
    		 0 0 0

    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.

    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.
    End point type
    Primary
    End point timeframe
    48 weeks
    End point values
    		 Oteseconazole Placebo
    Number of subjects analysed
    217
    109
    Units: percentage of subjects
        number (not applicable)
    6.7
    42.8
    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.
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    		 Oteseconazole Placebo
    Number of subjects analysed
    217 [1]
    109 [2]
    Units: weeks
        median (confidence interval 95%)
    999999 (999999 to 999999)
    999999 (32.6 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
    326
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 0.21

    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.
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    		 Oteseconazole Placebo
    Number of subjects analysed
    217
    109
    Units: percentage of subjects
        number (not applicable)
    29.4
    84.2
    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.
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Oteseconazole Placebo
    Number of subjects analysed
    217
    109
    Units: percentage of subjects
        number (not applicable)
    3.3
    37.4
    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: 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.
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    		 Oteseconazole Placebo
    Number of subjects analysed
    199
    100
    Units: scores on a scale
        least squares mean (confidence interval 95%)
    4.66 (2.61 to 6.70)
    2.61 (-0.27 to 5.49)
    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
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.255
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    2.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.49
         upper limit
    		 5.58

    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.
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    		 Oteseconazole Placebo
    Number of subjects analysed
    199
    100
    Units: scores on a scale
        least squares mean (confidence interval 95%)
    4.59 (2.80 to 6.38)
    2.57 (0.06 to 5.09)
    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
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    2.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.07
         upper limit
    		 5.1

    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
    3 / 217 (1.38%)
    3 / 109 (2.75%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Limb traumatic amputation
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 109 (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
    Endometriosis
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 217 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 217 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 217 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 217 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 217 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 217 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubo-ovarian abscess
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 109 (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
    99 / 217 (45.62%)
    51 / 109 (46.79%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    7 / 217 (3.23%)
    3 / 109 (2.75%)
         occurrences all number
    8
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 217 (3.69%)
    8 / 109 (7.34%)
         occurrences all number
    8
    10
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    5 / 217 (2.30%)
    4 / 109 (3.67%)
         occurrences all number
    5
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 217 (3.69%)
    3 / 109 (2.75%)
         occurrences all number
    10
    3
    Diarrhoea
         subjects affected / exposed
    8 / 217 (3.69%)
    2 / 109 (1.83%)
         occurrences all number
    8
    2
    Abdominal pain
         subjects affected / exposed
    5 / 217 (2.30%)
    3 / 109 (2.75%)
         occurrences all number
    6
    4
    Reproductive system and breast disorders
    Vulvovaginal pruritus
         subjects affected / exposed
    7 / 217 (3.23%)
    2 / 109 (1.83%)
         occurrences all number
    7
    4
    Metrorrhagia
         subjects affected / exposed
    5 / 217 (2.30%)
    3 / 109 (2.75%)
         occurrences all number
    7
    3
    Vaginal discharge
         subjects affected / exposed
    0 / 217 (0.00%)
    4 / 109 (3.67%)
         occurrences all number
    0
    5
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    5 / 217 (2.30%)
    1 / 109 (0.92%)
         occurrences all number
    5
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 217 (1.38%)
    5 / 109 (4.59%)
         occurrences all number
    3
    6
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    26 / 217 (11.98%)
    7 / 109 (6.42%)
         occurrences all number
    37
    10
    Bacterial vaginosis
         subjects affected / exposed
    14 / 217 (6.45%)
    11 / 109 (10.09%)
         occurrences all number
    19
    15
    Urinary tract infection
         subjects affected / exposed
    12 / 217 (5.53%)
    7 / 109 (6.42%)
         occurrences all number
    14
    9
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 217 (4.15%)
    7 / 109 (6.42%)
         occurrences all number
    9
    7
    Sinusitis
         subjects affected / exposed
    12 / 217 (5.53%)
    3 / 109 (2.75%)
         occurrences all number
    13
    3
    Cystitis
         subjects affected / exposed
    4 / 217 (1.84%)
    8 / 109 (7.34%)
         occurrences all number
    6
    13
    Influenza
         subjects affected / exposed
    7 / 217 (3.23%)
    1 / 109 (0.92%)
         occurrences all number
    7
    1
    Genital herpes
         subjects affected / exposed
    7 / 217 (3.23%)
    0 / 109 (0.00%)
         occurrences all number
    8
    0
    Pharyngitis
         subjects affected / exposed
    6 / 217 (2.76%)
    0 / 109 (0.00%)
         occurrences all number
    6
    0

    More information

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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 description to prevent confusion of dosing regimen. • Clarified subject population eligible for enrollment (post-menarcheal was previously assumed). • Established RVVC history based on locally approved testing, as outlined in the study design. • Improved clarity on timelines for Papanicolaou test requirement. • Improved clarity on collunarium/nasal steroid use. • Reduced potentially confounding factors for efficacy assessments. • Clarified complete list of narrow therapeutic index drugs metabolized by or sensitive to cytochrome P450 3A4. • Allowed flexibility for scheduling Screening visit with respect to Day 1 without impact to assessments. • Provided clarification on capsule formulation of oteseconazole. • Clarified Informed Consent Form and included assent for subjects aged 12 to 17 years. • Prevented confusion on which laboratory testing was being performed locally and centrally. • Additional discontinuation criteria added. • Defined study completion. • Provided additional information on plans for primary and secondary analyses and handling of missing data. • Provided explanation for how sample size was determined. • Provided additional information on the analysis and how missing data were to be handled for the primary endpoint.

    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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