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    Clinical Trial Results:
    A randomised controlled trial to assess the clinical and cost effectiveness of topical lactic acid gel for treating second and subsequent episodes of bacterial vaginosis

    Summary
    EudraCT number
    		 2016-004483-19
    Trial protocol
    		 GB  
    Global end of trial date
    26 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Dec 2021
    First version publication date
    18 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RRK5908
    Additional study identifiers
    ISRCTN number
    		 ISRCTN14161293
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospitals Birmingham NHS Foundation Trust
    Sponsor organisation address
    1st Floor Institute of Translational Medicine, Mindelsohn Way, Edgbaston, Birmingham, United Kingdom, B15 2TH
    Public contact
    VITA Trial Manager, Nottingham Clinical Trials Unit, vita@nottingham.ac.uk
    Scientific contact
    Professor Jonathan Ross (Chief Investigator for VITA trial), University Hospitals Birmingham NHS Foundation Trust, Jonathan.Ross@uhb.nhs.uk
    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
    04 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Feb 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The principle objective of the study is to determine whether intravaginal lactic acid gel is better than oral metronidazole for symptomatic resolution of recurrent bacterial vaginosis.
    Protection of trial subjects
    None required.
    Background therapy
    		 None.
    Evidence for comparator
    		 The control group received a 7 day course of twice daily 400mg oral metronidazole. This was chosen as the comparator because it is recommended as first line therapy in the UK national BV treatment guideline, active against a wide range of the anaerobic bacteria associated with BV, and commonly used in clinical practice supported by evidence from randomised controlled trials.
    Actual start date of recruitment
    01 Sep 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 518
    Worldwide total number of subjects
    518
    EEA total number of subjects
    0
    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)
    3
    Adults (18-64 years)
    515
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment took place between October 2017 and June 2019. The original planned end of recruitment was November 2019. Recruitment finished early after the DMC reviewed unblinded trial data at a planned meeting, and recommended early stopping as the primary question had been answered; this was agreed by the TSC. There were no safety concerns.

    Pre-assignment
    Screening details
    		 3141 approached. Of these 2618 did not participate: Did not have history of BV = 695; Receiving antibiotics/antifungals = 418; Not interested = 248; Using topical antibiotics/antifungals = 209; Takes too much time = 192; No staff available = 178; No current clinical diagnosis of BV = 83; Other = 595.

    Pre-assignment period milestones
    Number of subjects started
    		 3141 [1]
    Number of subjects completed
    		 518

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 2
    Reason: Number of subjects
    		 Did not participate: 2618
    Reason: Number of subjects
    		 inclusion criteria: 3
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: These are the numbers initially approached; less people took part in the trial for the reasons given.
    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Data analyst [2]
    Blinding implementation details
    Data analyst remained blinded until after database lock.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Metronidazole
    Arm description
    		 Metronidazole tablets; 400 mg to be taken orally twice daily, approximately 12 hours apart, for 7 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Metronidazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Metronidazole tablets; 400 mg to be taken orally twice daily, approximately 12 hours apart, for 7 days.

    Arm title
    		 Intravaginal lactic acid gel
    Arm description
    		 Lactic acid gel; 5ml to be inserted into the vagina before bedtime each day for 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lactic acid gel 5ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Vaginal gel
    Routes of administration
    Vaginal use
    Dosage and administration details
    5ml gel administered through an intravaginal tube applicator, once daily before bed, for 7 days

    Notes
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This is an open label trial, but the analysing statistician and laboratory staff remained blinded to treatment until after the database lock.
    Number of subjects in period 1
    		Metronidazole Intravaginal lactic acid gel
    Started
    259
    259
    week 2
    258
    257
    month 3
    256
    256
    month 6
    256
    256
    Completed
    256
    256
    Not completed
    3
    3
         Consent withdrawn by subject
    3
    2
         Dissatisfied with efficacy of treatment
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Metronidazole
    Reporting group description
    		 Metronidazole tablets; 400 mg to be taken orally twice daily, approximately 12 hours apart, for 7 days.

    Reporting group title
    Intravaginal lactic acid gel
    Reporting group description
    		 Lactic acid gel; 5ml to be inserted into the vagina before bedtime each day for 7 days.

    Reporting group values
    		 Metronidazole Intravaginal lactic acid gel Total
    Number of subjects
    		 259 259 518
    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)
    		 3 0 3
        Adults (18-64 years)
    		 256 259 515
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Age at consent (must be at least 16)
    Units: years
        arithmetic mean (standard deviation)
    		 29.0 ( 8.41 ) 29.4 ( 8.12 ) -
    Gender categorical
    Units: Subjects
        Female
    		 259 259 518
        Male
    		 0 0 0
    Ethnicity
    Categories were combined to aid anonymity.
    Units: Subjects
        White
    		 125 126 251
        Black
    		 89 78 167
        Other
    		 45 54 99
        Not recorded
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Metronidazole
    Reporting group description
    		 Metronidazole tablets; 400 mg to be taken orally twice daily, approximately 12 hours apart, for 7 days.

    Reporting group title
    Intravaginal lactic acid gel
    Reporting group description
    		 Lactic acid gel; 5ml to be inserted into the vagina before bedtime each day for 7 days.

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Treatment received at baseline (metronidazole or lactic acid gel)

    Subject analysis set title
    As randomised
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants analysed as randomised (metronidazole or lactic acid gel)

    Primary: Resolution of BV symptoms by week 2

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    End point title
    		 Resolution of BV symptoms by week 2
    End point description
    BV symptoms resolved within 2 weeks (yes/no)
    End point type
    Primary
    End point timeframe
    Week 2 (within 2 weeks of starting treatment)
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    204 [1]
    205 [2]
    Units: people
        yes
    143
    97
        no
    61
    108
    Notes
    [1] - Treatment as randomised, responses by questionnaire and phonecall.
    [2] - Treatment as randomised, responses by questionnaire and phonecall
    Statistical analysis title
    		 Primary outcome adjusted risk difference
    Statistical analysis description
    A generalised estimating equation with site as panel variable and adjusted for number of BV episodes in 12 months before baseline (0, 1-3, >3) and female partner in 12 months before baseline (yes/no).
    Comparison groups
    Metronidazole v Intravaginal lactic acid gel
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Adjusted risk difference
    Point estimate
    -23.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32.3
         upper limit
    		 -14
    Variability estimate
    Standard error of the mean

    Secondary: Time to first recurrence of BV

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    End point title
    		 Time to first recurrence of BV
    End point description
    A new episode of BV symptoms in those whose BV symptoms resolved within 2 weeks of starting treatment. Note: in the analysis the upper confidence bound that was not calculable, due to the censored observations, has been represented by 99999 since the system would not allow it to be left blank.
    End point type
    Secondary
    End point timeframe
    Between 2 weeks and 6 months
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    73 [3]
    50 [4]
    Units: days
        median (confidence interval 95%)
    92 (71 to 188)
    124 (74 to 99999)
    Attachments
    		 Kaplan Meier plot: time to recurrence of symptoms
    Notes
    [3] - As randomised. Data from questionnaires
    [4] - As randomised, data from questionnaires.
    No statistical analyses for this end point

    Secondary: Number of episodes of BV symptoms within 6 months

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    End point title
    		 Number of episodes of BV symptoms within 6 months
    End point description
    Number of new episodes of BV symptoms within 6 months for participants whose symptoms resolved within 2 weeks
    End point type
    Secondary
    End point timeframe
    2 weeks to 6 months
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    48 [5]
    29 [6]
    Units: episodes
        median (inter-quartile range (Q1-Q3))
    1 (0 to 3)
    1 (0 to 2)
    Notes
    [5] - Only those with episode data at both 3 and 6 months are included.
    [6] - Only those with episode data at both 3 and 6 months are included.
    Statistical analysis title
    		 Comparison of number of new episodes
    Statistical analysis description
    Negative binomial regression presenting adjusted incidence rate ratio. Adjusted for: site, number of BV episodes in 12 months before baseline, female partner in 12 months before baseline
    Comparison groups
    Metronidazole v Intravaginal lactic acid gel
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    Method
    Parameter type
    		 Adjusted incidence rate ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.69
    Notes
    [7] - Uses medians. Only CI, not p-values presented.

    Secondary: Number of BV treatment courses within 6 months

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    End point title
    		 Number of BV treatment courses within 6 months
    End point description
    Number of participant reported BV treatment courses between week 2 and 6 months per participant, for those who resolved by 2 weeks and had treatment data at both 3 and 6 months.
    End point type
    Secondary
    End point timeframe
    2 weeks to 6 months
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    59
    35
    Units: treatment course
        median (inter-quartile range (Q1-Q3))
    1 (0 to 3)
    1 (0 to 2)
    Statistical analysis title
    		 Comparison of number of BV treatment courses
    Statistical analysis description
    Negative binomial regression, presenting adjusted incidence rate ratio. Adjusted for: site, number of BV episodes in 12 months before baseline, female partners in 12 months before baseline.
    Comparison groups
    Metronidazole v Intravaginal lactic acid gel
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Adjusted incidence rate ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 2.01

    Secondary: Microbiological resolution of BV at week 2

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    End point title
    		 Microbiological resolution of BV at week 2
    End point description
    Microbiological resolution of BV (grade 0, 1, 2 or U) on microscopy of vaginal smears at Week 2 in those with positive baseline smear for BV (grade 3) using central lab results
    End point type
    Secondary
    End point timeframe
    week 2, for those with microbiologically confirmed BV (Ison-Hay 3) at baseline
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    77
    73
    Units: people
        yes
    59
    31
        no
    18
    42
    Statistical analysis title
    		 Comparison of microbiological resolution of BV
    Statistical analysis description
    Generalised estimating equation adjusted for: site and female partners in in 12 months before baseline; adding number of episodes in 12 months before baseline or vaginal douching causes the analysis to not converge.
    Comparison groups
    Metronidazole v Intravaginal lactic acid gel
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Adjusted risk difference
    Point estimate
    -34.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -49.1
         upper limit
    		 -19.5

    Secondary: Prevalence of STIs at week 2

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    End point title
    		 Prevalence of STIs at week 2
    End point description
    STIs included are gonorrhoea, chlamydia and trichomoniasis. Yes= have at least one of these STIs. Only includes data from sample kits that were known to be in date.
    End point type
    Secondary
    End point timeframe
    week 2
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    108
    111
    Units: people
        yes
    5
    1
        no
    103
    110
    Statistical analysis title
    		 Analysis of prevalence of STI at Week 2
    Statistical analysis description
    logit model adjusted for: site (panel variable) and baseline STI (12 in the metronidazole group and 3 in the lactic acid group); these are the only covariates that can be included without collinearity problems.
    Comparison groups
    Metronidazole v Intravaginal lactic acid gel
    Number of subjects included in analysis
    219
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Adjusted odds ratio
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 1.6

    Secondary: Time to resolution of BV symptoms

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    End point title
    		 Time to resolution of BV symptoms
    End point description
    Time in days to resolution of BV symptoms.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    192 [8]
    179 [9]
    Units: days
        median (standard error)
    14 ( 0.65 )
    14 ( 3.41 )
    Notes
    [8] - Where resolution known, but date missing time substituted with 14. If not yet resolved time censored
    [9] - Where resolution known, but date missing time substituted with 14. If not yet resolved time censored
    Statistical analysis title
    		 Analysis: median time to resolution of BV symptoms
    Statistical analysis description
    quantile (median) regression adjusted for: site, number of BV episodes in 12 months before baseline, female partner in 12 months before baseline, vaginal douching
    Comparison groups
    Metronidazole v Intravaginal lactic acid gel
    Number of subjects included in analysis
    371
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Adjusted median difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 1.9

    Secondary: Nausea

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    End point title
    		 Nausea
    End point description
    Nausea in the first 2 weeks as reported on the week 2 participant questionnaire. Incidence, severity, start time, duration and resolution were also reported, but only incidence given here. Treatment as received.
    End point type
    Secondary
    End point timeframe
    first 2 weeks
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    153
    157
    Units: people
        yes
    50
    13
        no
    103
    144
    No statistical analyses for this end point

    Secondary: vomiting

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    End point title
    		 vomiting
    End point description
    Vomiting in the first 2 weeks as reported on the week 2 participant questionnaire. Incidence, severity, start time, duration and resolution were also reported, but only incidence given here. Treatment as received.
    End point type
    Secondary
    End point timeframe
    first 2 weeks
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    150
    154
    Units: people
        yes
    9
    2
        no
    141
    152
    No statistical analyses for this end point

    Secondary: Taste changes

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    End point title
    		 Taste changes
    End point description
    Taste changes in the first 2 weeks as reported on the week 2 participant questionnaire. Incidence, severity, start time, duration and resolution were also reported, but only incidence given here. Treatment as received.
    End point type
    Secondary
    End point timeframe
    first 2 weeks
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    155
    158
    Units: people
        yes
    28
    2
        no
    127
    156
    No statistical analyses for this end point

    Secondary: Vaginal irritation

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    End point title
    		 Vaginal irritation
    End point description
    Vaginal irritation in the first 2 weeks as reported on the week 2 participant questionnaire. Incidence, severity, start time, duration and resolution were also reported, but only incidence given here. Treatment as received.
    End point type
    Secondary
    End point timeframe
    within 2 weeks
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    154
    159
    Units: people
        yes
    44
    34
        no
    110
    125
    No statistical analyses for this end point

    Secondary: Abdominal pain

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    End point title
    		 Abdominal pain
    End point description
    Abdominal pain in the first 2 weeks as reported on the week 2 participant questionnaire. Incidence, severity, start time, duration and resolution were also reported, but only incidence given here. Treatment as received.
    End point type
    Secondary
    End point timeframe
    within 2 weeks
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    154
    159
    Units: people
        yes
    31
    27
        no
    123
    132
    No statistical analyses for this end point

    Secondary: Diarrhoea

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    End point title
    		 Diarrhoea
    End point description
    Diarrhoea in the first 2 weeks as reported on the week 2 participant questionnaire. Incidence, severity, start time, duration and resolution were also reported, but only incidence given here. Treatment as received.
    End point type
    Secondary
    End point timeframe
    within 2 weeks
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    154
    159
    Units: people
        yes
    31
    9
        no
    123
    150
    No statistical analyses for this end point

    Secondary: Adherence to treatment

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    End point title
    		 Adherence to treatment
    End point description
    Percentage of treatment received - out of 14 possible doses of metronidazole and 7 of lactic acid - participant reported by questionnaire. Treatment as received.
    End point type
    Secondary
    End point timeframe
    7 days of treatment (usually starting on day of randomisation)
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    157
    161
    Units: percentage
        arithmetic mean (standard deviation)
    94 ( 18.4 )
    95 ( 12.9 )
    No statistical analyses for this end point

    Secondary: Quality adjusted life years

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    End point title
    		 Quality adjusted life years
    End point description
    SF-6D utility scores were derived from the SF12 responses at baseline, 2 weeks, 3 months and 6 months, and used to obtain QALYs.
    End point type
    Secondary
    End point timeframe
    over 6 months
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    61
    48
    Units: years
        arithmetic mean (standard deviation)
    0.351 ( 0.030 )
    0.348 ( 0.028 )
    Statistical analysis title
    		 Comparison of QALYs
    Statistical analysis description
    Health outcomes (QALYs) were compared between treatment groups, in an ITT analysis of cost utility.
    Comparison groups
    Metronidazole v Intravaginal lactic acid gel
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference
    Point estimate
    -0.003
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.013
         upper limit
    		 0.009

    Secondary: Mean cost per participant at 6 months

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    End point title
    		 Mean cost per participant at 6 months
    End point description
    Mean cost per participant at 6 months (Comparative cost effectiveness of using intravaginal lactic acid gel versus oral metronidazole tablets at 6 months). No analysis: Cost per QALY gained not presented as ICER dominated (intravaginal lactic acid gel was found to be less effective and more costly than metronidazole at 6 months)
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    69
    54
    Units: pounds sterling
        arithmetic mean (standard deviation)
    214.48 ( 302.45 )
    273.08 ( 366.14 )
    No statistical analyses for this end point

    Secondary: Cost per participant

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    End point title
    		 Cost per participant
    End point description
    Cost per participant (Comparative cost effectiveness of using intravaginal lactic acid gel versus oral metronidazole tablets at 2 weeks)
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    143
    151
    Units: Pounds sterling
        arithmetic mean (standard deviation)
    48.00 ( 112.68 )
    55.38 ( 134.89 )
    No statistical analyses for this end point

    Secondary: Cost per participant with resolved BV

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    End point title
    		 Cost per participant with resolved BV
    End point description
    Cost per participant with resolved BV (Comparative cost effectiveness of using intravaginal lactic acid gel versus oral metronidazole tablets at 2 weeks)
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Metronidazole Intravaginal lactic acid gel
    Number of subjects analysed
    259
    259
    Units: Pounds sterling
        arithmetic mean (confidence interval 95%)
    86.94 (2.16 to 331.83)
    147.00 (3.29 to 548.04)
    Statistical analysis title
    		 Cost-effectiveness comparison
    Statistical analysis description
    Difference in cost per participant with resolved BV. A sampling distribution for the incremental cost-effectiveness ratio was simulated based on a bootstrapped sample. The 2.5 and 97.5 percentiles for the ratio were used to establish the 95% confidence interval for the distribution.
    Comparison groups
    Metronidazole v Intravaginal lactic acid gel
    Number of subjects included in analysis
    518
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference
    Point estimate
    60.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -142.94
         upper limit
    		 180.54

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Six side effects were collected by questionnaire during the first 2 weeks of the trial - reported as secondary endpoints. Serious adverse events were collected throughout the trial, though there were none.
    Adverse event reporting additional description
    Side effects of nausea, vomiting, abnormal taste changes, vaginal irritation, abdominal pain and diarrhoea were recorded by the participant on the 2 week questionnaire - see secondary end points. Serious adverse events were identified from hospitalisations and other healthcare service use reported on all 3 questionnaires during the trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 No coding required
    Dictionary version
    N/A
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The safety profiles of the interventions in this trial are well characterised. Metronidazole was used for its licensed indication and lactic acid gel was used within its intended use covered by the CE-mark. In order to provide secondary outcome data to compare tolerability of the two treatments, only specified Adverse Reactions (ARs) experienced during treatment with either lactic acid gel or metronidazole were reported (see secondary outcomes).

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The trial was terminated early (518 randomised out of a proposed 1900), because the primary objective had been answered. This meant that data were limited for answering the secondary outcomes.
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