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    Clinical Trial Results:
    A phase 3, double-blind, multicenter, randomized, placebo-controlled study to assess the efficacy and safety of SPL7013 Gel (VivaGel®) for the treatment of bacterial vaginosis

    Summary
    EudraCT number
    		 2012-000752-33
    Trial protocol
    		 DE   BE  
    Global end of trial date
    05 Oct 2012

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

    Trial information

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    Trial identification
    Sponsor protocol code
    SPL7013-016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01577537
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Starpharma Pty Ltd
    Sponsor organisation address
    4-6 Southampton Crescent, Abbotsford, Australia, 3067
    Public contact
    VP Development and Regulatory Affairs, Starpharma Pty Ltd, 0061 385322700, jeremy.paull@starpharma.com
    Scientific contact
    VP Development and Regulatory Affairs, Starpharma Pty Ltd, 0061 385322700, jeremy.paull@starpharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Nov 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Oct 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Oct 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of 1% SPL7013 Gel compared with placebo gel for the treatment of bacterial vaginosis (BV)
    Protection of trial subjects
    The study was conducted in accordance with Good Clinical Practice (GCP) as required by the International Council for Harmonisation guidelines and in accordance with country-specific laws and regulations governing clinical studies of investigational products (IPs). Compliance with these requirements also constitutes conformity with the ethical principles of the Declaration of Helsinki. An informed consent document approved by each study centre’s IRB/IEC was signed by the subject or legal representative and the investigator before any study-related procedures were performed. The investigator provided copies of the signed informed consent to the subject or legal representative, and the original was retained by the investigator.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Mar 2012
    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: 21
    Country: Number of subjects enrolled
    Germany: 59
    Country: Number of subjects enrolled
    United States: 171
    Worldwide total number of subjects
    251
    EEA total number of subjects
    80
    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)
    250
    From 65 to 84 years
    0
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Post-menarchal females, aged 12 years or more, with current BV (4/4 Amsel criteria and Nugent score 4-10), otherwise healthy, as determined by medical history, physical examination, and normal Pap smear at, or documented within 24 months of, screening.

    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
    		 1% SPL7013 Gel
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    1% SPL7013 Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Vaginal use
    Dosage and administration details
    5 g once daily for 7 days

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Vaginal use
    Dosage and administration details
    5 g once daily for 7 days

    Number of subjects in period 1
    		1% SPL7013 Gel Placebo
    Started
    128
    123
    Completed
    120
    116
    Not completed
    8
    7
         Consent withdrawn by subject
    3
    2
         Pregnancy
    1
    -
         Lost to follow-up
    3
    4
         Scheduling difficulty
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1% SPL7013 Gel
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 1% SPL7013 Gel Placebo Total
    Number of subjects
    		 128 123 251
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35 ± 10 36.3 ± 12.1 -
    Gender categorical
    Units: Subjects
        Female
    		 128 123 251
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    SPL7013 Gel mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized participants who received (were dispensed) the study medication, excluding any participants who returned all the study medication unused, and whose whose vaginal fluid sample at baseline was determined to have a Nugent score of 4 or higher.

    Subject analysis set title
    Placebo mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized participants who received (were dispensed) the study medication, excluding any participants who returned all the study medication unused and whose vaginal fluid sample at baseline was determined to have a Nugent score of 4 or higher.

    Subject analysis set title
    SPL7013 Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized participants who received (were dispensed) the study medication, excluding any participants who returned all the study medication unused.

    Subject analysis set title
    Placebo Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized participants who received (were dispensed) the study medication, excluding any participants who returned all the study medication unused.

    Subject analysis sets values
    		 SPL7013 Gel mITT Placebo mITT SPL7013 Safety Placebo Safety
    Number of subjects
    120
    117
    126
    123
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    34.9 ± 9.9
    36.2 ± 12.3
    35 ± 10
    36.3 ± 12.1
    Gender categorical
    Units: Subjects
        Female
    120
    117
    126
    123
        Male
    0
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    1% SPL7013 Gel
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    SPL7013 Gel mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized participants who received (were dispensed) the study medication, excluding any participants who returned all the study medication unused, and whose whose vaginal fluid sample at baseline was determined to have a Nugent score of 4 or higher.

    Subject analysis set title
    Placebo mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized participants who received (were dispensed) the study medication, excluding any participants who returned all the study medication unused and whose vaginal fluid sample at baseline was determined to have a Nugent score of 4 or higher.

    Subject analysis set title
    SPL7013 Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized participants who received (were dispensed) the study medication, excluding any participants who returned all the study medication unused.

    Subject analysis set title
    Placebo Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized participants who received (were dispensed) the study medication, excluding any participants who returned all the study medication unused.

    Primary: Number of Women With Clinical Cure at the End of Treatment Visit (EOT)

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    End point title
    		 Number of Women With Clinical Cure at the End of Treatment Visit (EOT)
    End point description
    Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
    End point type
    Primary
    End point timeframe
    Day 9-12
    End point values
    		 SPL7013 Gel mITT Placebo mITT
    Number of subjects analysed
    120
    117
    Units: Participants
    68
    25
    Statistical analysis title
    		 SPL7013 Gel vs Placebo
    Comparison groups
    SPL7013 Gel mITT v Placebo mITT
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Number of Women With Nugent Cure at the EOT Visit

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    End point title
    		 Number of Women With Nugent Cure at the EOT Visit
    End point description
    Nugent Cure is defined as a Nugent score of 0-3 (normal)
    End point type
    Secondary
    End point timeframe
    Day 9-12
    End point values
    		 SPL7013 Gel mITT Placebo mITT
    Number of subjects analysed
    120
    117
    Units: Participants
    16
    6
    No statistical analyses for this end point

    Secondary: Number of Women With Clinical Cure at the Test of Cure Visit (TOC)

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    End point title
    		 Number of Women With Clinical Cure at the Test of Cure Visit (TOC)
    End point description
    Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
    End point type
    Secondary
    End point timeframe
    Day 21-30
    End point values
    		 SPL7013 Gel mITT Placebo mITT
    Number of subjects analysed
    120
    117
    Units: Participants
    34
    33
    No statistical analyses for this end point

    Secondary: Number of Women With Nugent Cure at the TOC Visit

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    End point title
    		 Number of Women With Nugent Cure at the TOC Visit
    End point description
    Nugent Cure is defined as a Nugent score of 0-3 (normal)
    End point type
    Secondary
    End point timeframe
    Day 21-30
    End point values
    		 SPL7013 Gel mITT Placebo mITT
    Number of subjects analysed
    120
    117
    Units: Participants
    16
    13
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening/baseline through TOC visit, Day 1-30
    Adverse event reporting additional description
    Number of participants experiencing adverse events.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    1% SPL7013 Gel
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 1% SPL7013 Gel Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 123 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 1% SPL7013 Gel Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 126 (11.90%)
    8 / 123 (6.50%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 126 (11.90%)
    8 / 123 (6.50%)
         occurrences all number
    15
    8
    Infections and infestations
    Vulvovaginal candidiasis
         subjects affected / exposed
    11 / 126 (8.73%)
    8 / 123 (6.50%)
         occurrences all number
    11
    8

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31812702
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