<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02236156</url>
  </required_header>
  <id_info>
    <org_study_id>SPL7013-018</org_study_id>
    <nct_id>NCT02236156</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)</brief_title>
  <official_title>A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Determine the Efficacy and Safety of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Starpharma Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Starpharma Pty Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on&#xD;
      alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in&#xD;
      women with a history of recurrent BV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible participants, with both a history of recurrent BV and a current episode of BV, will&#xD;
      receive a seven-day course of oral metronidazole. Participants who are successfully treated&#xD;
      for their BV, and continue to be eligible, will be randomly assigned to receive either 1%&#xD;
      SPL7013 Gel or placebo gel on alternate days at bed-time for 16 consecutive weeks.&#xD;
&#xD;
      The primary endpoint will be determined at the conclusion of this 16 week treatment phase.&#xD;
&#xD;
      Participants who experience a BV recurrence will be considered to have completed the study.&#xD;
      Such participants will receive BV treatment in line with local practice and will not attend&#xD;
      any further study visits.&#xD;
&#xD;
      Participants who successfully reach Week 16 without a BV recurrence will enter a 12-week&#xD;
      follow-up phase to Week 28.&#xD;
&#xD;
      Participants will attend a study visit at 4-weekly intervals throughout the duration of the&#xD;
      study to Week 28 (or up to the point of BV recurrence) to assess recurrence of BV and adverse&#xD;
      events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2014</start_date>
  <completion_date type="Actual">October 4, 2016</completion_date>
  <primary_completion_date type="Actual">July 4, 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence of BV where a diagnosis of BV is defined as the presence of at least 3 clinical findings</measure>
    <time_frame>At or by the Week 16 visit</time_frame>
    <description>Number of participants with a recurrence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to recurrence of BV according to the primary efficacy endpoint definition</measure>
    <time_frame>At or by the Week 28 visit</time_frame>
    <description>Time (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of patient-reported BV symptoms</measure>
    <time_frame>At or by the Week 16 visit</time_frame>
    <description>Number of participants with symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of individual Amsel criteria</measure>
    <time_frame>At or by the Week 16 visit</time_frame>
    <description>Individual Amsel criteria are:&#xD;
i) Presence of homogenous vaginal discharge characteristic of BV&#xD;
ii) Positive whiff test&#xD;
iii) Clue cells representing at least 20% of total epithelial cells&#xD;
iv) vaginal fluid pH greater than 4.5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of BV as determined by presence of a Nugent score of 7-10</measure>
    <time_frame>At or by the Week 16 visit</time_frame>
    <description>Number of participants with a recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of BV according to the primary efficacy endpoint definition</measure>
    <time_frame>At or by the Week 20, 24 and 28 visits</time_frame>
    <description>Number of participants with a recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of BV according to the composite definition of at least 3 clinical findings and a Nugent score of at least 4</measure>
    <time_frame>At or by the Week 16 visit</time_frame>
    <description>Number of participants with a recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (AEs)</measure>
    <time_frame>Study duration</time_frame>
    <description>Number of participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responses to Quality of Life (QoL) Questionnaires</measure>
    <time_frame>Screening to Week 16</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">637</enrollment>
  <condition>Bacterial Vaginosis</condition>
  <arm_group>
    <arm_group_label>1% SPL7013 Gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Gel</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole oral tablets 500mg</intervention_name>
    <description>One tablet taken orally twice daily for seven consecutive days</description>
    <arm_group_label>1% SPL7013 Gel</arm_group_label>
    <arm_group_label>Placebo Gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1% SPL7013 Gel</intervention_name>
    <description>5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.</description>
    <arm_group_label>1% SPL7013 Gel</arm_group_label>
    <other_name>VivaGel</other_name>
    <other_name>astodimer sodium</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo gel</intervention_name>
    <description>5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks</description>
    <arm_group_label>Placebo Gel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current active episode of BV (diagnosis defined as: at least 3 Amsel criteria; Nugent&#xD;
             score of at least 4; presence of BV-related symptoms)&#xD;
&#xD;
          -  History of recurrent BV (at least 3 episodes in previous year including current&#xD;
             episode)&#xD;
&#xD;
          -  Using an effective method of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Test positive for a sexually transmitted infection&#xD;
&#xD;
          -  Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV)&#xD;
             lesions requiring treatment&#xD;
&#xD;
          -  Abnormal pelvic exam, including presence of other vaginal or urinary tract infections&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeremy Paull, PhD.</last_name>
    <role>Study Chair</role>
    <affiliation>Starpharma Pty Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Precision Trials, LLC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center for Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Clinical Research Associates</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyndhurst Clinical Research</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Pleven</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Plovidiv</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Stara Zagora</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Brno</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Ceske Budejovice</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Olomouc</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Pisek</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Praha 2</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Vsetin</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Baja</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Balatonfured</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Gyomro</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Komarom</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Letavertes</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Zalaegerszeg</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Zaporizhzhia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Coventry</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sites Various</name>
      <address>
        <city>Plymouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Czechia</country>
    <country>Hungary</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <disposition_first_submitted>December 4, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>December 4, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 7, 2017</disposition_first_posted>
  <last_update_submitted>June 21, 2018</last_update_submitted>
  <last_update_submitted_qc>June 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaginosis, Bacterial</mesh_term>
    <mesh_term>Vaginal Diseases</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02236156
org study id: SPL7013-018
nct id: NCT02236156
lead sponsor: 
has dmc: No
A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on
      alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in
      women with a history of recurrent BV.
Eligible participants, with both a history of recurrent BV and a current episode of BV, will
      receive a seven-day course of oral metronidazole. Participants who are successfully treated
      for their BV, and continue to be eligible, will be randomly assigned to receive either 1%
      SPL7013 Gel or placebo gel on alternate days at bed-time for 16 consecutive weeks.

      The primary endpoint will be determined at the conclusion of this 16 week treatment phase.

      Participants who experience a BV recurrence will be considered to have completed the study.
      Such participants will receive BV treatment in line with local practice and will not attend
      any further study visits.

      Participants who successfully reach Week 16 without a BV recurrence will enter a 12-week
      follow-up phase to Week 28.

      Participants will attend a study visit at 4-weekly intervals throughout the duration of the
      study to Week 28 (or up to the point of BV recurrence) to assess recurrence of BV and adverse
      events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Recurrence of BV where a diagnosis of BV is defined as the presence of at least 3 clinical findings
time frame: At or by the Week 16 visit
description: Number of participants with a recurrence
measure: Time to recurrence of BV according to the primary efficacy endpoint definition
time frame: At or by the Week 28 visit
description: Time (days)
measure: Presence of patient-reported BV symptoms
time frame: At or by the Week 16 visit
description: Number of participants with symptoms
measure: Recurrence of individual Amsel criteria
time frame: At or by the Week 16 visit
description: Individual Amsel criteria are:
i) Presence of homogenous vaginal discharge characteristic of BV
ii) Positive whiff test
iii) Clue cells representing at least 20% of total epithelial cells
iv) vaginal fluid pH greater than 4.5
measure: Recurrence of BV as determined by presence of a Nugent score of 7-10
time frame: At or by the Week 16 visit
description: Number of participants with a recurrence
measure: Recurrence of BV according to the primary efficacy endpoint definition
time frame: At or by the Week 20, 24 and 28 visits
description: Number of participants with a recurrence
measure: Recurrence of BV according to the composite definition of at least 3 clinical findings and a Nugent score of at least 4
time frame: At or by the Week 16 visit
description: Number of participants with a recurrence
measure: Adverse events (AEs)
time frame: Study duration
description: Number of participants
measure: Responses to Quality of Life (QoL) Questionnaires
time frame: Screening to Week 16
arm group label: 1% SPL7013 Gel
arm group type: Experimental
description: Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
arm group label: Placebo Gel
arm group type: Placebo Comparator
description: Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
intervention type: Drug
intervention name: Metronidazole oral tablets 500mg
description: One tablet taken orally twice daily for seven consecutive days
arm group label: 1% SPL7013 Gel
arm group label: Placebo Gel
intervention type: Drug
intervention name: 1% SPL7013 Gel
description: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
arm group label: 1% SPL7013 Gel
other name: VivaGel
other name: astodimer sodium
intervention type: Drug
intervention name: Placebo gel
description: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks
arm group label: Placebo Gel
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Jeremy Paull, PhD.
role: Study Chair
affiliation: Starpharma Pty Ltd
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country: Bulgaria
country: Czechia
country: Hungary
country: Ukraine
country: United Kingdom
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Vaginosis, Bacterial
mesh term: Vaginal Diseases
mesh term: Recurrence
mesh term: Metronidazole