<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/NCT02237950</url>
  </required_header>
  <id_info>
    <org_study_id>SPL7013-017</org_study_id>
    <nct_id>NCT02237950</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 13, 2014</start_date>
  <completion_date type="Actual">February 22, 2017</completion_date>
  <primary_completion_date type="Actual">December 9, 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 of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to 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>Time to recurrence of BV (days), where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of Patient-reported BV Symptoms</measure>
    <time_frame>At or by the Week 16 visit</time_frame>
    <description>Number of participants with self-reported BV symptoms (vaginal discharge and/or odor)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of Individual Amsel Criteria</measure>
    <time_frame>At or by the Week 16 visit</time_frame>
    <description>Number of participants with positive individual Amsel criterion&#xD;
- Clue cells representing at least 20% of total epithelial cells</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 of BV as determined by presence of a Nugent score of 7-10 (BV), where 0-3 is normal, and 4-6 is intermediate.</description>
  </secondary_outcome>
  <secondary_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 24 visit</time_frame>
    <description>Number of participants with a recurrence of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10.</measure>
    <time_frame>At or by the Week 16 visit</time_frame>
    <description>Number of participants with a recurrence of BV according to the composite definition of at least 3 clinical findings (Amsel criteria) and a Nugent score of 4-10 (intermediate to BV), where 0-3 is normal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Change from baseline in brief index of sexual functioning for women (BISF-W) questionnaire composite score. The composite score includes scores from dimensions (D) of thoughts/desire (D1, 0-12), arousal (D2, 0-12), frequency of sexual activity (D3, 0-12), receptivity/initiation (D4, 0-12), pleasure (D5, 0-12), relationship satisfaction (D6, 0-12), and any problems affecting sexual functioning (D7, 0-16). The composite score is calculated as D1+D2+D3+D4+D5+D6-D7 with a range of -16 to +75. A positive change in composite score from baseline to Week 16 reflects an improvement in sexual functioning, with a greater change in score indicating a greater improvement in sexual functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events (AEs)</measure>
    <time_frame>From Baseline to end of Week 28</time_frame>
    <description>Number of participants with genitourinary AEs considered potentially related to study treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">586</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 of the 4 Amsel&#xD;
             criteria; Nugent 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>16 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>University of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montgomery Women's Health Associates</name>
      <address>
        <city>Montgomery</city>
        <state>Alabama</state>
        <zip>36117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Institute of the Ozarks</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Research Institute</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health Care</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Institute of the Rockies</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Downtown Women's Health Care</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Community Research South Florida</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Medical Research</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Medical Center and Research Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33142</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of South Florida</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Clinical Trials</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Medical Research Institute</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urban Family Practice Associates</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Research Associates, LLC</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Healthcare Specialists</name>
      <address>
        <city>Paw Paw</city>
        <state>Michigan</state>
        <zip>49079</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Clinic of Lincoln, PC</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alegent Creighton Health</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Clinical Research</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lawrence OB-GYN Associates</name>
      <address>
        <city>Lawrenceville</city>
        <state>New Jersey</state>
        <zip>08648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Cary, LLC</name>
      <address>
        <city>Cary</city>
        <state>North Carolina</state>
        <zip>27518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Salisbury</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44311</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Institute of Norman</name>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <zip>73069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Health Science Institute</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Advantage</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>49425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chattanooga Medical Research</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Volunteer Research Group</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Physician Group</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice Research Organization</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jordan River Family Medicine</name>
      <address>
        <city>South Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Virginia</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Clinical Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicine Professional Corporation</name>
      <address>
        <city>Kitchener</city>
        <state>Ontario</state>
        <zip>N2G1H6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SKDS Research Inc</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <zip>L3Y5G8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthy Image Centre</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N955C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DIEX Recherche Montreal Inc</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4N3C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DIEX Recherche Sherbrooke Inc.</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H1Z1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torre Auxillo Mutuo</name>
      <address>
        <city>Hato Rey</city>
        <zip>00917</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Latin Clinical Trial Center</name>
      <address>
        <city>San Juan</city>
        <zip>00918</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Puerto Rico</name>
      <address>
        <city>San Juan</city>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <results_first_submitted>May 7, 2019</results_first_submitted>
  <results_first_submitted_qc>June 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 9, 2019</results_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>July 8, 2019</last_update_submitted>
  <last_update_submitted_qc>July 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2019</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>1% SPL7013 Gel</title>
          <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.</description>
        </group>
        <group group_id="P2">
          <title>Placebo Gel</title>
          <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="295"/>
                <participants group_id="P2" count="291"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="247"/>
                <participants group_id="P2" count="243"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.</population>
      <group_list>
        <group group_id="B1">
          <title>1% SPL7013 Gel</title>
          <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.</description>
        </group>
        <group group_id="B2">
          <title>Placebo Gel</title>
          <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="294"/>
            <count group_id="B2" value="291"/>
            <count group_id="B3" value="585"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.6" spread="7.23"/>
                    <measurement group_id="B2" value="31.6" spread="6.99"/>
                    <measurement group_id="B3" value="31.6" spread="7.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="294"/>
                    <measurement group_id="B2" value="291"/>
                    <measurement group_id="B3" value="585"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings</title>
        <description>Number of participants with a recurrence of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)</description>
        <time_frame>At or by the Week 16 visit</time_frame>
        <population>Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.</population>
        <group_list>
          <group group_id="O1">
            <title>1% SPL7013 Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings</title>
          <description>Number of participants with a recurrence of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)</description>
          <population>Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="294"/>
                <count group_id="O2" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130"/>
                    <measurement group_id="O2" value="158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.015</p_value>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings</title>
        <description>Time to recurrence of BV (days), where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)</description>
        <time_frame>At or by the Week 16 visit</time_frame>
        <population>Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.</population>
        <group_list>
          <group group_id="O1">
            <title>1% SPL7013 Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings</title>
          <description>Time to recurrence of BV (days), where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)</description>
          <population>Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="294"/>
                <count group_id="O2" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105" lower_limit="98" upper_limit="111"/>
                    <measurement group_id="O2" value="99" lower_limit="87" upper_limit="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.007</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recurrence of Patient-reported BV Symptoms</title>
        <description>Number of participants with self-reported BV symptoms (vaginal discharge and/or odor)</description>
        <time_frame>At or by the Week 16 visit</time_frame>
        <population>Modified Intent-to-Treat, excluding patients with missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>1% SPL7013 Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Recurrence of Patient-reported BV Symptoms</title>
          <description>Number of participants with self-reported BV symptoms (vaginal discharge and/or odor)</description>
          <population>Modified Intent-to-Treat, excluding patients with missing values.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="269"/>
                <count group_id="O2" value="266"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recurrence of Individual Amsel Criteria</title>
        <description>Number of participants with positive individual Amsel criterion&#xD;
- Clue cells representing at least 20% of total epithelial cells</description>
        <time_frame>At or by the Week 16 visit</time_frame>
        <population>Modified Intent-to-Treat, excluding patients with missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>1% SPL7013 Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Recurrence of Individual Amsel Criteria</title>
          <description>Number of participants with positive individual Amsel criterion&#xD;
- Clue cells representing at least 20% of total epithelial cells</description>
          <population>Modified Intent-to-Treat, excluding patients with missing values.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="273"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.014</p_value>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recurrence of BV as Determined by Presence of a Nugent Score of 7-10</title>
        <description>Number of participants with a recurrence of BV as determined by presence of a Nugent score of 7-10 (BV), where 0-3 is normal, and 4-6 is intermediate.</description>
        <time_frame>At or by the Week 16 visit</time_frame>
        <population>Modified Intent-to-Treat, excluding patients with missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>1% SPL7013 Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Recurrence of BV as Determined by Presence of a Nugent Score of 7-10</title>
          <description>Number of participants with a recurrence of BV as determined by presence of a Nugent score of 7-10 (BV), where 0-3 is normal, and 4-6 is intermediate.</description>
          <population>Modified Intent-to-Treat, excluding patients with missing values.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="247"/>
                <count group_id="O2" value="273"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                    <measurement group_id="O2" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.012</p_value>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings</title>
        <description>Number of participants with a recurrence of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)</description>
        <time_frame>At or by the Week 24 visit</time_frame>
        <population>Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.</population>
        <group_list>
          <group group_id="O1">
            <title>1% SPL7013 Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings</title>
          <description>Number of participants with a recurrence of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)</description>
          <population>Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="294"/>
                <count group_id="O2" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="194"/>
                    <measurement group_id="O2" value="213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.059</p_value>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10.</title>
        <description>Number of participants with a recurrence of BV according to the composite definition of at least 3 clinical findings (Amsel criteria) and a Nugent score of 4-10 (intermediate to BV), where 0-3 is normal.</description>
        <time_frame>At or by the Week 16 visit</time_frame>
        <population>Modified Intent-to-Treat, excluding patients with missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>1% SPL7013 Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10.</title>
          <description>Number of participants with a recurrence of BV according to the composite definition of at least 3 clinical findings (Amsel criteria) and a Nugent score of 4-10 (intermediate to BV), where 0-3 is normal.</description>
          <population>Modified Intent-to-Treat, excluding patients with missing values.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="276"/>
                <count group_id="O2" value="276"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                    <measurement group_id="O2" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.008</p_value>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score</title>
        <description>Change from baseline in brief index of sexual functioning for women (BISF-W) questionnaire composite score. The composite score includes scores from dimensions (D) of thoughts/desire (D1, 0-12), arousal (D2, 0-12), frequency of sexual activity (D3, 0-12), receptivity/initiation (D4, 0-12), pleasure (D5, 0-12), relationship satisfaction (D6, 0-12), and any problems affecting sexual functioning (D7, 0-16). The composite score is calculated as D1+D2+D3+D4+D5+D6-D7 with a range of -16 to +75. A positive change in composite score from baseline to Week 16 reflects an improvement in sexual functioning, with a greater change in score indicating a greater improvement in sexual functioning.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>Analysis population includes only those participants who completed the survey, which was optional.</population>
        <group_list>
          <group group_id="O1">
            <title>1% SPL7013 Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score</title>
          <description>Change from baseline in brief index of sexual functioning for women (BISF-W) questionnaire composite score. The composite score includes scores from dimensions (D) of thoughts/desire (D1, 0-12), arousal (D2, 0-12), frequency of sexual activity (D3, 0-12), receptivity/initiation (D4, 0-12), pleasure (D5, 0-12), relationship satisfaction (D6, 0-12), and any problems affecting sexual functioning (D7, 0-16). The composite score is calculated as D1+D2+D3+D4+D5+D6-D7 with a range of -16 to +75. A positive change in composite score from baseline to Week 16 reflects an improvement in sexual functioning, with a greater change in score indicating a greater improvement in sexual functioning.</description>
          <population>Analysis population includes only those participants who completed the survey, which was optional.</population>
          <units>change in score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="-0.5" upper_limit="3.7"/>
                    <measurement group_id="O2" value="0.1" lower_limit="-2.0" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events (AEs)</title>
        <description>Number of participants with genitourinary AEs considered potentially related to study treatment</description>
        <time_frame>From Baseline to end of Week 28</time_frame>
        <population>Safety population was all patients in the Intent-to-Treat population, but excluding those who later returned all the study medication unused.</population>
        <group_list>
          <group group_id="O1">
            <title>1% SPL7013 Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Gel</title>
            <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events (AEs)</title>
          <description>Number of participants with genitourinary AEs considered potentially related to study treatment</description>
          <population>Safety population was all patients in the Intent-to-Treat population, but excluding those who later returned all the study medication unused.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="294"/>
                <count group_id="O2" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Safety population was all patients in the Intent-to-Treat population, but excluding those who later returned all the study medication unused.</desc>
      <group_list>
        <group group_id="E1">
          <title>1% SPL7013 Gel</title>
          <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.</description>
        </group>
        <group group_id="E2">
          <title>Placebo Gel</title>
          <description>Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks&#xD;
Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days&#xD;
Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="294"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="294"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bartholin's abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="294"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Klebsiella bacteremia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="294"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hemiplegic migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="294"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Blighted ovum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="294"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="294"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="294"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="92" subjects_at_risk="294"/>
                <counts group_id="E2" subjects_affected="80" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="294"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>UTI</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="294"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="294"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="294"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="294"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>For multicenter studies, PIs can publish data only after study data are published collectively.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Jeremy Paull</name_or_title>
      <organization>Starpharma</organization>
      <email>jeremy.paull@starpharma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02237950
org study id: SPL7013-017
nct id: NCT02237950
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 of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)
measure: Time to 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: Time to recurrence of BV (days), where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)
measure: Recurrence of Patient-reported BV Symptoms
time frame: At or by the Week 16 visit
description: Number of participants with self-reported BV symptoms (vaginal discharge and/or odor)
measure: Recurrence of Individual Amsel Criteria
time frame: At or by the Week 16 visit
description: Number of participants with positive individual Amsel criterion
- Clue cells representing at least 20% of total epithelial cells
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 of BV as determined by presence of a Nugent score of 7-10 (BV), where 0-3 is normal, and 4-6 is intermediate.
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 24 visit
description: Number of participants with a recurrence of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)
measure: Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10.
time frame: At or by the Week 16 visit
description: Number of participants with a recurrence of BV according to the composite definition of at least 3 clinical findings (Amsel criteria) and a Nugent score of 4-10 (intermediate to BV), where 0-3 is normal.
measure: Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score
time frame: Baseline to Week 16
description: Change from baseline in brief index of sexual functioning for women (BISF-W) questionnaire composite score. The composite score includes scores from dimensions (D) of thoughts/desire (D1, 0-12), arousal (D2, 0-12), frequency of sexual activity (D3, 0-12), receptivity/initiation (D4, 0-12), pleasure (D5, 0-12), relationship satisfaction (D6, 0-12), and any problems affecting sexual functioning (D7, 0-16). The composite score is calculated as D1+D2+D3+D4+D5+D6-D7 with a range of -16 to +75. A positive change in composite score from baseline to Week 16 reflects an improvement in sexual functioning, with a greater change in score indicating a greater improvement in sexual functioning.
measure: Adverse Events (AEs)
time frame: From Baseline to end of Week 28
description: Number of participants with genitourinary AEs considered potentially related to study treatment
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: 16 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: Canada
country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Vaginosis, Bacterial
mesh term: Vaginal Diseases
mesh term: Recurrence
mesh term: Metronidazole
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 