<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/NCT02209519</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT02209519</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Trial of Treatment of Male Partners of Women With BV</brief_title>
  <official_title>Randomized Controlled Trial of Treatment of Male Partners of Women With BV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wayne State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Male partners of womoen with recurrent bacteria vaginosis are randomized to treatment with&#xD;
      metronidazole or placebo to compare the rates of recurrent BV in the women&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be performed as a phase III randomized, double-blinded trial to evaluate the&#xD;
      efficacy of 1) metronidazole 500 mg PO BID for 7 days versus 2) placebo capsules alone for&#xD;
      treatment of the male sexual partner of women with recurrent BV. The primary outcome is the&#xD;
      rates of recurrent BV between these two groups. Although this is a phase III study we will&#xD;
      carefully monitor potential toxicity in the males since it is currently not standard of care&#xD;
      to treat males for this indication.&#xD;
&#xD;
      Women with symptomatic BV defined by Amsel criteria 1 and no evidence of STD will be invited&#xD;
      to participate. Inclusion criteria are that the woman be at least 18 years of age,&#xD;
      heterosexual, have symptoms of vaginal odor and/or discharge, meet the modified clinical&#xD;
      (Amsel) criteria for BV (all must have a vaginal pH of &gt;4.5, a positive whiff test, and clue&#xD;
      cells to be eligible), have an enrollment Nugent score of 7 or greater, and a history of 2 or&#xD;
      more episodes of BV in the previous year. She must have a regular current sex partner who&#xD;
      would be willing to participate. We will exclude women who have had recurrent BV for greater&#xD;
      than 3 years as well as women who have failed previous treatment studies since it is likely&#xD;
      that these women are having recurrent BV as a result of relapse of the BV biofilm as opposed&#xD;
      to reinfection.&#xD;
&#xD;
      Follow-up visits will be conducted at day 21, 8 and 16 weeks. At each follow-up visit, a&#xD;
      questionnaire will be administered, diary reviewed, pelvic examination conducted and&#xD;
      specimens (Gram stain, Amsel criteria, G vaginalis culture and detection of novel organisms)&#xD;
      obtained as done at the enrollment visit. Participants will be asked to return the medication&#xD;
      packages, a standard way of assessing adherence to the regimen. Cure will be ascertained&#xD;
      using the clinical criteria for BV of Amsel 1 as well as the Nugent scoring system 16. The&#xD;
      persistence or disappearance of specific organisms will be analyzed in relationship to these&#xD;
      standard definitions of cure. Women who fail initial therapy or have recurrence of&#xD;
      symptomatic BV during the course of the study will be re-treated with 7 days of metronidazole&#xD;
      and dropped from the study at that time. Any woman found to have a positive screening test&#xD;
      for gonorrhea or chlamydia will be treated appropriately and instructed to notify her partner&#xD;
      of the need to be treated. Women with intercurrent vaginal yeast infections, which may occur,&#xD;
      will be treated with oral fluconazole and continued in the study. Women with a positive&#xD;
      culture for trichomonas will be dropped from the study as their male partners will require&#xD;
      treatment with metronidazole.&#xD;
&#xD;
      Male Study Procedures&#xD;
&#xD;
      Males referred by their female sexual partner will be seen within 48 hours of enrollment of&#xD;
      the female. Males will be consented and asked behavioral and historical questions using a&#xD;
      gender appropriate questionnaire, with special emphasis on number of current sexual partners.&#xD;
      A couple verification screening tool will be utilized to be certain they are current sexual&#xD;
      partners48. The confidentiality of their answers will be emphasized. They will be examined&#xD;
      and a urethral swab specimen obtained to be used for G vaginalis culture and then archived.&#xD;
      Following the swabs, two external swabs from the coronal sulcus and a 10 ml first void urine&#xD;
      specimen will be obtained. These specimens will also be used for G vaginalis culture and&#xD;
      archived for possible use in detection of novel organisms. The urine will also be used for&#xD;
      NAATS for N gonorrhoeae and C trachomatis and for the determining the presence or absence of&#xD;
      Gardnerella biofilm24. They will then be randomized to one of two treatment arms:&#xD;
&#xD;
        1. Metronidazole 500 mg PO twice a day for 7 days .&#xD;
&#xD;
        2. Placebo capsules PO twice a day for 7 days.&#xD;
&#xD;
      Both arms will also contain an instruction sheet on metronidazole.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">March 2019</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Female Partners Whose Male Partners Received Metronidazole Versus Females Whose Male Partners Did Not Receive Metrodiazole With Recurrence of BV in the Female</measure>
    <time_frame>16 weeks post start of receipt of study drug</time_frame>
    <description>the female partners will be assessed for recurrence/persistence of BV. tRecurrence/persistence is measured by - Positive 3 - 4 Amsel criteria (vaginal pH &gt; 4.7, clue cells, positive whiff test, homogenous discharge); Nugent score &gt;3&#xD;
No Recurrence/Persistence is measured by:&#xD;
- Presence of 0 -2 Amsel criteria; Nugent score 0-3.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Recurrence of BV in Women Whose Partner Received Metronidazole Versus Females Whose Partners Did Not Receive Metronidazole</measure>
    <time_frame>from the end of week 1 up to 16 weeks</time_frame>
    <description>time to recurrence measured in days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">214</enrollment>
  <condition>Recurrent Bacterial Vaginosis</condition>
  <arm_group>
    <arm_group_label>Metronidazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole (male partner)</intervention_name>
    <description>500 mg PO BID for 7 days</description>
    <arm_group_label>Metronidazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placeob (male partner)</intervention_name>
    <description>matching placebo capsules PO BID for 7 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Female&#xD;
&#xD;
          1. At least 18 years of age (19 years of age in Alabama due to State law)&#xD;
&#xD;
          2. Sexual partner to a female who meets study eligibility&#xD;
&#xD;
          3. Willingness to provide informed consent&#xD;
&#xD;
          4. Willingness to abstain from sexual intercourse or use condoms {during the study}&#xD;
&#xD;
          5. Willingness to abstain from alcohol for the first week of the study&#xD;
&#xD;
        Inclusion Criteria: Male&#xD;
&#xD;
          1. At least 18 years of age (19 years of age in Alabama due to State law)&#xD;
&#xD;
          2. Heterosexual with a regular partner&#xD;
&#xD;
          3. History of 2 or more episodes of BV in the previous 12 months&#xD;
&#xD;
          4. Symptoms of BV including vaginal discharge and/or odor&#xD;
&#xD;
          5. Positive Amsel criteria for BV including vaginal pH &gt;4.5, positive whiff test,&#xD;
             presence of clue cells&#xD;
&#xD;
          6. Willingness to provide informed consent&#xD;
&#xD;
          7. Willingness to abstain from sexual intercourse or use condoms {during the study}&#xD;
&#xD;
          8. Willingness to abstain from alcohol for the first week of the study&#xD;
&#xD;
        Exclusion criteria (both genders)&#xD;
&#xD;
          1. Allergy to metronidazole&#xD;
&#xD;
          2. Failure of the male partner to keep his appointment to be seen within 48 hours&#xD;
&#xD;
          3. Pregnant or breast feeding (females)&#xD;
&#xD;
          4. HIV or other chronic disease which in the opinion of the investigator would interfere&#xD;
             with the ability to participate in this study&#xD;
&#xD;
          5. Subject requires concurrent lithium, coumadin, dilantin, or antabuse&#xD;
&#xD;
          6. Presence of trichomonas on wet prep of vaginal fluid (females)&#xD;
&#xD;
          7. Women with a history of recurrent BV for &gt;3 years or women who have failed previous&#xD;
             treatment studies for BV&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jane Schwebke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jane Schwebke</name>
      <address>
        <city>Pell City</city>
        <state>Alabama</state>
        <zip>35128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <results_first_submitted>March 27, 2020</results_first_submitted>
  <results_first_submitted_qc>April 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 27, 2020</results_first_posted>
  <last_update_submitted>April 24, 2020</last_update_submitted>
  <last_update_submitted_qc>April 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Jane Schwebke</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>bacterial vaginosis</keyword>
  <keyword>recurrence</keyword>
  <keyword>male partner</keyword>
  <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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT02209519/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Metronidazole</title>
          <description>Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days&#xD;
Metronidazole (male partner): 500 mg PO BID for 7 days</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days&#xD;
Placebo (male partner): matching placebo capsules PO BID for 7 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="107"/>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="107"/>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Metronidazole</title>
          <description>Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days&#xD;
Metronidazole (male partner): 500 mg PO BID for 7 days</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days&#xD;
Placebo (male partner): matching placebo capsules PO BID for 7 days</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="107"/>
            <count group_id="B2" value="107"/>
            <count group_id="B3" value="214"/>
          </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="31.5" spread="6.9"/>
                    <measurement group_id="B2" value="32.8" spread="8.1"/>
                    <measurement group_id="B3" value="32.1" spread="7.5"/>
                  </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="107"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="214"/>
                  </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>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>white</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>african american</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>multiracial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>non-hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="204"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Female Partners Whose Male Partners Received Metronidazole Versus Females Whose Male Partners Did Not Receive Metrodiazole With Recurrence of BV in the Female</title>
        <description>the female partners will be assessed for recurrence/persistence of BV. tRecurrence/persistence is measured by - Positive 3 - 4 Amsel criteria (vaginal pH &gt; 4.7, clue cells, positive whiff test, homogenous discharge); Nugent score &gt;3&#xD;
No Recurrence/Persistence is measured by:&#xD;
- Presence of 0 -2 Amsel criteria; Nugent score 0-3.</description>
        <time_frame>16 weeks post start of receipt of study drug</time_frame>
        <population>those completing the study</population>
        <group_list>
          <group group_id="O1">
            <title>Metronidazole</title>
            <description>Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days&#xD;
Metronidazole (male partner): 500 mg PO BID for 7 days</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days&#xD;
Placebo (male partner): matching placebo capsules PO BID for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Female Partners Whose Male Partners Received Metronidazole Versus Females Whose Male Partners Did Not Receive Metrodiazole With Recurrence of BV in the Female</title>
          <description>the female partners will be assessed for recurrence/persistence of BV. tRecurrence/persistence is measured by - Positive 3 - 4 Amsel criteria (vaginal pH &gt; 4.7, clue cells, positive whiff test, homogenous discharge); Nugent score &gt;3&#xD;
No Recurrence/Persistence is measured by:&#xD;
- Presence of 0 -2 Amsel criteria; Nugent score 0-3.</description>
          <population>those completing the study</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="107"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Recurrence of BV in Women Whose Partner Received Metronidazole Versus Females Whose Partners Did Not Receive Metronidazole</title>
        <description>time to recurrence measured in days</description>
        <time_frame>from the end of week 1 up to 16 weeks</time_frame>
        <population>unable to collect data due to lab issues</population>
        <group_list>
          <group group_id="O1">
            <title>Metronidazole</title>
            <description>Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days&#xD;
Metronidazole (male partner): 500 mg PO BID for 7 days</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days&#xD;
Placeob (male partner): matching placebo capsules PO BID for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Recurrence of BV in Women Whose Partner Received Metronidazole Versus Females Whose Partners Did Not Receive Metronidazole</title>
          <description>time to recurrence measured in days</description>
          <population>unable to collect data due to lab issues</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>baseline through 16 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Metronidazole</title>
          <description>Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days&#xD;
Metronidazole (male partner): 500 mg PO BID for 7 days</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days&#xD;
Placebo (male partner): matching placebo capsules PO BID for 7 days</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>trauma</sub_title>
                <description>motor vehicle accident</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="107"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>gastrointestinal</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="107"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="107"/>
                <counts group_id="E2" events="21" subjects_affected="21" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>musculoskelatal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>nervous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>psychiatric</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>reproductive system</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>respiratory</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="107"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jane Schwebke, MD</name_or_title>
      <organization>University of Alabama at Birmingham</organization>
      <phone>205-975-5665</phone>
      <email>jschwebk@uabmc.edu</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/NCT02209519
org study id: 001
nct id: NCT02209519
lead sponsor: 
collaborator: 
has dmc: No
Male partners of womoen with recurrent bacteria vaginosis are randomized to treatment with
      metronidazole or placebo to compare the rates of recurrent BV in the women
This study will be performed as a phase III randomized, double-blinded trial to evaluate the
      efficacy of 1) metronidazole 500 mg PO BID for 7 days versus 2) placebo capsules alone for
      treatment of the male sexual partner of women with recurrent BV. The primary outcome is the
      rates of recurrent BV between these two groups. Although this is a phase III study we will
      carefully monitor potential toxicity in the males since it is currently not standard of care
      to treat males for this indication.

      Women with symptomatic BV defined by Amsel criteria 1 and no evidence of STD will be invited
      to participate. Inclusion criteria are that the woman be at least 18 years of age,
      heterosexual, have symptoms of vaginal odor and/or discharge, meet the modified clinical
      (Amsel) criteria for BV (all must have a vaginal pH of >4.5, a positive whiff test, and clue
      cells to be eligible), have an enrollment Nugent score of 7 or greater, and a history of 2 or
      more episodes of BV in the previous year. She must have a regular current sex partner who
      would be willing to participate. We will exclude women who have had recurrent BV for greater
      than 3 years as well as women who have failed previous treatment studies since it is likely
      that these women are having recurrent BV as a result of relapse of the BV biofilm as opposed
      to reinfection.

      Follow-up visits will be conducted at day 21, 8 and 16 weeks. At each follow-up visit, a
      questionnaire will be administered, diary reviewed, pelvic examination conducted and
      specimens (Gram stain, Amsel criteria, G vaginalis culture and detection of novel organisms)
      obtained as done at the enrollment visit. Participants will be asked to return the medication
      packages, a standard way of assessing adherence to the regimen. Cure will be ascertained
      using the clinical criteria for BV of Amsel 1 as well as the Nugent scoring system 16. The
      persistence or disappearance of specific organisms will be analyzed in relationship to these
      standard definitions of cure. Women who fail initial therapy or have recurrence of
      symptomatic BV during the course of the study will be re-treated with 7 days of metronidazole
      and dropped from the study at that time. Any woman found to have a positive screening test
      for gonorrhea or chlamydia will be treated appropriately and instructed to notify her partner
      of the need to be treated. Women with intercurrent vaginal yeast infections, which may occur,
      will be treated with oral fluconazole and continued in the study. Women with a positive
      culture for trichomonas will be dropped from the study as their male partners will require
      treatment with metronidazole.

      Male Study Procedures

      Males referred by their female sexual partner will be seen within 48 hours of enrollment of
      the female. Males will be consented and asked behavioral and historical questions using a
      gender appropriate questionnaire, with special emphasis on number of current sexual partners.
      A couple verification screening tool will be utilized to be certain they are current sexual
      partners48. The confidentiality of their answers will be emphasized. They will be examined
      and a urethral swab specimen obtained to be used for G vaginalis culture and then archived.
      Following the swabs, two external swabs from the coronal sulcus and a 10 ml first void urine
      specimen will be obtained. These specimens will also be used for G vaginalis culture and
      archived for possible use in detection of novel organisms. The urine will also be used for
      NAATS for N gonorrhoeae and C trachomatis and for the determining the presence or absence of
      Gardnerella biofilm24. They will then be randomized to one of two treatment arms:

        1. Metronidazole 500 mg PO twice a day for 7 days .

        2. Placebo capsules PO twice a day for 7 days.

      Both arms will also contain an instruction sheet on metronidazole.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Female Partners Whose Male Partners Received Metronidazole Versus Females Whose Male Partners Did Not Receive Metrodiazole With Recurrence of BV in the Female
time frame: 16 weeks post start of receipt of study drug
description: the female partners will be assessed for recurrence/persistence of BV. tRecurrence/persistence is measured by - Positive 3 - 4 Amsel criteria (vaginal pH > 4.7, clue cells, positive whiff test, homogenous discharge); Nugent score >3
No Recurrence/Persistence is measured by:
- Presence of 0 -2 Amsel criteria; Nugent score 0-3.
measure: Time to Recurrence of BV in Women Whose Partner Received Metronidazole Versus Females Whose Partners Did Not Receive Metronidazole
time frame: from the end of week 1 up to 16 weeks
description: time to recurrence measured in days
arm group label: Metronidazole
arm group type: Experimental
description: Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days
arm group label: Placebo
arm group type: Placebo Comparator
description: Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days
intervention type: Drug
intervention name: Metronidazole (male partner)
description: 500 mg PO BID for 7 days
arm group label: Metronidazole
intervention type: Other
intervention name: Placeob (male partner)
description: matching placebo capsules PO BID for 7 days
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: No
last name: jane Schwebke, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Jane Schwebke
investigator title: Principal Investigator
mesh term: Vaginosis, Bacterial
mesh term: Vaginal Diseases
mesh term: Metronidazole
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 