<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/NCT03840616</url>
  </required_header>
  <id_info>
    <org_study_id>VMT-VT-1161-CL-017</org_study_id>
    <nct_id>NCT03840616</nct_id>
  </id_info>
  <brief_title>Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections</brief_title>
  <acronym>ultraVIOLET</acronym>
  <official_title>Phase 3, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules vs Fluconazole and Placebo in Treatment of Acute Vulvovaginal Candidiasis in Subjects With Recurrent Vulvovaginal Candidiasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mycovia Pharmaceuticals Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mycovia Pharmaceuticals Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is&#xD;
      defined as at least 3 episodes of acute vulvovaginal candidiasis (VVC) in the past 12 months.&#xD;
      Several properties of oteseconazole (VT-1161) suggest it might be a safer and more effective&#xD;
      treatment of RVVC than other oral antifungal medications.&#xD;
&#xD;
      This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the&#xD;
      treatment of acute VVC episodes in patients with RVVC and consists of 2 parts. The first part&#xD;
      of the study is a 2-week induction phase for the treatment of the patient's current VVC&#xD;
      episode when the patient will take either fluconazole or oteseconazole (VT-1161) according to&#xD;
      a random assignment. The second part consists of an 11-week maintenance phase, when the&#xD;
      patient will take either oteseconazole (VT-1161) or a placebo according to the random&#xD;
      assignment from the first part of the study, and then a 37-week follow-up period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2019</start_date>
  <completion_date type="Actual">December 2, 2020</completion_date>
  <primary_completion_date type="Actual">December 2, 2020</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population</measure>
    <time_frame>48 Weeks</time_frame>
    <description>The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population, which includes subjects who failed to clear their initial acute VVC episode during the induction phase. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and a clinical signs and symptoms score of ≥3. To calculate the signs and symptoms score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with a higher score indicating a worse outcome.&#xD;
0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">219</enrollment>
  <condition>Recurrent Vulvovaginal Candidiasis</condition>
  <arm_group>
    <arm_group_label>Oteseconazole (VT-1161) 150mg capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>600mg oteseconazole administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluconazole 150mg capsule / Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>150mg fluconazole administered every 72 hours in 3 sequential doses starting on Day 1, followed by placebo administered once weekly starting on Day 14</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oteseconazole (VT-1161) 150mg capsule</intervention_name>
    <description>600mg administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14.</description>
    <arm_group_label>Oteseconazole (VT-1161) 150mg capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluconazole 150mg capsule</intervention_name>
    <description>150mg administered every 72 hours in 3 sequential doses starting on Day 1.</description>
    <arm_group_label>Fluconazole 150mg capsule / Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered once weekly starting on Day 14.</description>
    <arm_group_label>Fluconazole 150mg capsule / Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  3 or more episodes of acute VVC in the past 12 months&#xD;
&#xD;
          -  Positive KOH test&#xD;
&#xD;
          -  Total vulvovaginal signs and symptoms score of ≥3 at screening visit&#xD;
&#xD;
          -  Total vulvovaginal signs and symptoms score of &lt;3 at Day 14&#xD;
&#xD;
          -  Must be able to swallow pills&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence or a history of another vaginal or vulvar condition(s)&#xD;
&#xD;
          -  Evidence of major organ system disease&#xD;
&#xD;
          -  History of cervical cancer&#xD;
&#xD;
          -  Poorly controlled diabetes mellitus&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Recent use of topical or systemic antifungal or antibacterial drugs&#xD;
&#xD;
          -  Recent use of immunosuppressive or systemic corticosteroid therapies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>34</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>39</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>25</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>22</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>49</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>14</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>13</name>
      <address>
        <city>Leesburg</city>
        <state>Florida</state>
        <zip>34748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>33</name>
      <address>
        <city>Loxahatchee Groves</city>
        <state>Florida</state>
        <zip>33470</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>36</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>17</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>27</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>10</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83687</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>62</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60643</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>41</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>30</name>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>50</name>
      <address>
        <city>Dearborn Heights</city>
        <state>Michigan</state>
        <zip>48127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>29</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>55</name>
      <address>
        <city>Traverse City</city>
        <state>Michigan</state>
        <zip>49686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>32</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>26</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>42</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>47</name>
      <address>
        <city>Ocean City</city>
        <state>New Jersey</state>
        <zip>07712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>37</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>38</name>
      <address>
        <city>Fayetteville</city>
        <state>North Carolina</state>
        <zip>28304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>15</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>18</name>
      <address>
        <city>Bluffton</city>
        <state>South Carolina</state>
        <zip>29910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>48</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>20</name>
      <address>
        <city>Bristol</city>
        <state>Tennessee</state>
        <zip>37620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>21</name>
      <address>
        <city>Murfreesboro</city>
        <state>Tennessee</state>
        <zip>37130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>24</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>23</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>63</name>
      <address>
        <city>Katy</city>
        <state>Texas</state>
        <zip>77450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>58</name>
      <address>
        <city>League City</city>
        <state>Texas</state>
        <zip>77573</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <results_first_submitted>November 29, 2021</results_first_submitted>
  <results_first_submitted_qc>February 3, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 4, 2022</results_first_posted>
  <last_update_submitted>February 3, 2022</last_update_submitted>
  <last_update_submitted_qc>February 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2022</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>Candidiasis</mesh_term>
    <mesh_term>Candidiasis, Vulvovaginal</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluconazole</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 17, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03840616/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03840616/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>After providing consent, 251 subjects were screened and, of those, a total of 219 subjects were randomly assigned to the oteseconazole or fluconazole/placebo group for a 2-week induction phase. During the induction phase, subjects received either oteseconazole or fluconazole. Subjects whose presenting acute VVC episode resolved during the induction phase (a total of 185 subjects) entered a 48-week maintenance phase comprised of an 11-week treatment period and a 37-week follow-up period.</recruitment_details>
      <pre_assignment_details>Of the 251 subjects screened, 32 did not meet eligibility requirements and were not enrolled (i.e., not assigned to a treatment arm for the 2-week induction phase).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Oteseconazole (VT-1161)</title>
          <description>600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14.</description>
        </group>
        <group group_id="P2">
          <title>Fluconazole / Placebo</title>
          <description>150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>2-Week Induction Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>48-Week Maintenance Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="112"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Oteseconazole (VT-1161)</title>
          <description>600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14.</description>
        </group>
        <group group_id="B2">
          <title>Fluconazole / Placebo</title>
          <description>150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14.</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="147"/>
            <count group_id="B2" value="72"/>
            <count group_id="B3" value="219"/>
          </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="34" spread="10.7"/>
                    <measurement group_id="B2" value="36" spread="11.7"/>
                    <measurement group_id="B3" value="35" spread="11.0"/>
                  </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="147"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="219"/>
                  </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 (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="130"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="147"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population</title>
        <description>The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population, which includes subjects who failed to clear their initial acute VVC episode during the induction phase. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and a clinical signs and symptoms score of ≥3. To calculate the signs and symptoms score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with a higher score indicating a worse outcome.&#xD;
0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense)</description>
        <time_frame>48 Weeks</time_frame>
        <population>Analysis was performed on the ITT population which includes subjects who failed to clear their initial acute VVC episode during the induction phase. The ITT population was defined as all randomized subjects. Missing values were imputed with multiple imputation using the following auxiliary information: treatment, baseline body mass index, baseline age, ethnicity, and visit. The 'percentage of participants' measure represents an average of 10 individual tests using multiple imputation.</population>
        <group_list>
          <group group_id="O1">
            <title>Oteseconazole (VT-1161)</title>
            <description>600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14.</description>
          </group>
          <group group_id="O2">
            <title>Fluconazole / Placebo</title>
            <description>150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population</title>
          <description>The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population, which includes subjects who failed to clear their initial acute VVC episode during the induction phase. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and a clinical signs and symptoms score of ≥3. To calculate the signs and symptoms score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with a higher score indicating a worse outcome.&#xD;
0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense)</description>
          <population>Analysis was performed on the ITT population which includes subjects who failed to clear their initial acute VVC episode during the induction phase. The ITT population was defined as all randomized subjects. Missing values were imputed with multiple imputation using the following auxiliary information: treatment, baseline body mass index, baseline age, ethnicity, and visit. The 'percentage of participants' measure represents an average of 10 individual tests using multiple imputation.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1"/>
                    <measurement group_id="O2" value="42.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 1 through Week 50</time_frame>
      <desc>The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.</desc>
      <group_list>
        <group group_id="E1">
          <title>Oteseconazole (Induction Phase)</title>
          <description>600mg oteseconazole on Day 1 and 450mg oteseconazole on Day 2</description>
        </group>
        <group group_id="E2">
          <title>Oteseconazole (Maintenance Phase)</title>
          <description>150mg oteseconazole once weekly for 11 weeks starting on Day 14.</description>
        </group>
        <group group_id="E3">
          <title>Fluconazole (Induction Phase)</title>
          <description>150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1</description>
        </group>
        <group group_id="E4">
          <title>Placebo (Maintenance Phase)</title>
          <description>Placebo once weekly for 11 weeks starting on Day 14.</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="146"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="123"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Retroperitoneal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</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="8" subjects_at_risk="146"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="123"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="72"/>
                <counts group_id="E4" subjects_affected="21" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="146"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E2" events="21" subjects_affected="17" subjects_at_risk="123"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E4" events="11" subjects_affected="11" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Bacterial vaginosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E2" events="24" subjects_affected="16" subjects_at_risk="123"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E4" events="15" subjects_affected="9" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="123"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="123"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Corona virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="146"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="123"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E4" events="10" subjects_affected="4" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vulvovaginal pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="123"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </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>Neither institution nor investigator can disclose information pertaining to study until sponsor issues multi-center publication. If multi-center publication is not issued within 18 months of study completion and database lock at all sites, sponsor has 30 days from receipt to review institution's and/or investigator's communication and can require removal of confidential information other than study data and/or delay release of institution's and/or investigator's communication for 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Administration</name_or_title>
      <organization>Mycovia Pharmaceuticals Inc</organization>
      <phone>919-467-8539</phone>
      <email>adminops@mycovia.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/NCT03840616
org study id: VMT-VT-1161-CL-017
nct id: NCT03840616
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is
      defined as at least 3 episodes of acute vulvovaginal candidiasis (VVC) in the past 12 months.
      Several properties of oteseconazole (VT-1161) suggest it might be a safer and more effective
      treatment of RVVC than other oral antifungal medications.

      This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the
      treatment of acute VVC episodes in patients with RVVC and consists of 2 parts. The first part
      of the study is a 2-week induction phase for the treatment of the patient's current VVC
      episode when the patient will take either fluconazole or oteseconazole (VT-1161) according to
      a random assignment. The second part consists of an 11-week maintenance phase, when the
      patient will take either oteseconazole (VT-1161) or a placebo according to the random
      assignment from the first part of the study, and then a 37-week follow-up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population
time frame: 48 Weeks
description: The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population, which includes subjects who failed to clear their initial acute VVC episode during the induction phase. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and a clinical signs and symptoms score of ≥3. To calculate the signs and symptoms score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with a higher score indicating a worse outcome.
0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense)
arm group label: Oteseconazole (VT-1161) 150mg capsule
arm group type: Experimental
description: 600mg oteseconazole administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14
arm group label: Fluconazole 150mg capsule / Placebo
arm group type: Active Comparator
description: 150mg fluconazole administered every 72 hours in 3 sequential doses starting on Day 1, followed by placebo administered once weekly starting on Day 14
intervention type: Drug
intervention name: Oteseconazole (VT-1161) 150mg capsule
description: 600mg administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14.
arm group label: Oteseconazole (VT-1161) 150mg capsule
intervention type: Drug
intervention name: Fluconazole 150mg capsule
description: 150mg administered every 72 hours in 3 sequential doses starting on Day 1.
arm group label: Fluconazole 150mg capsule / Placebo
intervention type: Drug
intervention name: Placebo
description: Administered once weekly starting on Day 14.
arm group label: Fluconazole 150mg capsule / Placebo
criteria: 
gender: Female
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Candidiasis
mesh term: Candidiasis, Vulvovaginal
mesh term: Recurrence
mesh term: Fluconazole
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certain agreements: 
point of contact: 