<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/NCT02971007</url>
  </required_header>
  <id_info>
    <org_study_id>MB-70005</org_study_id>
    <nct_id>NCT02971007</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)</brief_title>
  <official_title>A Multi-Center Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) Compared With Oral Fluconazole in the Treatment of Moderate to Severe Vulvovaginal Candidiasis (VVC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Matinas BioPharma Nanotechnologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Matinas BioPharma Nanotechnologies, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy&#xD;
      of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the&#xD;
      treatment of moderate to severe VVC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy&#xD;
      of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the&#xD;
      treatment of moderate to severe VVC.&#xD;
&#xD;
      Approximately 75 women with moderate to severe VVC will be randomized to 1 of 3 treatment&#xD;
      groups (200 mg CAMB, 400 mg CAMB, or fluconazole) to achieve approximately 25 subjects in&#xD;
      each group. The primary objective of this study is to evaluate the safety of 200 mg and 400&#xD;
      mg doses of oral CAMB for 5 days compared with a single 150 mg dose of oral fluconazole in&#xD;
      subjects with moderate to severe VVC. The secondary efficacy objectives of this study&#xD;
      included the clinical cure rate, mycology eradication and responder outcome. Tertiary&#xD;
      objectives include pharmacokinetics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>Phase 2</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Outcome Assessed at Test of Cure Visit</measure>
    <time_frame>12 days</time_frame>
    <description>Number of patients determined to be a Clinical Cure (resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment); Clinical Failure (incomplete resolution of signs and symptoms of VVC that were present at baseline or new signs and symptoms have developed and require the initiation of non-study antifungal drugs); or Clinical indeterminate (insufficient data are available to determine if the subject is a cure or failure)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mycological Outcome Assessed at Test of Cure</measure>
    <time_frame>12 days</time_frame>
    <description>Number of patients with mycological eradication (vaginal swab culture negative for growth of baseline Candida species); mycological persistence (vaginal swab culture positive for growth of baseline Candida species); or mycological indeterminate (vaginal swab culture not available or the culture cannot be interpreted or is considered contaminated)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response</measure>
    <time_frame>12 Days</time_frame>
    <description>Number of patients with overall response at Day 12 (Test of cure visit) of composite signs and symptoms defined as overall success (achievement of both a clinical cure and microbiological eradication); overall failure (clinical failure or microbiological persistence) or overall indeterminate (insufficient data are available to determine if the patient is an overall success or failure).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Composite Clinical Cure Score</measure>
    <time_frame>Between randomization visit (Baseline) and Day 12 visit (Test of Cure)</time_frame>
    <description>The percent change from baseline to Day 12 (Test of Cure Visit) of the composite clinical cure score of signs (erythema, edema or excoriation) and symptoms (itching, burning or irritation) on a scale of 0 to 3 for each sign and symptom where 0 = none (complete absence of any sign or symptom); 1 = mild (slight); 2 = moderate (definitely present) or 3 = severe (marked/intense). The maximum score at baseline = 18 (score of 3 for each sign and symptom). The minimum score at baseline = 4 (score of 2 for at least 2 signs or symptoms). A lower score at Day 12 represents a better outcome.&#xD;
The mean percent change from baseline score to Day 12 score is presented for each arm as a negative number and represents a decrease in severity of signs and symptoms. A bigger decrease represents a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">137</enrollment>
  <condition>Vulvovaginitis</condition>
  <condition>Yeast Infection</condition>
  <condition>Yeast Infection Vaginal</condition>
  <condition>Candidiasis, Vulvovaginal</condition>
  <arm_group>
    <arm_group_label>CAMB 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200 mg CAMB (MAT2203) Oral Amphotericin B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAMB 400 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>400 mg CAMB (MAT2203) Oral Amphotericin B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluconazole 150 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fluconazole Diflucan</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral Encochleated Amphotericin B (CAMB)</intervention_name>
    <description>lipid-crystal nano-particle formulation amphotericin B</description>
    <arm_group_label>CAMB 200 mg</arm_group_label>
    <arm_group_label>CAMB 400 mg</arm_group_label>
    <other_name>MAT2203</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluconazole</intervention_name>
    <arm_group_label>Fluconazole 150 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
        Informed consent&#xD;
&#xD;
        Clinical diagnosis of moderate to severe VVC&#xD;
&#xD;
        Negative pregnancy test&#xD;
&#xD;
        Vaginal pH less than 4.5&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
        Has an intolerance or hypersensitivity to any amphotericin B (AMB) product, or to azole&#xD;
        antifungal drugs&#xD;
&#xD;
        Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections&#xD;
        requiring antifungal therapy&#xD;
&#xD;
        Has received treatment for VVC within the past 30 days or has experienced 4 or more&#xD;
        episodes of VVC in the past 12 months&#xD;
&#xD;
        Has another cause of vulvovaginitis&#xD;
&#xD;
        Has other urogenital infection(s) that would potentially alter their response to disease&#xD;
&#xD;
        Has another vaginal or vulvar condition that would confound the interpretation of clinical&#xD;
        response&#xD;
&#xD;
        Has significant laboratory abnormality at screening&#xD;
&#xD;
        Has any known azole-resistant Candida infection;&#xD;
&#xD;
        Has any other condition the Investigator believes would interfere with the subject's&#xD;
        ability to provide informed consent, comply with study instructions, or puts the subject at&#xD;
        undue risk&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas Kling</last_name>
    <role>Study Director</role>
    <affiliation>Matinas BioPharma Nanotechnologies, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alabama Clinical Therapeutics</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Trials, LLC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Research Institute - Wilshire</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Medical Research</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neostart Corporation dba AGA Clinical Trials</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altus Research</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Institute Inc</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthcare Clinical Data, Inc.</name>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <zip>33161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of West Florida - Tampa</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visions Clinical Research</name>
      <address>
        <city>Wellington</city>
        <state>Florida</state>
        <zip>33414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mt. Vernon Clinical Research - Wake Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brighton Clinical Research Associates</name>
      <address>
        <city>Norcross</city>
        <state>Georgia</state>
        <zip>30092</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medpharmics</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New England Center for Clinical Research, Inc.</name>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <zip>02720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lawrence OB/GYN</name>
      <address>
        <city>Lawrenceville</city>
        <state>New Jersey</state>
        <zip>08648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProHEALTH Care Associates, LLC - Suffolk OB-GYN</name>
      <address>
        <city>Port Jefferson</city>
        <state>New York</state>
        <zip>11777</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Salisbury, LLC.</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Wilmington, LLC</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complete Health Care for Women</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson Clinic</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas, Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tidewater Clinical Research, Inc.</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <results_first_submitted>September 7, 2018</results_first_submitted>
  <results_first_submitted_qc>September 7, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 5, 2018</results_first_posted>
  <last_update_submitted>October 4, 2018</last_update_submitted>
  <last_update_submitted_qc>October 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Candidiasis</mesh_term>
    <mesh_term>Candidiasis, Vulvovaginal</mesh_term>
    <mesh_term>Mycoses</mesh_term>
    <mesh_term>Vulvovaginitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluconazole</mesh_term>
    <mesh_term>Amphotericin B</mesh_term>
    <mesh_term>Liposomal amphotericin B</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>January 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT02971007/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment period November 2016 to May 2017 at 22 medical clinics in USA</recruitment_details>
      <pre_assignment_details>Enrolled patients were excluded from the study before assignment to groups due to abnormal laboratory test results, negative potassium hydroxide test (KOH) for vaginal yeast or vaginal pH greater than 4.5 during the screening process.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CAMB 200 mg</title>
          <description>200 mg CAMB (MAT2203) Oral Amphotericin B&#xD;
Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B</description>
        </group>
        <group group_id="P2">
          <title>CAMB 400 mg</title>
          <description>400 mg CAMB (MAT2203) Oral Amphotericin B&#xD;
Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B</description>
        </group>
        <group group_id="P3">
          <title>Fluconazole 150 mg</title>
          <description>Fluconazole Diflucan&#xD;
Fluconazole</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="42"/>
                <participants group_id="P3" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Patient had yeast at Day 5 visit</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Patient discontinued study drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CAMB 200 mg</title>
          <description>200 mg CAMB (MAT2203) Oral Amphotericin B&#xD;
Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B</description>
        </group>
        <group group_id="B2">
          <title>CAMB 400 mg</title>
          <description>400 mg CAMB (MAT2203) Oral Amphotericin B&#xD;
Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B</description>
        </group>
        <group group_id="B3">
          <title>Fluconazole 150 mg</title>
          <description>Fluconazole Diflucan&#xD;
Fluconazole</description>
        </group>
        <group group_id="B4">
          <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="46"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="46"/>
            <count group_id="B4" value="137"/>
          </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="35.7" spread="12.63"/>
                    <measurement group_id="B2" value="36.2" spread="9.77"/>
                    <measurement group_id="B3" value="34.3" spread="11.25"/>
                    <measurement group_id="B4" value="35.4" spread="11.24"/>
                  </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="46"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="137"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" 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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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="46"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.49" spread="8.136"/>
                    <measurement group_id="B2" value="30.64" spread="8.411"/>
                    <measurement group_id="B3" value="29.50" spread="6.973"/>
                    <measurement group_id="B4" value="30.21" spread="7.819"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinical Outcome Assessed at Test of Cure Visit</title>
        <description>Number of patients determined to be a Clinical Cure (resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment); Clinical Failure (incomplete resolution of signs and symptoms of VVC that were present at baseline or new signs and symptoms have developed and require the initiation of non-study antifungal drugs); or Clinical indeterminate (insufficient data are available to determine if the subject is a cure or failure)</description>
        <time_frame>12 days</time_frame>
        <population>All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>CAMB 200 mg</title>
            <description>200 mg CAMB (MAT2203) Oral Amphotericin B&#xD;
Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B</description>
          </group>
          <group group_id="O2">
            <title>CAMB 400 mg</title>
            <description>400 mg CAMB (MAT2203) Oral Amphotericin B&#xD;
Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B</description>
          </group>
          <group group_id="O3">
            <title>Fluconazole 150 mg</title>
            <description>Fluconazole Diflucan&#xD;
Fluconazole</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Outcome Assessed at Test of Cure Visit</title>
          <description>Number of patients determined to be a Clinical Cure (resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment); Clinical Failure (incomplete resolution of signs and symptoms of VVC that were present at baseline or new signs and symptoms have developed and require the initiation of non-study antifungal drugs); or Clinical indeterminate (insufficient data are available to determine if the subject is a cure or failure)</description>
          <population>All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline</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="25"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Clinical Cure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Clinical Failure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Clinical Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>No formal sample size calculations were made. The sample size was determined empirically rather than with a specific statistical rationale and is considered sufficient to achieve the study objectives of this proof of concept study. Women with moderate to severe Vulvovaginal candidiasis were randomized in a 1:1:1 ratio to 1 of 3 treatment groups, stratified by signs and symptoms composite score of up to 12 (moderate) and greater than 13 (severe).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.</non_inferiority_desc>
            <other_analysis_desc>Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mycological Outcome Assessed at Test of Cure</title>
        <description>Number of patients with mycological eradication (vaginal swab culture negative for growth of baseline Candida species); mycological persistence (vaginal swab culture positive for growth of baseline Candida species); or mycological indeterminate (vaginal swab culture not available or the culture cannot be interpreted or is considered contaminated)</description>
        <time_frame>12 days</time_frame>
        <population>All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>CAMB 200 mg</title>
            <description>200 mg CAMB (MAT2203) Oral Amphotericin B&#xD;
Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B</description>
          </group>
          <group group_id="O2">
            <title>CAMB 400 mg</title>
            <description>400 mg CAMB (MAT2203) Oral Amphotericin B&#xD;
Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B</description>
          </group>
          <group group_id="O3">
            <title>Fluconazole 150 mg</title>
            <description>Fluconazole Diflucan&#xD;
Fluconazole</description>
          </group>
        </group_list>
        <measure>
          <title>Mycological Outcome Assessed at Test of Cure</title>
          <description>Number of patients with mycological eradication (vaginal swab culture negative for growth of baseline Candida species); mycological persistence (vaginal swab culture positive for growth of baseline Candida species); or mycological indeterminate (vaginal swab culture not available or the culture cannot be interpreted or is considered contaminated)</description>
          <population>All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline</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="25"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Mycological Eradication</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mycological Persistence</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mycological Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response</title>
        <description>Number of patients with overall response at Day 12 (Test of cure visit) of composite signs and symptoms defined as overall success (achievement of both a clinical cure and microbiological eradication); overall failure (clinical failure or microbiological persistence) or overall indeterminate (insufficient data are available to determine if the patient is an overall success or failure).</description>
        <time_frame>12 Days</time_frame>
        <population>All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>CAMB 200 mg</title>
            <description>200 mg CAMB (MAT2203) Oral Amphotericin B&#xD;
Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B</description>
          </group>
          <group group_id="O2">
            <title>CAMB 400 mg</title>
            <description>400 mg CAMB (MAT2203) Oral Amphotericin B&#xD;
Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B</description>
          </group>
          <group group_id="O3">
            <title>Fluconazole 150 mg</title>
            <description>Fluconazole Diflucan&#xD;
Fluconazole</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response</title>
          <description>Number of patients with overall response at Day 12 (Test of cure visit) of composite signs and symptoms defined as overall success (achievement of both a clinical cure and microbiological eradication); overall failure (clinical failure or microbiological persistence) or overall indeterminate (insufficient data are available to determine if the patient is an overall success or failure).</description>
          <population>All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline</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="25"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Overall Success</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Overall Failure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Overall Indeterminate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Composite Clinical Cure Score</title>
        <description>The percent change from baseline to Day 12 (Test of Cure Visit) of the composite clinical cure score of signs (erythema, edema or excoriation) and symptoms (itching, burning or irritation) on a scale of 0 to 3 for each sign and symptom where 0 = none (complete absence of any sign or symptom); 1 = mild (slight); 2 = moderate (definitely present) or 3 = severe (marked/intense). The maximum score at baseline = 18 (score of 3 for each sign and symptom). The minimum score at baseline = 4 (score of 2 for at least 2 signs or symptoms). A lower score at Day 12 represents a better outcome.&#xD;
The mean percent change from baseline score to Day 12 score is presented for each arm as a negative number and represents a decrease in severity of signs and symptoms. A bigger decrease represents a better outcome.</description>
        <time_frame>Between randomization visit (Baseline) and Day 12 visit (Test of Cure)</time_frame>
        <population>All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>CAMB 200 mg</title>
            <description>200 mg CAMB (MAT2203) Oral Amphotericin B&#xD;
Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B</description>
          </group>
          <group group_id="O2">
            <title>CAMB 400 mg</title>
            <description>400 mg CAMB (MAT2203) Oral Amphotericin B&#xD;
Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B</description>
          </group>
          <group group_id="O3">
            <title>Fluconazole 150 mg</title>
            <description>Fluconazole Diflucan&#xD;
Fluconazole</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Composite Clinical Cure Score</title>
          <description>The percent change from baseline to Day 12 (Test of Cure Visit) of the composite clinical cure score of signs (erythema, edema or excoriation) and symptoms (itching, burning or irritation) on a scale of 0 to 3 for each sign and symptom where 0 = none (complete absence of any sign or symptom); 1 = mild (slight); 2 = moderate (definitely present) or 3 = severe (marked/intense). The maximum score at baseline = 18 (score of 3 for each sign and symptom). The minimum score at baseline = 4 (score of 2 for at least 2 signs or symptoms). A lower score at Day 12 represents a better outcome.&#xD;
The mean percent change from baseline score to Day 12 score is presented for each arm as a negative number and represents a decrease in severity of signs and symptoms. A bigger decrease represents a better outcome.</description>
          <population>All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-80.9" spread="24.63"/>
                    <measurement group_id="O2" value="-80.1" spread="44.66"/>
                    <measurement group_id="O3" value="-94.0" spread="13.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data collected from randomization through follow-up phone call between Day 21 to Day 30.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CAMB 200 mg</title>
          <description>200 mg CAMB (MAT2203) Oral Amphotericin B&#xD;
Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B</description>
        </group>
        <group group_id="E2">
          <title>CAMB 400 mg</title>
          <description>400 mg CAMB (MAT2203) Oral Amphotericin B&#xD;
Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B</description>
        </group>
        <group group_id="E3">
          <title>Fluconazole 150 mg</title>
          <description>Fluconazole Diflucan&#xD;
Fluconazole</description>
        </group>
      </group_list>
      <serious_events>
        <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="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <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="10" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial Vaginosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </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>Data may be considered for publication in a scientific journal or for reporting at a scientific meeting. Each Investigator is obligated to keep data pertaining to the study confidential and must consult with the Sponsor before any study data are submitted for publication. Sponsor reserves the right to deny publication rights until mutual agreement on the content, format, interpretation of data in the manuscript, and journal selected for publication are achieved.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This is a proof of concept study not designed or powered to support an indication for the treatment of VVC but to establish safety, tolerability and efficacy in a non-life threatening fungal infection.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Director Clinical Development</name_or_title>
      <organization>Matinas Biopharma</organization>
      <phone>9082953235</phone>
      <email>jjohnson@matinasbiopharma.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/NCT02971007
org study id: MB-70005
nct id: NCT02971007
lead sponsor: 
has dmc: No
This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy
      of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the
      treatment of moderate to severe VVC.
This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy
      of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the
      treatment of moderate to severe VVC.

      Approximately 75 women with moderate to severe VVC will be randomized to 1 of 3 treatment
      groups (200 mg CAMB, 400 mg CAMB, or fluconazole) to achieve approximately 25 subjects in
      each group. The primary objective of this study is to evaluate the safety of 200 mg and 400
      mg doses of oral CAMB for 5 days compared with a single 150 mg dose of oral fluconazole in
      subjects with moderate to severe VVC. The secondary efficacy objectives of this study
      included the clinical cure rate, mycology eradication and responder outcome. Tertiary
      objectives include pharmacokinetics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Clinical Outcome Assessed at Test of Cure Visit
time frame: 12 days
description: Number of patients determined to be a Clinical Cure (resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment); Clinical Failure (incomplete resolution of signs and symptoms of VVC that were present at baseline or new signs and symptoms have developed and require the initiation of non-study antifungal drugs); or Clinical indeterminate (insufficient data are available to determine if the subject is a cure or failure)
measure: Mycological Outcome Assessed at Test of Cure
time frame: 12 days
description: Number of patients with mycological eradication (vaginal swab culture negative for growth of baseline Candida species); mycological persistence (vaginal swab culture positive for growth of baseline Candida species); or mycological indeterminate (vaginal swab culture not available or the culture cannot be interpreted or is considered contaminated)
measure: Overall Response
time frame: 12 Days
description: Number of patients with overall response at Day 12 (Test of cure visit) of composite signs and symptoms defined as overall success (achievement of both a clinical cure and microbiological eradication); overall failure (clinical failure or microbiological persistence) or overall indeterminate (insufficient data are available to determine if the patient is an overall success or failure).
measure: Change in Composite Clinical Cure Score
time frame: Between randomization visit (Baseline) and Day 12 visit (Test of Cure)
description: The percent change from baseline to Day 12 (Test of Cure Visit) of the composite clinical cure score of signs (erythema, edema or excoriation) and symptoms (itching, burning or irritation) on a scale of 0 to 3 for each sign and symptom where 0 = none (complete absence of any sign or symptom); 1 = mild (slight); 2 = moderate (definitely present) or 3 = severe (marked/intense). The maximum score at baseline = 18 (score of 3 for each sign and symptom). The minimum score at baseline = 4 (score of 2 for at least 2 signs or symptoms). A lower score at Day 12 represents a better outcome.
The mean percent change from baseline score to Day 12 score is presented for each arm as a negative number and represents a decrease in severity of signs and symptoms. A bigger decrease represents a better outcome.
arm group label: CAMB 200 mg
arm group type: Experimental
description: 200 mg CAMB (MAT2203) Oral Amphotericin B
arm group label: CAMB 400 mg
arm group type: Experimental
description: 400 mg CAMB (MAT2203) Oral Amphotericin B
arm group label: Fluconazole 150 mg
arm group type: Active Comparator
description: Fluconazole Diflucan
intervention type: Drug
intervention name: Oral Encochleated Amphotericin B (CAMB)
description: lipid-crystal nano-particle formulation amphotericin B
arm group label: CAMB 200 mg
arm group label: CAMB 400 mg
other name: MAT2203
intervention type: Drug
intervention name: Fluconazole
arm group label: Fluconazole 150 mg
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Douglas Kling
role: Study Director
affiliation: Matinas BioPharma Nanotechnologies, Inc.
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country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Candidiasis
mesh term: Candidiasis, Vulvovaginal
mesh term: Mycoses
mesh term: Vulvovaginitis
mesh term: Fluconazole
mesh term: Amphotericin B
mesh term: Liposomal amphotericin B
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This is a proof of concept study not designed or powered to support an indication for the treatment of VVC but to establish safety, tolerability and efficacy in a non-life threatening fungal infection.
point of contact: 