<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/NCT02248506</url>
  </required_header>
  <id_info>
    <org_study_id>GY-LAC-01-2012</org_study_id>
    <nct_id>NCT02248506</nct_id>
  </id_info>
  <brief_title>Epidemiological Study About the Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis</brief_title>
  <official_title>Epidemiological Study About the Clinical and Microbiological Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Palacios</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gynea Laboratorios SA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Palacios</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine proportion of women achieving clinical and mycological cure or have recurrences&#xD;
      / reinfection after being treated for an acute episode of vulvovaginal candidiasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vaginal swab test</measure>
    <time_frame>Baseline</time_frame>
    <description>To verify diagnosis of vaginal candidiasis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vaginal swab test</measure>
    <time_frame>month 2</time_frame>
    <description>To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vaginal swab test</measure>
    <time_frame>month 3</time_frame>
    <description>To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vaginal swab test</measure>
    <time_frame>month 6</time_frame>
    <description>To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis, only those with a history of more than four episodes in a year</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Candidiasis, Vulvovaginal</condition>
  <arm_group>
    <arm_group_label>Clotrimazole</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Clotrimazole 500 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clotrimazole</intervention_name>
    <description>All patients receive standard antifungal treatment for this type of infections consisting Clotrimazole 500 Single dose (standard treatment).</description>
    <arm_group_label>Clotrimazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sexually active women between 18 and 50 years&#xD;
&#xD;
          -  Patients attending to the gynecologist with acute vulvovaginal candidiasis.&#xD;
&#xD;
          -  Patients requiring standard treatment with clotrimazole 500 single dose and that the&#xD;
             decision to prescribe this treatment is prior to inclusion in the study.&#xD;
&#xD;
          -  Women who agree to participate in the study and has signed the informed consent sheet.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any medication that may interfere significantly with study assessments.&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Women with signs of other genital infection&#xD;
&#xD;
          -  Within 3 months after childbirth or abortion&#xD;
&#xD;
          -  Patients that is expected not to attend follow-up visits&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Instituto Palacios</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>March 24, 2015</last_update_submitted>
  <last_update_submitted_qc>March 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Candidiasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Candidiasis</mesh_term>
    <mesh_term>Candidiasis, Vulvovaginal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clotrimazole</mesh_term>
    <mesh_term>Miconazole</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02248506
org study id: GY-LAC-01-2012
nct id: NCT02248506
lead sponsor: 
collaborator: 
has dmc: Yes
To determine proportion of women achieving clinical and mycological cure or have recurrences
      / reinfection after being treated for an acute episode of vulvovaginal candidiasis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Vaginal swab test
time frame: Baseline
description: To verify diagnosis of vaginal candidiasis
measure: Vaginal swab test
time frame: month 2
description: To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis
measure: Vaginal swab test
time frame: month 3
description: To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis
measure: Vaginal swab test
time frame: month 6
description: To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis, only those with a history of more than four episodes in a year
arm group label: Clotrimazole
arm group type: Other
description: Clotrimazole 500 mg
intervention type: Other
intervention name: Clotrimazole
description: All patients receive standard antifungal treatment for this type of infections consisting Clotrimazole 500 Single dose (standard treatment).
arm group label: Clotrimazole
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Candidiasis
mesh term: Candidiasis, Vulvovaginal
mesh term: Clotrimazole
mesh term: Miconazole