<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/NCT02186145</url>
  </required_header>
  <id_info>
    <org_study_id>MJ 3002-13</org_study_id>
    <nct_id>NCT02186145</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in Bacterial and Fungal Vaginal Infections</brief_title>
  <official_title>Single Blind Randomized Study of Efficacy and Safety of Vaginal Cream With Association of Metronidazole, Nystatin and Dexamethasone in the Treatment of Bacterial and Fungal Vaginal Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marjan Industria e Comercio ltda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marjan Industria e Comercio ltda</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of association of&#xD;
      metronidazole, nystatin and dexamethasone in the treatment of bacterial and fungal vaginal&#xD;
      infections.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">January 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2017</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Therapeutic cure</measure>
    <time_frame>Day 21-35</time_frame>
    <description>Therapeutic cure which is based on a combination of clinical outcome and Gram's stain results (Nugentscore)/mycological eradication.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation on vulvovaginal inflammation</measure>
    <time_frame>21 - 35 days</time_frame>
    <description>Time resolution of symptoms; percentage of patients with Nugent score between 0-3; negative fungal culture; and subjective assessment of patients on the intensity of vulvar itching.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Bacterial Vaginosis</condition>
  <condition>Fungal Vaginal Infections</condition>
  <arm_group>
    <arm_group_label>Association of metronidazole; nystatin and dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravaginal cream containing metronidazole (500 mg), nystatin ( 100.000 UI) and dexamethasone (0,32 mg) once a day. Period: 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Flagyl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vaginal cream of metronidazole 500 mg, nystatin 100.000 UI - once a day. Period: 10 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Association of metronidazole; nystatin and dexamethasone</intervention_name>
    <arm_group_label>Association of metronidazole; nystatin and dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Flagyl</intervention_name>
    <description>Vaginal cream of metronidazole and nystatin</description>
    <arm_group_label>Flagyl</arm_group_label>
    <other_name>Flagyl-Nistatina (Sanofi Aventis)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Post-menarche women and premenopausal women, between 18 and 50 years old;&#xD;
&#xD;
          -  Diagnosis of bacterial vaginosis (Amsel criteria), fungal (positive KOH test)or mixed&#xD;
             vaginal infection;&#xD;
&#xD;
          -  Patients who have regular menstrual cycles (patients with regular menstrual cycles&#xD;
             with intervals between 21 to 35 days, duration of 1 to 7 days)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have a known hypersensitivity to components of the formula ;&#xD;
&#xD;
          -  Pregnant and lactating women ;&#xD;
&#xD;
          -  Patients with other vaginal infections, such as infection by Trichomonas vaginalis ,&#xD;
             C. trachomatis, Neisseria gonorrhoeae , herpes or HPV.&#xD;
&#xD;
          -  Knowledge of positive test result for human immunodeficiency virus ;&#xD;
&#xD;
          -  Patients in treatment of cervical intraepithelial neoplasia or carcinoma of the cervix&#xD;
             ;&#xD;
&#xD;
          -  Patients who have undergone gynecological procedures in the month prior to inclusion&#xD;
             (such as cauterization of the cervix , cervical biopsy, high-frequency surgery) ;&#xD;
&#xD;
          -  Patients with other vaginal or vulvar conditions that may confound interpretation of&#xD;
             clinical response;&#xD;
&#xD;
          -  Patients who received intravaginal or systemic antimicrobial or antifungal therapy 14&#xD;
             days before randomization ;&#xD;
&#xD;
          -  Patients on immunosuppressive medications (such as corticosteroids , cyclosporine ,&#xD;
             etc. ) ;&#xD;
&#xD;
          -  Known or suspected cancer ;&#xD;
&#xD;
          -  Participation in any experimental study or ingestion of any experimental drug 12&#xD;
             months before the start of this study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine of ABC (FMABC)</name>
      <address>
        <city>Santo André</city>
        <state>SP</state>
        <zip>09190-615</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <contact>
      <last_name>Marcus Vinícius Seroqui, Site Clinical Trials Manager</last_name>
      <phone>+55 11 2829-5148</phone>
      <email>mv_seroqui@yahoo.com.br</email>
    </contact>
    <investigator>
      <last_name>Emerson Oliveira, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>April 8, 2015</last_update_submitted>
  <last_update_submitted_qc>April 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 9, 2015</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>Vaginosis, Bacterial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
    <mesh_term>Nystatin</mesh_term>
    <mesh_term>Dexamethasone</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/NCT02186145
org study id: MJ 3002-13
nct id: NCT02186145
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the efficacy and safety of association of
      metronidazole, nystatin and dexamethasone in the treatment of bacterial and fungal vaginal
      infections.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Therapeutic cure
time frame: Day 21-35
description: Therapeutic cure which is based on a combination of clinical outcome and Gram's stain results (Nugentscore)/mycological eradication.
measure: Evaluation on vulvovaginal inflammation
time frame: 21 - 35 days
description: Time resolution of symptoms; percentage of patients with Nugent score between 0-3; negative fungal culture; and subjective assessment of patients on the intensity of vulvar itching.
arm group label: Association of metronidazole; nystatin and dexamethasone
arm group type: Experimental
description: Intravaginal cream containing metronidazole (500 mg), nystatin ( 100.000 UI) and dexamethasone (0,32 mg) once a day. Period: 10 days.
arm group label: Flagyl
arm group type: Active Comparator
description: Vaginal cream of metronidazole 500 mg, nystatin 100.000 UI - once a day. Period: 10 days
intervention type: Drug
intervention name: Association of metronidazole; nystatin and dexamethasone
arm group label: Association of metronidazole; nystatin and dexamethasone
intervention type: Drug
intervention name: Flagyl
description: Vaginal cream of metronidazole and nystatin
arm group label: Flagyl
other name: Flagyl-Nistatina (Sanofi Aventis)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
contact: 
investigator: 
country: Brazil
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Vaginosis, Bacterial
mesh term: Metronidazole
mesh term: Nystatin
mesh term: Dexamethasone