<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/NCT03839875</url>
  </required_header>
  <id_info>
    <org_study_id>MON564.130.1</org_study_id>
    <nct_id>NCT03839875</nct_id>
  </id_info>
  <brief_title>Evaluation of Efficacy and Safety of Gynomax® XL Ovule</brief_title>
  <acronym>Gyno-Türk</acronym>
  <official_title>A National, Multi-central, Open-label, Single-arm, Phase IV Study to Evaluate Efficacy and Safety of Gynomax® XL Ovule in the Treatment of Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis and Mixed Vaginal Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Exeltis Turkey</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Monitor CRO</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Exeltis Turkey</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Efficacy and safety of Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial&#xD;
      vaginosis, candidal vulvovaginitis and mixed vaginal infections will be evaluated in this&#xD;
      open label, single-arm, multicentral study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2019</start_date>
  <completion_date type="Actual">August 9, 2019</completion_date>
  <primary_completion_date type="Actual">August 9, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients with complete response to treatment</measure>
    <time_frame>10 Days after completion of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with partial response to treatment</measure>
    <time_frame>10 Days after completion of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with no response to treatment</measure>
    <time_frame>10 Days after completion of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>Trichomonal Vaginitis</condition>
  <condition>Bacterial Vaginosis</condition>
  <condition>Candidal Vulvovaginitis</condition>
  <condition>Mixed Vaginal Infections</condition>
  <arm_group>
    <arm_group_label>Active Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gynomax® XL Vaginal Ovule</intervention_name>
    <description>tioconazole, tinidazole, lidocaine</description>
    <arm_group_label>Active Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients with age ≥ 18 and ≤ 45 years&#xD;
&#xD;
          -  Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis or mixed&#xD;
             infections according to the investigator's decision&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to active ingredients of the study medications&#xD;
&#xD;
          -  Vaginismus, endometriosis, dyspareunia&#xD;
&#xD;
          -  Detection of urinary tract infection in urinalysis&#xD;
&#xD;
          -  Acute or chronic infections such as pancreatitis, hypertriglyceridemia, liver&#xD;
             diseases, benign or malign tumors&#xD;
&#xD;
          -  Usage of herbal medicines that interfere with microsomal enzymes, especially&#xD;
             cytochrome P450 (phenytoin, phenobarbital, primidone, carbamazepine, rifampicin,&#xD;
             topiramate, felbamate, griseofulvin, HIV protease inhibitors such as ritonavir,&#xD;
             nucleoside reverse transcriptase inhibitors such as efavirenz)&#xD;
&#xD;
          -  History of cardiovascular event&#xD;
&#xD;
          -  Advanced hypertension and diabetes&#xD;
&#xD;
          -  Presence or known risk or of venous or arterial thromboembolism&#xD;
&#xD;
          -  Undiagnosed abnormal vaginal bleeding, bleeding disorders, genital tumors&#xD;
&#xD;
          -  Use of drugs containing ombitasvir / paritaprevir / ritonavir or dasabuvir during or&#xD;
             two weeks before initiation of the study&#xD;
&#xD;
          -  Pregnancy and/or breastfeeding&#xD;
&#xD;
          -  Participation in any other trial 30 days before initiation of the study&#xD;
&#xD;
          -  Postmenopausal women&#xD;
&#xD;
          -  Abuse of alcohol&#xD;
&#xD;
          -  Usage of medications containing acenocoumarol, anisindione, dicoumarol, phenindione,&#xD;
             phenprocoumon, warfarin, cholestyramine, cimetidine, cyclosporine, disulfiram,&#xD;
             fluorouracil, fosphenitoin, ketoconazole, lithium, rifampin, tacrolimus or propranolol&#xD;
&#xD;
          -  Presence of a sexually transmitted disease such as syphilis, gonorrhea, etc. according&#xD;
             to the investigators decision&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ege University Family Planning and Infertility Application and Research Centeraştırma Merkezi</name>
      <address>
        <city>İzmir</city>
        <zip>35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>January 30, 2020</last_update_submitted>
  <last_update_submitted_qc>January 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2020</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>Vaginosis, Bacterial</mesh_term>
    <mesh_term>Candidiasis, Vulvovaginal</mesh_term>
    <mesh_term>Trichomonas Vaginitis</mesh_term>
    <mesh_term>Vaginal Diseases</mesh_term>
    <mesh_term>Vaginitis</mesh_term>
    <mesh_term>Vulvovaginitis</mesh_term>
  </condition_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/NCT03839875
org study id: MON564.130.1
nct id: NCT03839875
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Efficacy and safety of Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial
      vaginosis, candidal vulvovaginitis and mixed vaginal infections will be evaluated in this
      open label, single-arm, multicentral study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients with complete response to treatment
time frame: 10 Days after completion of treatment
measure: Percentage of patients with partial response to treatment
time frame: 10 Days after completion of treatment
measure: Percentage of patients with no response to treatment
time frame: 10 Days after completion of treatment
arm group label: Active Treatment
arm group type: Experimental
intervention type: Drug
intervention name: Gynomax® XL Vaginal Ovule
description: tioconazole, tinidazole, lidocaine
arm group label: Active Treatment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Infections
mesh term: Vaginosis, Bacterial
mesh term: Candidiasis, Vulvovaginal
mesh term: Trichomonas Vaginitis
mesh term: Vaginal Diseases
mesh term: Vaginitis
mesh term: Vulvovaginitis