<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/NCT03234517</url>
  </required_header>
  <id_info>
    <org_study_id>zuh- 8</org_study_id>
    <nct_id>NCT03234517</nct_id>
  </id_info>
  <brief_title>Vaginal Clindamycin Cream Plus Vaginal Probiotic for Bacterial Vaginosis</brief_title>
  <official_title>Continuous Versus Interrupted Use.of Vaginal Probiotic Plus Vaginal Clindamycin Cream for Bacterial Vaginosis a Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vaginal Clindamycin Cream was used initially for treatment of Bacterial Vaginosis followed by&#xD;
      Vaginal probiotic either in cnotinous or interrupted manner, then assessment of the results&#xD;
      of treatment at different time intervals was done.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Anticipated">August 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2018</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>initial cure rate</measure>
    <time_frame>2 months</time_frame>
    <description>number of women completely cured</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>recurrence rate</measure>
    <time_frame>4,6,8and12 months</time_frame>
    <description>number of women had recurrence</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Bacterial Vaginosis Treatment</condition>
  <arm_group>
    <arm_group_label>Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vaginal Clindamycin Cream followed by continuous Vaginal Probiotic use for 60 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vaginal Clindamycin Cream followed by interrupted Vaginal Probiotic use</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vaginal Clindamycin Cream</intervention_name>
    <description>Vaginal Clindamycin Cream</description>
    <arm_group_label>Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic</arm_group_label>
    <arm_group_label>Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic</arm_group_label>
    <other_name>dalacin c cream</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vaginal Probiotic</intervention_name>
    <description>Vaginal Probiotic</description>
    <arm_group_label>Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic</arm_group_label>
    <arm_group_label>Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic</arm_group_label>
    <other_name>dicoflor vaginal capsules</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  more than 18 years&#xD;
&#xD;
          -  has recurrent Bacterial Vaginosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  use of other antmicrobial&#xD;
&#xD;
          -  not provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ibrahim A EL sharkwy</last_name>
    <role>Principal Investigator</role>
    <affiliation>FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ibrahim A EL sharkwy</last_name>
    <phone>00966554818576</phone>
    <email>ibrahimsharkwy@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohamed L Elsayed</last_name>
    <phone>00201222442467</phone>
    <email>drmohamedlotfy@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zagazig University</name>
      <address>
        <city>Zagazig</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>August 5, 2018</last_update_submitted>
  <last_update_submitted_qc>August 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>IBRAHIM ABD ELGAFOR</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaginosis, Bacterial</mesh_term>
    <mesh_term>Vaginal Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clindamycin</mesh_term>
    <mesh_term>Clindamycin palmitate</mesh_term>
    <mesh_term>Clindamycin phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03234517
org study id: zuh- 8
nct id: NCT03234517
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis
Vaginal Clindamycin Cream was used initially for treatment of Bacterial Vaginosis followed by
      Vaginal probiotic either in cnotinous or interrupted manner, then assessment of the results
      of treatment at different time intervals was done.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: initial cure rate
time frame: 2 months
description: number of women completely cured
measure: recurrence rate
time frame: 4,6,8and12 months
description: number of women had recurrence
arm group label: Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic
arm group type: Experimental
description: Vaginal Clindamycin Cream followed by continuous Vaginal Probiotic use for 60 days
arm group label: Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic
arm group type: Active Comparator
description: Vaginal Clindamycin Cream followed by interrupted Vaginal Probiotic use
intervention type: Drug
intervention name: Vaginal Clindamycin Cream
description: Vaginal Clindamycin Cream
arm group label: Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic
arm group label: Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic
other name: dalacin c cream
intervention type: Drug
intervention name: Vaginal Probiotic
description: Vaginal Probiotic
arm group label: Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic
arm group label: Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic
other name: dicoflor vaginal capsules
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ibrahim A EL sharkwy
role: Principal Investigator
affiliation: FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY
last name: Ibrahim A EL sharkwy
phone: 00966554818576
email: ibrahimsharkwy@yahoo.com
last name: Mohamed L Elsayed
phone: 00201222442467
email: drmohamedlotfy@yahoo.com
facility: 
status: Recruiting
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: IBRAHIM ABD ELGAFOR
investigator title: assistant professor
mesh term: Vaginosis, Bacterial
mesh term: Vaginal Diseases
mesh term: Clindamycin
mesh term: Clindamycin palmitate
mesh term: Clindamycin phosphate
sharing ipd: Undecided