<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/NCT03770065</url>
  </required_header>
  <id_info>
    <org_study_id>VML-0001-003</org_study_id>
    <nct_id>NCT03770065</nct_id>
  </id_info>
  <brief_title>Exploratory Study on Two Different Doses of VML-0001 on the Effects on Vaginal pH in Healthy Post-Menopausal Women</brief_title>
  <official_title>A Phase II, Open-label, Single-Centre, Randomized, Cross-over, Exploratory Study on Two Different Doses of VML-0001, the Base Formulation of Viramal's pH Regulating and Vaginal Moisturizing Cream, on the Effects on Vaginal pH in Healthy Post-Menopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Viramal Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Viramal Limited</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>
      The study is designed to determine the effect on vaginal pH and the duration of action&#xD;
      measured on the ability of the base formulation to reduce the vaginal pH&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Actual">April 8, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To determine the duration of action measured on the ability of VML-0001 (base formulation) to reduce vaginal pH.</measure>
    <time_frame>7-14 days</time_frame>
    <description>The Vaginal pH will be measured daily for 7 days after single dose of VML-0001 using pH kits.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">14</enrollment>
  <condition>Vaginal Atrophy</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VML-0001</intervention_name>
    <description>Medical device</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy Post-Menopausal women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be greater than 45 years&#xD;
&#xD;
          -  no positive findings on screening gynaecological examination&#xD;
&#xD;
          -  negative smear test within the last 5 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  has signs of vaginal infection&#xD;
&#xD;
          -  has evidence of alcohol abuse&#xD;
&#xD;
          -  has used hormonal replacement therapy in three months prior to study entry&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Healthy post-menopausal women</gender_description>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Murray, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Doctor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Affiliated Research Center, Inc. (MARC)</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>October 5, 2020</last_update_submitted>
  <last_update_submitted_qc>October 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 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>Atrophy</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/NCT03770065
org study id: VML-0001-003
nct id: NCT03770065
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is designed to determine the effect on vaginal pH and the duration of action
      measured on the ability of the base formulation to reduce the vaginal pH
observational model: Case-Only
time perspective: Prospective
measure: To determine the duration of action measured on the ability of VML-0001 (base formulation) to reduce vaginal pH.
time frame: 7-14 days
description: The Vaginal pH will be measured daily for 7 days after single dose of VML-0001 using pH kits.
arm group label: Group A
arm group label: Group B
intervention type: Device
intervention name: VML-0001
description: Medical device
arm group label: Group A
arm group label: Group B
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Healthy post-menopausal women
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James Murray, MD
role: Principal Investigator
affiliation: Doctor
facility: 
country: United States
responsible party type: Sponsor
mesh term: Atrophy