<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/NCT03782961</url>
  </required_header>
  <id_info>
    <org_study_id>FE4 - HIDRAFEMME - PA - 010</org_study_id>
    <nct_id>NCT03782961</nct_id>
  </id_info>
  <brief_title>Evaluation of Viscosity of a Vaginal Moisturizer</brief_title>
  <official_title>Evaluation of Perceived Effectiveness to Evaluate Viscosity of a Vaginal Moisturizer in Menopaused Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Farmoquimica S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Farmoquimica S.A.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the perception of viscosity of a vaginal moisturizer in postmenopausal women&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A unicentric, blind, non-comparative clinical study to prove the perceived efficacy of the&#xD;
      research product.&#xD;
&#xD;
      It will be necessary 33 female research participants, aged between 45 and 70 years menopause&#xD;
      with complaint of vaginal dryness.&#xD;
&#xD;
      The participant will remain in the study for one day, making use of the research product in&#xD;
      the Research Center.&#xD;
&#xD;
      Participants will be divided into 2 groups so that each group observes the viscosity (flow)&#xD;
      of the test product in a different anatomical position (lying down and standing) immediately&#xD;
      after application of the product, after 15 and 30 minutes.&#xD;
&#xD;
      Participants will respond to a subjective assessment using a standardized questionnaire to&#xD;
      capture possible feelings of discomfort during the study.&#xD;
&#xD;
      A gynecologist will be available to monitor the participants throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 14, 2019</start_date>
  <completion_date type="Anticipated">January 25, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 25, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate subjectively the perceived viscosity change</measure>
    <time_frame>Immediately after application, 15 and 30 minutes after application</time_frame>
    <description>Perceived viscosity change of the research product from the point of view of the target public under normal conditions of use through a questionnaire</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">33</enrollment>
  <condition>Vaginal Dryness</condition>
  <condition>Menopausal Women</condition>
  <arm_group>
    <arm_group_label>Stand up</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After application of the product (sodium lactate and combination of polymers) will remain standing for 30 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lying down</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After application of the product (sodium lactate and combination of polymers) remained lying down with the legs stretched for 30 minutes;</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sodium lactate and combination of polymers</intervention_name>
    <description>sodium lactate and combination of polymers (polycarbophil, carbomer and PVM / MA copolymer)</description>
    <arm_group_label>Lying down</arm_group_label>
    <arm_group_label>Stand up</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Menopausal participants for at least 6 months;&#xD;
&#xD;
          -  Participants with complaints of vaginal dryness;&#xD;
&#xD;
          -  Skin integrity in the region of product analysis;&#xD;
&#xD;
          -  Agreement to comply the procedures of the trial and attend the clinic on the days and&#xD;
             times determined for applications and / or evaluations;&#xD;
&#xD;
          -  Understanding, agreement and signing of the Informed Consent Term.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of anti-inflammatory / immunosuppressive / antihistamine drugs up to 3 weeks prior&#xD;
             to selection;&#xD;
&#xD;
          -  Pathologies and / or active skin lesions (local and / or disseminated) in the&#xD;
             evaluation area;&#xD;
&#xD;
          -  Immunosuppression by drugs or active diseases;&#xD;
&#xD;
          -  Decompensated endocrinopathies;&#xD;
&#xD;
          -  Relevant clinical history or current evidence of alcohol or other drug abuse;&#xD;
&#xD;
          -  known history or suspected intolerance to products of the same category;&#xD;
&#xD;
          -  Intense sun exposure up to 15 days before evaluation;&#xD;
&#xD;
          -  Gynecological treatment up to 4 weeks before evaluation;&#xD;
&#xD;
          -  Other conditions considered by the researcher to be reasonable for disqualification of&#xD;
             study participation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03782961
org study id: FE4 - HIDRAFEMME - PA - 010
nct id: NCT03782961
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the perception of viscosity of a vaginal moisturizer in postmenopausal women
A unicentric, blind, non-comparative clinical study to prove the perceived efficacy of the
      research product.

      It will be necessary 33 female research participants, aged between 45 and 70 years menopause
      with complaint of vaginal dryness.

      The participant will remain in the study for one day, making use of the research product in
      the Research Center.

      Participants will be divided into 2 groups so that each group observes the viscosity (flow)
      of the test product in a different anatomical position (lying down and standing) immediately
      after application of the product, after 15 and 30 minutes.

      Participants will respond to a subjective assessment using a standardized questionnaire to
      capture possible feelings of discomfort during the study.

      A gynecologist will be available to monitor the participants throughout the study.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: To evaluate subjectively the perceived viscosity change
time frame: Immediately after application, 15 and 30 minutes after application
description: Perceived viscosity change of the research product from the point of view of the target public under normal conditions of use through a questionnaire
arm group label: Stand up
arm group type: Experimental
description: After application of the product (sodium lactate and combination of polymers) will remain standing for 30 minutes
arm group label: Lying down
arm group type: Experimental
description: After application of the product (sodium lactate and combination of polymers) remained lying down with the legs stretched for 30 minutes;
intervention type: Device
intervention name: sodium lactate and combination of polymers
description: sodium lactate and combination of polymers (polycarbophil, carbomer and PVM / MA copolymer)
arm group label: Lying down
arm group label: Stand up
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor