<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/NCT01716000</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00038440</org_study_id>
    <secondary_id>U19AI077289</secondary_id>
    <nct_id>NCT01716000</nct_id>
  </id_info>
  <brief_title>Optical Imaging and User Perception Study of Vaginal Gel</brief_title>
  <official_title>Optical Imaging and User Perception Study of Vaginal Gel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>ImQuest Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Miriam Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare two investigational techniques for measuring how vaginal gels spread&#xD;
      and coat the vagina. This study will also explore the experiences and opinions of women using&#xD;
      this vaginal gel. We want to understand how the characteristics of a gel, such as a gel's&#xD;
      thickness or consistency, affect how the gel spreads and feels in the body. We hope to use&#xD;
      the information we learn from this study to develop future vaginal gels that could be&#xD;
      combined with medications and used to slow down or stop the spread of sexually transmitted&#xD;
      infections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The pharmacokinetics of a microbicide gel, i.e. the time- and space-dependent distribution of&#xD;
      its active microbicidal ingredient(s) (APIs) throughout the body, derives from the time- and&#xD;
      space-dependent distribution of the gel itself within the vaginal canal. That distribution&#xD;
      may also serve as a physical barrier that retards migration of semen-borne HIV virions to&#xD;
      epithelial surfaces. Within the vagina, the gel creates local physical forces (&quot;stresses&quot;)&#xD;
      against the epithelial surfaces; and its distribution along the canal might be so extensive&#xD;
      that gel leaks out from the introitus. A woman may have sensations of those stresses and also&#xD;
      feel gel leakage. Thus, intravaginal microbicide gel distribution is central to both its&#xD;
      biological functioning (to deliver APIs and also to slow HIV transport) and the behavioral&#xD;
      perception of it by users (i.e. how it &quot;feels&quot; and whether that experience is pleasurable or&#xD;
      not). The latter, in turn, can govern acceptability of the gel and adherence to designated&#xD;
      gel use in clinical trials. This study will characterize and correlate gel distribution and&#xD;
      women's sensory perceptions and preferences of that distribution, for two relevant volumes (2&#xD;
      mL and 4 mL) of a current microbicide placebo gel. An optical vaginal imaging device will&#xD;
      measure gel distribution in the vagina. A computer-assisted self-interview (CASI) survey will&#xD;
      capture women's perceptions and preferences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number and frequency of adverse events</measure>
    <time_frame>up to 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>extent of vaginal gel coating</measure>
    <time_frame>at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1)</time_frame>
    <description>extent of vaginal gel coating is measured by: algebraic and harmonic mean gel thickness, total vaginal surface area with detectable gel coating, fraction of total vaginal surface area containing detectable gel coating, linear extent of gel coating along the vaginal canal, ratio of linear extent of coating to the length of the vaginal canal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>uniformity of vaginal gel coating</measure>
    <time_frame>at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1)</time_frame>
    <description>uniformity of vaginal gel coating is measured by: coefficient of variation of local coating thickness and the number, location, and sizes of individual bare spots of uncoated vaginal surface within the overall gel coating envelope</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>subject perception and preference of vaginal gel</measure>
    <time_frame>at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1)</time_frame>
    <description>responses to the computer aided self interview questions, grouped into the following scales: Leaks with Application, Ease of Application, Portability, Intravaginal Feel, Perception of Leakage with Ambulation, Leaking with Ambulation, Leakage Across Time, Sticky with Ambulation, Perception of Natural Wetness, and Lubrication Moisture on Ambulation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Characterize Gel Distribution in the Vagina</condition>
  <condition>Study Women's Sensory Perceptions and Preferences of Gel</condition>
  <arm_group>
    <arm_group_label>2 mL vaginal gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 mL gel inserted vaginally for completion of vaginal gel imaging and computer aided self interview.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4 mL vaginal gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 mL gel inserted vaginally for completion of vaginal gel imaging and computer aided self interview.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>vaginal gel imaging</intervention_name>
    <description>Imaging of vaginal gel distribution using two investigational techniques (low coherence interferometry and fluorimetry).</description>
    <arm_group_label>2 mL vaginal gel</arm_group_label>
    <arm_group_label>4 mL vaginal gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>computer aided self interview</intervention_name>
    <description>Questionnaire to gather the perceptions and preferences of the subject with respect to the vaginal gel.</description>
    <arm_group_label>2 mL vaginal gel</arm_group_label>
    <arm_group_label>4 mL vaginal gel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have had vaginal penetrative intercourse within the last 12 months&#xD;
&#xD;
          -  have a regular menstrual cycle (between 24-35 days) and be able to record the day of&#xD;
             onset of menses in a menstrual diary&#xD;
&#xD;
          -  able to ambulate for 20 consecutive minutes after vaginal self-insertion of gel using&#xD;
             an applicator&#xD;
&#xD;
          -  willing to use a condom when engaging in sexual intercourse within 4 days before a&#xD;
             study visit&#xD;
&#xD;
          -  willing to avoid using any mechanical sex toy within 1 day before a study visit&#xD;
&#xD;
          -  willing to use one of the following contraception methods if engaging in sexual&#xD;
             intercourse during the length of participation in the study (hormonal contraceptive,&#xD;
             tubal ligation, non-surgical procedure such as permanent transcervical sterilization,&#xD;
             Fallopian tubes removed, partner vasectomy)&#xD;
&#xD;
          -  able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant, potentially pregnant, nursing, or trying to conceive&#xD;
&#xD;
          -  allergic to latex, fluorescein, hydroxyethylcellulose, ascorbic acid, sodium citrate,&#xD;
             citric acid&#xD;
&#xD;
          -  using an intrauterine device (IUD)&#xD;
&#xD;
          -  using depo-provera&#xD;
&#xD;
          -  douching during the course of participation in the study&#xD;
&#xD;
          -  had medical or cosmetic surgery involving the reproductive organs or genitals within&#xD;
             the past 6 months&#xD;
&#xD;
          -  have a gynecological infection or other condition requiring treatment, such as&#xD;
             candidiasis, chlamydia trachomatis, trichomoniasis, HIV, herpes simplex virus (HSV),&#xD;
             neisseria gonorrhea, symptomatic bacterial vaginosis, or syphilis&#xD;
&#xD;
          -  currently enrolled in any other research studies involving the application of vaginal&#xD;
             formulations&#xD;
&#xD;
          -  employed or supervised by the study investigators&#xD;
&#xD;
          -  have any other condition that, in the opinion of the study physician, would&#xD;
             contraindicate participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David F. Katz, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>July 23, 2014</last_update_submitted>
  <last_update_submitted_qc>July 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vaginal gel</keyword>
  <keyword>vaginal coating</keyword>
  <keyword>sensory perceptions</keyword>
  <!-- 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/NCT01716000
org study id: Pro00038440
secondary id: U19AI077289
nct id: NCT01716000
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study will compare two investigational techniques for measuring how vaginal gels spread
      and coat the vagina. This study will also explore the experiences and opinions of women using
      this vaginal gel. We want to understand how the characteristics of a gel, such as a gel's
      thickness or consistency, affect how the gel spreads and feels in the body. We hope to use
      the information we learn from this study to develop future vaginal gels that could be
      combined with medications and used to slow down or stop the spread of sexually transmitted
      infections.
The pharmacokinetics of a microbicide gel, i.e. the time- and space-dependent distribution of
      its active microbicidal ingredient(s) (APIs) throughout the body, derives from the time- and
      space-dependent distribution of the gel itself within the vaginal canal. That distribution
      may also serve as a physical barrier that retards migration of semen-borne HIV virions to
      epithelial surfaces. Within the vagina, the gel creates local physical forces ("stresses")
      against the epithelial surfaces; and its distribution along the canal might be so extensive
      that gel leaks out from the introitus. A woman may have sensations of those stresses and also
      feel gel leakage. Thus, intravaginal microbicide gel distribution is central to both its
      biological functioning (to deliver APIs and also to slow HIV transport) and the behavioral
      perception of it by users (i.e. how it "feels" and whether that experience is pleasurable or
      not). The latter, in turn, can govern acceptability of the gel and adherence to designated
      gel use in clinical trials. This study will characterize and correlate gel distribution and
      women's sensory perceptions and preferences of that distribution, for two relevant volumes (2
      mL and 4 mL) of a current microbicide placebo gel. An optical vaginal imaging device will
      measure gel distribution in the vagina. A computer-assisted self-interview (CASI) survey will
      capture women's perceptions and preferences.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: number and frequency of adverse events
time frame: up to 6 months
measure: extent of vaginal gel coating
time frame: at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1)
description: extent of vaginal gel coating is measured by: algebraic and harmonic mean gel thickness, total vaginal surface area with detectable gel coating, fraction of total vaginal surface area containing detectable gel coating, linear extent of gel coating along the vaginal canal, ratio of linear extent of coating to the length of the vaginal canal
measure: uniformity of vaginal gel coating
time frame: at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1)
description: uniformity of vaginal gel coating is measured by: coefficient of variation of local coating thickness and the number, location, and sizes of individual bare spots of uncoated vaginal surface within the overall gel coating envelope
measure: subject perception and preference of vaginal gel
time frame: at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1)
description: responses to the computer aided self interview questions, grouped into the following scales: Leaks with Application, Ease of Application, Portability, Intravaginal Feel, Perception of Leakage with Ambulation, Leaking with Ambulation, Leakage Across Time, Sticky with Ambulation, Perception of Natural Wetness, and Lubrication Moisture on Ambulation.
arm group label: 2 mL vaginal gel
arm group type: Experimental
description: 2 mL gel inserted vaginally for completion of vaginal gel imaging and computer aided self interview.
arm group label: 4 mL vaginal gel
arm group type: Experimental
description: 4 mL gel inserted vaginally for completion of vaginal gel imaging and computer aided self interview.
intervention type: Other
intervention name: vaginal gel imaging
description: Imaging of vaginal gel distribution using two investigational techniques (low coherence interferometry and fluorimetry).
arm group label: 2 mL vaginal gel
arm group label: 4 mL vaginal gel
intervention type: Behavioral
intervention name: computer aided self interview
description: Questionnaire to gather the perceptions and preferences of the subject with respect to the vaginal gel.
arm group label: 2 mL vaginal gel
arm group label: 4 mL vaginal gel
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David F. Katz, Ph.D.
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor