<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/NCT01696825</url>
  </required_header>
  <id_info>
    <org_study_id>2012-182</org_study_id>
    <nct_id>NCT01696825</nct_id>
  </id_info>
  <brief_title>Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems</brief_title>
  <official_title>COMPARISON OF ABSORPTION OF VAGINAL DIAZEPAM USING DIFFERENT DELIVERY SYSTEMS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jason Gilleran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>William Beaumont Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine which of three delivery systems of vaginal diazepam&#xD;
      have the best systemic absorption, measured by serum diazepam levels. The three delivery&#xD;
      systems are: moistened tablet, suppository or cream. Additionally the study will compare the&#xD;
      side effects and absorption of vaginal diazepam with oral diazepam. Vaginal diazepam is used&#xD;
      off-label vaginally to relax pelvic floor muscles and reduce pelvic pain caused from pelvic&#xD;
      floor dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 1</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum diazepam levels measured over time</measure>
    <time_frame>Baseline then 2 hours, 4 hours and 8 hours post-medication administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side effects observed with each of three types of vaginal diazepam</measure>
    <time_frame>Baseline and 2 hours, 4 hours and 8 hours post medication administration</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Metabolism, Drug</condition>
  <arm_group>
    <arm_group_label>Diazepam Tablet, 5 mg, Vaginal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Diazepam Suppository, 5 mg, Vaginal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Diazepam Cream, 5 mg, Vaginal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Diazepam Tablet, 5 Mg, Oral</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diazepam tablet, 5 mg, vaginal</intervention_name>
    <description>Diazepam tablet, 5 mg, moistened and inserted vaginally</description>
    <arm_group_label>Diazepam Tablet, 5 Mg, Oral</arm_group_label>
    <arm_group_label>Diazepam Tablet, 5 mg, Vaginal</arm_group_label>
    <other_name>Valium</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diazepam Suppository, 5 mg, vaginal</intervention_name>
    <description>Compounded diazepam 5 mg suppository administered vaginally</description>
    <arm_group_label>Diazepam Suppository, 5 mg, Vaginal</arm_group_label>
    <arm_group_label>Diazepam Tablet, 5 Mg, Oral</arm_group_label>
    <other_name>Valium</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diazepam Cream, 5 mg, Vaginal</intervention_name>
    <description>Compounded diazepam cream, 5 mg, inserted vaginally</description>
    <arm_group_label>Diazepam Cream, 5 mg, Vaginal</arm_group_label>
    <arm_group_label>Diazepam Tablet, 5 Mg, Oral</arm_group_label>
    <other_name>Valium</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provide informed consent&#xD;
&#xD;
          -  Premenopausal women &gt; age 18&#xD;
&#xD;
          -  Able to provide urine and serum samples during the time period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current use of benzodiazepines in any form. If history of benzodiazepine use, must not&#xD;
             have taken for one week prior to study screening and enrollment&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Concomitant use of any narcotic drug, ethanol, or any illicit drug use during the&#xD;
             study period that could be deemed unsafe in combination with benzodiazepine medication&#xD;
             use as judged by the investigators.&#xD;
&#xD;
          -  Any evidence of vaginitis on wet mount slide&#xD;
&#xD;
          -  Postmenopausal&#xD;
&#xD;
          -  Subject with any other vaginal epithelial disorder that could affect absorption of&#xD;
             medication as deemed by the investigators.&#xD;
&#xD;
          -  Any indication/condition/medication that the investigators identify as contraindicated&#xD;
             in conjunction with diazepam.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason Gilleran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>William Beaumont Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Women's Urology Center, William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>December 12, 2014</last_update_submitted>
  <last_update_submitted_qc>December 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Jason Gilleran</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diazepam</mesh_term>
  </intervention_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/NCT01696825
org study id: 2012-182
nct id: NCT01696825
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine which of three delivery systems of vaginal diazepam
      have the best systemic absorption, measured by serum diazepam levels. The three delivery
      systems are: moistened tablet, suppository or cream. Additionally the study will compare the
      side effects and absorption of vaginal diazepam with oral diazepam. Vaginal diazepam is used
      off-label vaginally to relax pelvic floor muscles and reduce pelvic pain caused from pelvic
      floor dysfunction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Serum diazepam levels measured over time
time frame: Baseline then 2 hours, 4 hours and 8 hours post-medication administration
measure: Side effects observed with each of three types of vaginal diazepam
time frame: Baseline and 2 hours, 4 hours and 8 hours post medication administration
arm group label: Diazepam Tablet, 5 mg, Vaginal
arm group type: Experimental
arm group label: Diazepam Suppository, 5 mg, Vaginal
arm group type: Experimental
arm group label: Diazepam Cream, 5 mg, Vaginal
arm group type: Experimental
arm group label: Diazepam Tablet, 5 Mg, Oral
arm group type: Active Comparator
intervention type: Drug
intervention name: Diazepam tablet, 5 mg, vaginal
description: Diazepam tablet, 5 mg, moistened and inserted vaginally
arm group label: Diazepam Tablet, 5 Mg, Oral
arm group label: Diazepam Tablet, 5 mg, Vaginal
other name: Valium
intervention type: Drug
intervention name: Diazepam Suppository, 5 mg, vaginal
description: Compounded diazepam 5 mg suppository administered vaginally
arm group label: Diazepam Suppository, 5 mg, Vaginal
arm group label: Diazepam Tablet, 5 Mg, Oral
other name: Valium
intervention type: Drug
intervention name: Diazepam Cream, 5 mg, Vaginal
description: Compounded diazepam cream, 5 mg, inserted vaginally
arm group label: Diazepam Cream, 5 mg, Vaginal
arm group label: Diazepam Tablet, 5 Mg, Oral
other name: Valium
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jason Gilleran, MD
role: Principal Investigator
affiliation: William Beaumont Hospitals
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Jason Gilleran
investigator title: Physician
mesh term: Diazepam