<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/NCT01724242</url>
  </required_header>
  <id_info>
    <org_study_id>DHEA-HMO-CTIL</org_study_id>
    <nct_id>NCT01724242</nct_id>
  </id_info>
  <brief_title>Vaginal DHEA for Women After Breast Cancer</brief_title>
  <official_title>Vaginal DHEA to Ease Vaginal Dryness in Women With a Contraindication to Estrogen Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There does not appear to be a consensus regarding the treatment of vaginal dryness in women&#xD;
      who have a contraindication to the use of estrogen products. DHEA, when used locally, may&#xD;
      improve the symptoms of vaginal dryness due to its chemical properties.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Inability to recruit patients&#xD;
  </why_stopped>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">January 2014</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>improvement in vaginal dryness</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>improvement in urinary incontinence</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>improvement in sexual satisfaction</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Vaginal Dryness</condition>
  <condition>Breast Cancer</condition>
  <condition>Urinary Incontinence</condition>
  <condition>Quality of Life</condition>
  <condition>Sexual Satisfaction</condition>
  <arm_group>
    <arm_group_label>Vaginal DHEA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vaginal DHEA 0.5%(6.5mg)inserted nightly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vaginal DHEA</intervention_name>
    <arm_group_label>Vaginal DHEA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women post menopausal aged 35-55, suffering from vaginal dryness, secondary to&#xD;
             chemotherapy for breast cancer, within 5 years of diagnosis. Follicle Stimulating&#xD;
             Hormone and Estradiol levels in the post menopausal range are needed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women using products to alleviate vaginal dryness.&#xD;
&#xD;
          -  women taking medication for urinary incontinence&#xD;
&#xD;
          -  women not sexually active, for other reasons.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Drorith Hochner-Celnikier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hadassah Medical Organization</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>November 26, 2017</last_update_submitted>
  <last_update_submitted_qc>November 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vaginal dryness</keyword>
  <keyword>Breast Cancer</keyword>
  <keyword>Urinary Incontinence</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Sexual Satisfaction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</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/NCT01724242
org study id: DHEA-HMO-CTIL
nct id: NCT01724242
lead sponsor: 
has dmc: No
There does not appear to be a consensus regarding the treatment of vaginal dryness in women
      who have a contraindication to the use of estrogen products. DHEA, when used locally, may
      improve the symptoms of vaginal dryness due to its chemical properties.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: improvement in vaginal dryness
time frame: 12 weeks
measure: improvement in urinary incontinence
time frame: 12 weeks
measure: improvement in sexual satisfaction
time frame: 12 weeks
arm group label: Vaginal DHEA
arm group type: Experimental
description: Vaginal DHEA 0.5%(6.5mg)inserted nightly
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Vaginal DHEA
arm group label: Vaginal DHEA
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 55 Years
healthy volunteers: No
last name: Drorith Hochner-Celnikier, MD
role: Principal Investigator
affiliation: Hadassah Medical Organization
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Urinary Incontinence
mesh term: Enuresis