<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/NCT01697345</url>
  </required_header>
  <id_info>
    <org_study_id>MelissaDahir</org_study_id>
    <nct_id>NCT01697345</nct_id>
  </id_info>
  <brief_title>Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy</brief_title>
  <official_title>Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: A Pilot Study on the Effects of Vaginal Testosterone Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Creighton University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Creighton University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is well documented that women who have breast cancer may experience a decrease in quality&#xD;
      of life and sexual functioning due to side effects from adjuvant endocrine therapy, typically&#xD;
      aromatase inhibitors (AIs). Women taking AIs are more likely to report unpleasant urogenital&#xD;
      and vaginal symptoms due to the physiologic suppression of estradiol. This treatment can&#xD;
      impair sexual functioning and cause a decreased sexual health quality of life.&#xD;
&#xD;
      At the present time, there are no Food and Drug Administration (FDA) approved medications for&#xD;
      the vulvovaginal or sexual side effects related to the use of AIs. The lack of treatment&#xD;
      options is concerning because the number of women diagnosed with breast cancer continues to&#xD;
      increase; their longevity, also, continues to increase with the use of newer adjuvant&#xD;
      chemotherapies. Local health care practitioners have observed that the benefits of vaginal&#xD;
      testosterone for sexual health in breast cancer survivors are similar to the benefits of&#xD;
      vaginal estrogen in women without breast cancer.&#xD;
&#xD;
      The purpose of this study is to evaluate the impact of using a daily compounded vaginal&#xD;
      testosterone cream for 4 weeks (28 days) on breast cancer survivor's reported experience of&#xD;
      vulvovaginal symptoms accompanying the use of AIs and their associated quality of life and&#xD;
      sexual functioning.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Female Sexual Function Index (FSFI) Score</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>The Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score &lt; 26.5 suggests female sexual dysfunction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FSFI Desire Domain</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>The desire score is calculated by adding the individual scores from the desire domain (question #1 and #2) and multiplying the sum by the domain factor of 0.6. The domain score for desire ranges from 1.2 (minimum) to 6 (maximum) and a higher value represents a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FSFI Arousal Domain</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>The arousal score is calculated by adding the individual scores from the arousal domain (question #3, #4, #5, #6) and multiplying the sum by the domain factor of 0.3. The arousal domain score ranges from 0 (minimum) to 6 (maximum)and a higher value represents a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FSFI Lubrication Domain</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>The lubrication score is calculated by adding the individual scores from the lubrication domain (question #7, #8, #9, #10) and multiplying the sum by the domain factor of 0.3. The domain score for lubrication ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FSFI Orgasm Domain</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>The orgasm score is calculated by adding the individual scores from the orgasm domain (question #11, #12, #13) and multiplying the sum by the domain factor of 0.4. The domain score for orgasm ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FSFI Satisfaction Domain</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>The satisfaction score is calculated by adding the individual scores from the satisfaction domain (question #14, #15, #16) and multiplying the sum by the domain factor of 0.4. The satisfaction domain score ranges from 0.8 (minimum) to 6 (maximum) and a higher value represents a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FSFI Pain Domain</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>The score for pain is calculated by adding the individual scores from the pain domain (question #17, #18, #19) and multiplying the sum by the domain factor of 0.4. The domain score for pain ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study</measure>
    <time_frame>After 4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Vaginal Dryness</condition>
  <condition>Dyspareunia</condition>
  <condition>Sexual Health Quality of Life</condition>
  <arm_group>
    <arm_group_label>Vaginal Testosterone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Testosterone</intervention_name>
    <arm_group_label>Vaginal Testosterone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with breast cancer&#xD;
&#xD;
          -  Currently taking an aromatase inhibitor (AI)&#xD;
&#xD;
          -  Age &gt; 50 years of age&#xD;
&#xD;
          -  Postmenopausal, or two years since last menstrual cycle&#xD;
&#xD;
          -  Urogenital/vulvovaginal symptoms such as vaginal dryness and pain with intercourse&#xD;
&#xD;
          -  Changes in sexual health quality of life/sexual functioning since starting AI therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The use of other treatments for breast cancer such as chemotherapy or radiation within&#xD;
             the past 12 months&#xD;
&#xD;
          -  A known sensitivity to medications containing testosterone&#xD;
&#xD;
          -  The use of exogenous hormone replacement therapy (HRT) in the past three months,&#xD;
             including systemic and local estrogen or testosterone therapy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa A Dahir, DNP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Creighton University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dianne Travers-Gustafson, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Creighton University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Langdon, MD</last_name>
    <role>Study Director</role>
    <affiliation>Nebraska Cancer Specialists</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nebraska Cancer Specialists/Midwest Cancer Center - Legacy</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <results_first_submitted>August 15, 2013</results_first_submitted>
  <results_first_submitted_qc>December 18, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 24, 2014</results_first_posted>
  <last_update_submitted>December 18, 2013</last_update_submitted>
  <last_update_submitted_qc>December 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Creighton University</investigator_affiliation>
    <investigator_full_name>Melissa Dahir</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Vaginal Testosterone</keyword>
  <keyword>Vaginal atrophy</keyword>
  <keyword>Female Sexual Dysfunction</keyword>
  <keyword>Aromatase Inhibitors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Dyspareunia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Testosterone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were prospectively recruited from Nebraska Cancer Specialists in Omaha, NE, between January 11, 2013, and April 23, 2013.</recruitment_details>
      <pre_assignment_details>During the first study visit, the the PI procured a vaginal swab because women with suppressed estrogen levels have an increased risk for infection. Also, in the clinical setting, the PI has observed that women who develop a yeast or bacterial infection while using vaginal testosterone frequently report symptoms of vaginal burning or irritation.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Vaginal Testosterone</title>
          <description>Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12">One patient withdrew due to symptoms of recurrent Gardnerella vaginalis.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>One patient withdrew due to symptoms of recurrent Gardnerella vaginalis.</population>
      <group_list>
        <group group_id="B1">
          <title>Vaginal Testosterone</title>
          <description>Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.67" spread="6.095"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Length of Marriage</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>0-5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-10 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11-15 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16-20 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>21-25 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>26-30 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>31-35 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36-40 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>41-50 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>51-55 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Highest Level of Education</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>High school degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Associate's degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bachelor's degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Master's degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Oophorectomy</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Estrogen-receptor (ER) Status</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>ER+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ER-</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Progesterone-receptor (PR) Status</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>PR+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR-</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Human Epidermal Growth Factor Receptor 2 (HER2) Status</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>HER2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HER2-</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Aromatase Inhibitor</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>anastrozole (Arimidex)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>letrozole (Femara)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>exemestane (Aromasin)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Vaginal Swab Test</title>
          <description>A vaginal swab was obtained prior to prescribing testosterone therapy because women with suppressed estrogen levels have an increased risk of infection.</description>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>No vaginal infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gardnerella vaginalis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Candidiasis species</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sexually Active Prior to Study</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sexually Active During Study</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Female Sexual Function Index (FSFI) Score</title>
        <description>The Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score &lt; 26.5 suggests female sexual dysfunction.</description>
        <time_frame>Baseline, 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FSFI Total Score (Pretest)</title>
            <description>Administered to participants prior to starting vaginal testosterone therapy.</description>
          </group>
          <group group_id="O2">
            <title>FSFI Total Score (Postteset)</title>
            <description>Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Female Sexual Function Index (FSFI) Score</title>
          <description>The Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score &lt; 26.5 suggests female sexual dysfunction.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.691" spread="3.803"/>
                    <measurement group_id="O2" value="18.783" spread="7.050"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0005</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-10.092</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>6.0378</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.928</ci_lower_limit>
            <ci_upper_limit>-6.256</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>FSFI Desire Domain</title>
        <description>The desire score is calculated by adding the individual scores from the desire domain (question #1 and #2) and multiplying the sum by the domain factor of 0.6. The domain score for desire ranges from 1.2 (minimum) to 6 (maximum) and a higher value represents a better outcome.</description>
        <time_frame>Baseline, 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FSFI Desire Domain Score (Pretest)</title>
            <description>Administered to participants prior to starting vaginal testosterone therapy.</description>
          </group>
          <group group_id="O2">
            <title>FSFI Desire Domain Score (Posttest)</title>
            <description>Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).</description>
          </group>
        </group_list>
        <measure>
          <title>FSFI Desire Domain</title>
          <description>The desire score is calculated by adding the individual scores from the desire domain (question #1 and #2) and multiplying the sum by the domain factor of 0.6. The domain score for desire ranges from 1.2 (minimum) to 6 (maximum) and a higher value represents a better outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.350" spread="0.373"/>
                    <measurement group_id="O2" value="2.650" spread="0.866"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0005</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.30</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.880</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.859</ci_lower_limit>
            <ci_upper_limit>-0.741</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>FSFI Arousal Domain</title>
        <description>The arousal score is calculated by adding the individual scores from the arousal domain (question #3, #4, #5, #6) and multiplying the sum by the domain factor of 0.3. The arousal domain score ranges from 0 (minimum) to 6 (maximum)and a higher value represents a better outcome.</description>
        <time_frame>Baseline, 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FSFI Arousal Domain Score (Pretest)</title>
            <description>Administered to participants prior to starting vaginal testosterone therapy.</description>
          </group>
          <group group_id="O2">
            <title>FSFI Arousal Domain Score (Posttest)</title>
            <description>Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).</description>
          </group>
        </group_list>
        <measure>
          <title>FSFI Arousal Domain</title>
          <description>The arousal score is calculated by adding the individual scores from the arousal domain (question #3, #4, #5, #6) and multiplying the sum by the domain factor of 0.3. The arousal domain score ranges from 0 (minimum) to 6 (maximum)and a higher value represents a better outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.200" spread="0.677"/>
                    <measurement group_id="O2" value="2.825" spread="1.256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-1.625</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.369</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.495</ci_lower_limit>
            <ci_upper_limit>-0.755</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>FSFI Lubrication Domain</title>
        <description>The lubrication score is calculated by adding the individual scores from the lubrication domain (question #7, #8, #9, #10) and multiplying the sum by the domain factor of 0.3. The domain score for lubrication ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.</description>
        <time_frame>Baseline, 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FSFI Lubrication Domain Score (Pretest)</title>
            <description>Administered to participants prior to starting vaginal testosterone therapy.</description>
          </group>
          <group group_id="O2">
            <title>FSFI Lubrication Domain Score (Posttest)</title>
            <description>Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).</description>
          </group>
        </group_list>
        <measure>
          <title>FSFI Lubrication Domain</title>
          <description>The lubrication score is calculated by adding the individual scores from the lubrication domain (question #7, #8, #9, #10) and multiplying the sum by the domain factor of 0.3. The domain score for lubrication ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.175" spread="0.620"/>
                    <measurement group_id="O2" value="2.675" spread="1.929"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.018</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.500</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.876</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.692</ci_lower_limit>
            <ci_upper_limit>-0.308</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>FSFI Orgasm Domain</title>
        <description>The orgasm score is calculated by adding the individual scores from the orgasm domain (question #11, #12, #13) and multiplying the sum by the domain factor of 0.4. The domain score for orgasm ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.</description>
        <time_frame>Baseline, 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FSFI Orgasm Domain Score (Pretest)</title>
            <description>Administered to participants prior to starting vaginal testosterone therapy.</description>
          </group>
          <group group_id="O2">
            <title>FSFI Orgasm Domain Score (Posttest)</title>
            <description>Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).</description>
          </group>
        </group_list>
        <measure>
          <title>FSFI Orgasm Domain</title>
          <description>The orgasm score is calculated by adding the individual scores from the orgasm domain (question #11, #12, #13) and multiplying the sum by the domain factor of 0.4. The domain score for orgasm ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.733" spread="1.767"/>
                    <measurement group_id="O2" value="2.933" spread="2.049"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.005</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.20000</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.18168</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.95080</ci_lower_limit>
            <ci_upper_limit>-.44920</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>FSFI Satisfaction Domain</title>
        <description>The satisfaction score is calculated by adding the individual scores from the satisfaction domain (question #14, #15, #16) and multiplying the sum by the domain factor of 0.4. The satisfaction domain score ranges from 0.8 (minimum) to 6 (maximum) and a higher value represents a better outcome.</description>
        <time_frame>Baseline, 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FSFI Satisfaction Domain Score (Pretest)</title>
            <description>Administered to participants prior to starting vaginal testosterone therapy.</description>
          </group>
          <group group_id="O2">
            <title>FSFI Satisfaction Domain Score (Posttest)</title>
            <description>Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).</description>
          </group>
        </group_list>
        <measure>
          <title>FSFI Satisfaction Domain</title>
          <description>The satisfaction score is calculated by adding the individual scores from the satisfaction domain (question #14, #15, #16) and multiplying the sum by the domain factor of 0.4. The satisfaction domain score ranges from 0.8 (minimum) to 6 (maximum) and a higher value represents a better outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.300" spread="1.311"/>
                    <measurement group_id="O2" value="4.200" spread="1.293"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.900</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.355</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.761</ci_lower_limit>
            <ci_upper_limit>-1.039</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>FSFI Pain Domain</title>
        <description>The score for pain is calculated by adding the individual scores from the pain domain (question #17, #18, #19) and multiplying the sum by the domain factor of 0.4. The domain score for pain ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.</description>
        <time_frame>Baseline, 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FSFI Pain Domain Score (Pretest)</title>
            <description>Administered to participants prior to starting vaginal testosterone therapy.</description>
          </group>
          <group group_id="O2">
            <title>FSFI Pain Domain Score (Posttest)</title>
            <description>Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).</description>
          </group>
        </group_list>
        <measure>
          <title>FSFI Pain Domain</title>
          <description>The score for pain is calculated by adding the individual scores from the pain domain (question #17, #18, #19) and multiplying the sum by the domain factor of 0.4. The domain score for pain ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.933" spread="0.875"/>
                    <measurement group_id="O2" value="3.500" spread="2.276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0005</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.567</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.793</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.706</ci_lower_limit>
            <ci_upper_limit>-1.428</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study</title>
        <time_frame>After 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Continued Vaginal Testosterone Therapy</title>
            <description>Participants who chose to continue vaginal testosterone therapy upon completion of the study.</description>
          </group>
          <group group_id="O2">
            <title>Did Not Continue Vaginal Testosterone Therapy</title>
            <description>Participants who chose not to continue vaginal testosterone upon completion of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Vaginal Testosterone</title>
          <description>Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Limitations of this pilot study included the narrow time frame for enrollment, the exclusion of surgically menopausal women under the age of 50, and symptoms of recurrent Gardnerella vaginalis.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Melissa A Dahir</name_or_title>
      <organization>Creighton University</organization>
      <phone>402-657-2847</phone>
      <email>melissadahir@creighton.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01697345
org study id: MelissaDahir
nct id: NCT01697345
lead sponsor: 
has dmc: No
It is well documented that women who have breast cancer may experience a decrease in quality
      of life and sexual functioning due to side effects from adjuvant endocrine therapy, typically
      aromatase inhibitors (AIs). Women taking AIs are more likely to report unpleasant urogenital
      and vaginal symptoms due to the physiologic suppression of estradiol. This treatment can
      impair sexual functioning and cause a decreased sexual health quality of life.

      At the present time, there are no Food and Drug Administration (FDA) approved medications for
      the vulvovaginal or sexual side effects related to the use of AIs. The lack of treatment
      options is concerning because the number of women diagnosed with breast cancer continues to
      increase; their longevity, also, continues to increase with the use of newer adjuvant
      chemotherapies. Local health care practitioners have observed that the benefits of vaginal
      testosterone for sexual health in breast cancer survivors are similar to the benefits of
      vaginal estrogen in women without breast cancer.

      The purpose of this study is to evaluate the impact of using a daily compounded vaginal
      testosterone cream for 4 weeks (28 days) on breast cancer survivor's reported experience of
      vulvovaginal symptoms accompanying the use of AIs and their associated quality of life and
      sexual functioning.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total Female Sexual Function Index (FSFI) Score
time frame: Baseline, 4 weeks
description: The Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score < 26.5 suggests female sexual dysfunction.
measure: FSFI Desire Domain
time frame: Baseline, 4 weeks
description: The desire score is calculated by adding the individual scores from the desire domain (question #1 and #2) and multiplying the sum by the domain factor of 0.6. The domain score for desire ranges from 1.2 (minimum) to 6 (maximum) and a higher value represents a better outcome.
measure: FSFI Arousal Domain
time frame: Baseline, 4 weeks
description: The arousal score is calculated by adding the individual scores from the arousal domain (question #3, #4, #5, #6) and multiplying the sum by the domain factor of 0.3. The arousal domain score ranges from 0 (minimum) to 6 (maximum)and a higher value represents a better outcome.
measure: FSFI Lubrication Domain
time frame: Baseline, 4 weeks
description: The lubrication score is calculated by adding the individual scores from the lubrication domain (question #7, #8, #9, #10) and multiplying the sum by the domain factor of 0.3. The domain score for lubrication ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.
measure: FSFI Orgasm Domain
time frame: Baseline, 4 weeks
description: The orgasm score is calculated by adding the individual scores from the orgasm domain (question #11, #12, #13) and multiplying the sum by the domain factor of 0.4. The domain score for orgasm ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.
measure: FSFI Satisfaction Domain
time frame: Baseline, 4 weeks
description: The satisfaction score is calculated by adding the individual scores from the satisfaction domain (question #14, #15, #16) and multiplying the sum by the domain factor of 0.4. The satisfaction domain score ranges from 0.8 (minimum) to 6 (maximum) and a higher value represents a better outcome.
measure: FSFI Pain Domain
time frame: Baseline, 4 weeks
description: The score for pain is calculated by adding the individual scores from the pain domain (question #17, #18, #19) and multiplying the sum by the domain factor of 0.4. The domain score for pain ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.
measure: Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study
time frame: After 4 weeks
arm group label: Vaginal Testosterone
arm group type: Experimental
description: Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
intervention type: Drug
intervention name: Testosterone
arm group label: Vaginal Testosterone
criteria: 
gender: Female
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Melissa A Dahir, DNP
role: Principal Investigator
affiliation: Creighton University
last name: Dianne Travers-Gustafson, PhD
role: Study Chair
affiliation: Creighton University
last name: Robert Langdon, MD
role: Study Director
affiliation: Nebraska Cancer Specialists
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Creighton University
investigator full name: Melissa Dahir
investigator title: Principal Investigator
mesh term: Breast Neoplasms
mesh term: Dyspareunia
mesh term: Testosterone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Limitations of this pilot study included the narrow time frame for enrollment, the exclusion of surgically menopausal women under the age of 50, and symptoms of recurrent Gardnerella vaginalis.
point of contact: 