<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/NCT01725451</url>
  </required_header>
  <id_info>
    <org_study_id>15083</org_study_id>
    <secondary_id>I5E-MC-TSBD</secondary_id>
    <nct_id>NCT01725451</nct_id>
  </id_info>
  <brief_title>A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants</brief_title>
  <official_title>Effects of Deodorant and Antiperspirant Use and the Presence of Axillary Hair on the Absorption of Testosterone Applied as Testosterone 2% Solution</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the effect of deodorant and antiperspirant use and the presence of&#xD;
      underarm hair on the absorption of testosterone. Each participant in this study will receive&#xD;
      6 single doses of 30 milligrams (mg) testosterone applied as a solution to each underarm.&#xD;
      There is a minimum one day washout period between each dose. This study will last&#xD;
      approximately 24 days not including screening. Screening is required within 30 days prior to&#xD;
      the start of the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone</measure>
    <time_frame>Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug</time_frame>
    <description>The AUC from time 0 to 72 hours [AUC (0-72)] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone</measure>
    <time_frame>Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug</time_frame>
    <description>The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>Testosterone Unshaved</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each unshaved axilla in 1 of 6 treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Testosterone Unshaved + Deodorant Spray</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deodorant spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Testosterone Unshaved + Deodorant Antiperspirant Spray</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deodorant antiperspirant combination spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Testosterone Unshaved + Deodorant Antiperspirant Stick</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deodorant antiperspirant combination stick applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Testosterone Shaved</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each shaved axilla in 1 of 6 treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Testosterone Shaved + Deodorant Antiperspirant Spray</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deodorant antiperspirant combination spray applied to shaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Testosterone</intervention_name>
    <description>Administered topically to axillae</description>
    <arm_group_label>Testosterone Shaved</arm_group_label>
    <arm_group_label>Testosterone Shaved + Deodorant Antiperspirant Spray</arm_group_label>
    <arm_group_label>Testosterone Unshaved</arm_group_label>
    <arm_group_label>Testosterone Unshaved + Deodorant Antiperspirant Spray</arm_group_label>
    <arm_group_label>Testosterone Unshaved + Deodorant Antiperspirant Stick</arm_group_label>
    <arm_group_label>Testosterone Unshaved + Deodorant Spray</arm_group_label>
    <other_name>Axiron</other_name>
    <other_name>LY900011</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Deodorant Spray</intervention_name>
    <description>Administered topically to axillae</description>
    <arm_group_label>Testosterone Unshaved + Deodorant Spray</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Deodorant and Antiperspirant Combination Spray</intervention_name>
    <description>Administered topically to axillae</description>
    <arm_group_label>Testosterone Shaved + Deodorant Antiperspirant Spray</arm_group_label>
    <arm_group_label>Testosterone Unshaved + Deodorant Antiperspirant Spray</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Deodorant and Antiperspirant Combination Stick</intervention_name>
    <description>Administered topically to axillae</description>
    <arm_group_label>Testosterone Unshaved + Deodorant Antiperspirant Stick</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are overtly healthy males, as determined by medical history and physical examination&#xD;
&#xD;
          -  Agree to use a reliable method of birth control (for example, condom or vasectomy)&#xD;
             during the study and for 1 month following the last dose of testosterone&#xD;
&#xD;
          -  Have a total testosterone level &lt;400 nanograms per deciliter (ng/dL) based on local&#xD;
             laboratory result&#xD;
&#xD;
          -  Have a hemoglobin ≥12 grams per deciliter (g/dL) at screening and, if the participant&#xD;
             takes a break from the study, at the re-test&#xD;
&#xD;
          -  Weigh at least 60 kilograms (kg)&#xD;
&#xD;
          -  Have venous access sufficient to allow for blood sampling&#xD;
&#xD;
          -  Are reliable and willing to make themselves available for the duration of the study&#xD;
             and are willing to follow study procedures&#xD;
&#xD;
          -  Have given written informed consent approved by Eli Lilly and Company (Lilly) and the&#xD;
             ethical review board (ERB) governing the site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use any topical testosterone replacement therapy within the 2 weeks prior to&#xD;
             randomization through the last dosing period, except for use of testosterone solution&#xD;
             as directed by study procedures&#xD;
&#xD;
          -  Use parenteral testosterone replacement (testosterone enanthanate, testosterone&#xD;
             cypionate) within the 30 days prior to screening. Use long-acting intramuscular&#xD;
             testosterone undecanoate 6 months prior to screening, or use of testosterone pellets&#xD;
             12 months prior to screening&#xD;
&#xD;
          -  Have a body mass index &gt;35 kilograms per square meter (kg/m^2)&#xD;
&#xD;
          -  Have a significant history of allergy and/or sensitivity to the drug products or&#xD;
             excipients, including any history of sensitivity to testosterone&#xD;
&#xD;
          -  Currently use any medications, herbal, and/or nutritional supplements that can&#xD;
             interfere with testosterone&#xD;
&#xD;
          -  Have a dermatologic condition in the underarm area that might interfere with&#xD;
             testosterone absorption (for example, eczema) or be exacerbated by topical&#xD;
             testosterone replacement therapy&#xD;
&#xD;
          -  Have a history or presence of/significant history of or current cardiovascular,&#xD;
             respiratory, hepatic, renal, endocrine, hematological, or neurological disorders&#xD;
             constituting a risk when taking the study medication of that could interfere with the&#xD;
             interpretation of the data&#xD;
&#xD;
          -  Have had lymphoma, leukemia, or any malignancy within the past 5 years except for&#xD;
             basal cell or squamous epithelial carcinomas of the skin that have been resected with&#xD;
             no evidence of metastatic disease for 3 years&#xD;
&#xD;
          -  Have an abnormal prostate-specific antigen (PSA) test result&#xD;
&#xD;
          -  Have known allergies to testosterone solution, related compounds or any components of&#xD;
             the formulation, or history of significant atopy&#xD;
&#xD;
          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the&#xD;
             investigator, increases the risks associated with participating in the study&#xD;
&#xD;
          -  Have an abnormal blood pressure as determined by the investigator&#xD;
&#xD;
          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug&#xD;
             screening&#xD;
&#xD;
          -  Show evidence of hepatitis B and/or positive hepatitis B surface antigen&#xD;
&#xD;
          -  Show evidence of hepatitis C and/or positive hepatitis C antibody&#xD;
&#xD;
          -  Show evidence of human immunodeficiency (HIV) infection and/or positive human HIV&#xD;
             antibodies&#xD;
&#xD;
          -  Are participants who have previously completed or withdrawn from this study or any&#xD;
             other study investigating testosterone&#xD;
&#xD;
          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical&#xD;
             trial involving an investigational product or nonapproved use of a drug or device&#xD;
             (other than the investigational product used in this study), or are concurrently&#xD;
             enrolled in any other type of medical research judged not to be scientifically or&#xD;
             medically compatible with this study&#xD;
&#xD;
          -  In the opinion of the investigator or sponsor, are unsuitable for inclusion in the&#xD;
             study&#xD;
&#xD;
          -  Have shaved the axillae within 3 months of screening&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <results_first_submitted>January 17, 2014</results_first_submitted>
  <results_first_submitted_qc>January 17, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 3, 2014</results_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Testosterone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sequence 1</title>
          <description>30-milligram (mg) testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.</description>
        </group>
        <group group_id="P2">
          <title>Sequence 2</title>
          <description>30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.</description>
        </group>
        <group group_id="P3">
          <title>Sequence 3</title>
          <description>30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.</description>
        </group>
        <group group_id="P4">
          <title>Sequence 4</title>
          <description>30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </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 group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Washout From Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout From Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout From Period 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 4</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Washout From Period 4</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 5</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout From Period 5</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 6</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants who received at least 1 dose of testosterone 2% solution.</population>
      <group_list>
        <group group_id="B1">
          <title>Testosterone 2% Solution</title>
          <description>Participants randomized to 1 of 4 treatment sequences involving 6 treatments in each sequence. Each sequence involved 4 single-dose treatments of testosterone 2% solution to unshaved axillae with or without the use of deodorant or antiperspirant products followed by 2 single-dose treatments of testosterone 2% solution to shaved axillae with or without the use of deodorant or antiperspirant products. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </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="59.7" spread="7.9"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native/White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Screening Testosterone</title>
          <units>nanograms per deciliter (ng/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="290.8" spread="78.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone</title>
        <description>The AUC from time 0 to 72 hours [AUC (0-72)] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.</description>
        <time_frame>Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug</time_frame>
        <population>All randomized participants who received at least 1 dose of testosterone 2% solution and had evaluable 72-hour testosterone concentrations.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Unshaved</title>
            <description>No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.</description>
          </group>
          <group group_id="O2">
            <title>Testosterone Unshaved + Deodorant Spray</title>
            <description>Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.</description>
          </group>
          <group group_id="O3">
            <title>Testosterone Unshaved + Deodorant Antiperspirant Spray</title>
            <description>Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.</description>
          </group>
          <group group_id="O4">
            <title>Testosterone Unshaved + Deodorant Antiperspirant Stick</title>
            <description>Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.</description>
          </group>
          <group group_id="O5">
            <title>Testosterone Shaved</title>
            <description>No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.</description>
          </group>
          <group group_id="O6">
            <title>Testosterone Shaved + Deodorant Antiperspirant Spray</title>
            <description>Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone</title>
          <description>The AUC from time 0 to 72 hours [AUC (0-72)] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.</description>
          <population>All randomized participants who received at least 1 dose of testosterone 2% solution and had evaluable 72-hour testosterone concentrations.</population>
          <units>nanograms* hours per deciliter (ng*h/dL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="28"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2120" spread="164.0"/>
                    <measurement group_id="O2" value="2400" spread="196.0"/>
                    <measurement group_id="O3" value="2970" spread="92.0"/>
                    <measurement group_id="O4" value="2880" spread="129.0"/>
                    <measurement group_id="O5" value="3110" spread="129.0"/>
                    <measurement group_id="O6" value="2070" spread="1733.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone</title>
        <description>The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.</description>
        <time_frame>Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug</time_frame>
        <population>All randomized participants who received at least 1 dose of testosterone 2% solution for the specified treatment regimen.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Unshaved</title>
            <description>No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.</description>
          </group>
          <group group_id="O2">
            <title>Testosterone Unshaved + Deodorant Spray</title>
            <description>Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.</description>
          </group>
          <group group_id="O3">
            <title>Testosterone Unshaved + Deodorant Antiperspirant Spray</title>
            <description>Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution .</description>
          </group>
          <group group_id="O4">
            <title>Testosterone Unshaved + Deodorant Antiperspirant Stick</title>
            <description>Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.</description>
          </group>
          <group group_id="O5">
            <title>Testosterone Shaved</title>
            <description>No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.</description>
          </group>
          <group group_id="O6">
            <title>Testosterone Shaved + Deodorant Antiperspirant Spray</title>
            <description>Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone</title>
          <description>The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.</description>
          <population>All randomized participants who received at least 1 dose of testosterone 2% solution for the specified treatment regimen.</population>
          <units>nanograms per deciliter (ng/dL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="28"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="214" spread="97.0"/>
                    <measurement group_id="O2" value="209" spread="119.0"/>
                    <measurement group_id="O3" value="234" spread="106.0"/>
                    <measurement group_id="O4" value="202" spread="97.0"/>
                    <measurement group_id="O5" value="231" spread="102.0"/>
                    <measurement group_id="O6" value="151" spread="519.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Testosterone Unshaved</title>
          <description>No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.</description>
        </group>
        <group group_id="E2">
          <title>Testosterone Unshaved + Deodorant Spray</title>
          <description>Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.</description>
        </group>
        <group group_id="E3">
          <title>Testosterone Unshaved + Deodorant Antiperspirant Spray</title>
          <description>Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.</description>
        </group>
        <group group_id="E4">
          <title>Testosterone Unshaved + Deodorant Antiperspirant Stick</title>
          <description>Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.</description>
        </group>
        <group group_id="E5">
          <title>Testosterone Shaved</title>
          <description>No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.</description>
        </group>
        <group group_id="E6">
          <title>Testosterone Shaved + Deodorant Antiperspirant Spray</title>
          <description>Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.</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="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Nodule</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </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/NCT01725451
org study id: 15083
secondary id: I5E-MC-TSBD
nct id: NCT01725451
lead sponsor: 
has dmc: No
This study will evaluate the effect of deodorant and antiperspirant use and the presence of
      underarm hair on the absorption of testosterone. Each participant in this study will receive
      6 single doses of 30 milligrams (mg) testosterone applied as a solution to each underarm.
      There is a minimum one day washout period between each dose. This study will last
      approximately 24 days not including screening. Screening is required within 30 days prior to
      the start of the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone
time frame: Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug
description: The AUC from time 0 to 72 hours [AUC (0-72)] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.
measure: Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone
time frame: Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug
description: The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.
arm group label: Testosterone Unshaved
arm group type: Experimental
description: No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each unshaved axilla in 1 of 6 treatment periods.
arm group label: Testosterone Unshaved + Deodorant Spray
arm group type: Experimental
description: Deodorant spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.
arm group label: Testosterone Unshaved + Deodorant Antiperspirant Spray
arm group type: Experimental
description: Deodorant antiperspirant combination spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.
arm group label: Testosterone Unshaved + Deodorant Antiperspirant Stick
arm group type: Experimental
description: Deodorant antiperspirant combination stick applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.
arm group label: Testosterone Shaved
arm group type: Experimental
description: No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each shaved axilla in 1 of 6 treatment periods.
arm group label: Testosterone Shaved + Deodorant Antiperspirant Spray
arm group type: Experimental
description: Deodorant antiperspirant combination spray applied to shaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.
intervention type: Drug
intervention name: Testosterone
description: Administered topically to axillae
arm group label: Testosterone Shaved
arm group label: Testosterone Shaved + Deodorant Antiperspirant Spray
arm group label: Testosterone Unshaved
arm group label: Testosterone Unshaved + Deodorant Antiperspirant Spray
arm group label: Testosterone Unshaved + Deodorant Antiperspirant Stick
arm group label: Testosterone Unshaved + Deodorant Spray
other name: Axiron
other name: LY900011
intervention type: Other
intervention name: Deodorant Spray
description: Administered topically to axillae
arm group label: Testosterone Unshaved + Deodorant Spray
intervention type: Other
intervention name: Deodorant and Antiperspirant Combination Spray
description: Administered topically to axillae
arm group label: Testosterone Shaved + Deodorant Antiperspirant Spray
arm group label: Testosterone Unshaved + Deodorant Antiperspirant Spray
intervention type: Other
intervention name: Deodorant and Antiperspirant Combination Stick
description: Administered topically to axillae
arm group label: Testosterone Unshaved + Deodorant Antiperspirant Stick
criteria: 
gender: Male
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Testosterone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 