<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/NCT01703741</url>
  </required_header>
  <id_info>
    <org_study_id>000077</org_study_id>
    <nct_id>NCT01703741</nct_id>
  </id_info>
  <brief_title>A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel</brief_title>
  <official_title>A Multicenter Extension Trial to Evaluate the Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter extension trial in adult hypogonadal males. The purpose of this study&#xD;
      is to evaluate the safety of testosterone gel delivered using an applicator over an extended&#xD;
      period of time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>Phase 3</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>Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL</measure>
    <time_frame>Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)</time_frame>
    <description>Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.</measure>
    <time_frame>Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)</time_frame>
    <description>Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire</measure>
    <time_frame>At Month 6</time_frame>
    <description>Data collected from the five domains of sexual functions were summarized by descriptive statistics.&#xD;
The domains are:&#xD;
Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30)&#xD;
Orgasmic function (2 items, questions 9-10) (Score range: 0-10)&#xD;
Sexual desire (2 items, questions 11-12) (Score range: 2-10)&#xD;
Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)&#xD;
Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)&#xD;
A score of 0-5 is awarded to questions 1-10 and a score of 1-5 is awarded to questions 11-15. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function, in each domain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire</measure>
    <time_frame>At Month 6</time_frame>
    <description>In ADAM questionnaire, subjects had to respond in &quot;yes or no&quot; to 10 questions. A positive result (with severity and symptoms of low testosterone) on the questionnaire was defined as an affirmative answer (&quot;yes&quot;) to questions 1 or 7, or to any 3 other questions.&#xD;
The data were presented using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire</measure>
    <time_frame>At Month 6</time_frame>
    <description>The MAF contains four sub-domains:&#xD;
Severity (2 items, questions 1-2) (Score range: 2-20)&#xD;
Distress (1 item, question 3) (Score range: 1-10)&#xD;
Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)&#xD;
Timing (2 items, questions 15-16) (Score range: 5-20)&#xD;
A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.&#xD;
To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum scores of questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue).&#xD;
The data were presented using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Domain Scores for the Short Form-12 (SF-12) Questionnaire</measure>
    <time_frame>At Month 6</time_frame>
    <description>Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains:&#xD;
PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item)&#xD;
MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item)&#xD;
The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0-100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and SD of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.&#xD;
The data were presented using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL</measure>
    <time_frame>At Month 3</time_frame>
    <description>The data were presented using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL</measure>
    <time_frame>At Month 6</time_frame>
    <description>The data were presented using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone</measure>
    <time_frame>Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)</time_frame>
    <description>Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone</measure>
    <time_frame>Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)</time_frame>
    <description>Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone</measure>
    <time_frame>Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)</time_frame>
    <description>Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone</measure>
    <time_frame>Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)</time_frame>
    <description>Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone</measure>
    <time_frame>Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)</time_frame>
    <description>Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">145</enrollment>
  <condition>Adult Male Hypogonadism</condition>
  <arm_group>
    <arm_group_label>Testosterone gel (FE 999093)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Testosterone Gel (FE 999093)</intervention_name>
    <arm_group_label>Testosterone gel (FE 999093)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Completion of the Phase 3 protocol (NCT01665599)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of another investigational product&#xD;
&#xD;
          -  Use of any medications that could be considered anabolic or interfere with androgen&#xD;
             metabolism&#xD;
&#xD;
          -  Use of estrogens, gonadotropin releasing hormone agonists/antagonists, antiandrogens,&#xD;
             or human growth hormone&#xD;
&#xD;
          -  Use of another testosterone product&#xD;
&#xD;
          -  Chronic use of any drug of abuse&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Development Support</last_name>
    <role>Study Director</role>
    <affiliation>Ferring Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Affiliated Research Center</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Professional Research</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Diego Sexual Medicine</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connecticut Clinical Research</name>
      <address>
        <city>Middlebury</city>
        <state>Connecticut</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Medical Research</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Institute of Urology</name>
      <address>
        <city>Saint Clair Shores</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Urology Associates</name>
      <address>
        <city>Lawrenceville</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Urology</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Medical Group of the Hudson Valley</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Wilmington</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tristate Urologic Services</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Medical Research</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Carolina Research Center</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Urologic Research Center</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Associates</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Clinics of North Texas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Healthcare</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Practice and Clinical Research</name>
      <address>
        <city>North Bay</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <results_first_submitted>June 29, 2017</results_first_submitted>
  <results_first_submitted_qc>September 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 6, 2017</results_first_posted>
  <disposition_first_submitted>October 7, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>October 7, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">October 16, 2014</disposition_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypogonadism</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>Subjects were recruited from 16 study centers in United States and 2 study centers in Canada.</recruitment_details>
      <pre_assignment_details>Of the 172 subjects who completed study 000023 (NCT01665599), 145 subjects were enrolled into this extension study and continued to receive treatment (23 mg, 46 mg or 69 mg).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Testosterone Gel (FE 999303)</title>
          <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="145"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Per Protocol (PP) Population</title>
              <participants_list>
                <participants group_id="P1" count="106">Subjects having 24 hr pharmacokinetic (PK) data for testosterone, with no major protocol violations.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject did not want to continue</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject cannot comply with study visits</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject started testosterone injections</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>Intent-to-treat (ITT) Population consists of all subjects who received at least one dose of Investigational Medicinal Product (IMP).</population>
      <group_list>
        <group group_id="B1">
          <title>Testosterone Gel (FE 999303)</title>
          <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="145"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="57.1" spread="9.4"/>
                  </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="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="133"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <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>Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL</title>
        <description>Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
        <time_frame>Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)</time_frame>
        <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL</title>
          <description>Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
          <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total testosterone level between 1500-1799 ng/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone level between 1800-2499 ng/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone level above 2500 ng/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.</title>
        <description>Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
        <time_frame>Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)</time_frame>
        <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.</title>
          <description>Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
          <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire</title>
        <description>Data collected from the five domains of sexual functions were summarized by descriptive statistics.&#xD;
The domains are:&#xD;
Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30)&#xD;
Orgasmic function (2 items, questions 9-10) (Score range: 0-10)&#xD;
Sexual desire (2 items, questions 11-12) (Score range: 2-10)&#xD;
Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)&#xD;
Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)&#xD;
A score of 0-5 is awarded to questions 1-10 and a score of 1-5 is awarded to questions 11-15. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function, in each domain.</description>
        <time_frame>At Month 6</time_frame>
        <population>ITT population was used which consists of all subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available IIEF questionnaire results.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire</title>
          <description>Data collected from the five domains of sexual functions were summarized by descriptive statistics.&#xD;
The domains are:&#xD;
Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30)&#xD;
Orgasmic function (2 items, questions 9-10) (Score range: 0-10)&#xD;
Sexual desire (2 items, questions 11-12) (Score range: 2-10)&#xD;
Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)&#xD;
Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)&#xD;
A score of 0-5 is awarded to questions 1-10 and a score of 1-5 is awarded to questions 11-15. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function, in each domain.</description>
          <population>ITT population was used which consists of all subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available IIEF questionnaire results.</population>
          <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="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Erectile function domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.8" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orgasmic function domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sexual desire domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intercourse satisfaction domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall satisfaction domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire</title>
        <description>In ADAM questionnaire, subjects had to respond in &quot;yes or no&quot; to 10 questions. A positive result (with severity and symptoms of low testosterone) on the questionnaire was defined as an affirmative answer (&quot;yes&quot;) to questions 1 or 7, or to any 3 other questions.&#xD;
The data were presented using descriptive statistics.</description>
        <time_frame>At Month 6</time_frame>
        <population>ITT population was used which consists of all the subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available ADAM questionnaire results.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire</title>
          <description>In ADAM questionnaire, subjects had to respond in &quot;yes or no&quot; to 10 questions. A positive result (with severity and symptoms of low testosterone) on the questionnaire was defined as an affirmative answer (&quot;yes&quot;) to questions 1 or 7, or to any 3 other questions.&#xD;
The data were presented using descriptive statistics.</description>
          <population>ITT population was used which consists of all the subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available ADAM questionnaire results.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire</title>
        <description>The MAF contains four sub-domains:&#xD;
Severity (2 items, questions 1-2) (Score range: 2-20)&#xD;
Distress (1 item, question 3) (Score range: 1-10)&#xD;
Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)&#xD;
Timing (2 items, questions 15-16) (Score range: 5-20)&#xD;
A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.&#xD;
To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum scores of questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue).&#xD;
The data were presented using descriptive statistics.</description>
        <time_frame>At Month 6</time_frame>
        <population>ITT population was used which consists of all subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available MAF questionnaire results.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire</title>
          <description>The MAF contains four sub-domains:&#xD;
Severity (2 items, questions 1-2) (Score range: 2-20)&#xD;
Distress (1 item, question 3) (Score range: 1-10)&#xD;
Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)&#xD;
Timing (2 items, questions 15-16) (Score range: 5-20)&#xD;
A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.&#xD;
To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum scores of questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue).&#xD;
The data were presented using descriptive statistics.</description>
          <population>ITT population was used which consists of all subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available MAF questionnaire results.</population>
          <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="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Severity domain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Distress domain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Degree of interference in daily activities</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.3" spread="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Timing domain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global fatigue index score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.3" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Domain Scores for the Short Form-12 (SF-12) Questionnaire</title>
        <description>Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains:&#xD;
PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item)&#xD;
MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item)&#xD;
The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0-100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and SD of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.&#xD;
The data were presented using descriptive statistics.</description>
        <time_frame>At Month 6</time_frame>
        <population>ITT population was used which consists of all the subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available SF-12 questionnaire results.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Domain Scores for the Short Form-12 (SF-12) Questionnaire</title>
          <description>Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains:&#xD;
PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item)&#xD;
MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item)&#xD;
The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0-100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and SD of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.&#xD;
The data were presented using descriptive statistics.</description>
          <population>ITT population was used which consists of all the subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available SF-12 questionnaire results.</population>
          <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="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>General health domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.3" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical functioning domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.7" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-physical domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.2" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bodily pain domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.1" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical component summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.9" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-emotional domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.8" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental health domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.7" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vitality domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.1" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social functioning domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.2" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental component summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.2" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL</title>
        <description>The data were presented using descriptive statistics.</description>
        <time_frame>At Month 3</time_frame>
        <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL</title>
          <description>The data were presented using descriptive statistics.</description>
          <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total testosterone level between 1500-1799 ng/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone level between 1800-2499 ng/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone level above 2500 ng/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL</title>
        <description>The data were presented using descriptive statistics.</description>
        <time_frame>At Month 6</time_frame>
        <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL</title>
          <description>The data were presented using descriptive statistics.</description>
          <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total testosterone level between 1500-1799 ng/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone level between 1800-2499 ng/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone level above 2500 ng/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone</title>
        <description>Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
        <time_frame>Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)</time_frame>
        <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone</title>
          <description>Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
          <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
          <units>ng*hr/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total testosterone at 23 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7732" spread="1874"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone at 46 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10583" spread="3863"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone at 69 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10842" spread="3927"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone all doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10451" spread="3836"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone at 23 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1361" spread="233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone at 46 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1675" spread="944"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone at 69 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1751" spread="801"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone all doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1685" spread="827"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone</title>
        <description>Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
        <time_frame>Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)</time_frame>
        <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone</title>
          <description>Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
          <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total testosterone at 23 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.09" lower_limit="1.75" upper_limit="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone at 46 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.11" lower_limit="0.0" upper_limit="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone at 69 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.97" lower_limit="1.85" upper_limit="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone all doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.88" lower_limit="0.0" upper_limit="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone at 23 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.96" lower_limit="0.0" upper_limit="24.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone at 46 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="0.0" upper_limit="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone at 69 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="0.0" upper_limit="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone all doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="0.0" upper_limit="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone</title>
        <description>Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
        <time_frame>Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)</time_frame>
        <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone</title>
          <description>Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
          <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
          <units>ng/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total testosterone at 23 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="747" spread="236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone at 46 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1085" spread="742"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone at 69 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="999" spread="525"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone all doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1008" spread="602"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone at 23 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.7" spread="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone at 46 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111" spread="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone at 69 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114" spread="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone all doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111" spread="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone</title>
        <description>Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
        <time_frame>Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)</time_frame>
        <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone</title>
          <description>Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
          <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
          <units>ng/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total testosterone at 23 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162" spread="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone at 46 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="201" spread="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone at 69 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="219" spread="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone all doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="207" spread="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone at 23 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.8" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone at 46 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.5" spread="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone at 69 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.8" spread="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone all doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.4" spread="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone</title>
        <description>Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
        <time_frame>Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)</time_frame>
        <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone</title>
          <description>Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.&#xD;
The data were presented using descriptive statistics.</description>
          <population>PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.</population>
          <units>ng/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total testosterone at 23 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="322" spread="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone at 46 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="438" spread="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone at 69 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="449" spread="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total testosterone all doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="433" spread="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone at 23 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.6" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone at 46 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.3" spread="39.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone at 69 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.4" spread="33.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dihydrotestosterone all doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.7" spread="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Overall study period (From Day 1 to Month 6)</time_frame>
      <desc>The treatment-emergent adverse event (TEAE), defined as any adverse event (AE) occurring after start of IMP administration and within the time of residual drug effect (5 days of the last dosing), or a pretreatment AE or pre-existing medical condition that worsens in intensity after treatment with the IMP and within the time of residual drug effect, were presented.</desc>
      <group_list>
        <group group_id="E1">
          <title>Testosterone Gel (FE 999303)</title>
          <description>Subjects received testosterone gel with initial dose as fixed on Day 56 during the 000023 study. The dose was further down titrated based on serum testosterone levels. Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 14.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 14.0</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="28" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Periodontal disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Orchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Meniscus lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Haematocrit abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Haematocrit increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Haemoglobin abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Haemoglobin increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Red blood cell count abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Osteopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Thyroid neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Libido increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertonic bladder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Testicular pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Paranasal sinus hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Lichen planus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="145"/>
              </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 the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Development Support</name_or_title>
      <organization>Ferring Pharmaceuticals</organization>
      <email>DK0-Disclosure@ferring.com</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/NCT01703741
org study id: 000077
nct id: NCT01703741
lead sponsor: 
has dmc: No
This is a multicenter extension trial in adult hypogonadal males. The purpose of this study
      is to evaluate the safety of testosterone gel delivered using an applicator over an extended
      period of time.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL
time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
description: Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics.
measure: Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.
time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
description: Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics.
measure: Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire
time frame: At Month 6
description: Data collected from the five domains of sexual functions were summarized by descriptive statistics.
The domains are:
Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30)
Orgasmic function (2 items, questions 9-10) (Score range: 0-10)
Sexual desire (2 items, questions 11-12) (Score range: 2-10)
Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)
Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)
A score of 0-5 is awarded to questions 1-10 and a score of 1-5 is awarded to questions 11-15. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function, in each domain.
measure: Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire
time frame: At Month 6
description: In ADAM questionnaire, subjects had to respond in "yes or no" to 10 questions. A positive result (with severity and symptoms of low testosterone) on the questionnaire was defined as an affirmative answer ("yes") to questions 1 or 7, or to any 3 other questions.
The data were presented using descriptive statistics.
measure: Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire
time frame: At Month 6
description: The MAF contains four sub-domains:
Severity (2 items, questions 1-2) (Score range: 2-20)
Distress (1 item, question 3) (Score range: 1-10)
Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)
Timing (2 items, questions 15-16) (Score range: 5-20)
A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.
To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum scores of questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue).
The data were presented using descriptive statistics.
measure: Domain Scores for the Short Form-12 (SF-12) Questionnaire
time frame: At Month 6
description: Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains:
PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item)
MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item)
The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0-100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and SD of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
The data were presented using descriptive statistics.
measure: Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL
time frame: At Month 3
description: The data were presented using descriptive statistics.
measure: Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL
time frame: At Month 6
description: The data were presented using descriptive statistics.
measure: Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
description: Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics.
measure: Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone
time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
description: Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics.
measure: Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
description: Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics.
measure: Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
description: Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics.
measure: Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
description: Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics.
arm group label: Testosterone gel (FE 999093)
arm group type: Experimental
description: Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
intervention type: Drug
intervention name: Testosterone Gel (FE 999093)
arm group label: Testosterone gel (FE 999093)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Clinical Development Support
role: Study Director
affiliation: Ferring Pharmaceuticals
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Hypogonadism
mesh term: Testosterone
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