<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/NCT01665599</url>
  </required_header>
  <id_info>
    <org_study_id>000023</org_study_id>
    <nct_id>NCT01665599</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel</brief_title>
  <official_title>A Phase 3, Open-label, Non-randomized, Clinical Trial to Evaluate the Efficacy and 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 Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone&#xD;
      concentrations &lt;300 ng/dL. The purpose of this study is to evaluate the safety and efficacy&#xD;
      of testosterone gel (2%) delivered using an applicator.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">April 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>The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL</measure>
    <time_frame>Day 90</time_frame>
    <description>The data were presented using descriptive statistics. No statistical analysis was performed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL</measure>
    <time_frame>Day 1</time_frame>
    <description>The data were presented using descriptive statistics. No statistical analysis was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)</measure>
    <time_frame>Day 1; Day 90</time_frame>
    <description>A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)</measure>
    <time_frame>Day 1; Day 90</time_frame>
    <description>A validated LC/MS/MS method was used to determine the levels of total testosterone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)</measure>
    <time_frame>Day 1; Day 90</time_frame>
    <description>A validated LC/MS/MS method was used to determine the levels of total testosterone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)</measure>
    <time_frame>Day 1; Day 90</time_frame>
    <description>A validated LC/MS/MS method was used to determine the levels of total testosterone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)</measure>
    <time_frame>Day 1; Day 90</time_frame>
    <description>A validated LC/MS/MS method was used to determine the levels of total testosterone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)</measure>
    <time_frame>Day 1; Day 90</time_frame>
    <description>A validated LC/MS/MS method was used to determine the levels of total testosterone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ</measure>
    <time_frame>Day 1; Day 90</time_frame>
    <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of DHT Measuring Tmax</measure>
    <time_frame>Day 1; Day 90</time_frame>
    <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of DHT Measuring Cmax</measure>
    <time_frame>Day 1; Day 90</time_frame>
    <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of DHT Measuring Cave</measure>
    <time_frame>Day 1; Day 90</time_frame>
    <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of DHT Measuring Cmin</measure>
    <time_frame>Day 1; Day 90</time_frame>
    <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of DHT Measuring Tmin</measure>
    <time_frame>Day 1; Day 90</time_frame>
    <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire</measure>
    <time_frame>Day 91</time_frame>
    <description>Data collected from the five domains of sexual functions were summarized by descriptive statistics. 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 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire</measure>
    <time_frame>Day 91</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 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>Change From Baseline in the SF-12 Health Questionnaire</measure>
    <time_frame>Day 91</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 standard deviation 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>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Adult Male Hypogonadism</condition>
  <arm_group>
    <arm_group_label>Testosterone gel (FE 999303)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Testosterone gel (FE 999303)</intervention_name>
    <arm_group_label>Testosterone gel (FE 999303)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males between 18-75 years of age&#xD;
&#xD;
          2. Two screening serum testosterone values less than 300 ng/dL&#xD;
&#xD;
          3. One or more symptoms of testosterone deficiency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous use of the investigational product&#xD;
&#xD;
          2. Use of any investigational product within 30 days prior to screening and during the&#xD;
             study&#xD;
&#xD;
          3. BMI less than 18 kg/m^2 or more than 35 kg/m^2&#xD;
&#xD;
          4. Prostatic mass(es)&#xD;
&#xD;
          5. Generalized skin irritation or skin disease&#xD;
&#xD;
          6. Lower urinary tract obstruction&#xD;
&#xD;
          7. Myocardial infarction or cerebrovascular accident in the last 6 months&#xD;
&#xD;
          8. Unstable angina or congestive heart failure&#xD;
&#xD;
          9. Thromboembolic disorders&#xD;
&#xD;
         10. Sleep apnea&#xD;
&#xD;
         11. Hyperparathyroidism or uncontrolled diabetes&#xD;
&#xD;
         12. Untreated moderate to severe depression&#xD;
&#xD;
         13. History of testicular, prostate, or breast cancer&#xD;
&#xD;
         14. HIV, Hepatitis B, or Hepatitis C positive&#xD;
&#xD;
         15. PSA more or equal to 3 ng/mL&#xD;
&#xD;
         16. Use of any medications that could be considered anabolic&#xD;
&#xD;
         17. Use of estrogens, Gonadotropin Releasing Hormone agonists/antagonists, antiandrogens,&#xD;
             or human Growth Hormone&#xD;
&#xD;
         18. Chronic use of any drug of abuse&#xD;
&#xD;
         19. Involvement in a sport in which there is a screening for anabolic steroids&#xD;
&#xD;
         20. Not willing to use adequate contraception during the study&#xD;
&#xD;
         21. Partner is pregnant and/or breast feeding&#xD;
&#xD;
         22. Partner has a history of breast, uterine or ovarian cancer&#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 Cente</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>Quality Clinical Research</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</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>August 1, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <results_first_submitted>July 3, 2017</results_first_submitted>
  <results_first_submitted_qc>September 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">September 20, 2017</results_first_posted>
  <disposition_first_submitted>April 8, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>April 8, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">May 2, 2014</disposition_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 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 19 study centers (17 in the US and 2 in Canada).</recruitment_details>
      <pre_assignment_details>Of the 656 screened subjects, 180 subjects were enrolled into the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Testosterone Gel (FE 999303)</title>
          <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="180"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Consent Withdrawn</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator/Sponsor decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</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="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Left for More Than 3 Months</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Could Not Continue Due to Time Constrain</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>Demographics analysis was done on the intent-to-treat (ITT) population consisting of all participants 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 a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="180"/>
          </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="145"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </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="56.8" 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="180"/>
                  </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="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="164"/>
                  </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="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                  </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>
          <title>Height, Continuous</title>
          <units>Inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.3" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight, Continuous</title>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="211.3" spread="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI, Continuous</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total International Index of Erectile Function (IIEF) Score</title>
          <description>IIEF questionnaire have 15 questions (Q) divided into 5 domains-&#xD;
Erectile function (6 items, Q 1-5 and 15) (Score range: 1-30)&#xD;
Orgasmic function (2 items, Q 9-10) (Score range: 0-10)&#xD;
Sexual desire (2 items, Q 11-12) (Score range: 2-10)&#xD;
Intercourse satisfaction (3 items, Q 6-8) (Score range: 0-15)&#xD;
Overall satisfaction (2 items, Q 13-14) (Score range: 2-10)&#xD;
Total score was calculated by summing up scores of each domain and ranged from 5-75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.9" spread="18.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Multidimensional Assessment of Fatigue</title>
          <description>The MAF have 16 questions (Q) divided into 4 domains:&#xD;
Severity (Q 1-2) (Score range [SR]: 2-20)&#xD;
Distress (Q 3) (SR: 1-10)&#xD;
Degree of interference in activities of daily living (Q 4-14) (SR: 11-110)&#xD;
Timing (Q 15-16) (SR: 5-20)&#xD;
First 14 Q are scored from 1-10. Questions 15-16 are scored from 1-4 and converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.&#xD;
GFI was calculated by summing up scores of Q 1, 2, 3, average of 4-14, and revised score of 15. Range of GFI: 1 (no fatigue) to 50 (severe fatigue).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Severity domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.9" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Distress domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.9" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Degree of interference domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.9" spread="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Timing domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.8" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global Fatigue Index (GFI)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.2" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Short Form -12 (SF-12) Health survey</title>
          <description>Data collected from the SF-12 questionnaire, based on the norm-based scores is used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four subdomains (A total of 12 questions).&#xD;
PCS and MCS composite scores are computed using the scores of the 12 questions and transforming these to range from 0-100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health. Positive change from baseline indicates improvement in physical and mental health.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Physical Component Summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.5" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Component Summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.0" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL</title>
        <description>The data were presented using descriptive statistics. No statistical analysis was performed.</description>
        <time_frame>Day 90</time_frame>
        <population>Full Analysis set (FAS) population was used which comprised of subjects who had any available pharmacokinetic (PK) data for testosterone on Day 90.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL</title>
          <description>The data were presented using descriptive statistics. No statistical analysis was performed.</description>
          <population>Full Analysis set (FAS) population was used which comprised of subjects who had any available pharmacokinetic (PK) data for testosterone on Day 90.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>23 mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>46 mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>69 mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL</title>
        <description>The data were presented using descriptive statistics. No statistical analysis was performed.</description>
        <time_frame>Day 1</time_frame>
        <population>FAS population was used which comprised of subjects who had any available PK data for testosterone on Day 90.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL</title>
          <description>The data were presented using descriptive statistics. No statistical analysis was performed.</description>
          <population>FAS population was used which comprised of subjects who had any available PK data for testosterone on Day 90.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)</title>
        <description>A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone.</description>
        <time_frame>Day 1; Day 90</time_frame>
        <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)</title>
          <description>A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone.</description>
          <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1; 46 mg (n=180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7,616" spread="2,242"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 23 mg (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12,433" spread="3,100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 46 mg (n=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9,835" spread="3,831"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 69 mg (n=155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11,967" spread="4,439"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; all doses (n=172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11,825" spread="4,382"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)</title>
        <description>A validated LC/MS/MS method was used to determine the levels of total testosterone.</description>
        <time_frame>Day 1; Day 90</time_frame>
        <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)</title>
          <description>A validated LC/MS/MS method was used to determine the levels of total testosterone.</description>
          <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1; 46 mg (n=180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="0" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 23 mg (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="1.75" upper_limit="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 46 mg (n=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.01" lower_limit="0" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 69 mg (n=155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.03" lower_limit="0" upper_limit="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; all doses (n=172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.03" lower_limit="0" upper_limit="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)</title>
        <description>A validated LC/MS/MS method was used to determine the levels of total testosterone.</description>
        <time_frame>Day 1; Day 90</time_frame>
        <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)</title>
          <description>A validated LC/MS/MS method was used to determine the levels of total testosterone.</description>
          <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1; 46 mg (n=180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="490" spread="234"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 23 mg (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="944" spread="253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 46 mg (n=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="916" spread="514"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 69 mg (n=155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1,432" spread="1,050"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; all doses (n=172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1,382" spread="1,017"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)</title>
        <description>A validated LC/MS/MS method was used to determine the levels of total testosterone.</description>
        <time_frame>Day 1; Day 90</time_frame>
        <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)</title>
          <description>A validated LC/MS/MS method was used to determine the levels of total testosterone.</description>
          <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1; 46 mg (n=180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="316" spread="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 23 mg (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="515" spread="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 46 mg (n=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="407" spread="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 69 mg (n=155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="495" spread="184"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; all doses (n=172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="489" spread="182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)</title>
        <description>A validated LC/MS/MS method was used to determine the levels of total testosterone.</description>
        <time_frame>Day 1; Day 90</time_frame>
        <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)</title>
          <description>A validated LC/MS/MS method was used to determine the levels of total testosterone.</description>
          <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1; 46 mg (n=180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="201" spread="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 23 mg (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="317" spread="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 46 mg (n=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="219" spread="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 69 mg (n=155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="222" spread="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; all doses (n=172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="225" spread="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)</title>
        <description>A validated LC/MS/MS method was used to determine the levels of total testosterone.</description>
        <time_frame>Day 1; Day 90</time_frame>
        <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)</title>
          <description>A validated LC/MS/MS method was used to determine the levels of total testosterone.</description>
          <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1; 46 mg (n=180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 23 mg (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.00" lower_limit="0" upper_limit="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 46 mg (n=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" lower_limit="0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 69 mg (n=155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; all doses (n=172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ</title>
        <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
        <time_frame>Day 1; Day 90</time_frame>
        <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ</title>
          <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
          <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1; 46 mg (n=180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="982" spread="588"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 23 mg (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1,537" spread="263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 46 mg (n=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1,329" spread="593"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 69 mg (n=155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1,604" spread="698"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; all doses (n=172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1,582" spread="683"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of DHT Measuring Tmax</title>
        <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
        <time_frame>Day 1; Day 90</time_frame>
        <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of DHT Measuring Tmax</title>
          <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
          <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1; 46 mg (n=180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="0" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 23 mg (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.08" lower_limit="2" upper_limit="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 46 mg (n=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.11" lower_limit="0" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 69 mg (n=155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.98" lower_limit="0" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; all doses (n=172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.97" lower_limit="0" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of DHT Measuring Cmax</title>
        <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
        <time_frame>Day 1; Day 90</time_frame>
        <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of DHT Measuring Cmax</title>
          <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
          <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1; 46 mg (n=180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.7" spread="40.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 23 mg (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.1" spread="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 46 mg (n=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.5" spread="37.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 69 mg (n=155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108" spread="51.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; all doses (n=172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106" spread="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of DHT Measuring Cave</title>
        <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
        <time_frame>Day 1; Day 90</time_frame>
        <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of DHT Measuring Cave</title>
          <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
          <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1; 46 mg (n=180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.8" spread="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 23 mg (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.7" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 46 mg (n=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.1" spread="24.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 69 mg (n=155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.3" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; all doses (n=172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.4" spread="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of DHT Measuring Cmin</title>
        <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
        <time_frame>Day 1; Day 90</time_frame>
        <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of DHT Measuring Cmin</title>
          <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
          <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1; 46 mg (n=180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.0" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 23 mg (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.4" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 46 mg (n=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.7" spread="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 69 mg (n=155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.8" spread="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; all doses (n=172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.4" spread="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of DHT Measuring Tmin</title>
        <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
        <time_frame>Day 1; Day 90</time_frame>
        <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of DHT Measuring Tmin</title>
          <description>A validated LC/MS/MS method was used to determine the levels of DHT.</description>
          <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1; 46 mg (n=180)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 23 mg (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.00" lower_limit="0" upper_limit="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 46 mg (n=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0" lower_limit="0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; 69 mg (n=155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90; all doses (n=172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire</title>
        <description>Data collected from the five domains of sexual functions were summarized by descriptive statistics. 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 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function.</description>
        <time_frame>Day 91</time_frame>
        <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire</title>
          <description>Data collected from the five domains of sexual functions were summarized by descriptive statistics. 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 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function.</description>
          <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.8" spread="17.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Multidimensional Assessment 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 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>Day 91</time_frame>
        <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Multidimensional Assessment 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 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 comprised of all participants who received at least one dose of IMP.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Severity domain score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Distress domain score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Degree of interference domain score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.9" spread="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Timing domain score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GFI score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.4" spread="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the SF-12 Health 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 standard deviation 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>Day 91</time_frame>
        <population>ITT population was used which comprised of all participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Gel (FE 999303)</title>
            <description>Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the SF-12 Health 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 standard deviation 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 comprised of all participants who received at least one dose of IMP.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Component Summary (PCS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Component Summary (MCS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Overall study period (From Day -45 [screening] to Day 91 [last visit])</time_frame>
      <desc>The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of 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 a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.&#xD;
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="3" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Tachyarrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Compression fracture lumbar spine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </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="62" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Colonic polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Pancreatitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </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="180"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Periumbilical abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Joint sprain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Meniscus lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Muscle injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Haematocrit increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Haemoglobin increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Heart rate irregular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Prostatic specific antigen increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </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="180"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus bladder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Calculus ureteric</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ejaculation failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Scrotal cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </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="180"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Snoring</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Hair growth abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cataract operation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Dental operation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="180"/>
              </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/NCT01665599
org study id: 000023
nct id: NCT01665599
lead sponsor: 
has dmc: No
This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone
      concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy
      of testosterone gel (2%) delivered using an applicator.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
time frame: Day 90
description: The data were presented using descriptive statistics. No statistical analysis was performed.
measure: The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
time frame: Day 1
description: The data were presented using descriptive statistics. No statistical analysis was performed.
measure: Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)
time frame: Day 1; Day 90
description: A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone.
measure: Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)
time frame: Day 1; Day 90
description: A validated LC/MS/MS method was used to determine the levels of total testosterone.
measure: Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)
time frame: Day 1; Day 90
description: A validated LC/MS/MS method was used to determine the levels of total testosterone.
measure: Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)
time frame: Day 1; Day 90
description: A validated LC/MS/MS method was used to determine the levels of total testosterone.
measure: Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)
time frame: Day 1; Day 90
description: A validated LC/MS/MS method was used to determine the levels of total testosterone.
measure: Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)
time frame: Day 1; Day 90
description: A validated LC/MS/MS method was used to determine the levels of total testosterone.
measure: Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ
time frame: Day 1; Day 90
description: A validated LC/MS/MS method was used to determine the levels of DHT.
measure: Pharmacokinetics of DHT Measuring Tmax
time frame: Day 1; Day 90
description: A validated LC/MS/MS method was used to determine the levels of DHT.
measure: Pharmacokinetics of DHT Measuring Cmax
time frame: Day 1; Day 90
description: A validated LC/MS/MS method was used to determine the levels of DHT.
measure: Pharmacokinetics of DHT Measuring Cave
time frame: Day 1; Day 90
description: A validated LC/MS/MS method was used to determine the levels of DHT.
measure: Pharmacokinetics of DHT Measuring Cmin
time frame: Day 1; Day 90
description: A validated LC/MS/MS method was used to determine the levels of DHT.
measure: Pharmacokinetics of DHT Measuring Tmin
time frame: Day 1; Day 90
description: A validated LC/MS/MS method was used to determine the levels of DHT.
measure: Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire
time frame: Day 91
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 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function.
measure: Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire
time frame: Day 91
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 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: Change From Baseline in the SF-12 Health Questionnaire
time frame: Day 91
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 standard deviation 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.
arm group label: Testosterone gel (FE 999303)
arm group type: Experimental
description: Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
intervention type: Drug
intervention name: Testosterone gel (FE 999303)
arm group label: Testosterone gel (FE 999303)
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
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 