<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/NCT04456296</url>
  </required_header>
  <id_info>
    <org_study_id>EN3000-101</org_study_id>
    <nct_id>NCT04456296</nct_id>
  </id_info>
  <brief_title>A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism</brief_title>
  <official_title>An Open-Label, Randomized, Parallel-Group, Three Treatment Arm, Multicenter Study on Hypogonadal Males to Evaluate the Effect on 24-Hour Ambulatory Blood Pressure After 16-Week Continuous Administration With Marketed Testosterone Products</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Endo Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Endo Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Testosterone is the principal androgen produced by the male testes. Hypogonadism is the&#xD;
      result of inadequate production of testosterone by the Leydig cells of the testes and is&#xD;
      reflected by total serum concentrations of testosterone of &lt; 300 nanograms (ng)/deciliters&#xD;
      (dL), with discernible diurnal pattern. The etiology of hypogonadism may be primary or&#xD;
      secondary. The treatment of males with primary, and in some cases, secondary hypogonadism&#xD;
      includes administration of testosterone.&#xD;
&#xD;
      Testim® and Fortesta® are topical gels that when applied daily help to increase the total&#xD;
      testosterone levels in the blood through skin absorption. Aveed® is an injectable form of&#xD;
      testosterone treatment and participants randomized to this treatment arm will receive 3&#xD;
      injections over the course of 16 weeks.&#xD;
&#xD;
      This study is designed to evaluate the effect on blood pressure of approved testosterone&#xD;
      products (Testim®, Fortesta®, and Aveed®) after 16 weeks of therapy using 24-hour ambulatory&#xD;
      blood pressure to reveal shifts in blood pressure levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">July 12, 2023</completion_date>
  <primary_completion_date type="Actual">July 12, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in 24-Hour Average Systolic Ambulatory Blood Pressure</measure>
    <time_frame>Baseline (Day 1), Week 16</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in 24-Hour Average Arterial Pressure</measure>
    <time_frame>Baseline (Day 1), Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in 24-Hour Average Systolic Blood Pressure</measure>
    <time_frame>Baseline (Day 1), Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in 24-Hour Average Diastolic Blood Pressure</measure>
    <time_frame>Baseline (Day 1), Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in 24-Hour Average Heart Rate</measure>
    <time_frame>Baseline (Day 1), Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in 24-Hour Average Pulse Pressure</measure>
    <time_frame>Baseline (Day 1), Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Participants Taking New Antihypertensive Medications</measure>
    <time_frame>Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Participants with Dose Increases From Baseline in Antihypertensive Medications</measure>
    <time_frame>Week 16</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">676</enrollment>
  <condition>Hypogonadism</condition>
  <condition>Hypogonadism, Male</condition>
  <condition>Hypogonadotropic Hypogonadism</condition>
  <arm_group>
    <arm_group_label>AVEED (Testosterone Undecanoate Injection)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fixed dosage level of 750 milligrams (mg)/3 milliliters (mL) administered by intramuscular injections.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FORTESTA (Testosterone Gel)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 mg once daily topical gel administration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TESTIM (Testosterone Gel)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 mg once daily topical gel administration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aveed Injectable Product</intervention_name>
    <description>Testosterone undecanoate administered by intramuscular injections.</description>
    <arm_group_label>AVEED (Testosterone Undecanoate Injection)</arm_group_label>
    <other_name>Testosterone undecanoate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fortesta</intervention_name>
    <description>Testosterone gel administered topically. The daily dose of the study drug will be titrated for each participant, according to approved dosage and administration instructions, until the circulating testosterone concentrations of the participant reaches normal concentrations (300-1000 ng/dL).</description>
    <arm_group_label>FORTESTA (Testosterone Gel)</arm_group_label>
    <other_name>Testosterone gel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Testim</intervention_name>
    <description>Testosterone gel administered topically. The daily dose of the study drug will be titrated for each participant, according to approved dosage and administration instructions, until the circulating testosterone concentrations of the participant reaches normal concentrations (300-1000 ng/dL).</description>
    <arm_group_label>TESTIM (Testosterone Gel)</arm_group_label>
    <other_name>Testosterone gel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have a diagnosis of primary hypogonadism or hypogonadotropic hypogonadism.&#xD;
&#xD;
          2. Have a total serum testosterone at screening &lt; 300 ng/dL based on 2 blood samples&#xD;
             obtained at 10 am (+/-2 hours) on 2 separate occasions at least 48 hours apart&#xD;
&#xD;
          3. Be naïve to androgen replacement or washout of 12 weeks following intramuscular&#xD;
             androgen injections; 4 weeks following topical or buccal, nasal, or oral androgens.&#xD;
&#xD;
          4. Have a screening blood pressure at rest of less than 140 millimeters of mercury (mm&#xD;
             Hg) for systolic blood pressure and less than 90 mm Hg for diastolic blood pressure.&#xD;
&#xD;
          5. Be judged to be in good health.&#xD;
&#xD;
          6. Participants enrolled in the Testim or Fortesta treatment arms: take necessary&#xD;
             precautions to avoid skin-to-skin contact and potential transfer and if male use&#xD;
             effective contraception.&#xD;
&#xD;
          7. Be willing and able to cooperate with the requirements of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Is from a vulnerable population, as defined by the US Code of Federal Regulations&#xD;
             (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations,&#xD;
             including but not limited to, employees (temporary, part-time, full time, etc) or a&#xD;
             family member of the research staff conducting the study, or of the sponsor, or of the&#xD;
             contract research organization, or of the Institutional Review Board/Independent&#xD;
             Ethics Committee (IRB/IEC).&#xD;
&#xD;
          2. Has a history of significant sensitivity or allergy to the study drugs, including&#xD;
             androgens, or product excipients.&#xD;
&#xD;
          3. Has a history of or medical examination findings renal, hepatic, neurologic,&#xD;
             hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric conditions,&#xD;
             cardiovascular disease/dysrhythmia) or any other condition(s) that restricts study&#xD;
             participation.&#xD;
&#xD;
          4. Has clinically significant changes in any medications (including dosages) or medical&#xD;
             conditions in the 28 days prior to screening&#xD;
&#xD;
          5. Is not on a stable medication regimen for at least 3 months for the treatment of a&#xD;
             chronic condition.&#xD;
&#xD;
          6. Has had a cardiovascular and/or cerebrovascular event within the last 6 months.&#xD;
&#xD;
          7. Needs blood pressure cuff size larger than 50 centimeters.&#xD;
&#xD;
          8. Works a night shift or performs heavy manual labor.&#xD;
&#xD;
          9. Has any known contraindication(s) to active study treatment including, but not limited&#xD;
             to: known or suspected carcinoma of the prostate or breast, previous history of cancer&#xD;
             (except basal cell carcinoma of the skin) liver disease, active deep vein thrombosis,&#xD;
             atrial fibrillation, untreated sleep apnea, or is immune compromised.&#xD;
&#xD;
         10. Uses known inhibitors (for example, ketoconazole) or inducers of cytochrome P450 3A&#xD;
             (for example, dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A&#xD;
             (CYP3A) within 30 days prior to study drug administration and through the end of the&#xD;
             study.&#xD;
&#xD;
               1. Uses any of the above listed drugs within 5 half lives of the last dose in the&#xD;
                  past 6 months prior to study drug administration.&#xD;
&#xD;
               2. Has received any of the above listed drugs by injection within 30 days or 10 half&#xD;
                  lives (whichever is longer) prior to study drug administration.&#xD;
&#xD;
               3. Uses nutraceuticals or homeopathic compounds.&#xD;
&#xD;
         11. Has a history of drug or alcohol abuse within 6 months prior to study drug&#xD;
             administration.&#xD;
&#xD;
         12. Has untreated moderate to severe depression.&#xD;
&#xD;
         13. Has any skin lesions/cuts/injury at the application site.&#xD;
&#xD;
         14. Has suspected reversible hypogonadism.&#xD;
&#xD;
         15. Donated blood or blood products or experienced significant blood loss within 90 days&#xD;
             prior to study drug administration.&#xD;
&#xD;
         16. Intends to conceive at any time during the study.&#xD;
&#xD;
         17. Donated bone marrow within 6 months prior to study drug administration.&#xD;
&#xD;
         18. Has participated in a previous investigational study or received treatment with an&#xD;
             investigational product within 30 days of screening.&#xD;
&#xD;
         19. Has a diagnosis of, is undergoing therapy for, or has received therapy for a&#xD;
             hematologic malignancy in the 5 years prior to screening.&#xD;
&#xD;
         20. Has a history of substance abuse or is taking any substance of abuse (Note:&#xD;
             participants on a stable dose of any medications that have been prescribed by a&#xD;
             healthcare practitioner for a properly documented medical condition are exempt).&#xD;
&#xD;
         21. Abnormal electrocardiogram (ECG) (QT prolongation with QTc ≥450 milliseconds).&#xD;
&#xD;
         22. Has evidence of abnormalities on physical examination, vital signs, ECG, or clinical&#xD;
             lab values, unless judged to be clinically insignificant by the investigator&#xD;
&#xD;
         23. Has any other condition that might indicate the participant to be unsuitable for the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Kang</last_name>
    <role>Study Director</role>
    <affiliation>Endo Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #8</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #22</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #15</name>
      <address>
        <city>North Little Rock</city>
        <state>Arkansas</state>
        <zip>72116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #32</name>
      <address>
        <city>Bell Gardens</city>
        <state>California</state>
        <zip>90201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #33</name>
      <address>
        <city>Canoga Park</city>
        <state>California</state>
        <zip>91304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #30</name>
      <address>
        <city>Beverly Hills</city>
        <state>Florida</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #12</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #34</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #29</name>
      <address>
        <city>Fleming Island</city>
        <state>Florida</state>
        <zip>32003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #10</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #18</name>
      <address>
        <city>Miami Gardens</city>
        <state>Florida</state>
        <zip>33023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #26</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #2</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #28</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33183</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #3</name>
      <address>
        <city>Oviedo</city>
        <state>Florida</state>
        <zip>32765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #4</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #11</name>
      <address>
        <city>Pompano Beach</city>
        <state>Florida</state>
        <zip>33060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #23</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #16</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #27</name>
      <address>
        <city>Glen Burnie</city>
        <state>Maryland</state>
        <zip>21061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #17</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #35</name>
      <address>
        <city>East Orange</city>
        <state>New Jersey</state>
        <zip>07018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #9</name>
      <address>
        <city>Garden City</city>
        <state>New York</state>
        <zip>11530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #7</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #25</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #5</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #13</name>
      <address>
        <city>Bala-Cynwyd</city>
        <state>Pennsylvania</state>
        <zip>19004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #19</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #31</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #20</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77087</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #21</name>
      <address>
        <city>Missouri City</city>
        <state>Texas</state>
        <zip>77459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #1</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #14</name>
      <address>
        <city>Rutland</city>
        <state>Vermont</state>
        <zip>05701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #6</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #24</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 27, 2023</last_update_submitted>
  <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</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>
    <mesh_term>Eunuchism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methyltestosterone</mesh_term>
    <mesh_term>Testosterone</mesh_term>
    <mesh_term>Testosterone undecanoate</mesh_term>
    <mesh_term>Testosterone enanthate</mesh_term>
    <mesh_term>Testosterone 17 beta-cypionate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04456296
org study id: EN3000-101
nct id: NCT04456296
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Testosterone is the principal androgen produced by the male testes. Hypogonadism is the
      result of inadequate production of testosterone by the Leydig cells of the testes and is
      reflected by total serum concentrations of testosterone of < 300 nanograms (ng)/deciliters
      (dL), with discernible diurnal pattern. The etiology of hypogonadism may be primary or
      secondary. The treatment of males with primary, and in some cases, secondary hypogonadism
      includes administration of testosterone.

      Testim® and Fortesta® are topical gels that when applied daily help to increase the total
      testosterone levels in the blood through skin absorption. Aveed® is an injectable form of
      testosterone treatment and participants randomized to this treatment arm will receive 3
      injections over the course of 16 weeks.

      This study is designed to evaluate the effect on blood pressure of approved testosterone
      products (Testim®, Fortesta®, and Aveed®) after 16 weeks of therapy using 24-hour ambulatory
      blood pressure to reveal shifts in blood pressure levels.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline in 24-Hour Average Systolic Ambulatory Blood Pressure
time frame: Baseline (Day 1), Week 16
measure: Change from Baseline in 24-Hour Average Arterial Pressure
time frame: Baseline (Day 1), Week 16
measure: Change from Baseline in 24-Hour Average Systolic Blood Pressure
time frame: Baseline (Day 1), Week 16
measure: Change from Baseline in 24-Hour Average Diastolic Blood Pressure
time frame: Baseline (Day 1), Week 16
measure: Change from Baseline in 24-Hour Average Heart Rate
time frame: Baseline (Day 1), Week 16
measure: Change from Baseline in 24-Hour Average Pulse Pressure
time frame: Baseline (Day 1), Week 16
measure: Percent of Participants Taking New Antihypertensive Medications
time frame: Week 16
measure: Percent of Participants with Dose Increases From Baseline in Antihypertensive Medications
time frame: Week 16
arm group label: AVEED (Testosterone Undecanoate Injection)
arm group type: Active Comparator
description: Fixed dosage level of 750 milligrams (mg)/3 milliliters (mL) administered by intramuscular injections.
arm group label: FORTESTA (Testosterone Gel)
arm group type: Active Comparator
description: 40 mg once daily topical gel administration.
arm group label: TESTIM (Testosterone Gel)
arm group type: Active Comparator
description: 50 mg once daily topical gel administration.
intervention type: Drug
intervention name: Aveed Injectable Product
description: Testosterone undecanoate administered by intramuscular injections.
arm group label: AVEED (Testosterone Undecanoate Injection)
other name: Testosterone undecanoate
intervention type: Drug
intervention name: Fortesta
description: Testosterone gel administered topically. The daily dose of the study drug will be titrated for each participant, according to approved dosage and administration instructions, until the circulating testosterone concentrations of the participant reaches normal concentrations (300-1000 ng/dL).
arm group label: FORTESTA (Testosterone Gel)
other name: Testosterone gel
intervention type: Drug
intervention name: Testim
description: Testosterone gel administered topically. The daily dose of the study drug will be titrated for each participant, according to approved dosage and administration instructions, until the circulating testosterone concentrations of the participant reaches normal concentrations (300-1000 ng/dL).
arm group label: TESTIM (Testosterone Gel)
other name: Testosterone gel
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karen Kang
role: Study Director
affiliation: Endo Pharmaceuticals
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country: United States
responsible party type: Sponsor
mesh term: Hypogonadism
mesh term: Eunuchism
mesh term: Methyltestosterone
mesh term: Testosterone
mesh term: Testosterone undecanoate
mesh term: Testosterone enanthate
mesh term: Testosterone 17 beta-cypionate
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)