<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/NCT03792477</url>
  </required_header>
  <id_info>
    <org_study_id>B5341002</org_study_id>
    <secondary_id>DEPO-T BE STUDY</secondary_id>
    <nct_id>NCT03792477</nct_id>
  </id_info>
  <brief_title>A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males</brief_title>
  <official_title>A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-TREATMENT SINGLE-DOSE, CROSS-OVER STUDY, 2-PART DESIGN TO EVALUATE THE BIOEQUIVALENCE AND TOLERABILITY OF TESTOSTERONE CYPIONATE FOLLOWING INTRAMUSCULAR (IM) INJECTION IN HEALTHY HYPOGONADAL MALE SUBJECTS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</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>
      This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study,&#xD;
      2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of&#xD;
      testosterone cypionate solution for injection relative to the currently approved marked&#xD;
      formulation (reference). In the first part of the study (Part 1), an estimate of the exposure&#xD;
      variability will be evaluated for both test and reference. This will help guide sample size&#xD;
      in Part 2. Part 2 will be powered to assess the BE of both test and reference formulations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2019</start_date>
  <completion_date type="Actual">April 2, 2020</completion_date>
  <primary_completion_date type="Actual">April 2, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>This is an open-label, randomized, 2-treatment, 2-period, single dose (200 mg), cross-over study, 2-part design to evaluate the bioequivalence and tolerability of a reformulated presentation of testosterone cypionate relative to a currently marketed and approved formulation</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Corrected Area Under The Serum Concentration-time Profile From Time 0 to The Last Quantifiable Concentration (AUClast) of Total Testosterone (Part 1).</measure>
    <time_frame>At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.</time_frame>
    <description>The AUClast of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Corrected AUC From Tme 0 Extrapolated to Infinite Time (AUCinf) of Total Testosterone (Part 1).</measure>
    <time_frame>At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.</time_frame>
    <description>The AUCinf of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Corrected Maximum Observed Concentration (Cmax) of Total Testosterone (Part 1).</measure>
    <time_frame>At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.</time_frame>
    <description>The Cmax of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Corrected AUClast of Total Testosterone (Part 2).</measure>
    <time_frame>At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.</time_frame>
    <description>The AUClast of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Corrected AUCinf of Total Testosterone (Part 2).</measure>
    <time_frame>At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.</time_frame>
    <description>The AUCinf of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Corrected Cmax of Total Testosterone (Part 2)</measure>
    <time_frame>At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.</time_frame>
    <description>The Cmax of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Hypogonadism</condition>
  <arm_group>
    <arm_group_label>Part 1: Treatment A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single 200mg IM testosterone cypionate solution (Test formulation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Treatment B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single 200 mg IM testosterone cypionate solution (Reference formulation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Treatment A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single 200 mg IM testosterone cypionate solution (Test formulation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Treatment B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single 200 mg IM testosterone cypionate solution (Reference formulation)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Test formulation</intervention_name>
    <description>A single testosterone cypionate solution for injection (new formulation) 200 mg dose administered IM deep in the gluteal muscle (Test formulation).</description>
    <arm_group_label>Part 1: Treatment A</arm_group_label>
    <arm_group_label>Part 2: Treatment A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Reference formulation</intervention_name>
    <description>A single testosterone cypionate solution for injection (currently marketed formulation) 200 mg dose administered IM deep in the gluteal muscle (Reference formulation).</description>
    <arm_group_label>Part 1: Treatment B</arm_group_label>
    <arm_group_label>Part 2: Treatment B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hypogonadal male subjects who, at the time of screening, are otherwise healthy and&#xD;
             between the ages of 18 and 65 years, inclusive. Healthy is defined as no clinically&#xD;
             relevant abnormalities identified by a detailed medical history, full physical&#xD;
             examination, including blood pressure (BP) and pulse rate measurement, 12 lead&#xD;
             electrocardiogram (ECG), or clinical laboratory tests.&#xD;
&#xD;
             Hypogonadism is defined as serum testosterone levels below 2.5 ng/mL (250 ng/dL).&#xD;
&#xD;
          2. Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight &gt;50 kg (110 lb).&#xD;
&#xD;
          3. Evidence of a personally signed and dated informed consent document indicating that&#xD;
             the subject has been informed of all pertinent aspects of the study.&#xD;
&#xD;
          4. Subjects who are willing and able to comply with all scheduled visits, treatment plan,&#xD;
             laboratory tests, and other study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or&#xD;
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,&#xD;
             seasonal allergies at the time of dosing).&#xD;
&#xD;
          2. Subjects who are currently being treated for hypogonadism. This is defined as either&#xD;
             patients who have received a testosterone injectable product within the past 3 months&#xD;
             or have used a transdermal or gel product within the past 2 weeks.&#xD;
&#xD;
          3. A positive urine drug test.&#xD;
&#xD;
          4. History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces&#xD;
             [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor)&#xD;
             within 6 months before screening.&#xD;
&#xD;
          5. Treatment with an investigational drug within 30 days (or as determined by the local&#xD;
             requirement) or 5 half lives preceding the first dose of investigational product&#xD;
             (whichever is longer).&#xD;
&#xD;
          6. Screening supine BP greater than or equal to 140 mm Hg (systolic) or greater than or&#xD;
             equal to 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is&#xD;
             greater than or equal to 140 mm Hg (systolic) or greater than or equal to 90 mm Hg&#xD;
             (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values&#xD;
             should be used to determine the subject's eligibility.&#xD;
&#xD;
          7. Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval &gt;450 msec or&#xD;
             a QRS interval &gt;120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG&#xD;
             should be repeated 2 more times and the average of the 3 QTc or QRS values should be&#xD;
             used to determine the subject's eligibility.&#xD;
&#xD;
          8. Subjects with ANY of the following abnormalities in clinical laboratory tests at&#xD;
             screening, as assessed by the study-specific laboratory and confirmed by a single&#xD;
             repeat test, if deemed necessary:&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level greater&#xD;
                  than or equal to 3 times the upper limit of normal (ULN).&#xD;
&#xD;
               -  Total bilirubin level greater than or equal to 1.5 times the ULN; subject with a&#xD;
                  history of Gilbert's syndrome may have direct bilirubin measured and would be&#xD;
                  eligible for this study provided the direct bilirubin level is less than or equal&#xD;
                  to ULN.&#xD;
&#xD;
          9. Fertile male subjects who are unwilling or unable to use a highly effective method of&#xD;
             contraception as outlined in this protocol [Contraception (Section 4.3.4)] for the&#xD;
             duration of the study and for at least 45 days after the last dose of investigational&#xD;
             product.&#xD;
&#xD;
         10. Use of prescription or nonprescription drugs and dietary supplements within 7 days or&#xD;
             5 half lives (whichever is longer) prior to the first dose of investigational product.&#xD;
             As an exception, acetaminophen/paracetamol may be used at doses of greater than or&#xD;
             equal to 1 g/day. Limited use of nonprescription medications that are not believed to&#xD;
             affect subject safety or the overall results of the study may be permitted on a case&#xD;
             by case basis following approval by the sponsor.&#xD;
&#xD;
         11. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more&#xD;
             within 56 days prior to dosing.&#xD;
&#xD;
         12. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive&#xD;
             testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody&#xD;
             (HepBcAb), or hepatitis C antibody (HCVAb).&#xD;
&#xD;
         13. History of sensitivity to heparin or heparin induced thrombocytopenia.&#xD;
&#xD;
         14. Unwilling or unable to comply with the criteria in the Lifestyle Requirements section&#xD;
             of this protocol.&#xD;
&#xD;
         15. Subjects who are investigator site staff members directly involved in the conduct of&#xD;
             the study and their family members, site staff members otherwise supervised by the&#xD;
             investigator, or subjects who are Pfizer employees, including their family members,&#xD;
             directly involved in the conduct of the study.&#xD;
&#xD;
         16. Other acute or chronic medical or psychiatric condition including recent (within the&#xD;
             past year) or active suicidal ideation or behavior or laboratory abnormality that may&#xD;
             increase the risk associated with study participation or investigational product&#xD;
             administration or may interfere with the interpretation of study results and, in the&#xD;
             judgment of the investigator, would make the subject inappropriate for entry into this&#xD;
             study.&#xD;
&#xD;
         17. Subjects with carcinoma of the breast.&#xD;
&#xD;
         18. Subjects with known or suspected carcinoma of the prostate gland.&#xD;
&#xD;
         19. Subjects who are hypersensitive to testosterone cypionate or its inactive ingredients.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Avail Clinical Research</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Syneos Health</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=B5341002</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <results_first_submitted>April 2, 2021</results_first_submitted>
  <results_first_submitted_qc>April 2, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 29, 2021</results_first_posted>
  <last_update_submitted>April 2, 2021</last_update_submitted>
  <last_update_submitted_qc>April 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT03792477/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT03792477/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>There were 2 parts in the study, different participants were enrolled into the 2 individual parts.</recruitment_details>
      <pre_assignment_details>This study was a multi-period crossover study. In Part 1, there were 2 treatment periods with a washout period of 45 days. In Part 2, there were 3 treatment periods with 2 washout periods of 45 days each.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1: Treatment A&gt;Treatment B</title>
          <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (intramuscular [IM]) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 1, where participants received the treatments in the order of A, B.</description>
        </group>
        <group group_id="P2">
          <title>Part 1: Treatment B&gt;Treatment A</title>
          <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 2, where participants received the treatments in the order of B, A.</description>
        </group>
        <group group_id="P3">
          <title>Part 2: Treatment A&gt;Treatment B&gt;Treatment B</title>
          <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 1, where participants received the treatments in the order of A, B, B.</description>
        </group>
        <group group_id="P4">
          <title>Part 2: Treatment B&gt;Treatment A&gt;Treatment B</title>
          <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 2, where participants received the treatments in the order of B, A, B.</description>
        </group>
        <group group_id="P5">
          <title>Part 2: Treatment B&gt;Treatment B&gt;Treatment A</title>
          <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 3, where participants received the treatments in the order of B, B, A.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="21"/>
                <participants group_id="P5" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="20"/>
                <participants group_id="P5" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline analysis population included all participants enrolled in the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Part 1: Treatment A&gt;Treatment B</title>
          <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 1, where participants received the treatments in the order of A, B.</description>
        </group>
        <group group_id="B2">
          <title>Part 1: Treatment B&gt;Treatment A</title>
          <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 2, where participants received the treatments in the order of B, A.</description>
        </group>
        <group group_id="B3">
          <title>Part 2: Treatment A&gt;Treatment B&gt;Treatment B</title>
          <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 1, where participants received the treatments in the order of A, B, B.</description>
        </group>
        <group group_id="B4">
          <title>Part 2: Treatment B&gt;Treatment A&gt;Treatment B</title>
          <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 2, where participants received the treatments in the order of B, A, B.</description>
        </group>
        <group group_id="B5">
          <title>Part 2: Treatment B&gt;Treatment B&gt;Treatment A</title>
          <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 3, where participants received the treatments in the order of B, B, A.</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="21"/>
            <count group_id="B4" value="21"/>
            <count group_id="B5" value="20"/>
            <count group_id="B6" value="74"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;18 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18-45 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45-65 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="15"/>
                    <measurement group_id="B6" value="62"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="20"/>
                    <measurement group_id="B6" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Corrected Area Under The Serum Concentration-time Profile From Time 0 to The Last Quantifiable Concentration (AUClast) of Total Testosterone (Part 1).</title>
        <description>The AUClast of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
        <time_frame>At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.</time_frame>
        <population>The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.</description>
          </group>
        </group_list>
        <measure>
          <title>Corrected Area Under The Serum Concentration-time Profile From Time 0 to The Last Quantifiable Concentration (AUClast) of Total Testosterone (Part 1).</title>
          <description>The AUClast of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
          <population>The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.</population>
          <units>nanogram*hour per milliliter (ng*hr/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1444" spread="62"/>
                    <measurement group_id="O2" value="1362" spread="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Corrected AUC From Tme 0 Extrapolated to Infinite Time (AUCinf) of Total Testosterone (Part 1).</title>
        <description>The AUCinf of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
        <time_frame>At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.</time_frame>
        <population>The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.</description>
          </group>
        </group_list>
        <measure>
          <title>Corrected AUC From Tme 0 Extrapolated to Infinite Time (AUCinf) of Total Testosterone (Part 1).</title>
          <description>The AUCinf of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
          <population>The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1424" spread="66"/>
                    <measurement group_id="O2" value="1392" spread="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Corrected Maximum Observed Concentration (Cmax) of Total Testosterone (Part 1).</title>
        <description>The Cmax of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
        <time_frame>At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.</time_frame>
        <population>The analysis population included all participants randomized and treated who had at least 1 concentration in at least 1 treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.</description>
          </group>
        </group_list>
        <measure>
          <title>Corrected Maximum Observed Concentration (Cmax) of Total Testosterone (Part 1).</title>
          <description>The Cmax of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
          <population>The analysis population included all participants randomized and treated who had at least 1 concentration in at least 1 treatment period.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.834" spread="58"/>
                    <measurement group_id="O2" value="8.193" spread="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Corrected AUClast of Total Testosterone (Part 2).</title>
        <description>The AUClast of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
        <time_frame>At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.</time_frame>
        <population>The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.</description>
          </group>
        </group_list>
        <measure>
          <title>Corrected AUClast of Total Testosterone (Part 2).</title>
          <description>The AUClast of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
          <population>The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1251" spread="59"/>
                    <measurement group_id="O2" value="1384" spread="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Corrected AUCinf of Total Testosterone (Part 2).</title>
        <description>The AUCinf of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
        <time_frame>At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.</time_frame>
        <population>The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.</description>
          </group>
        </group_list>
        <measure>
          <title>Corrected AUCinf of Total Testosterone (Part 2).</title>
          <description>The AUCinf of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
          <population>The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1459" spread="44"/>
                    <measurement group_id="O2" value="1493" spread="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Corrected Cmax of Total Testosterone (Part 2)</title>
        <description>The Cmax of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
        <time_frame>At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.</time_frame>
        <population>The analysis population included all participants randomized and treated who had at least 1 concentration in at least 1 treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.</description>
          </group>
        </group_list>
        <measure>
          <title>Corrected Cmax of Total Testosterone (Part 2)</title>
          <description>The Cmax of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.</description>
          <population>The analysis population included all participants randomized and treated who had at least 1 concentration in at least 1 treatment period.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.891" spread="61"/>
                    <measurement group_id="O2" value="9.207" spread="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the signing of informed consent through and including a minimum of 28 calendar days and up to 35 calendar days after the last administration of the investigational product.</time_frame>
      <desc>Serious adverse events (SAEs) and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial (CT) SAE report form to Pfizer Safety within 24 hours of awareness.</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment A (Parts 1 and 2)</title>
          <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This group included the participants enrolled in both Part 1 and Part 2 of the study.</description>
        </group>
        <group group_id="E2">
          <title>Treatment B (Parts 1 and 2)</title>
          <description>This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This group included the participants enrolled in both Part 1 and Part 2 of the study.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA v23.0</default_vocab>
        <default_assessment>Non-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="7" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Lip disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Skin Abrasion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc.</organization>
      <phone>18007181021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT03792477
org study id: B5341002
secondary id: DEPO-T BE STUDY
nct id: NCT03792477
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study,
      2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of
      testosterone cypionate solution for injection relative to the currently approved marked
      formulation (reference). In the first part of the study (Part 1), an estimate of the exposure
      variability will be evaluated for both test and reference. This will help guide sample size
      in Part 2. Part 2 will be powered to assess the BE of both test and reference formulations.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This is an open-label, randomized, 2-treatment, 2-period, single dose (200 mg), cross-over study, 2-part design to evaluate the bioequivalence and tolerability of a reformulated presentation of testosterone cypionate relative to a currently marketed and approved formulation
primary purpose: Other
masking: None (Open Label)
measure: Corrected Area Under The Serum Concentration-time Profile From Time 0 to The Last Quantifiable Concentration (AUClast) of Total Testosterone (Part 1).
time frame: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
description: The AUClast of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
measure: Corrected AUC From Tme 0 Extrapolated to Infinite Time (AUCinf) of Total Testosterone (Part 1).
time frame: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
description: The AUCinf of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
measure: Corrected Maximum Observed Concentration (Cmax) of Total Testosterone (Part 1).
time frame: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
description: The Cmax of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
measure: Corrected AUClast of Total Testosterone (Part 2).
time frame: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
description: The AUClast of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
measure: Corrected AUCinf of Total Testosterone (Part 2).
time frame: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
description: The AUCinf of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
measure: Corrected Cmax of Total Testosterone (Part 2)
time frame: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
description: The Cmax of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
arm group label: Part 1: Treatment A
arm group type: Experimental
description: Single 200mg IM testosterone cypionate solution (Test formulation)
arm group label: Part 1: Treatment B
arm group type: Active Comparator
description: Single 200 mg IM testosterone cypionate solution (Reference formulation)
arm group label: Part 2: Treatment A
arm group type: Experimental
description: Single 200 mg IM testosterone cypionate solution (Test formulation)
arm group label: Part 2: Treatment B
arm group type: Active Comparator
description: Single 200 mg IM testosterone cypionate solution (Reference formulation)
intervention type: Biological
intervention name: Test formulation
description: A single testosterone cypionate solution for injection (new formulation) 200 mg dose administered IM deep in the gluteal muscle (Test formulation).
arm group label: Part 1: Treatment A
arm group label: Part 2: Treatment A
intervention type: Biological
intervention name: Reference formulation
description: A single testosterone cypionate solution for injection (currently marketed formulation) 200 mg dose administered IM deep in the gluteal muscle (Reference formulation).
arm group label: Part 1: Treatment B
arm group label: Part 2: Treatment B
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=B5341002
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Hypogonadism
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 