<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/NCT03242408</url>
  </required_header>
  <id_info>
    <org_study_id>LPCN 1021-16-003</org_study_id>
    <nct_id>NCT03242408</nct_id>
  </id_info>
  <brief_title>Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021)</brief_title>
  <acronym>DF</acronym>
  <official_title>Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lipocine Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lipocine Inc.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021&#xD;
      in adult hypogonadal male subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range</measure>
    <time_frame>Following 24 days of treatment</time_frame>
    <description>Safety Set; Proportion of LPCN 1021-treated subjects who achieve a total testosterone average concentration [Cavg] in the normal range</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Hypogonadism, Male</condition>
  <arm_group>
    <arm_group_label>Oral testosterone undecanoate, LPCN 1021</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LPCN 1021</intervention_name>
    <description>Oral testosterone undecanoate</description>
    <arm_group_label>Oral testosterone undecanoate, LPCN 1021</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Serum total T below 300 ng/dL based on 2 consecutive blood samples obtained between 6&#xD;
             and 10 AM, on two separate days at approximately the same time of day, following an&#xD;
             appropriate washout of current androgen replacement therapy.&#xD;
&#xD;
          2. Subjects should be diagnosed to be primary (congenital or acquired) or secondary&#xD;
             hypogonadal (congenital or acquired).&#xD;
&#xD;
          3. Naïve to androgen replacement or has discontinued current treatment and completed&#xD;
             adequate washout of prior androgen therapy. Washout must be completed prior to&#xD;
             collection of baseline serum T samples to determine study eligibility.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of significant sensitivity or allergy to androgens, or product excipients.&#xD;
&#xD;
          2. Clinically significant findings in the pre-study examinations including abnormal&#xD;
             breast examination requiring follow-up.&#xD;
&#xD;
          3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s).&#xD;
&#xD;
          4. Subjects with symptoms of moderate to severe benign prostatic hyperplasia.&#xD;
&#xD;
          5. Clinically significant abnormal laboratory value, in the opinion of the investigator,&#xD;
             in serum chemistry, hematology, or urinalysis&#xD;
&#xD;
          6. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B&#xD;
             surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human&#xD;
             immunodeficiency virus antibodies (HIV Ab).&#xD;
&#xD;
          7. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical&#xD;
             procedure that might interfere with gastrointestinal motility, pH or absorption.&#xD;
&#xD;
          8. History of any clinically significant illness, infection, or surgical procedure within&#xD;
             1 month prior to study drug administration.&#xD;
&#xD;
          9. History of stroke or myocardial infarction within the past 5 years.&#xD;
&#xD;
         10. History of or current or suspected prostate or breast cancer.&#xD;
&#xD;
         11. History of untreated and severe obstructive sleep apnea.&#xD;
&#xD;
         12. History of long QT syndrome (QTc &gt; 450) or unexplained sudden death in a first degree&#xD;
             relative (parent, sibling, or child).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony DelConte, MD</last_name>
    <role>Study Director</role>
    <affiliation>Lipocine Inc.</affiliation>
  </overall_official>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <results_first_submitted>August 16, 2019</results_first_submitted>
  <results_first_submitted_qc>August 16, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 11, 2019</results_first_posted>
  <last_update_submitted>October 11, 2019</last_update_submitted>
  <last_update_submitted_qc>October 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2019</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 17 beta-cypionate</mesh_term>
    <mesh_term>Testosterone</mesh_term>
    <mesh_term>Testosterone undecanoate</mesh_term>
    <mesh_term>Testosterone enanthate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 7, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03242408/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Oral Testosterone Undecanoate, LPCN 1021</title>
          <description>Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day&#xD;
LPCN 1021: Oral testosterone undecanoate</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Oral Testosterone Undecanoate, LPCN 1021</title>
          <description>Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day&#xD;
LPCN 1021: Oral testosterone undecanoate</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.1" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Testosterone Value (ng/dL)</title>
          <units>ng/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="189" spread="72.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range</title>
        <description>Safety Set; Proportion of LPCN 1021-treated subjects who achieve a total testosterone average concentration [Cavg] in the normal range</description>
        <time_frame>Following 24 days of treatment</time_frame>
        <population>Safety Set</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Testosterone Undecanoate, LPCN 1021</title>
            <description>Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day&#xD;
LPCN 1021: Oral testosterone undecanoate</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range</title>
          <description>Safety Set; Proportion of LPCN 1021-treated subjects who achieve a total testosterone average concentration [Cavg] in the normal range</description>
          <population>Safety Set</population>
          <units>Percent of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69" lower_limit="60" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Oral Testosterone Undecanoate, LPCN 1021</title>
          <description>Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day&#xD;
LPCN 1021: Oral testosterone undecanoate</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="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Tooth Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Edema Peripheral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin Ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Nachiappan Chidambaram, Vice President, Product Development</name_or_title>
      <organization>Lipocine, INC.</organization>
      <phone>8018819495</phone>
      <email>nc@lipocine.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/NCT03242408
org study id: LPCN 1021-16-003
nct id: NCT03242408
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021
      in adult hypogonadal male subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range
time frame: Following 24 days of treatment
description: Safety Set; Proportion of LPCN 1021-treated subjects who achieve a total testosterone average concentration [Cavg] in the normal range
arm group label: Oral testosterone undecanoate, LPCN 1021
arm group type: Experimental
description: Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day
intervention type: Drug
intervention name: LPCN 1021
description: Oral testosterone undecanoate
arm group label: Oral testosterone undecanoate, LPCN 1021
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Anthony DelConte, MD
role: Study Director
affiliation: Lipocine Inc.
responsible party type: Sponsor
mesh term: Hypogonadism
mesh term: Eunuchism
mesh term: Methyltestosterone
mesh term: Testosterone 17 beta-cypionate
mesh term: Testosterone
mesh term: Testosterone undecanoate
mesh term: Testosterone enanthate
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 