<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/NCT02232425</url>
  </required_header>
  <id_info>
    <org_study_id>IX-0103</org_study_id>
    <nct_id>NCT02232425</nct_id>
  </id_info>
  <brief_title>IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)</brief_title>
  <official_title>An 8-Week, Double-Blind, Placebo-Controlled Parallel Group Study to Evaluate the Effect of IX-01 on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Lifelong Premature Ejaculation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ixchelsis Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Carelon Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Novotech (Australia) Pty Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>ICON plc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>PHT Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ixchelsis Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong&#xD;
      premature ejaculation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)</measure>
    <time_frame>Last 4 weeks of treatment compared to baseline</time_frame>
    <description>IX-01 versus placebo. Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale</measure>
    <time_frame>Baseline to the end of treatment (approximately 8 weeks)</time_frame>
    <description>7 point scale ranging from much worse (-3) to much better (3). The proportion refers to the proportion of patients who had the best 2 possible responses [better(2) or much better (3)] on this 7 point scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)</measure>
    <time_frame>Last 4 weeks of treatment compared to baseline</time_frame>
    <description>Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred. Outcome measured proportion of patients with at least a 2.5-fold increase in geometric mean IELT over the last 4 weeks of treatment as compared to baseline. Proportion of participants adjusted for baseline IELT, country and site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)</measure>
    <time_frame>Last 4 weeks of treatment compared to baseline</time_frame>
    <description>IX-01 versus placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Score on Control of Timing of Ejaculation</measure>
    <time_frame>Last 4 weeks of treatment compared to baseline</time_frame>
    <description>Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP question on control of timing is scored on a 5 point scale with the scores ranging from very poor (this is the worst answer) scored as 0 to very good (this is the best answer scored as 4)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Score on Ejaculation-related Personal Distress</measure>
    <time_frame>Last 4 weeks of treatment compared to baseline</time_frame>
    <description>Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With ≥ 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Based on Premature Ejaculation Profile (PEP) 5 point scale with the scores ranging from 0 (worse answer) to 4 (best answer).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With ≥ 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With ≥ 2 Category Increase in Control and ≥ 1 Category Decrease in Personal Distress on a Patient Reported Outcome (PRO) Measure</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Each of the PEP questions is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percentage of Intercourse Attempts Lasting Longer Than 1 Minute From Baseline to Last 4 Weeks on Treatment</measure>
    <time_frame>Baseline to last 4 weeks on treatment</time_frame>
    <description>'Baseline' time period defined as Day -28 - Day 0. 'Last 4 Weeks' time period defined as the 28 days prior to last time subject took study drug and after Day 14.&#xD;
Analysis excludes two subjects from ITT population: #010-012 (placebo) and #888-018 (active). Adjusted for treatment, baseline IELT, baseline percentage, country and site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-emergent Adverse Events</measure>
    <time_frame>Start of Treatment to end of study (approximately 10 weeks)</time_frame>
    <description>Number of participants with at least one treatment-emergent adverse event</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Premature Ejaculation</condition>
  <arm_group>
    <arm_group_label>Drug: IX-01</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IX-01</intervention_name>
    <arm_group_label>Drug: IX-01</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In stable (≥ 6 months) heterosexual relationship&#xD;
&#xD;
          -  Have life-long (primary) premature ejaculation&#xD;
&#xD;
          -  Have premature ejaculation confirmed by Intravaginal Ejaculatory Latency Time (IELT)&#xD;
             less than or equal to (≤) 1 minute on ≥ 75% attempts at sexual intercourse&#xD;
&#xD;
          -  Meet other aspects of the International Society for Sexual Medicine (ISSM) definition&#xD;
             for lifelong premature ejaculation (PE), including inability to delay ejaculation on&#xD;
             all or nearly all vaginal penetrations and negative personal consequences such as&#xD;
             distress, bother and frustration&#xD;
&#xD;
          -  Willing to attempt intercourse at least 4 times during run-in period and at least 8&#xD;
             more times during double-blind part of the study&#xD;
&#xD;
          -  Not planning pregnancy with his partner and he is willing to use contraception (unless&#xD;
             not of child-bearing potential, e.g., surgically sterilised)&#xD;
&#xD;
          -  Willing to limit use of alcohol on days in which they take study drug (not more than&#xD;
             three drinks, where one drink is defined as a 12 ounce (oz), 360 milliliter (mL)&#xD;
             bottle of beer, a 5 oz (150 mL) glass of wine, or a 1½ oz (45 mL distilled spirits)&#xD;
&#xD;
          -  Capable of giving written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An Intravaginal Ejaculatory Latency Time (IELT) value ≥ 2 minutes during run-in period&#xD;
&#xD;
          -  Less than (&lt;) 4 attempts at sexual intercourse during run-in (screening may be&#xD;
             extended or patient may be rescreened if there are extenuating circumstances)&#xD;
&#xD;
          -  A rating of control of ejaculation as fair, good, or very good on the Premature&#xD;
             Ejaculation Profile (PEP) questionnaire prior to study&#xD;
&#xD;
          -  Co-existing Erectile Dysfunction - International Index of Erectile Dysfunction (IIEF)&#xD;
             erectile function domain &lt; 22 during run-in&#xD;
&#xD;
          -  Concomitant use of Phosphodiesterase 5 (PDE5) inhibitors, intracavernosal injections,&#xD;
             penile implants, Selective Serotonin Reuptake Inhibitors (SSRI's) or&#xD;
             Serotonin-Norepinephrine Reuptake Inhibitors (SSNRI's), tricyclic antidepressants (for&#xD;
             example (e.g.) clomipramine), monoamine oxidase inhibitors, alpha blockers, 5 alpha&#xD;
             reductase inhibitors (including propecia for hair loss), topical anaesthetics, and/or&#xD;
             tramadol&#xD;
&#xD;
          -  History (last 6 months) of use of Botox or similar product to treat premature&#xD;
             ejaculation&#xD;
&#xD;
          -  Unwilling to stop other treatments for premature ejaculation (including but not&#xD;
             limited to pharmacological, herbal, multiple condoms, psychosexual treatment, prior&#xD;
             masturbation)&#xD;
&#xD;
          -  Other sexual disorder of patient or partner that could interfere with results&#xD;
&#xD;
          -  Current active sexually transmitted disease&#xD;
&#xD;
          -  Major medical condition of patient that could interfere with ability to have sexual&#xD;
             activity and or require hospital treatment&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt; 40 kg/m2&#xD;
&#xD;
          -  Participation in a clinical drug trial anytime during the 30 days prior to screening&#xD;
&#xD;
          -  Human Immunodeficiency Virus (HIV) or hepatitis B&#xD;
&#xD;
          -  History of clinically significant prostate disease&#xD;
&#xD;
          -  History of myocardial infarction, coronary bypass surgery, coronary artery&#xD;
             angioplasty, unstable angina, clinically evident congestive heart failure, cardiac&#xD;
             pacemaker, or cerebrovascular accident&#xD;
&#xD;
          -  Cardiac arrhythmia: significant cardiac arrhythmia shown on Electrocardiogram (ECG),&#xD;
             or a known or suspected history of significant cardiac arrhythmias within last six&#xD;
             months&#xD;
&#xD;
          -  History of congenital QT prolongation and/ corrected QT (QTc) interval &gt; 450&#xD;
             milliseconds (msec) using the Bazett formula&#xD;
&#xD;
          -  Mean systolic cuff blood pressure (BP) &gt; 140 millimeter of mercury (mmHg), as assessed&#xD;
             by up to three measurements taken in sequence within 5-10 minutes of last measure&#xD;
&#xD;
          -  Mean diastolic cuff BP &gt; 90 mmHg, as assessed by up to three measurements taken in&#xD;
             sequence within 5-10 minutes of the last measure&#xD;
&#xD;
          -  Major psychiatric disease or risk of suicidal tendency as assessed by clinical&#xD;
             evaluation and Patient Health Questionnaire (PHQ)-9 and Columbia Suicide Assessment&#xD;
&#xD;
          -  PHQ-9 questionnaire total score &gt; 9 and/or score &gt; 0 for question 9 of PHQ-9, and/or&#xD;
             suicidal ideation or behavior as assessed by Columbia Suicide Assessment&#xD;
&#xD;
          -  Clinically significant abnormal laboratory function test results (including liver&#xD;
             enzymes &gt; 2 x Upper Limit of Normal (ULN) or bilirubin &gt; 1.5 x ULN)&#xD;
&#xD;
          -  Taking Cytochrome P450 3A4 (CYP3A4) inducers, or moderate and potent CYP3A4 inhibitors&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Email Katie.George@Ixchelsis.com</last_name>
    <role>Study Director</role>
    <affiliation>Ixchelsis Limited</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Diego Sexual Medicine</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Medical Research Inc.</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Marital and Sexual Health of South Florida</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University School of Medicine</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cooper Research Institute</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manhattan Medical Research</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urologic Consultants of Southeastern Pennsylvania</name>
      <address>
        <city>Bala-Cynwyd</city>
        <state>Pennsylvania</state>
        <zip>19004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miriam Hospital / The Men's Health Center</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Australian Centre for Sexual Health</name>
      <address>
        <city>Saint Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keogh Institute for Medical Research</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <results_first_submitted>November 1, 2018</results_first_submitted>
  <results_first_submitted_qc>January 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 24, 2019</results_first_posted>
  <disposition_first_submitted>September 21, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>September 22, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">September 23, 2016</disposition_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2020</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>Premature Birth</mesh_term>
    <mesh_term>Premature Ejaculation</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Drug: IX-01</title>
          <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Drug: IX-01</title>
          <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
        </group>
        <group group_id="B3">
          <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="58"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="88"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="42" spread="9"/>
                    <measurement group_id="B2" value="43" spread="8"/>
                    <measurement group_id="B3" value="43" spread="9"/>
                  </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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="47"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)</title>
        <description>IX-01 versus placebo. Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred</description>
        <time_frame>Last 4 weeks of treatment compared to baseline</time_frame>
        <population>Efficacy data set excluding outliers</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: IX-01</title>
            <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)</title>
          <description>IX-01 versus placebo. Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred</description>
          <population>Efficacy data set excluding outliers</population>
          <units>No units for fold change</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="1.5" upper_limit="3.1"/>
                    <measurement group_id="O2" value="1.1" lower_limit="0.7" upper_limit="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale</title>
        <description>7 point scale ranging from much worse (-3) to much better (3). The proportion refers to the proportion of patients who had the best 2 possible responses [better(2) or much better (3)] on this 7 point scale</description>
        <time_frame>Baseline to the end of treatment (approximately 8 weeks)</time_frame>
        <population>Intent to treat, excluding outliers</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: IX-01</title>
            <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale</title>
          <description>7 point scale ranging from much worse (-3) to much better (3). The proportion refers to the proportion of patients who had the best 2 possible responses [better(2) or much better (3)] on this 7 point scale</description>
          <population>Intent to treat, excluding outliers</population>
          <units>proportion of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Better/Much Better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.44"/>
                    <measurement group_id="O2" value="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)</title>
        <description>Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred. Outcome measured proportion of patients with at least a 2.5-fold increase in geometric mean IELT over the last 4 weeks of treatment as compared to baseline. Proportion of participants adjusted for baseline IELT, country and site</description>
        <time_frame>Last 4 weeks of treatment compared to baseline</time_frame>
        <population>Intent to treat, excluding outliers</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: IX-01</title>
            <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)</title>
          <description>Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred. Outcome measured proportion of patients with at least a 2.5-fold increase in geometric mean IELT over the last 4 weeks of treatment as compared to baseline. Proportion of participants adjusted for baseline IELT, country and site</description>
          <population>Intent to treat, excluding outliers</population>
          <units>Proportion 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="55"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" lower_limit="0.14" upper_limit="0.54"/>
                    <measurement group_id="O2" value="0.07" lower_limit="0.01" upper_limit="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)</title>
        <description>IX-01 versus placebo</description>
        <time_frame>Last 4 weeks of treatment compared to baseline</time_frame>
        <population>Intent to treat, excluding outliers</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: IX-01</title>
            <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)</title>
          <description>IX-01 versus placebo</description>
          <population>Intent to treat, excluding outliers</population>
          <units>No units for fold change</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="2.2" upper_limit="5.0"/>
                    <measurement group_id="O2" value="1.8" lower_limit="0.9" upper_limit="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Score on Control of Timing of Ejaculation</title>
        <description>Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP question on control of timing is scored on a 5 point scale with the scores ranging from very poor (this is the worst answer) scored as 0 to very good (this is the best answer scored as 4)</description>
        <time_frame>Last 4 weeks of treatment compared to baseline</time_frame>
        <population>Intent to treat, excluding outliers</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: IX-01</title>
            <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Score on Control of Timing of Ejaculation</title>
          <description>Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP question on control of timing is scored on a 5 point scale with the scores ranging from very poor (this is the worst answer) scored as 0 to very good (this is the best answer scored as 4)</description>
          <population>Intent to treat, excluding outliers</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" lower_limit="-0.08" upper_limit="0.93"/>
                    <measurement group_id="O2" value="-0.03" lower_limit="-0.59" upper_limit="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Score on Ejaculation-related Personal Distress</title>
        <description>Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.</description>
        <time_frame>Last 4 weeks of treatment compared to baseline</time_frame>
        <population>Intent to treat, excluding outliers</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: IX-01</title>
            <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Score on Ejaculation-related Personal Distress</title>
          <description>Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.</description>
          <population>Intent to treat, excluding outliers</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" lower_limit="0.37" upper_limit="0.88"/>
                    <measurement group_id="O2" value="0.03" lower_limit="-0.34" upper_limit="0.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With ≥ 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire</title>
        <description>Based on Premature Ejaculation Profile (PEP) 5 point scale with the scores ranging from 0 (worse answer) to 4 (best answer).</description>
        <time_frame>Baseline to 8 weeks</time_frame>
        <population>Intent to treat, excluding outliers</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: IX-01</title>
            <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With ≥ 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire</title>
          <description>Based on Premature Ejaculation Profile (PEP) 5 point scale with the scores ranging from 0 (worse answer) to 4 (best answer).</description>
          <population>Intent to treat, excluding outliers</population>
          <units>adjusted proportion 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="52"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" lower_limit="0.33" upper_limit="0.72"/>
                    <measurement group_id="O2" value="0.30" lower_limit="0.13" upper_limit="0.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With ≥ 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire</title>
        <description>Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)</description>
        <time_frame>Baseline to 8 weeks</time_frame>
        <population>Intent to treat, excluding outliers</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: IX-01</title>
            <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With ≥ 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire</title>
          <description>Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)</description>
          <population>Intent to treat, excluding outliers</population>
          <units>adjusted proportion 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="52"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" lower_limit="0.42" upper_limit="0.69"/>
                    <measurement group_id="O2" value="0.36" lower_limit="0.19" upper_limit="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire</title>
        <description>Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.</description>
        <time_frame>Baseline to 8 weeks</time_frame>
        <population>Intent to treat, excluding outliers</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: IX-01</title>
            <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire</title>
          <description>Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.</description>
          <population>Intent to treat, excluding outliers</population>
          <units>adjusted proportion 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="52"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.60" lower_limit="0.46" upper_limit="0.73"/>
                    <measurement group_id="O2" value="0.36" lower_limit="0.19" upper_limit="0.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire</title>
        <description>Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.</description>
        <time_frame>Baseline to 8 weeks</time_frame>
        <population>Intent to treat, excluding outliers</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: IX-01</title>
            <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire</title>
          <description>Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.</description>
          <population>Intent to treat, excluding outliers</population>
          <units>adjusted proportion 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="52"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.60" lower_limit="0.45" upper_limit="0.72"/>
                    <measurement group_id="O2" value="0.48" lower_limit="0.29" upper_limit="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With ≥ 2 Category Increase in Control and ≥ 1 Category Decrease in Personal Distress on a Patient Reported Outcome (PRO) Measure</title>
        <description>Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Each of the PEP questions is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)</description>
        <time_frame>Baseline to 8 weeks</time_frame>
        <population>Intent to treat, excluding outliers</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: IX-01</title>
            <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With ≥ 2 Category Increase in Control and ≥ 1 Category Decrease in Personal Distress on a Patient Reported Outcome (PRO) Measure</title>
          <description>Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Each of the PEP questions is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)</description>
          <population>Intent to treat, excluding outliers</population>
          <units>proportion of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Percentage of Intercourse Attempts Lasting Longer Than 1 Minute From Baseline to Last 4 Weeks on Treatment</title>
        <description>'Baseline' time period defined as Day -28 - Day 0. 'Last 4 Weeks' time period defined as the 28 days prior to last time subject took study drug and after Day 14.&#xD;
Analysis excludes two subjects from ITT population: #010-012 (placebo) and #888-018 (active). Adjusted for treatment, baseline IELT, baseline percentage, country and site.</description>
        <time_frame>Baseline to last 4 weeks on treatment</time_frame>
        <population>Intent to treat, excluding outliers</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: IX-01</title>
            <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Percentage of Intercourse Attempts Lasting Longer Than 1 Minute From Baseline to Last 4 Weeks on Treatment</title>
          <description>'Baseline' time period defined as Day -28 - Day 0. 'Last 4 Weeks' time period defined as the 28 days prior to last time subject took study drug and after Day 14.&#xD;
Analysis excludes two subjects from ITT population: #010-012 (placebo) and #888-018 (active). Adjusted for treatment, baseline IELT, baseline percentage, country and site.</description>
          <population>Intent to treat, excluding outliers</population>
          <units>percentage of attempts</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.6" lower_limit="17.8" upper_limit="57.3"/>
                    <measurement group_id="O2" value="13.5" lower_limit="-9.1" upper_limit="36.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Treatment-emergent Adverse Events</title>
        <description>Number of participants with at least one treatment-emergent adverse event</description>
        <time_frame>Start of Treatment to end of study (approximately 10 weeks)</time_frame>
        <population>Intent to treat, excluding outliers</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: IX-01</title>
            <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Treatment-emergent Adverse Events</title>
          <description>Number of participants with at least one treatment-emergent adverse event</description>
          <population>Intent to treat, excluding outliers</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Two patients did not take any study medication hence 56 reported and not 58</desc>
      <group_list>
        <group group_id="E1">
          <title>Drug: IX-01</title>
          <description>Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity&#xD;
IX-01</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Two to four capsules administered orally, 1-6 hours prior to sexual activity&#xD;
Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Peridontal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling jittery</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Lacerations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Laboratory test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Metabolic function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Libido decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rhinitis, allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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>Sponsor may choose to collaborate on authorship, and sponsor's agent has 60-day review</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Ixchelsis Limited</organization>
      <phone>44(0)1227-832760</phone>
      <email>ian.osterloh@ixchelsis.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/NCT02232425
org study id: IX-0103
nct id: NCT02232425
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong
      premature ejaculation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
time frame: Last 4 weeks of treatment compared to baseline
description: IX-01 versus placebo. Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred
measure: Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale
time frame: Baseline to the end of treatment (approximately 8 weeks)
description: 7 point scale ranging from much worse (-3) to much better (3). The proportion refers to the proportion of patients who had the best 2 possible responses [better(2) or much better (3)] on this 7 point scale
measure: Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)
time frame: Last 4 weeks of treatment compared to baseline
description: Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred. Outcome measured proportion of patients with at least a 2.5-fold increase in geometric mean IELT over the last 4 weeks of treatment as compared to baseline. Proportion of participants adjusted for baseline IELT, country and site
measure: Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)
time frame: Last 4 weeks of treatment compared to baseline
description: IX-01 versus placebo
measure: Mean Change in Score on Control of Timing of Ejaculation
time frame: Last 4 weeks of treatment compared to baseline
description: Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP question on control of timing is scored on a 5 point scale with the scores ranging from very poor (this is the worst answer) scored as 0 to very good (this is the best answer scored as 4)
measure: Mean Change in Score on Ejaculation-related Personal Distress
time frame: Last 4 weeks of treatment compared to baseline
description: Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.
measure: Proportion of Participants With ≥ 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire
time frame: Baseline to 8 weeks
description: Based on Premature Ejaculation Profile (PEP) 5 point scale with the scores ranging from 0 (worse answer) to 4 (best answer).
measure: Proportion of Participants With ≥ 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire
time frame: Baseline to 8 weeks
description: Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)
measure: Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire
time frame: Baseline to 8 weeks
description: Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.
measure: Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire
time frame: Baseline to 8 weeks
description: Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.
measure: Proportion of Participants With ≥ 2 Category Increase in Control and ≥ 1 Category Decrease in Personal Distress on a Patient Reported Outcome (PRO) Measure
time frame: Baseline to 8 weeks
description: Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Each of the PEP questions is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)
measure: Change in Percentage of Intercourse Attempts Lasting Longer Than 1 Minute From Baseline to Last 4 Weeks on Treatment
time frame: Baseline to last 4 weeks on treatment
description: 'Baseline' time period defined as Day -28 - Day 0. 'Last 4 Weeks' time period defined as the 28 days prior to last time subject took study drug and after Day 14.
Analysis excludes two subjects from ITT population: #010-012 (placebo) and #888-018 (active). Adjusted for treatment, baseline IELT, baseline percentage, country and site.
measure: Incidence of Treatment-emergent Adverse Events
time frame: Start of Treatment to end of study (approximately 10 weeks)
description: Number of participants with at least one treatment-emergent adverse event
arm group label: Drug: IX-01
arm group type: Experimental
description: Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity
arm group label: Placebo
arm group type: Placebo Comparator
description: Two to four capsules administered orally, 1-6 hours prior to sexual activity
intervention type: Drug
intervention name: IX-01
arm group label: Drug: IX-01
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Email Katie.George@Ixchelsis.com
role: Study Director
affiliation: Ixchelsis Limited
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: United States
responsible party type: Sponsor
mesh term: Premature Birth
mesh term: Premature Ejaculation
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 