<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/NCT01698684</url>
  </required_header>
  <id_info>
    <org_study_id>TA-501</org_study_id>
    <nct_id>NCT01698684</nct_id>
  </id_info>
  <brief_title>Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men With Erectile Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VIVUS LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VIVUS LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to examine the therapeutic effects of two doses of avanafil&#xD;
      after dosing in men with erectile dysfunction&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing</measure>
    <time_frame>Week 0 (Baseline) up to Week 8 (End of Study)</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">440</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Avanafil 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Avanafil 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>One dose 15 minutes before attempting intercourse</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Avanafil 100 mg</intervention_name>
    <description>One dose 15 minutes before attempting intercourse</description>
    <arm_group_label>Avanafil 100 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Avanafil 200 mg</intervention_name>
    <description>One dose 15 minutes before attempting intercourse</description>
    <arm_group_label>Avanafil 200 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males ≥ 18 years of age;&#xD;
&#xD;
          -  Minimum 6 months of erectile dysfunction;&#xD;
&#xD;
          -  In a monogamous, heterosexual relationship for at least 3 months;&#xD;
&#xD;
          -  Agree to make at least 4 attempts at intercourse per month;&#xD;
&#xD;
          -  Provide written informed consent;&#xD;
&#xD;
          -  Agree not to use any other ED treatments for erectile dysfunction;&#xD;
&#xD;
          -  Willing and able to comply with all study requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy or hypersensitivity to PDE5 inhibitors;&#xD;
&#xD;
          -  History of dose-limiting AEs with a PDE5 inhibitor or discontinued use of a PDE5&#xD;
             inhibitor;&#xD;
&#xD;
          -  Concomitant use of one or more of the following medications:&#xD;
&#xD;
               -  Other prescription or OTC drugs known to interfere with metabolism by the CYP 3A4&#xD;
                  enzyme;&#xD;
&#xD;
               -  Dose of an alpha blocker that has not been stable for at least 14 days;&#xD;
&#xD;
               -  Any nitrate;&#xD;
&#xD;
          -  ED as a consequence of advanced neurologic disease, spinal cord injury,or radical&#xD;
             prostatectomy;&#xD;
&#xD;
          -  Myocardial infarction, stroke, life-threatening arrhythmia or coronary&#xD;
             revascularization within the past 6 months;&#xD;
&#xD;
          -  Unstable angina, angina with sexual intercourse, or congestive heart failure &gt; NYHA&#xD;
             Class II;&#xD;
&#xD;
          -  Poorly controlled type 1 or type 2 diabetes;&#xD;
&#xD;
          -  Evidence of prostate cancer or previous radical prostatectomy;&#xD;
&#xD;
          -  Untreated hypogonadism or total testosterone levels outside normal reference range;&#xD;
&#xD;
          -  Abnormal laboratory value(s) judged to be clinically significant by the investigator;&#xD;
&#xD;
          -  Positive urine drug screen;&#xD;
&#xD;
          -  History of retinitis pigmentosa, nonarteritic anterior ischemic optic neuropathy or&#xD;
             glaucoma;&#xD;
&#xD;
          -  Previous participation in any other study with avanafil;&#xD;
&#xD;
          -  Use of any other investigational medication or device for any indication within 30&#xD;
             days prior to enrollment or at any time during this study;&#xD;
&#xD;
          -  Evidence of any clinically significant medical, psychiatric, social or other condition&#xD;
             by history, physical examination or laboratory studies that, in the opinion of the&#xD;
             investigator, would contraindicate the administration of study medications, affect&#xD;
             compliance, interfere with study evaluations, limit study participation,&#xD;
             contraindicate sexual activity or confound the interpretation of study results.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chuck Bowden, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>VIVUS LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Jupiter</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>October 15, 2014</results_first_submitted>
  <results_first_submitted_qc>October 21, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 27, 2014</results_first_posted>
  <disposition_first_submitted>January 13, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>January 13, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">February 10, 2014</disposition_first_posted>
  <last_update_submitted>October 21, 2014</last_update_submitted>
  <last_update_submitted_qc>October 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ED</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo: One dose 15 minutes before attempting intercourse</description>
        </group>
        <group group_id="P2">
          <title>Avanafil 100 mg</title>
          <description>Avanafil 100 mg: One dose 15 minutes before attempting intercourse</description>
        </group>
        <group group_id="P3">
          <title>Avanafil 200 mg</title>
          <description>Avanafil 200 mg: One dose 15 minutes before attempting intercourse</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="145"/>
                <participants group_id="P2" count="147"/>
                <participants group_id="P3" count="148"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>ITT Population</title>
              <participants_list>
                <participants group_id="P1" count="136"/>
                <participants group_id="P2" count="139"/>
                <participants group_id="P3" count="139"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="143"/>
                <participants group_id="P2" count="146"/>
                <participants group_id="P3" count="146"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
                <participants group_id="P2" count="124"/>
                <participants group_id="P3" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo: One dose 15 minutes before attempting intercourse</description>
        </group>
        <group group_id="B2">
          <title>Avanafil 100 mg</title>
          <description>Avanafil 100 mg: One dose 15 minutes before attempting intercourse</description>
        </group>
        <group group_id="B3">
          <title>Avanafil 200 mg</title>
          <description>Avanafil 200 mg: One dose 15 minutes before attempting intercourse</description>
        </group>
        <group group_id="B4">
          <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="145"/>
            <count group_id="B2" value="147"/>
            <count group_id="B3" value="148"/>
            <count group_id="B4" value="440"/>
          </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="58.3" spread="9.92"/>
                    <measurement group_id="B2" value="58.5" spread="10.19"/>
                    <measurement group_id="B3" value="57.9" spread="10.61"/>
                    <measurement group_id="B4" value="58.2" spread="10.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;50 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=50 to &lt;65 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="76"/>
                    <measurement group_id="B4" value="228"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="145"/>
                    <measurement group_id="B2" value="147"/>
                    <measurement group_id="B3" value="148"/>
                    <measurement group_id="B4" value="440"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="124"/>
                    <measurement group_id="B4" value="333"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiple Races</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </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="145"/>
                    <measurement group_id="B2" value="147"/>
                    <measurement group_id="B3" value="148"/>
                    <measurement group_id="B4" value="440"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing</title>
        <time_frame>Week 0 (Baseline) up to Week 8 (End of Study)</time_frame>
        <population>The intent-to-treat (ITT) population consists of all subjects who are randomized, take at least 1 dose of study medication, and have at least 1 post-dose efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo: One dose 15 minutes before attempting intercourse</description>
          </group>
          <group group_id="O2">
            <title>Avanafil 100 mg</title>
            <description>Avanafil 100 mg: One dose 15 minutes before attempting intercourse</description>
          </group>
          <group group_id="O3">
            <title>Avanafil 200 mg</title>
            <description>Avanafil 200 mg: One dose 15 minutes before attempting intercourse</description>
          </group>
        </group_list>
        <measure>
          <title>Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing</title>
          <population>The intent-to-treat (ITT) population consists of all subjects who are randomized, take at least 1 dose of study medication, and have at least 1 post-dose efficacy assessment.</population>
          <units>percentage of successes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="139"/>
                <count group_id="O3" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" spread="25.1"/>
                    <measurement group_id="O2" value="25.9" spread="32.0"/>
                    <measurement group_id="O3" value="29.1" spread="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 16 weeks (from written informed consent provided and until 28 calendar days after the last dose of the study drug was administered, or until the subject was discontinued from the study, whichever was later)</time_frame>
      <desc>The safety population includes all subjects who receive at least 1 dose of study medication and have any safety data available.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo: One dose 15 minutes before attempting intercourse</description>
        </group>
        <group group_id="E2">
          <title>Avanafil 100 mg</title>
          <description>Avanafil 100 mg: One dose 15 minutes before attempting intercourse</description>
        </group>
        <group group_id="E3">
          <title>Avanafil 200 mg</title>
          <description>Avanafil 200 mg: One dose 15 minutes before attempting intercourse</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="2" subjects_at_risk="143"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="146"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="146"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="146"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="146"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="146"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="146"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Bladder outlet obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="146"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="146"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="146"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="146"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="143"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="146"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="146"/>
              </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" events="9" subjects_affected="9" subjects_at_risk="143"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="146"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="146"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="146"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="146"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="146"/>
                <counts group_id="E3" events="37" subjects_affected="13" subjects_at_risk="146"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E3" events="9" subjects_affected="6" subjects_at_risk="146"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Wesley W Day, PhD</name_or_title>
      <organization>Vivus, Inc.</organization>
      <phone>650-934-5200</phone>
    </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/NCT01698684
org study id: TA-501
nct id: NCT01698684
lead sponsor: 
has dmc: No
The objectives of this study are to examine the therapeutic effects of two doses of avanafil
      after dosing in men with erectile dysfunction
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing
time frame: Week 0 (Baseline) up to Week 8 (End of Study)
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: Avanafil 100 mg
arm group type: Experimental
arm group label: Avanafil 200 mg
arm group type: Experimental
intervention type: Drug
intervention name: Placebo
description: One dose 15 minutes before attempting intercourse
arm group label: Placebo
intervention type: Drug
intervention name: Avanafil 100 mg
description: One dose 15 minutes before attempting intercourse
arm group label: Avanafil 100 mg
intervention type: Drug
intervention name: Avanafil 200 mg
description: One dose 15 minutes before attempting intercourse
arm group label: Avanafil 200 mg
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chuck Bowden, M.D.
role: Study Director
affiliation: VIVUS LLC
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Erectile Dysfunction
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 