<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/NCT03038867</url>
  </required_header>
  <id_info>
    <org_study_id>1603017099</org_study_id>
    <nct_id>NCT03038867</nct_id>
  </id_info>
  <brief_title>Impact of Duloxetine on Male Fertility</brief_title>
  <official_title>Impact of Duloxetine on Male Fertility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are conducting a placebo-controlled, randomized control trial with&#xD;
      duloxetine in healthy, fertile men not previously on any antidepressants. Participants will&#xD;
      be randomized to either the duloxetine or placebo groups for 6 weeks. The investigators will&#xD;
      assess changes in sperm DNA fragmentation at 0, 2, 6, 8, and 10 weeks. Other outcomes&#xD;
      measured will include semen parameters (sperm concentration, motility, morphology), hormone&#xD;
      levels (testosterone, estrogen, prolactin, LH, FSH), and sexual function (IIEF and MSHQ)&#xD;
      surveys.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Antidepressant medications are commonly prescribed in the USA not only for depression, but&#xD;
      also for anxiety disorders such as generalized anxiety disorder and obsessive-compulsive&#xD;
      disorder, premature ejaculation, post-traumatic stress disorder, and neuropathic pain.&#xD;
      Despite being widely prescribed in the United States in men of reproductive age, the impact&#xD;
      of antidepressants on fertility has not been extensively studied.&#xD;
&#xD;
      After noticing worsened semen parameters in men on anti-depressants, the investigators&#xD;
      performed the first prospective study to demonstrate a deleterious impact of selective&#xD;
      serotonin reuptake inhibitors (SSRI) on sperm DNA integrity, which has been linked to&#xD;
      reproductive outcomes. Further small studies have corroborated the negative impact of SSRIs&#xD;
      on male fertility, as assessed by semen parameters and/or sperm DNA integrity.&#xD;
&#xD;
      No studies have examined the impact of a newer, but similar, class of antidepressant - the&#xD;
      serotonin-norepinephrine reuptake inhibitor (SNRI). Like SSRIs, SNRIs inhibit the reuptake of&#xD;
      serotonin, but also act on norepinephrine. The use of SNRIs has increased recently due to&#xD;
      their slightly improved efficacy profile when compared to SSRIs. Duloxetine is an SNRI and is&#xD;
      one of the most commonly prescribed anti-depressants in the United States.&#xD;
&#xD;
      The investigators are conducting this trial to determine whether or not the administration of&#xD;
      duloxetine will result in a deterioration in sperm DNA fragmentation in healthy, fertile men.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2016</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</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>
    <intervention_model_description>Blinded, placebo-controlled, randomized controlled trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participant, investigator, and outcomes assessor are all blinded to participant's assigned group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks</measure>
    <time_frame>6 Weeks (primary time point of interest)</time_frame>
    <description>Number of participants with TUNEL values &gt; 25% at 6 weeks in each treatment group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks</measure>
    <time_frame>0 weeks</time_frame>
    <description>Number of participants with Tunel Values &gt; 25% at 0 Weeks (baseline) in each treatment group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>Number of participants with Tunel values &gt; 25% at 2 weeks in each treatment group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of participants with Tunel values &gt; 25% at 8 weeks in each treatment group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks</measure>
    <time_frame>10 Weeks</time_frame>
    <description>Number of participants with Tunel values &gt; 25% at 10 weeks in each treatment group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sperm Concentration at 0 Weeks</measure>
    <time_frame>0 weeks</time_frame>
    <description>Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Concentration at 2 Weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>Sperm concentration (number of sperm/mL) in semen analysis at 2 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Concentration at 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Sperm concentration (number of sperm/mL) in semen analysis at 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Concentration at 8 Weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>Sperm concentration (number of sperm/mL) in semen analysis at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Concentration at 10 Weeks</measure>
    <time_frame>10 Weeks</time_frame>
    <description>Sperm concentration (number of sperm/mL) in semen analysis at 10 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Motility at 0 Weeks</measure>
    <time_frame>0 weeks</time_frame>
    <description>Sperm motility (mean percent) at 0 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Motility at 2 Weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>Sperm motility (mean percent) at 2 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Motility at 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Sperm motility (mean percent) at 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Motility at 8 Weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>Sperm motility (mean percent) at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Motility at 10 Weeks</measure>
    <time_frame>10 Weeks</time_frame>
    <description>Sperm motility (mean percent) at 10 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Head Defects at 0 Weeks</measure>
    <time_frame>0 weeks</time_frame>
    <description>Sperm head defects (mean number) at 0 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Head Defects at 2 Weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>Sperm head defects (mean number) at 2 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Head Defects at 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Sperm head defects (mean number) at 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Head Defects at 8 Weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>Sperm head defects (mean number) at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Head Defects at 10 Weeks</measure>
    <time_frame>10 Weeks</time_frame>
    <description>Sperm head defects (mean number) at 10 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Neck Defects at 0 Weeks</measure>
    <time_frame>0 weeks</time_frame>
    <description>Sperm neck defects (mean number) at 0 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Neck Defects at 2 Weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>Sperm neck defects (mean number) at 2 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Neck Defects at 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Sperm neck defects (mean number) at 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Neck Defects at 8 Weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>Sperm neck defects (mean number) at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Neck Defects at 10 Weeks</measure>
    <time_frame>10 Weeks</time_frame>
    <description>Sperm neck defects (mean number) at 10 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Tail Defects at 0 Weeks</measure>
    <time_frame>0 weeks</time_frame>
    <description>Sperm tail defects (mean number) at 0 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Tail Defects at 2 Weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>Sperm tail defects (mean number) at 2 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Tail Defects at 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Sperm tail defects (mean number) at 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Tail Defects at 8 Weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>Sperm tail defects (mean number) at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sperm Tail Defects at 10 Weeks</measure>
    <time_frame>10 Weeks</time_frame>
    <description>Sperm tail defects (mean number) at 10 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Testosterone Level at 0 Weeks</measure>
    <time_frame>0 weeks</time_frame>
    <description>Testosterone level (ng/dL) at 0 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Testosterone Level at 2 Weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>Testosterone level (ng/dL) at 2 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Testosterone Level at 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Testosterone level (ng/dL) at 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Testosterone Level at 8 Weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>Testosterone level (ng/dL) at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Testosterone Level at 10 Weeks</measure>
    <time_frame>10 Weeks</time_frame>
    <description>Testosterone level (ng/dL) at 10 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estrogen Level at 0 Weeks</measure>
    <time_frame>0 weeks</time_frame>
    <description>Estrogen level (pg/mL) at 0 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estrogen Level at 2 Weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>Estrogen level (pg/mL) at 2 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estrogen Level at 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Estrogen level (pg/mL) at 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estrogen Level at 8 Weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>Estrogen level (pg/mL) at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estrogen Level at 10 Weeks</measure>
    <time_frame>10 Weeks</time_frame>
    <description>Estrogen level (pg/mL) at 10 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolactin Level at 0 Weeks</measure>
    <time_frame>0 weeks</time_frame>
    <description>Prolactin level (ng/mL) at 0 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolactin Level at 2 Weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>Prolactin level (ng/mL) at 2 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolactin Level at 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Prolactin level (ng/mL) at 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolactin Level at 8 Weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>Prolactin level (ng/mL) at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolactin Level at 10 Weeks</measure>
    <time_frame>10 Weeks</time_frame>
    <description>Prolactin level (ng/mL) at 10 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Luteinizing Hormone Level at 0 Weeks</measure>
    <time_frame>0 weeks</time_frame>
    <description>Luteinizing hormone level (mIU/mL) at 0 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Luteinizing Hormone Level at 2 Weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>Luteinizing hormone level (mIU/mL) at 2 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Luteinizing Hormone Level at 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Luteinizing hormone level (mIU/mL) at 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Luteinizing Hormone Level at 8 Weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>Luteinizing hormone level (mIU/mL) at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Luteinizing Hormone Level at 10 Weeks</measure>
    <time_frame>10 Weeks</time_frame>
    <description>Luteinizing hormone level (mIU/mL) at 10 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follicle Stimulating Hormone Level at 0 Weeks</measure>
    <time_frame>0 weeks</time_frame>
    <description>Follicle stimulating hormone level (mIU/mL) at 0 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follicle Stimulating Hormone Level at 2 Weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>Follicle stimulating hormone level (mIU/mL) at 2 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follicle Stimulating Hormone Level at 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>Follicle stimulating hormone level (mIU/mL) at 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follicle Stimulating Hormone Level at 8 Weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>Follicle stimulating hormone level (mIU/mL) at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follicle Stimulating Hormone Level at 10 Weeks</measure>
    <time_frame>10 Weeks</time_frame>
    <description>Follicle stimulating hormone level (mIU/mL) at 10 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Infertility, Male</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Duloxetine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duloxetine</intervention_name>
    <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
    <arm_group_label>Duloxetine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men aged 18-65 years old;&#xD;
&#xD;
          -  normal or borderline semen analysis (sperm concentration &gt; 10 million/mL, sperm&#xD;
             motility &gt; 30%, sperm morphology &gt; 3%);&#xD;
&#xD;
          -  willing to engage in sexual activity (alone or with a partner) at least once per week&#xD;
             for the duration of the study;&#xD;
&#xD;
          -  capable of providing semen sample.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically detected varicocele;&#xD;
&#xD;
          -  oligoasthenoteratospermia or azoospermia on semen analysis;&#xD;
&#xD;
          -  ongoing attempts to initiate pregnancy;&#xD;
&#xD;
          -  current sexual dysfunction (classified as moderate or worse on IIEF);&#xD;
&#xD;
          -  history of seizure disorder;&#xD;
&#xD;
          -  history of previous chemotherapy or radiation therapy;&#xD;
&#xD;
          -  current psychiatric history or history of bipolar disorder;&#xD;
&#xD;
          -  family history of bipolar disorder, depression, or suicide;&#xD;
&#xD;
          -  use of any psychotropic medications or anticonvulsants;&#xD;
&#xD;
          -  use of sleeping pills more than once per week;&#xD;
&#xD;
          -  use of any hormonal medications on a daily or intermittent basis during the preceding&#xD;
             3 months;&#xD;
&#xD;
          -  use of medications which may affect hormone measures and/or sexual function;&#xD;
&#xD;
          -  inability to read, follow instructions, or complete questionnaires in English;&#xD;
&#xD;
          -  consumption of tobacco or illicit drugs;&#xD;
&#xD;
          -  consumption of &gt;2oz of alcohol daily.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Schlegel, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nahid Punjani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <results_first_submitted>February 12, 2020</results_first_submitted>
  <results_first_submitted_qc>February 12, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 26, 2020</results_first_posted>
  <last_update_submitted>February 26, 2020</last_update_submitted>
  <last_update_submitted_qc>February 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 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>Infertility</mesh_term>
    <mesh_term>Infertility, Male</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Duloxetine Hydrochloride</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 25, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03038867/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Duloxetine</title>
          <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Duloxetine</title>
          <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</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="37"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="69"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="37"/>
                    <count group_id="B2" value="32"/>
                    <count group_id="B3" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="37"/>
                    <count group_id="B2" value="32"/>
                    <count group_id="B3" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="37"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="37"/>
                    <count group_id="B2" value="32"/>
                    <count group_id="B3" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks</title>
        <description>Number of participants with TUNEL values &gt; 25% at 6 weeks in each treatment group</description>
        <time_frame>6 Weeks (primary time point of interest)</time_frame>
        <population>11 patients in the Duloxetine group and 7 patients in the Placebo group did not have Tunel data measured at 6 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks</title>
          <description>Number of participants with TUNEL values &gt; 25% at 6 weeks in each treatment group</description>
          <population>11 patients in the Duloxetine group and 7 patients in the Placebo group did not have Tunel data measured at 6 weeks (patients were not available).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <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"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks</title>
        <description>Number of participants with Tunel Values &gt; 25% at 0 Weeks (baseline) in each treatment group</description>
        <time_frame>0 weeks</time_frame>
        <population>5 patients in the Duloxetine group did not have Tunel data measured at 0 weeks (patients were not available)</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks</title>
          <description>Number of participants with Tunel Values &gt; 25% at 0 Weeks (baseline) in each treatment group</description>
          <population>5 patients in the Duloxetine group did not have Tunel data measured at 0 weeks (patients were not available)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks</title>
        <description>Number of participants with Tunel values &gt; 25% at 2 weeks in each treatment group</description>
        <time_frame>2 weeks</time_frame>
        <population>12 patients in the Duloxetine group and 2 patients in the Placebo group did not have Tunel data at 2 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks</title>
          <description>Number of participants with Tunel values &gt; 25% at 2 weeks in each treatment group</description>
          <population>12 patients in the Duloxetine group and 2 patients in the Placebo group did not have Tunel data at 2 weeks (patients were not available).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks</title>
        <description>Number of participants with Tunel values &gt; 25% at 8 weeks in each treatment group</description>
        <time_frame>8 weeks</time_frame>
        <population>15 patients in the Duloxetine group and 4 patients in the Placebo group did not have Tunel data at 8 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks</title>
          <description>Number of participants with Tunel values &gt; 25% at 8 weeks in each treatment group</description>
          <population>15 patients in the Duloxetine group and 4 patients in the Placebo group did not have Tunel data at 8 weeks (patients were not available).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks</title>
        <description>Number of participants with Tunel values &gt; 25% at 10 weeks in each treatment group</description>
        <time_frame>10 Weeks</time_frame>
        <population>18 patients in the Duloxetine group and 4 patients in the Placebo group did not have Tunel data at 10 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks</title>
          <description>Number of participants with Tunel values &gt; 25% at 10 weeks in each treatment group</description>
          <population>18 patients in the Duloxetine group and 4 patients in the Placebo group did not have Tunel data at 10 weeks (patients were not available).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Concentration at 0 Weeks</title>
        <description>Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks</description>
        <time_frame>0 weeks</time_frame>
        <population>3 patients in the Duloxetine group did not have sperm concentration measured at 0 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Concentration at 0 Weeks</title>
          <description>Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks</description>
          <population>3 patients in the Duloxetine group did not have sperm concentration measured at 0 weeks (patients were not available).</population>
          <units>Number of sperm/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.4" spread="40.3"/>
                    <measurement group_id="O2" value="50.2" spread="33.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Concentration at 2 Weeks</title>
        <description>Sperm concentration (number of sperm/mL) in semen analysis at 2 weeks</description>
        <time_frame>2 weeks</time_frame>
        <population>10 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 2 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Concentration at 2 Weeks</title>
          <description>Sperm concentration (number of sperm/mL) in semen analysis at 2 weeks</description>
          <population>10 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 2 weeks (patients were not available).</population>
          <units>Number of sperm/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.9" spread="38.7"/>
                    <measurement group_id="O2" value="50.0" spread="41.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Concentration at 6 Weeks</title>
        <description>Sperm concentration (number of sperm/mL) in semen analysis at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <population>11 patients in the Duloxetine group and 5 patients in the Placebo group did not have sperm concentration measured at 6 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Concentration at 6 Weeks</title>
          <description>Sperm concentration (number of sperm/mL) in semen analysis at 6 weeks</description>
          <population>11 patients in the Duloxetine group and 5 patients in the Placebo group did not have sperm concentration measured at 6 weeks (patients were not available).</population>
          <units>Number of sperm/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.6" spread="24.2"/>
                    <measurement group_id="O2" value="43.9" spread="32.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Concentration at 8 Weeks</title>
        <description>Sperm concentration (number of sperm/mL) in semen analysis at 8 weeks</description>
        <time_frame>8 weeks</time_frame>
        <population>14 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 8 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Concentration at 8 Weeks</title>
          <description>Sperm concentration (number of sperm/mL) in semen analysis at 8 weeks</description>
          <population>14 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 8 weeks (patients were not available).</population>
          <units>Number of sperm/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.7" spread="29.8"/>
                    <measurement group_id="O2" value="47.1" spread="28.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Concentration at 10 Weeks</title>
        <description>Sperm concentration (number of sperm/mL) in semen analysis at 10 weeks</description>
        <time_frame>10 Weeks</time_frame>
        <population>16 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 10 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Concentration at 10 Weeks</title>
          <description>Sperm concentration (number of sperm/mL) in semen analysis at 10 weeks</description>
          <population>16 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 10 weeks (patients were not available).</population>
          <units>Number of sperm/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.0" spread="26.3"/>
                    <measurement group_id="O2" value="42.7" spread="26.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Motility at 0 Weeks</title>
        <description>Sperm motility (mean percent) at 0 weeks</description>
        <time_frame>0 weeks</time_frame>
        <population>3 patients in the Duloxetine group did not have motility measured at 0 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Motility at 0 Weeks</title>
          <description>Sperm motility (mean percent) at 0 weeks</description>
          <population>3 patients in the Duloxetine group did not have motility measured at 0 weeks (patients were not available).</population>
          <units>percent motility</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.7" spread="9.5"/>
                    <measurement group_id="O2" value="59.7" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Motility at 2 Weeks</title>
        <description>Sperm motility (mean percent) at 2 weeks</description>
        <time_frame>2 weeks</time_frame>
        <population>11 patients in the Duloxetine group and 2 patients in the Placebo group did not have motility measured at 2 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Motility at 2 Weeks</title>
          <description>Sperm motility (mean percent) at 2 weeks</description>
          <population>11 patients in the Duloxetine group and 2 patients in the Placebo group did not have motility measured at 2 weeks (patients were not available).</population>
          <units>percent motility</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.3" spread="13.3"/>
                    <measurement group_id="O2" value="55.2" spread="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Motility at 6 Weeks</title>
        <description>Sperm motility (mean percent) at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <population>11 patients in the Duloxetine group and 5 patients in the Placebo group did not have motility measured at 6 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Motility at 6 Weeks</title>
          <description>Sperm motility (mean percent) at 6 weeks</description>
          <population>11 patients in the Duloxetine group and 5 patients in the Placebo group did not have motility measured at 6 weeks (patients were not available).</population>
          <units>percent motility</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.2" spread="11.2"/>
                    <measurement group_id="O2" value="50.4" spread="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Motility at 8 Weeks</title>
        <description>Sperm motility (mean percent) at 8 weeks</description>
        <time_frame>8 weeks</time_frame>
        <population>13 patients in the Duloxetine group and 2 patients in the Placebo group did not have motility measured at 8 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Motility at 8 Weeks</title>
          <description>Sperm motility (mean percent) at 8 weeks</description>
          <population>13 patients in the Duloxetine group and 2 patients in the Placebo group did not have motility measured at 8 weeks (patients were not available).</population>
          <units>percent motility</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.1" spread="18.6"/>
                    <measurement group_id="O2" value="58.5" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Motility at 10 Weeks</title>
        <description>Sperm motility (mean percent) at 10 weeks</description>
        <time_frame>10 Weeks</time_frame>
        <population>15 patients in the Duloxetine group and 3 patients in the Placebo group did not have motility measured at 10 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Motility at 10 Weeks</title>
          <description>Sperm motility (mean percent) at 10 weeks</description>
          <population>15 patients in the Duloxetine group and 3 patients in the Placebo group did not have motility measured at 10 weeks (patients were not available).</population>
          <units>percent motility</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.4" spread="17.4"/>
                    <measurement group_id="O2" value="53.9" spread="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Head Defects at 0 Weeks</title>
        <description>Sperm head defects (mean number) at 0 weeks</description>
        <time_frame>0 weeks</time_frame>
        <population>3 patients in the Duloxetine group did not have head defects measured at 0 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Head Defects at 0 Weeks</title>
          <description>Sperm head defects (mean number) at 0 weeks</description>
          <population>3 patients in the Duloxetine group did not have head defects measured at 0 weeks (patients were not available).</population>
          <units>defects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.4" spread="16.0"/>
                    <measurement group_id="O2" value="89.9" spread="8.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Head Defects at 2 Weeks</title>
        <description>Sperm head defects (mean number) at 2 weeks</description>
        <time_frame>2 weeks</time_frame>
        <population>11 patients in the Duloxetine group and 2 patients in the Placebo group did not have head defects measured at 2 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Head Defects at 2 Weeks</title>
          <description>Sperm head defects (mean number) at 2 weeks</description>
          <population>11 patients in the Duloxetine group and 2 patients in the Placebo group did not have head defects measured at 2 weeks (patients were not available).</population>
          <units>defects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.5" spread="4.02"/>
                    <measurement group_id="O2" value="90.7" spread="7.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Head Defects at 6 Weeks</title>
        <description>Sperm head defects (mean number) at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <population>11 patients in the Duloxetine group and 5 patients in the Placebo group did not have head defects measured at 6 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Head Defects at 6 Weeks</title>
          <description>Sperm head defects (mean number) at 6 weeks</description>
          <population>11 patients in the Duloxetine group and 5 patients in the Placebo group did not have head defects measured at 6 weeks (patients were not available).</population>
          <units>defects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.6" spread="4.38"/>
                    <measurement group_id="O2" value="91.3" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Head Defects at 8 Weeks</title>
        <description>Sperm head defects (mean number) at 8 weeks</description>
        <time_frame>8 weeks</time_frame>
        <population>13 patients in the Duloxetine group and 2 patients in the Placebo group did not have head defects measured at 8 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Head Defects at 8 Weeks</title>
          <description>Sperm head defects (mean number) at 8 weeks</description>
          <population>13 patients in the Duloxetine group and 2 patients in the Placebo group did not have head defects measured at 8 weeks (patients were not available).</population>
          <units>defects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.3" spread="4.54"/>
                    <measurement group_id="O2" value="88.7" spread="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Head Defects at 10 Weeks</title>
        <description>Sperm head defects (mean number) at 10 weeks</description>
        <time_frame>10 Weeks</time_frame>
        <population>15 patients in the Duloxetine group and 3 patients in the Placebo group did not have head defects measured at 10 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Head Defects at 10 Weeks</title>
          <description>Sperm head defects (mean number) at 10 weeks</description>
          <population>15 patients in the Duloxetine group and 3 patients in the Placebo group did not have head defects measured at 10 weeks (patients were not available).</population>
          <units>defects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.8" spread="5.65"/>
                    <measurement group_id="O2" value="88.3" spread="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Neck Defects at 0 Weeks</title>
        <description>Sperm neck defects (mean number) at 0 weeks</description>
        <time_frame>0 weeks</time_frame>
        <population>3 patients in the Duloxetine group did not have neck defects measured at 0 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Neck Defects at 0 Weeks</title>
          <description>Sperm neck defects (mean number) at 0 weeks</description>
          <population>3 patients in the Duloxetine group did not have neck defects measured at 0 weeks (patients were not available).</population>
          <units>defects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.36" spread="2.97"/>
                    <measurement group_id="O2" value="2.55" spread="4.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Neck Defects at 2 Weeks</title>
        <description>Sperm neck defects (mean number) at 2 weeks</description>
        <time_frame>2 weeks</time_frame>
        <population>11 patients in the Duloxetine group and 2 patients in the Placebo group did not have neck defects measured at 2 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Neck Defects at 2 Weeks</title>
          <description>Sperm neck defects (mean number) at 2 weeks</description>
          <population>11 patients in the Duloxetine group and 2 patients in the Placebo group did not have neck defects measured at 2 weeks (patients were not available).</population>
          <units>defects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.65" spread="5.83"/>
                    <measurement group_id="O2" value="1.00" spread="3.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Neck Defects at 6 Weeks</title>
        <description>Sperm neck defects (mean number) at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <population>11 patients in the Duloxetine group and 11 patients in the Placebo group did not have neck defects measured at 6 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Neck Defects at 6 Weeks</title>
          <description>Sperm neck defects (mean number) at 6 weeks</description>
          <population>11 patients in the Duloxetine group and 11 patients in the Placebo group did not have neck defects measured at 6 weeks (patients were not available).</population>
          <units>defects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.12" spread="4.35"/>
                    <measurement group_id="O2" value="0.62" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Neck Defects at 8 Weeks</title>
        <description>Sperm neck defects (mean number) at 8 weeks</description>
        <time_frame>8 weeks</time_frame>
        <population>14 patients in the Duloxetine group and 2 patients in the Placebo group did not have neck defects measured at 8 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Neck Defects at 8 Weeks</title>
          <description>Sperm neck defects (mean number) at 8 weeks</description>
          <population>14 patients in the Duloxetine group and 2 patients in the Placebo group did not have neck defects measured at 8 weeks (patients were not available).</population>
          <units>defects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.17" spread="2.66"/>
                    <measurement group_id="O2" value="0.50" spread="1.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Neck Defects at 10 Weeks</title>
        <description>Sperm neck defects (mean number) at 10 weeks</description>
        <time_frame>10 Weeks</time_frame>
        <population>15 patients in the Duloxetine group and 3 patients in the Placebo group did not have neck defects measured at 10 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Neck Defects at 10 Weeks</title>
          <description>Sperm neck defects (mean number) at 10 weeks</description>
          <population>15 patients in the Duloxetine group and 3 patients in the Placebo group did not have neck defects measured at 10 weeks (patients were not available).</population>
          <units>defects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.91" spread="2.72"/>
                    <measurement group_id="O2" value="1.55" spread="3.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Tail Defects at 0 Weeks</title>
        <description>Sperm tail defects (mean number) at 0 weeks</description>
        <time_frame>0 weeks</time_frame>
        <population>6 patients in the Duloxetine group and 4 patients in the Placebo group did not have tail defects measured at 0 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Tail Defects at 0 Weeks</title>
          <description>Sperm tail defects (mean number) at 0 weeks</description>
          <population>6 patients in the Duloxetine group and 4 patients in the Placebo group did not have tail defects measured at 0 weeks (patients were not available).</population>
          <units>defects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="0.72"/>
                    <measurement group_id="O2" value="1.89" spread="7.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Tail Defects at 2 Weeks</title>
        <description>Sperm tail defects (mean number) at 2 weeks</description>
        <time_frame>2 weeks</time_frame>
        <population>16 patients in the Duloxetine group and 3 patients in the Placebo group did not have tail defects measured at 2 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Tail Defects at 2 Weeks</title>
          <description>Sperm tail defects (mean number) at 2 weeks</description>
          <population>16 patients in the Duloxetine group and 3 patients in the Placebo group did not have tail defects measured at 2 weeks (patients were not available).</population>
          <units>defects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="1.66" spread="7.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Tail Defects at 6 Weeks</title>
        <description>Sperm tail defects (mean number) at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <population>11 patients in the Duloxetine group and 7 patients in the Placebo group did not have tail defects measured at 6 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Tail Defects at 6 Weeks</title>
          <description>Sperm tail defects (mean number) at 6 weeks</description>
          <population>11 patients in the Duloxetine group and 7 patients in the Placebo group did not have tail defects measured at 6 weeks (patients were not available).</population>
          <units>defects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.20"/>
                    <measurement group_id="O2" value="2.64" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Tail Defects at 8 Weeks</title>
        <description>Sperm tail defects (mean number) at 8 weeks</description>
        <time_frame>8 weeks</time_frame>
        <population>14 patients in the Duloxetine group and 4 patients in the Placebo group did not have tail defects measured at 8 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Tail Defects at 8 Weeks</title>
          <description>Sperm tail defects (mean number) at 8 weeks</description>
          <population>14 patients in the Duloxetine group and 4 patients in the Placebo group did not have tail defects measured at 8 weeks (patients were not available).</population>
          <units>defects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="1.30"/>
                    <measurement group_id="O2" value="1.25" spread="3.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sperm Tail Defects at 10 Weeks</title>
        <description>Sperm tail defects (mean number) at 10 weeks</description>
        <time_frame>10 Weeks</time_frame>
        <population>15 patients in the Duloxetine group and 4 patients in the Placebo group did not have tail defects measured at 10 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Sperm Tail Defects at 10 Weeks</title>
          <description>Sperm tail defects (mean number) at 10 weeks</description>
          <population>15 patients in the Duloxetine group and 4 patients in the Placebo group did not have tail defects measured at 10 weeks (patients were not available).</population>
          <units>defects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.09" spread="5.12"/>
                    <measurement group_id="O2" value="0.96" spread="3.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Testosterone Level at 0 Weeks</title>
        <description>Testosterone level (ng/dL) at 0 weeks</description>
        <time_frame>0 weeks</time_frame>
        <population>3 patients in the Duloxetine group did not have testosterone measured at 0 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Testosterone Level at 0 Weeks</title>
          <description>Testosterone level (ng/dL) at 0 weeks</description>
          <population>3 patients in the Duloxetine group did not have testosterone measured at 0 weeks (patients were not available).</population>
          <units>ng/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="464" spread="165"/>
                    <measurement group_id="O2" value="448" spread="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Testosterone Level at 2 Weeks</title>
        <description>Testosterone level (ng/dL) at 2 weeks</description>
        <time_frame>2 weeks</time_frame>
        <population>8 patients in the Duloxetine group did not have testosterone measured at 2 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Testosterone Level at 2 Weeks</title>
          <description>Testosterone level (ng/dL) at 2 weeks</description>
          <population>8 patients in the Duloxetine group did not have testosterone measured at 2 weeks (patients were not available).</population>
          <units>ng/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="431" spread="126"/>
                    <measurement group_id="O2" value="482" spread="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Testosterone Level at 6 Weeks</title>
        <description>Testosterone level (ng/dL) at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <population>12 patients in the Duloxetine group and 2 patients in the Placebo group did not have testosterone measured at 6 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Testosterone Level at 6 Weeks</title>
          <description>Testosterone level (ng/dL) at 6 weeks</description>
          <population>12 patients in the Duloxetine group and 2 patients in the Placebo group did not have testosterone measured at 6 weeks (patients were not available).</population>
          <units>ng/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="485" spread="170"/>
                    <measurement group_id="O2" value="438" spread="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Testosterone Level at 8 Weeks</title>
        <description>Testosterone level (ng/dL) at 8 weeks</description>
        <time_frame>8 weeks</time_frame>
        <population>12 patients in the Duloxetine group and 4 patients in the Placebo group did not have testosterone measured at 8 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Testosterone Level at 8 Weeks</title>
          <description>Testosterone level (ng/dL) at 8 weeks</description>
          <population>12 patients in the Duloxetine group and 4 patients in the Placebo group did not have testosterone measured at 8 weeks (patients were not available).</population>
          <units>ng/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="534" spread="237"/>
                    <measurement group_id="O2" value="460" spread="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Testosterone Level at 10 Weeks</title>
        <description>Testosterone level (ng/dL) at 10 weeks</description>
        <time_frame>10 Weeks</time_frame>
        <population>21 patients in the Duloxetine group and 8 patients in the Placebo group did not have testosterone measured at 10 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Testosterone Level at 10 Weeks</title>
          <description>Testosterone level (ng/dL) at 10 weeks</description>
          <population>21 patients in the Duloxetine group and 8 patients in the Placebo group did not have testosterone measured at 10 weeks (patients were not available).</population>
          <units>ng/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="445" spread="165"/>
                    <measurement group_id="O2" value="509" spread="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Estrogen Level at 0 Weeks</title>
        <description>Estrogen level (pg/mL) at 0 weeks</description>
        <time_frame>0 weeks</time_frame>
        <population>6 patients in the Duloxetine group and 3 patients in the Placebo group did not have estrogen measured at 0 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Estrogen Level at 0 Weeks</title>
          <description>Estrogen level (pg/mL) at 0 weeks</description>
          <population>6 patients in the Duloxetine group and 3 patients in the Placebo group did not have estrogen measured at 0 weeks (patients were not available).</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.8" spread="39.4"/>
                    <measurement group_id="O2" value="58.5" spread="51.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Estrogen Level at 2 Weeks</title>
        <description>Estrogen level (pg/mL) at 2 weeks</description>
        <time_frame>2 weeks</time_frame>
        <population>16 patients in the Duloxetine group did not have estrogen measured at 2 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Estrogen Level at 2 Weeks</title>
          <description>Estrogen level (pg/mL) at 2 weeks</description>
          <population>16 patients in the Duloxetine group did not have estrogen measured at 2 weeks (patients were not available).</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.0" spread="37.6"/>
                    <measurement group_id="O2" value="44.4" spread="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Estrogen Level at 6 Weeks</title>
        <description>Estrogen level (pg/mL) at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <population>16 patients in the Duloxetine group and 5 patients in the Placebo group did not have estrogen measured at 6 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Estrogen Level at 6 Weeks</title>
          <description>Estrogen level (pg/mL) at 6 weeks</description>
          <population>16 patients in the Duloxetine group and 5 patients in the Placebo group did not have estrogen measured at 6 weeks (patients were not available).</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.8" spread="30.7"/>
                    <measurement group_id="O2" value="43.5" spread="28.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Estrogen Level at 8 Weeks</title>
        <description>Estrogen level (pg/mL) at 8 weeks</description>
        <time_frame>8 weeks</time_frame>
        <population>17 patients in the Duloxetine group and 6 patients in the Placebo group did not have testosterone measured at 8 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Estrogen Level at 8 Weeks</title>
          <description>Estrogen level (pg/mL) at 8 weeks</description>
          <population>17 patients in the Duloxetine group and 6 patients in the Placebo group did not have testosterone measured at 8 weeks (patients were not available).</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.3" spread="31.9"/>
                    <measurement group_id="O2" value="39.0" spread="24.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Estrogen Level at 10 Weeks</title>
        <description>Estrogen level (pg/mL) at 10 weeks</description>
        <time_frame>10 Weeks</time_frame>
        <population>23 patients in the Duloxetine group and 8 patients in the Placebo group did not have estrogen measured at 10 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Estrogen Level at 10 Weeks</title>
          <description>Estrogen level (pg/mL) at 10 weeks</description>
          <population>23 patients in the Duloxetine group and 8 patients in the Placebo group did not have estrogen measured at 10 weeks (patients were not available).</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.7" spread="12.2"/>
                    <measurement group_id="O2" value="133" spread="467"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prolactin Level at 0 Weeks</title>
        <description>Prolactin level (ng/mL) at 0 weeks</description>
        <time_frame>0 weeks</time_frame>
        <population>3 patients in the Duloxetine group did not have prolactin measured at 0 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Prolactin Level at 0 Weeks</title>
          <description>Prolactin level (ng/mL) at 0 weeks</description>
          <population>3 patients in the Duloxetine group did not have prolactin measured at 0 weeks (patients were not available).</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" spread="5.78"/>
                    <measurement group_id="O2" value="12.4" spread="4.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prolactin Level at 2 Weeks</title>
        <description>Prolactin level (ng/mL) at 2 weeks</description>
        <time_frame>2 weeks</time_frame>
        <population>8 patients in the Duloxetine group did not have prolactin measured at 2 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Prolactin Level at 2 Weeks</title>
          <description>Prolactin level (ng/mL) at 2 weeks</description>
          <population>8 patients in the Duloxetine group did not have prolactin measured at 2 weeks (patients were not available).</population>
          <units>ng/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.74" spread="3.69"/>
                    <measurement group_id="O2" value="11.3" spread="6.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prolactin Level at 6 Weeks</title>
        <description>Prolactin level (ng/mL) at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <population>11 patients in the Duloxetine group and 1 patient in the Placebo group did not have prolactin measured at 6 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Prolactin Level at 6 Weeks</title>
          <description>Prolactin level (ng/mL) at 6 weeks</description>
          <population>11 patients in the Duloxetine group and 1 patient in the Placebo group did not have prolactin measured at 6 weeks (patients were not available).</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" spread="5.05"/>
                    <measurement group_id="O2" value="9.60" spread="6.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prolactin Level at 8 Weeks</title>
        <description>Prolactin level (ng/mL) at 8 weeks</description>
        <time_frame>8 weeks</time_frame>
        <population>12 patients in the Duloxetine group and 2 patients in the Placebo group did not have prolactin measured at 8 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Prolactin Level at 8 Weeks</title>
          <description>Prolactin level (ng/mL) at 8 weeks</description>
          <population>12 patients in the Duloxetine group and 2 patients in the Placebo group did not have prolactin measured at 8 weeks (patients were not available).</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" spread="4.91"/>
                    <measurement group_id="O2" value="8.98" spread="3.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prolactin Level at 10 Weeks</title>
        <description>Prolactin level (ng/mL) at 10 weeks</description>
        <time_frame>10 Weeks</time_frame>
        <population>20 patients in the Duloxetine group and 5 patients in the Placebo group did not have prolactin measured at 10 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Prolactin Level at 10 Weeks</title>
          <description>Prolactin level (ng/mL) at 10 weeks</description>
          <population>20 patients in the Duloxetine group and 5 patients in the Placebo group did not have prolactin measured at 10 weeks (patients were not available).</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.83" spread="3.31"/>
                    <measurement group_id="O2" value="11.6" spread="6.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Luteinizing Hormone Level at 0 Weeks</title>
        <description>Luteinizing hormone level (mIU/mL) at 0 weeks</description>
        <time_frame>0 weeks</time_frame>
        <population>3 patients in the Duloxetine group did not have LH measured at 0 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Luteinizing Hormone Level at 0 Weeks</title>
          <description>Luteinizing hormone level (mIU/mL) at 0 weeks</description>
          <population>3 patients in the Duloxetine group did not have LH measured at 0 weeks (patients were not available).</population>
          <units>mIU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.11" spread="4.98"/>
                    <measurement group_id="O2" value="3.37" spread="1.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Luteinizing Hormone Level at 2 Weeks</title>
        <description>Luteinizing hormone level (mIU/mL) at 2 weeks</description>
        <time_frame>2 weeks</time_frame>
        <population>8 patients in the Duloxetine group did not have LH measured at 2 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Luteinizing Hormone Level at 2 Weeks</title>
          <description>Luteinizing hormone level (mIU/mL) at 2 weeks</description>
          <population>8 patients in the Duloxetine group did not have LH measured at 2 weeks (patients were not available).</population>
          <units>mIU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" spread="5.47"/>
                    <measurement group_id="O2" value="3.57" spread="1.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Luteinizing Hormone Level at 6 Weeks</title>
        <description>Luteinizing hormone level (mIU/mL) at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <population>11 patients in the Duloxetine group and 1 patient in the Placebo group did not have LH measured at 6 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Luteinizing Hormone Level at 6 Weeks</title>
          <description>Luteinizing hormone level (mIU/mL) at 6 weeks</description>
          <population>11 patients in the Duloxetine group and 1 patient in the Placebo group did not have LH measured at 6 weeks (patients were not available).</population>
          <units>mIU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.51" spread="5.92"/>
                    <measurement group_id="O2" value="3.42" spread="1.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Luteinizing Hormone Level at 8 Weeks</title>
        <description>Luteinizing hormone level (mIU/mL) at 8 weeks</description>
        <time_frame>8 weeks</time_frame>
        <population>13 patients in the Duloxetine group and 2 patients in the Placebo group did not have LH measured at 8 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Luteinizing Hormone Level at 8 Weeks</title>
          <description>Luteinizing hormone level (mIU/mL) at 8 weeks</description>
          <population>13 patients in the Duloxetine group and 2 patients in the Placebo group did not have LH measured at 8 weeks (patients were not available).</population>
          <units>mIU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.18" spread="5.50"/>
                    <measurement group_id="O2" value="3.70" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Luteinizing Hormone Level at 10 Weeks</title>
        <description>Luteinizing hormone level (mIU/mL) at 10 weeks</description>
        <time_frame>10 Weeks</time_frame>
        <population>22 patients in the Duloxetine group and 5 patients in the Placebo group did not have LH measured at 10 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Luteinizing Hormone Level at 10 Weeks</title>
          <description>Luteinizing hormone level (mIU/mL) at 10 weeks</description>
          <population>22 patients in the Duloxetine group and 5 patients in the Placebo group did not have LH measured at 10 weeks (patients were not available).</population>
          <units>mIU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.98" spread="6.40"/>
                    <measurement group_id="O2" value="3.78" spread="1.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Follicle Stimulating Hormone Level at 0 Weeks</title>
        <description>Follicle stimulating hormone level (mIU/mL) at 0 weeks</description>
        <time_frame>0 weeks</time_frame>
        <population>5 patients in the Duloxetine group and 1 patient in the Placebo group did not have FSH measured at 0 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Follicle Stimulating Hormone Level at 0 Weeks</title>
          <description>Follicle stimulating hormone level (mIU/mL) at 0 weeks</description>
          <population>5 patients in the Duloxetine group and 1 patient in the Placebo group did not have FSH measured at 0 weeks (patients were not available).</population>
          <units>mIU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.56" spread="12.3"/>
                    <measurement group_id="O2" value="5.26" spread="4.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Follicle Stimulating Hormone Level at 2 Weeks</title>
        <description>Follicle stimulating hormone level (mIU/mL) at 2 weeks</description>
        <time_frame>2 weeks</time_frame>
        <population>9 patients in the Duloxetine group and 1 patient in the Placebo group did not have FSH measured at 2 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Follicle Stimulating Hormone Level at 2 Weeks</title>
          <description>Follicle stimulating hormone level (mIU/mL) at 2 weeks</description>
          <population>9 patients in the Duloxetine group and 1 patient in the Placebo group did not have FSH measured at 2 weeks (patients were not available).</population>
          <units>mIU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.56" spread="5.86"/>
                    <measurement group_id="O2" value="5.30" spread="4.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Follicle Stimulating Hormone Level at 6 Weeks</title>
        <description>Follicle stimulating hormone level (mIU/mL) at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <population>16 patients in the Duloxetine group and 2 patients in the Placebo group did not have FSH measured at 6 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Follicle Stimulating Hormone Level at 6 Weeks</title>
          <description>Follicle stimulating hormone level (mIU/mL) at 6 weeks</description>
          <population>16 patients in the Duloxetine group and 2 patients in the Placebo group did not have FSH measured at 6 weeks (patients were not available).</population>
          <units>mIU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.57" spread="5.71"/>
                    <measurement group_id="O2" value="5.14" spread="4.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Follicle Stimulating Hormone Level at 8 Weeks</title>
        <description>Follicle stimulating hormone level (mIU/mL) at 8 weeks</description>
        <time_frame>8 weeks</time_frame>
        <population>15 patients in the Duloxetine group and 4 patients in the Placebo group did not have FSH measured at 8 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Follicle Stimulating Hormone Level at 8 Weeks</title>
          <description>Follicle stimulating hormone level (mIU/mL) at 8 weeks</description>
          <population>15 patients in the Duloxetine group and 4 patients in the Placebo group did not have FSH measured at 8 weeks (patients were not available).</population>
          <units>mIU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.18" spread="3.97"/>
                    <measurement group_id="O2" value="5.29" spread="3.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Follicle Stimulating Hormone Level at 10 Weeks</title>
        <description>Follicle stimulating hormone level (mIU/mL) at 10 weeks</description>
        <time_frame>10 Weeks</time_frame>
        <population>23 patients in the Duloxetine group and 6 patients in the Placebo group did not have FSH measured at 10 weeks (patients were not available).</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
          </group>
        </group_list>
        <measure>
          <title>Follicle Stimulating Hormone Level at 10 Weeks</title>
          <description>Follicle stimulating hormone level (mIU/mL) at 10 weeks</description>
          <population>23 patients in the Duloxetine group and 6 patients in the Placebo group did not have FSH measured at 10 weeks (patients were not available).</population>
          <units>mIU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.54" spread="5.44"/>
                    <measurement group_id="O2" value="5.95" spread="5.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year, 4 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Duloxetine</title>
          <description>Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week&#xD;
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo&#xD;
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Research coordinator</name_or_title>
      <organization>Weill Cornell Medical College</organization>
      <phone>212-746-5385</phone>
      <email>mac4015@med.cornell.edu</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/NCT03038867
org study id: 1603017099
nct id: NCT03038867
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The investigators are conducting a placebo-controlled, randomized control trial with
      duloxetine in healthy, fertile men not previously on any antidepressants. Participants will
      be randomized to either the duloxetine or placebo groups for 6 weeks. The investigators will
      assess changes in sperm DNA fragmentation at 0, 2, 6, 8, and 10 weeks. Other outcomes
      measured will include semen parameters (sperm concentration, motility, morphology), hormone
      levels (testosterone, estrogen, prolactin, LH, FSH), and sexual function (IIEF and MSHQ)
      surveys.
Antidepressant medications are commonly prescribed in the USA not only for depression, but
      also for anxiety disorders such as generalized anxiety disorder and obsessive-compulsive
      disorder, premature ejaculation, post-traumatic stress disorder, and neuropathic pain.
      Despite being widely prescribed in the United States in men of reproductive age, the impact
      of antidepressants on fertility has not been extensively studied.

      After noticing worsened semen parameters in men on anti-depressants, the investigators
      performed the first prospective study to demonstrate a deleterious impact of selective
      serotonin reuptake inhibitors (SSRI) on sperm DNA integrity, which has been linked to
      reproductive outcomes. Further small studies have corroborated the negative impact of SSRIs
      on male fertility, as assessed by semen parameters and/or sperm DNA integrity.

      No studies have examined the impact of a newer, but similar, class of antidepressant - the
      serotonin-norepinephrine reuptake inhibitor (SNRI). Like SSRIs, SNRIs inhibit the reuptake of
      serotonin, but also act on norepinephrine. The use of SNRIs has increased recently due to
      their slightly improved efficacy profile when compared to SSRIs. Duloxetine is an SNRI and is
      one of the most commonly prescribed anti-depressants in the United States.

      The investigators are conducting this trial to determine whether or not the administration of
      duloxetine will result in a deterioration in sperm DNA fragmentation in healthy, fertile men.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Blinded, placebo-controlled, randomized controlled trial
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Participant, investigator, and outcomes assessor are all blinded to participant's assigned group.
measure: Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks
time frame: 6 Weeks (primary time point of interest)
description: Number of participants with TUNEL values > 25% at 6 weeks in each treatment group
measure: Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks
time frame: 0 weeks
description: Number of participants with Tunel Values > 25% at 0 Weeks (baseline) in each treatment group
measure: Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks
time frame: 2 weeks
description: Number of participants with Tunel values > 25% at 2 weeks in each treatment group
measure: Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks
time frame: 8 weeks
description: Number of participants with Tunel values > 25% at 8 weeks in each treatment group
measure: Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks
time frame: 10 Weeks
description: Number of participants with Tunel values > 25% at 10 weeks in each treatment group
measure: Sperm Concentration at 0 Weeks
time frame: 0 weeks
description: Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks
measure: Sperm Concentration at 2 Weeks
time frame: 2 weeks
description: Sperm concentration (number of sperm/mL) in semen analysis at 2 weeks
measure: Sperm Concentration at 6 Weeks
time frame: 6 weeks
description: Sperm concentration (number of sperm/mL) in semen analysis at 6 weeks
measure: Sperm Concentration at 8 Weeks
time frame: 8 weeks
description: Sperm concentration (number of sperm/mL) in semen analysis at 8 weeks
measure: Sperm Concentration at 10 Weeks
time frame: 10 Weeks
description: Sperm concentration (number of sperm/mL) in semen analysis at 10 weeks
measure: Sperm Motility at 0 Weeks
time frame: 0 weeks
description: Sperm motility (mean percent) at 0 weeks
measure: Sperm Motility at 2 Weeks
time frame: 2 weeks
description: Sperm motility (mean percent) at 2 weeks
measure: Sperm Motility at 6 Weeks
time frame: 6 weeks
description: Sperm motility (mean percent) at 6 weeks
measure: Sperm Motility at 8 Weeks
time frame: 8 weeks
description: Sperm motility (mean percent) at 8 weeks
measure: Sperm Motility at 10 Weeks
time frame: 10 Weeks
description: Sperm motility (mean percent) at 10 weeks
measure: Sperm Head Defects at 0 Weeks
time frame: 0 weeks
description: Sperm head defects (mean number) at 0 weeks
measure: Sperm Head Defects at 2 Weeks
time frame: 2 weeks
description: Sperm head defects (mean number) at 2 weeks
measure: Sperm Head Defects at 6 Weeks
time frame: 6 weeks
description: Sperm head defects (mean number) at 6 weeks
measure: Sperm Head Defects at 8 Weeks
time frame: 8 weeks
description: Sperm head defects (mean number) at 8 weeks
measure: Sperm Head Defects at 10 Weeks
time frame: 10 Weeks
description: Sperm head defects (mean number) at 10 weeks
measure: Sperm Neck Defects at 0 Weeks
time frame: 0 weeks
description: Sperm neck defects (mean number) at 0 weeks
measure: Sperm Neck Defects at 2 Weeks
time frame: 2 weeks
description: Sperm neck defects (mean number) at 2 weeks
measure: Sperm Neck Defects at 6 Weeks
time frame: 6 weeks
description: Sperm neck defects (mean number) at 6 weeks
measure: Sperm Neck Defects at 8 Weeks
time frame: 8 weeks
description: Sperm neck defects (mean number) at 8 weeks
measure: Sperm Neck Defects at 10 Weeks
time frame: 10 Weeks
description: Sperm neck defects (mean number) at 10 weeks
measure: Sperm Tail Defects at 0 Weeks
time frame: 0 weeks
description: Sperm tail defects (mean number) at 0 weeks
measure: Sperm Tail Defects at 2 Weeks
time frame: 2 weeks
description: Sperm tail defects (mean number) at 2 weeks
measure: Sperm Tail Defects at 6 Weeks
time frame: 6 weeks
description: Sperm tail defects (mean number) at 6 weeks
measure: Sperm Tail Defects at 8 Weeks
time frame: 8 weeks
description: Sperm tail defects (mean number) at 8 weeks
measure: Sperm Tail Defects at 10 Weeks
time frame: 10 Weeks
description: Sperm tail defects (mean number) at 10 weeks
measure: Testosterone Level at 0 Weeks
time frame: 0 weeks
description: Testosterone level (ng/dL) at 0 weeks
measure: Testosterone Level at 2 Weeks
time frame: 2 weeks
description: Testosterone level (ng/dL) at 2 weeks
measure: Testosterone Level at 6 Weeks
time frame: 6 weeks
description: Testosterone level (ng/dL) at 6 weeks
measure: Testosterone Level at 8 Weeks
time frame: 8 weeks
description: Testosterone level (ng/dL) at 8 weeks
measure: Testosterone Level at 10 Weeks
time frame: 10 Weeks
description: Testosterone level (ng/dL) at 10 weeks
measure: Estrogen Level at 0 Weeks
time frame: 0 weeks
description: Estrogen level (pg/mL) at 0 weeks
measure: Estrogen Level at 2 Weeks
time frame: 2 weeks
description: Estrogen level (pg/mL) at 2 weeks
measure: Estrogen Level at 6 Weeks
time frame: 6 weeks
description: Estrogen level (pg/mL) at 6 weeks
measure: Estrogen Level at 8 Weeks
time frame: 8 weeks
description: Estrogen level (pg/mL) at 8 weeks
measure: Estrogen Level at 10 Weeks
time frame: 10 Weeks
description: Estrogen level (pg/mL) at 10 weeks
measure: Prolactin Level at 0 Weeks
time frame: 0 weeks
description: Prolactin level (ng/mL) at 0 weeks
measure: Prolactin Level at 2 Weeks
time frame: 2 weeks
description: Prolactin level (ng/mL) at 2 weeks
measure: Prolactin Level at 6 Weeks
time frame: 6 weeks
description: Prolactin level (ng/mL) at 6 weeks
measure: Prolactin Level at 8 Weeks
time frame: 8 weeks
description: Prolactin level (ng/mL) at 8 weeks
measure: Prolactin Level at 10 Weeks
time frame: 10 Weeks
description: Prolactin level (ng/mL) at 10 weeks
measure: Luteinizing Hormone Level at 0 Weeks
time frame: 0 weeks
description: Luteinizing hormone level (mIU/mL) at 0 weeks
measure: Luteinizing Hormone Level at 2 Weeks
time frame: 2 weeks
description: Luteinizing hormone level (mIU/mL) at 2 weeks
measure: Luteinizing Hormone Level at 6 Weeks
time frame: 6 weeks
description: Luteinizing hormone level (mIU/mL) at 6 weeks
measure: Luteinizing Hormone Level at 8 Weeks
time frame: 8 weeks
description: Luteinizing hormone level (mIU/mL) at 8 weeks
measure: Luteinizing Hormone Level at 10 Weeks
time frame: 10 Weeks
description: Luteinizing hormone level (mIU/mL) at 10 weeks
measure: Follicle Stimulating Hormone Level at 0 Weeks
time frame: 0 weeks
description: Follicle stimulating hormone level (mIU/mL) at 0 weeks
measure: Follicle Stimulating Hormone Level at 2 Weeks
time frame: 2 weeks
description: Follicle stimulating hormone level (mIU/mL) at 2 weeks
measure: Follicle Stimulating Hormone Level at 6 Weeks
time frame: 6 weeks
description: Follicle stimulating hormone level (mIU/mL) at 6 weeks
measure: Follicle Stimulating Hormone Level at 8 Weeks
time frame: 8 weeks
description: Follicle stimulating hormone level (mIU/mL) at 8 weeks
measure: Follicle Stimulating Hormone Level at 10 Weeks
time frame: 10 Weeks
description: Follicle stimulating hormone level (mIU/mL) at 10 weeks
arm group label: Duloxetine
arm group type: Experimental
description: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: Duloxetine
description: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week
arm group label: Duloxetine
intervention type: Drug
intervention name: Placebo
description: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Schlegel, MD
role: Study Chair
affiliation: Weill Medical College of Cornell University
last name: Nahid Punjani, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Male
mesh term: Duloxetine Hydrochloride
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 