<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/NCT03297398</url>
  </required_header>
  <id_info>
    <org_study_id>SAR-202</org_study_id>
    <nct_id>NCT03297398</nct_id>
  </id_info>
  <brief_title>Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Dose-ranging Study of OPK-88004 Once-a-day Dosing for 16 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OPKO Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OPKO Health, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety and effectiveness of different doses of OPK-88004&#xD;
      compared to placebo on serum PSA compared to placebo in men with benign prostatic hyperplasia&#xD;
      (BPH).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study SAR-202 is a phase 2 multicenter, placebo-controlled, double-blind trial to evaluate&#xD;
      the effect of OPK-88004 doses (OPK-88004 15 mg, or OPK-88004 25 mg) on serum PSA compared to&#xD;
      placebo in men with BPH. Approximately 115 men with BPH will be enrolled in the study,&#xD;
      randomized 1:1:1 across three arms (placebo, OPK-88004 15 mg, or OPK-88004 25 mg). The trial&#xD;
      will be conducted at approximately up to 35 sites within the US.&#xD;
&#xD;
      The study duration for individual subjects will be up to 24 weeks and will include three&#xD;
      phases:&#xD;
&#xD;
        -  a screening period (up to 4 weeks, including 1-week washout if required),&#xD;
&#xD;
        -  a treatment period (16 weeks), and&#xD;
&#xD;
        -  a follow-up period (4 weeks) Subjects will be randomized and receive their first dose of&#xD;
           study drug at visit 2. They will begin the once daily oral dosing regimen and return&#xD;
           every 4 weeks to the study site during the 16-week treatment period. Assessments during&#xD;
           the study period will include vital signs, laboratory testing, weight, adverse events&#xD;
           (AEs), concomitant drugs, and study drug compliance. Efficacy assessments will include&#xD;
           serum PSA, LBM and fat mass by DXA scans, uroflowmetry parameters, PVR (by ultrasound),&#xD;
           and assessment of symptoms by IPSS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    study terminated by sponsor decision&#xD;
  </why_stopped>
  <start_date type="Actual">February 21, 2018</start_date>
  <completion_date type="Actual">June 10, 2019</completion_date>
  <primary_completion_date type="Actual">April 18, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in PSA (%) to Week 16</measure>
    <time_frame>16 weeks</time_frame>
    <description>The trial will evaluate the effect of two doses of OPK-88004 (15 mg and 25 mg) daily for 16 weeks on serum PSA compared with placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Lean Body Mass and Fat Mass From Baseline to 16 Weeks</measure>
    <time_frame>16 weeks</time_frame>
    <description>To assess the effect of OPK-88004 on body composition by DXA, specifically Lean Body Mass (LBM) and fat mass</description>
  </secondary_outcome>
  <other_outcome>
    <measure>To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Peak Flow Rate (Qmax)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Analysis peak flow rate of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16</description>
  </other_outcome>
  <other_outcome>
    <measure>To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Mean Flow Rate (Qave)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Analysis mean flow rate of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16</description>
  </other_outcome>
  <other_outcome>
    <measure>To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter-voided Volume (Vcomp)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Analysis voided of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16</description>
  </other_outcome>
  <other_outcome>
    <measure>To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Postvoid Residual Volume (PVR)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Analysis postvoid residual volume of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16</description>
  </other_outcome>
  <other_outcome>
    <measure>International Prostate Symptom Score- IPSS</measure>
    <time_frame>16 weeks</time_frame>
    <description>To evaluate the effects of OPK-88004 on the symptoms of BPH as determined by International prostate symptom score (IPSS score), Total IPSS score as measured by the sum of questions 1 through 7, the IPSS Irritative Domain (sum of questions 2, 4 and 7), and the IPSS Obstructive Domain (sum of questions 1, 3, 5 and 6)IPSS QoL question (IPSS question 8). Mild (symptoms score less than or equal to 7), moderate (symptoms score range 8-19), severe (symptom score 20-35)</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Benign Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Other</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15mg, OPK-88004</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25,mg OPK-88004</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Group-1 (15mg, OPK-88004)</intervention_name>
    <description>15mg, OPK-88004</description>
    <arm_group_label>Drug Group 1</arm_group_label>
    <other_name>Selective Androgen Receptor Modulator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Group-2 (25 mg,OPK-88004)</intervention_name>
    <description>25 mg,OPK-88004</description>
    <arm_group_label>Drug Group 2</arm_group_label>
    <other_name>Selective Androgen Receptor Modulator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Other</arm_group_label>
    <other_name>Inactive</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Subjects are eligible if they meet the following criteria:&#xD;
&#xD;
          1. Present with BPH-LUTS based on disease diagnostic criteria at visit 1&#xD;
&#xD;
          2. Are men aged 45 years or older at visit 1&#xD;
&#xD;
          3. Have prostate volume &gt;40 cm3 and &lt;80 cm3 assessed by TRUS at visit 1&#xD;
&#xD;
          4. Have a PSA &gt;1.5 and &lt;10.0 ng/mL at visit 1. This PSA blood draw must be performed at&#xD;
             least 1 week after any digital rectal exam (DRE) and/or transrectal ultrasound (TRUS)&#xD;
             procedures&#xD;
&#xD;
          5. Subjects with a PSA ≥4.0 and &lt;10.0 ng/mL must have documentation of a negative&#xD;
             histologic biopsy of carcinoma of the prostate within 12 months of screening (visit&#xD;
             1). For subjects aged ≤80 years and who have not undergone any invasive urological&#xD;
             procedure within 6 months, if biopsy has not been performed, then 4Kscore Test value&#xD;
             must be &lt;7.5% at visit 1&#xD;
&#xD;
          6. Have laboratory tests within normal limits (with the exception of total serum or free&#xD;
             testosterone). If laboratory test results are outside normal limits they are&#xD;
             determined to be not clinically significant at visit 1&#xD;
&#xD;
          7. Have not received prior treatment with 5-ARIs (finasteride, dutasteride) within the&#xD;
             past one year for any indication&#xD;
&#xD;
          8. Have not received herbal BPH preparations within 1 week of visit 1. If the subject is&#xD;
             currently on such treatment, a 1-week washout period will be required&#xD;
&#xD;
          9. Agree not to use 5-ARIs, herbal or experimental treatments for BPH, at any time during&#xD;
             the study. Subjects on daily PDE5i's, alpha-blockers or anticholinergic medications&#xD;
             for BPH should remain on a stable dose during the study, unless a change in dose is&#xD;
             medically warranted. Occasional-use PDE5i's for ED are permitted at a stable dose and&#xD;
             frequency, however should not be taken within 72 hours prior to a study visit&#xD;
&#xD;
         10. Agree to use an acceptable method of birth control during the study and for 60 days&#xD;
             after the last dose of IP, unless the female partner is postmenopausal. Postmenopausal&#xD;
             is defined as a female &gt;50 years of age and 12 months of amenorrhea, or surgically&#xD;
             postmenopausal&#xD;
&#xD;
         11. Are reliable and willing to make themselves available for the duration of the study,&#xD;
             and who will comply with the required study and dosing visits and abide by the&#xD;
             Clinical Research Site policy and procedure and study restrictions&#xD;
&#xD;
         12. Have given written informed consent&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        Patients will be excluded from study enrollment if they meet any of the following criteria&#xD;
        at visit 1:&#xD;
&#xD;
          1. History of any of the following pelvic conditions:&#xD;
&#xD;
               -  radical prostatectomy, pelvic surgery for removal of malignancy, or bowel&#xD;
                  resection&#xD;
&#xD;
               -  pelvic radiotherapy&#xD;
&#xD;
               -  any pelvic surgical procedure on the urinary tract, including transurethral&#xD;
                  resection of the prostate (TURP), penile implant surgery&#xD;
&#xD;
               -  lower urinary tract malignancy or trauma&#xD;
&#xD;
               -  pelvic surgery or any other pelvic procedure less than 6 months prior to visit 1&#xD;
&#xD;
          2. Lower urinary tract instrumentation (including prostate biopsy) within 6 weeks prior&#xD;
             to screening PSA blood draw&#xD;
&#xD;
          3. History of urinary retention or lower urinary tract (bladder) stones within 1 month of&#xD;
             visit 1&#xD;
&#xD;
          4. Minimally invasive procedures for BPH, such as prostatic stent, high intensity focused&#xD;
             ultrasound (HIFU), holmium laser enucleation of prostate (HoLEP), interstitial laser&#xD;
             coagulation (ILC), transurethral electroevaporation of the prostate (TUVP),&#xD;
             transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA),&#xD;
             photoselective vaporization (PVP), UroLift, within 6 weeks&#xD;
&#xD;
          5. Clinical evidence of urinary tract infection or urinary tract inflammation (including&#xD;
             prostatitis)&#xD;
&#xD;
          6. Intravesical obstruction (eg, intravesical median lobe of the prostate)&#xD;
&#xD;
          7. Current neurologic disease or condition associated with neurogenic bladder (eg,&#xD;
             Parkinson's disease, multiple sclerosis)&#xD;
&#xD;
          8. History of significant renal insufficiency, defined as receiving renal dialysis or&#xD;
             having an estimated creatinine clearance &lt;45 mL/min&#xD;
&#xD;
          9. Active hepatobiliary disease or serologic evidence of active hepatitis A, B, C,&#xD;
             hepatitis E or HIV&#xD;
&#xD;
         10. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2X the&#xD;
             upper limit of normal (ULN)&#xD;
&#xD;
         11. Glycosylated hemoglobin (HbA1c) &gt;9%&#xD;
&#xD;
         12. Hematocrit ≥50%&#xD;
&#xD;
         13. HDL-C &lt;35 mg/dL and LDL-C &gt;130 mg/dL&#xD;
&#xD;
         14. QTcB interval &gt;450 msec. For heart rates over 75, the ECG may be repeated after 5&#xD;
             minutes of resting quietly&#xD;
&#xD;
         15. Abnormality in ECG (eg, left bundle branch block, complete right bundle branch block,&#xD;
             or delayed intraventricular conduction with a QRS interval &gt;120 msec) that in the&#xD;
             opinion of the investigator places the subject at an unacceptable risk for study&#xD;
             participation, or subject has implanted pacemaker&#xD;
&#xD;
         16. History of any of the following cardiac/coronary conditions within 90 days:&#xD;
&#xD;
               -  history of myocardial infarction or coronary artery bypass graft&#xD;
&#xD;
               -  percutaneous coronary intervention&#xD;
&#xD;
               -  stroke&#xD;
&#xD;
         17. Any evidence of heart disease (NYHA ≥Class II, Appendix 4) within 6 months, or are&#xD;
             receiving treatment for congestive heart failure (CHF)&#xD;
&#xD;
         18. Any supraventricular or ventricular arrhythmia with uncontrolled ventricular response&#xD;
             (mean heart rate &gt;100 bpm) at rest despite medical therapy&#xD;
&#xD;
         19. Systolic blood pressure &gt;160 or &lt;90 mm Hg or diastolic blood pressure &gt;100 or &lt;50 mm&#xD;
             Hg as determined by a sitting measurement (if stress is suspected, retest up to two&#xD;
             times under basal conditions), or malignant hypertension&#xD;
&#xD;
         20. Have a history or presence of prostatic carcinoma, as well as any conditions that may&#xD;
             be exacerbated by androgenic medications such as (but not limited to) epilepsy,&#xD;
             seizures, convulsions, migraine or polycythemia&#xD;
&#xD;
         21. History of cancer within the previous 5 years, except for excised superﬁcial lesions&#xD;
             (such as basal cell carcinoma and squamous cell carcinoma of the skin)&#xD;
&#xD;
         22. History of drug, alcohol, or substance abuse within 6 months&#xD;
&#xD;
         23. Have an alcohol intake of ≥3 units/day or ≥14 units/week during the study (1 unit = 12&#xD;
             ounces of beer, 5 ounces of wine, 1.5 ounces of distilled spirits)&#xD;
&#xD;
         24. Any condition that would interfere with subject's ability to provide informed consent&#xD;
             or comply with study instructions, would impair ability to perform the study&#xD;
             assessments, or would place subject at increased risk, or might confound the&#xD;
             interpretation of the study results&#xD;
&#xD;
         25. Current treatment with androgens, antiandrogens, estrogens, or anabolic steroids&#xD;
             within the prior 1 month. Any prior or current treatment with LHRH&#xD;
             agonists/antagonists&#xD;
&#xD;
         26. Current treatment with potent CYP3A4 inhibitors such as itraconazole or ritonavir&#xD;
&#xD;
         27. Have taken prescription or over-the-counter medications to promote weight loss within&#xD;
             the prior 3 months&#xD;
&#xD;
         28. Any prior use of OPK-88004 Allergic to any component of OPK-88004&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Militza Vera De Alba, MD</last_name>
    <role>Study Director</role>
    <affiliation>Dr.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pinnacle Research Group</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <zip>36207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Research</name>
      <address>
        <city>Lincoln</city>
        <state>California</state>
        <zip>95648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern California Research</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bayview Research Group, LLC - Valley Village</name>
      <address>
        <city>Valley Village</city>
        <state>California</state>
        <zip>91607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Medical Research</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APF Research, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research - Brooksville</name>
      <address>
        <city>Spring Hill</city>
        <state>Florida</state>
        <zip>34609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Urology Partners</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research - Boise</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Urology</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centennial Medical Group</name>
      <address>
        <city>Elkridge</city>
        <state>Maryland</state>
        <zip>21075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AccuMed Research Associates</name>
      <address>
        <city>Garden City</city>
        <state>New York</state>
        <zip>11530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manhattan Medical Research Practice PLLC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas, Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <results_first_submitted>July 2, 2021</results_first_submitted>
  <results_first_submitted_qc>July 2, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 28, 2021</results_first_posted>
  <last_update_submitted>August 23, 2021</last_update_submitted>
  <last_update_submitted_qc>August 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ascorbic Acid</mesh_term>
    <mesh_term>Methyltestosterone</mesh_term>
    <mesh_term>Androgens</mesh_term>
    <mesh_term>Estrogens, Conjugated (USP)</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03297398/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03297398/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo Group&#xD;
Placebo: Placebo</description>
        </group>
        <group group_id="P2">
          <title>OPK-88004 15 mg</title>
          <description>15mg, OPK-88004&#xD;
Group-1 (15mg, OPK-88004): 15mg, OPK-88004</description>
        </group>
        <group group_id="P3">
          <title>OPK-88004 25 mg</title>
          <description>25mg, OPK-88004&#xD;
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Sponsor's decision</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Other</title>
          <description>Placebo Group&#xD;
Placebo: Placebo</description>
        </group>
        <group group_id="B2">
          <title>Drug Group 1</title>
          <description>15mg, OPK-88004&#xD;
Group-1 (15mg, OPK-88004): 15mg, OPK-88004</description>
        </group>
        <group group_id="B3">
          <title>Drug Group 2</title>
          <description>25,mg OPK-88004&#xD;
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="36"/>
            <count group_id="B2" value="40"/>
            <count group_id="B3" value="38"/>
            <count group_id="B4" value="114"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.1" spread="6.52"/>
                    <measurement group_id="B2" value="64.5" spread="5.77"/>
                    <measurement group_id="B3" value="65.3" spread="6.01"/>
                    <measurement group_id="B4" value="64.6" spread="6.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="99"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight (kilogram)</title>
          <units>Kilogram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94.97" spread="16.937"/>
                    <measurement group_id="B2" value="95.31" spread="19.128"/>
                    <measurement group_id="B3" value="91.35" spread="13.564"/>
                    <measurement group_id="B4" value="93.88" spread="16.692"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index (kilogram/meter^2)</title>
          <units>Kilogram/meter^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.17" spread="5.114"/>
                    <measurement group_id="B2" value="30.37" spread="5.286"/>
                    <measurement group_id="B3" value="29.36" spread="3.442"/>
                    <measurement group_id="B4" value="29.97" spread="4.671"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in PSA (%) to Week 16</title>
        <description>The trial will evaluate the effect of two doses of OPK-88004 (15 mg and 25 mg) daily for 16 weeks on serum PSA compared with placebo</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Other</title>
            <description>Placebo Group&#xD;
Placebo: Placebo</description>
          </group>
          <group group_id="O2">
            <title>Drug Group 1</title>
            <description>15mg, OPK-88004&#xD;
Group-1 (15mg, OPK-88004): 15mg, OPK-88004</description>
          </group>
          <group group_id="O3">
            <title>Drug Group 2</title>
            <description>25,mg OPK-88004&#xD;
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PSA (%) to Week 16</title>
          <description>The trial will evaluate the effect of two doses of OPK-88004 (15 mg and 25 mg) daily for 16 weeks on serum PSA compared with placebo</description>
          <units>Percentage of serum PSA change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.96" spread="5.198"/>
                    <measurement group_id="O2" value="-1.48" spread="5.569"/>
                    <measurement group_id="O3" value="-15.44" spread="5.509"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Lean Body Mass and Fat Mass From Baseline to 16 Weeks</title>
        <description>To assess the effect of OPK-88004 on body composition by DXA, specifically Lean Body Mass (LBM) and fat mass</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Other</title>
            <description>Placebo Group&#xD;
Placebo: Placebo</description>
          </group>
          <group group_id="O2">
            <title>Drug Group 1</title>
            <description>15mg, OPK-88004&#xD;
Group-1 (15mg, OPK-88004): 15mg, OPK-88004</description>
          </group>
          <group group_id="O3">
            <title>Drug Group 2</title>
            <description>25,mg OPK-88004&#xD;
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Lean Body Mass and Fat Mass From Baseline to 16 Weeks</title>
          <description>To assess the effect of OPK-88004 on body composition by DXA, specifically Lean Body Mass (LBM) and fat mass</description>
          <units>gram</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline in Lean Body Mass (g) to Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.8" spread="439.62"/>
                    <measurement group_id="O2" value="1610.3" spread="489.45"/>
                    <measurement group_id="O3" value="1961.6" spread="522.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in Fat Mass (g) to Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-198.2" spread="326.84"/>
                    <measurement group_id="O2" value="-1468.7" spread="373.06"/>
                    <measurement group_id="O3" value="-1491.3" spread="388.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Peak Flow Rate (Qmax)</title>
        <description>Analysis peak flow rate of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Other</title>
            <description>Placebo Group&#xD;
Placebo: Placebo</description>
          </group>
          <group group_id="O2">
            <title>Drug Group 1</title>
            <description>15mg, OPK-88004&#xD;
Group-1 (15mg, OPK-88004): 15mg, OPK-88004</description>
          </group>
          <group group_id="O3">
            <title>Drug Group 2</title>
            <description>25,mg OPK-88004&#xD;
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004</description>
          </group>
        </group_list>
        <measure>
          <title>To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Peak Flow Rate (Qmax)</title>
          <description>Analysis peak flow rate of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16</description>
          <units>millilitre/second</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.26" spread="3.810"/>
                    <measurement group_id="O2" value="0.61" spread="4.072"/>
                    <measurement group_id="O3" value="1.08" spread="4.043"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Mean Flow Rate (Qave)</title>
        <description>Analysis mean flow rate of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Other</title>
            <description>Placebo Group&#xD;
Placebo: Placebo</description>
          </group>
          <group group_id="O2">
            <title>Drug Group 1</title>
            <description>15mg, OPK-88004&#xD;
Group-1 (15mg, OPK-88004): 15mg, OPK-88004</description>
          </group>
          <group group_id="O3">
            <title>Drug Group 2</title>
            <description>25,mg OPK-88004&#xD;
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004</description>
          </group>
        </group_list>
        <measure>
          <title>To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Mean Flow Rate (Qave)</title>
          <description>Analysis mean flow rate of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16</description>
          <units>millilitre/second</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.40" spread="0.475"/>
                    <measurement group_id="O2" value="-0.30" spread="0.509"/>
                    <measurement group_id="O3" value="0.15" spread="0.505"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter-voided Volume (Vcomp)</title>
        <description>Analysis voided of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Other</title>
            <description>Placebo Group&#xD;
Placebo: Placebo</description>
          </group>
          <group group_id="O2">
            <title>Drug Group 1</title>
            <description>15mg, OPK-88004&#xD;
Group-1 (15mg, OPK-88004): 15mg, OPK-88004</description>
          </group>
          <group group_id="O3">
            <title>Drug Group 2</title>
            <description>25,mg OPK-88004&#xD;
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004</description>
          </group>
        </group_list>
        <measure>
          <title>To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter-voided Volume (Vcomp)</title>
          <description>Analysis voided of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16</description>
          <units>millilitre</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-49.12" spread="21.294"/>
                    <measurement group_id="O2" value="-2.28" spread="22.501"/>
                    <measurement group_id="O3" value="-29.12" spread="22.714"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Postvoid Residual Volume (PVR)</title>
        <description>Analysis postvoid residual volume of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Other</title>
            <description>Placebo Group&#xD;
Placebo: Placebo</description>
          </group>
          <group group_id="O2">
            <title>Drug Group 1</title>
            <description>15mg, OPK-88004&#xD;
Group-1 (15mg, OPK-88004): 15mg, OPK-88004</description>
          </group>
          <group group_id="O3">
            <title>Drug Group 2</title>
            <description>25,mg OPK-88004&#xD;
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004</description>
          </group>
        </group_list>
        <measure>
          <title>To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Postvoid Residual Volume (PVR)</title>
          <description>Analysis postvoid residual volume of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16</description>
          <units>millilitre</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="10.365"/>
                    <measurement group_id="O2" value="17.63" spread="11.325"/>
                    <measurement group_id="O3" value="-15.19" spread="10.925"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>International Prostate Symptom Score- IPSS</title>
        <description>To evaluate the effects of OPK-88004 on the symptoms of BPH as determined by International prostate symptom score (IPSS score), Total IPSS score as measured by the sum of questions 1 through 7, the IPSS Irritative Domain (sum of questions 2, 4 and 7), and the IPSS Obstructive Domain (sum of questions 1, 3, 5 and 6)IPSS QoL question (IPSS question 8). Mild (symptoms score less than or equal to 7), moderate (symptoms score range 8-19), severe (symptom score 20-35)</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Other</title>
            <description>Placebo Group&#xD;
Placebo: Placebo</description>
          </group>
          <group group_id="O2">
            <title>Drug Group 1</title>
            <description>15mg, OPK-88004&#xD;
Group-1 (15mg, OPK-88004): 15mg, OPK-88004</description>
          </group>
          <group group_id="O3">
            <title>Drug Group 2</title>
            <description>25,mg OPK-88004&#xD;
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004</description>
          </group>
        </group_list>
        <measure>
          <title>International Prostate Symptom Score- IPSS</title>
          <description>To evaluate the effects of OPK-88004 on the symptoms of BPH as determined by International prostate symptom score (IPSS score), Total IPSS score as measured by the sum of questions 1 through 7, the IPSS Irritative Domain (sum of questions 2, 4 and 7), and the IPSS Obstructive Domain (sum of questions 1, 3, 5 and 6)IPSS QoL question (IPSS question 8). Mild (symptoms score less than or equal to 7), moderate (symptoms score range 8-19), severe (symptom score 20-35)</description>
          <units>Total IPSS score</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="23"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" spread="7.70"/>
                    <measurement group_id="O2" value="12.8" spread="6.21"/>
                    <measurement group_id="O3" value="14.2" spread="7.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Other</title>
          <description>Placebo Group&#xD;
Placebo: Placebo</description>
        </group>
        <group group_id="E2">
          <title>Drug Group 1</title>
          <description>15mg, OPK-88004&#xD;
Group-1 (15mg, OPK-88004): 15mg, OPK-88004</description>
        </group>
        <group group_id="E3">
          <title>Drug Group 2</title>
          <description>25,mg OPK-88004&#xD;
Group-2 (25 mg,OPK-88004): 25 mg,OPK-88004</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="30" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood testosterone decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Low density lipoprotein increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>High density lipoprotein decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Prostatic specific antigen increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Blood testosterone free decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Sperm concentration decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Apolipoprotein B increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Blood creatine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The obligations of non-disclosure and non-use set forth in the confidentiality is 10 years after expiration of the agreement</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>OPKO Health Inc</name_or_title>
      <organization>OPKO Health Inc</organization>
      <phone>3055754100</phone>
      <email>contact@opko.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03297398
org study id: SAR-202
nct id: NCT03297398
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the safety and effectiveness of different doses of OPK-88004
      compared to placebo on serum PSA compared to placebo in men with benign prostatic hyperplasia
      (BPH).
Study SAR-202 is a phase 2 multicenter, placebo-controlled, double-blind trial to evaluate
      the effect of OPK-88004 doses (OPK-88004 15 mg, or OPK-88004 25 mg) on serum PSA compared to
      placebo in men with BPH. Approximately 115 men with BPH will be enrolled in the study,
      randomized 1:1:1 across three arms (placebo, OPK-88004 15 mg, or OPK-88004 25 mg). The trial
      will be conducted at approximately up to 35 sites within the US.

      The study duration for individual subjects will be up to 24 weeks and will include three
      phases:

        -  a screening period (up to 4 weeks, including 1-week washout if required),

        -  a treatment period (16 weeks), and

        -  a follow-up period (4 weeks) Subjects will be randomized and receive their first dose of
           study drug at visit 2. They will begin the once daily oral dosing regimen and return
           every 4 weeks to the study site during the 16-week treatment period. Assessments during
           the study period will include vital signs, laboratory testing, weight, adverse events
           (AEs), concomitant drugs, and study drug compliance. Efficacy assessments will include
           serum PSA, LBM and fat mass by DXA scans, uroflowmetry parameters, PVR (by ultrasound),
           and assessment of symptoms by IPSS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change From Baseline in PSA (%) to Week 16
time frame: 16 weeks
description: The trial will evaluate the effect of two doses of OPK-88004 (15 mg and 25 mg) daily for 16 weeks on serum PSA compared with placebo
measure: Absolute Change in Lean Body Mass and Fat Mass From Baseline to 16 Weeks
time frame: 16 weeks
description: To assess the effect of OPK-88004 on body composition by DXA, specifically Lean Body Mass (LBM) and fat mass
measure: To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Peak Flow Rate (Qmax)
time frame: 16 weeks
description: Analysis peak flow rate of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
measure: To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Mean Flow Rate (Qave)
time frame: 16 weeks
description: Analysis mean flow rate of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
measure: To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter-voided Volume (Vcomp)
time frame: 16 weeks
description: Analysis voided of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
measure: To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Postvoid Residual Volume (PVR)
time frame: 16 weeks
description: Analysis postvoid residual volume of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
measure: International Prostate Symptom Score- IPSS
time frame: 16 weeks
description: To evaluate the effects of OPK-88004 on the symptoms of BPH as determined by International prostate symptom score (IPSS score), Total IPSS score as measured by the sum of questions 1 through 7, the IPSS Irritative Domain (sum of questions 2, 4 and 7), and the IPSS Obstructive Domain (sum of questions 1, 3, 5 and 6)IPSS QoL question (IPSS question 8). Mild (symptoms score less than or equal to 7), moderate (symptoms score range 8-19), severe (symptom score 20-35)
arm group label: Other
arm group type: Placebo Comparator
description: Placebo Group
arm group label: Drug Group 1
arm group type: Experimental
description: 15mg, OPK-88004
arm group label: Drug Group 2
arm group type: Experimental
description: 25,mg OPK-88004
intervention type: Drug
intervention name: Group-1 (15mg, OPK-88004)
description: 15mg, OPK-88004
arm group label: Drug Group 1
other name: Selective Androgen Receptor Modulator
intervention type: Drug
intervention name: Group-2 (25 mg,OPK-88004)
description: 25 mg,OPK-88004
arm group label: Drug Group 2
other name: Selective Androgen Receptor Modulator
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Other
other name: Inactive
criteria: 
gender: Male
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Militza Vera De Alba, MD
role: Study Director
affiliation: Dr.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Ascorbic Acid
mesh term: Methyltestosterone
mesh term: Androgens
mesh term: Estrogens, Conjugated (USP)
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 