xml: <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/NCT05979467</url>
    </required_header>
    <id_info>
      <org_study_id>E-18-23-52</org_study_id>
      <nct_id>NCT05979467</nct_id>
    </id_info>
    <brief_title>The Relationship Between Serum Endocan and ADMA Levels and Penile Doppler Ultrasonography in Erectile Dysfunction</brief_title>
    <official_title>The Relationship Between Serum Endocan and ADMA Levels and Penile Doppler Ultrasonography Findings in Patients With Vasculogenic Erectile Dysfunction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ankara Etlik City Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ankara Etlik City Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        The gold standard diagnosis in patients admitted to the hospital with the complaint of&#xD;
        erectile dysfunction is penile doppler ultrasonography. This procedure is an invasive&#xD;
        procedure and can cause various complications. Therefore, in this study, we aimed to support&#xD;
        and define the diagnosis of erectile dysfunction with some biomarkers that can be measured in&#xD;
        blood samples. At this point, we performed penile doppler ultrasonography, which is the gold&#xD;
        standard test, for all patients who applied with the complaint of erectile dysfunction, and&#xD;
        compared the results of penile doppler and serum biomarkers in the patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 17, 2017</start_date>
    <completion_date type="Actual">June 12, 2020</completion_date>
    <primary_completion_date type="Actual">January 20, 2020</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate the relationship between serum endocan (endothelial cell-specific molecule-1), ADMA (asymmetric dimethylarginine) values and penile Doppler ultrasonography findings in patients with severe Erectile dysfunction.</measure>
      <time_frame>10 days from the outpatient clinic admission</time_frame>
    </primary_outcome>
    <enrollment type="Actual">73</enrollment>
    <condition>Evaluation of the Relationship Between Serum Biomarkers (Endocan and ADMA) and Penile Doppler Ultrasonography Findings of Patients With Severe Erectile Dysf</condition>
    <eligibility>
      <study_pop>
        <textblock>
          tertiary care clinic&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with severe erectile dysfunction according to International Index of Erectile&#xD;
               Function-15 questionnaire&#xD;
  &#xD;
            -  Patients who have not received medical or surgical treatment before&#xD;
  &#xD;
            -  Patients without comorbidity and related drug use&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have had previous pelvic trauma or surgery,&#xD;
  &#xD;
            -  Patients who have benefited from using phosphodiesterase-5 enzyme inhibitors,&#xD;
  &#xD;
            -  Patients with psychogenic erectile dysfunction and moderate or mild erectile&#xD;
               dysfunction according to International Index of Erectile Function-15 questionnaire,&#xD;
  &#xD;
            -  Patients who have neurological disease, chronic liver disease and patients with&#xD;
               chronic renal failure and those who used drugs that could cause erectile dysfunction&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Because erectile dysfunction is a male-specific disease</gender_description>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Ankara City Hospital Bilkent</name>
        <address>
          <city>Ankara</city>
          <zip>06800</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ankara Etlik City Hospital</investigator_affiliation>
      <investigator_full_name>Cagri Akpinar</investigator_full_name>
      <investigator_title>M.D.</investigator_title>
    </responsible_party>
    <keyword>Erectile dysfunction</keyword>
    <keyword>Endocan</keyword>
    <keyword>ADMA</keyword>
    <keyword>Penile Doppler</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Erectile Dysfunction</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979467
  org study id: E-18-23-52
  nct id: NCT05979467
  lead sponsor: 
  has dmc: No
  The gold standard diagnosis in patients admitted to the hospital with the complaint of
        erectile dysfunction is penile doppler ultrasonography. This procedure is an invasive
        procedure and can cause various complications. Therefore, in this study, we aimed to support
        and define the diagnosis of erectile dysfunction with some biomarkers that can be measured in
        blood samples. At this point, we performed penile doppler ultrasonography, which is the gold
        standard test, for all patients who applied with the complaint of erectile dysfunction, and
        compared the results of penile doppler and serum biomarkers in the patients.
  observational model: Cohort
  time perspective: Prospective
  measure: To evaluate the relationship between serum endocan (endothelial cell-specific molecule-1), ADMA (asymmetric dimethylarginine) values and penile Doppler ultrasonography findings in patients with severe Erectile dysfunction.
  time frame: 10 days from the outpatient clinic admission
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Because erectile dysfunction is a male-specific disease
  minimum age: 50 Years
  maximum age: 70 Years
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ankara Etlik City Hospital
  investigator full name: Cagri Akpinar
  investigator title: M.D.
  mesh term: Erectile Dysfunction