<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/NCT03002948</url>
  </required_header>
  <id_info>
    <org_study_id>ECTO</org_study_id>
    <nct_id>NCT03002948</nct_id>
  </id_info>
  <brief_title>Effect of Clitoris Location on Orgasm</brief_title>
  <acronym>ECTO</acronym>
  <official_title>Effect of Clitoris Topography on Orgasm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Topography and location of clitoris and its parts may affect the orgasm&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Orgasm measurement via Orgasm domain of Female Sexual Function Index, clitoris volume,&#xD;
      suprapubic angle, urethra-levator gap, suburethral triangle area measurement could made using&#xD;
      4 D transperineal ultrasonography. Clitoris fourchette distance, clitoris perineal body&#xD;
      distance, clitoris urethra distance could made with special compasses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>orgasm score</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Sexual Dysfunction</condition>
  <arm_group>
    <arm_group_label>Low orgasm</arm_group_label>
    <description>Female Sexual Function Index orgasm score below 3.6</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Orgasm</intervention_name>
    <description>clitoris volume, suprapubic angle, urethra-levator gap, suburethral triangle area measurement could made using 4 D transperineal ultrasonography. Clitoris fourchette distance, clitoris perineal body distance, clitoris urethra distance could made with special compasses.&#xD;
Female Sexual Function Index orgasm domain score</description>
    <arm_group_label>Low orgasm</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        sexually active women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sexually active women between 18 and 50 years old&#xD;
&#xD;
          -  BMI below 40 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI over 40 mhg/m2,&#xD;
&#xD;
          -  Women younger than 18 years old&#xD;
&#xD;
          -  Virgins&#xD;
&#xD;
          -  No active sexual intercourse, women with&#xD;
&#xD;
          -  Handicapped to get lithotomy position&#xD;
&#xD;
          -  Active vulvar and vaginal infection&#xD;
&#xD;
          -  Psychiatric diseases&#xD;
&#xD;
          -  Drug usage that may cause sexual dysfunction, menopause.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>March 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bezmialem Vakif University</investigator_affiliation>
    <investigator_full_name>Serdar Aydın</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03002948
org study id: ECTO
nct id: NCT03002948
lead sponsor: 
has dmc: No
Topography and location of clitoris and its parts may affect the orgasm
Orgasm measurement via Orgasm domain of Female Sexual Function Index, clitoris volume,
      suprapubic angle, urethra-levator gap, suburethral triangle area measurement could made using
      4 D transperineal ultrasonography. Clitoris fourchette distance, clitoris perineal body
      distance, clitoris urethra distance could made with special compasses.
observational model: Cohort
time perspective: Cross-Sectional
measure: orgasm score
time frame: 12 weeks
arm group label: Low orgasm
description: Female Sexual Function Index orgasm score below 3.6
intervention type: Other
intervention name: Orgasm
description: clitoris volume, suprapubic angle, urethra-levator gap, suburethral triangle area measurement could made using 4 D transperineal ultrasonography. Clitoris fourchette distance, clitoris perineal body distance, clitoris urethra distance could made with special compasses.
Female Sexual Function Index orgasm domain score
arm group label: Low orgasm
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Bezmialem Vakif University
investigator full name: Serdar Aydın
investigator title: MD
sharing ipd: No