<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/NCT04451746</url>
  </required_header>
  <id_info>
    <org_study_id>000000114</org_study_id>
    <nct_id>NCT04451746</nct_id>
  </id_info>
  <brief_title>The Influence of Combined Oral Contraception on the DEvelopment and progRession of Chronic venoUs diSeases</brief_title>
  <acronym>ICODERUS</acronym>
  <official_title>The Influence of Combined Oral Contraception on the DEvelopment and progRession of Chronic venoUs diSeases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigation of the influence of combined oral contraception on the development and&#xD;
      progression of chronic venous diseases&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 24, 2020</start_date>
  <completion_date type="Anticipated">June 24, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 24, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Development and progression of chronic venous diseases</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Deep venous thrombosis</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chronic Venous Diseases</condition>
  <arm_group>
    <arm_group_label>Tableted hormonal drugs for contraception</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Tableted hormonal drugs for contraception, 1) COCs with bioidentical estrogen; 2) COCs with ethinyl estradiol 30mkg according to the scheme 21 + 7; 3) COCs with ethinyl estradiol 20mkg according to the scheme 21 + 7.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Combined Oral Contraceptive</intervention_name>
    <description>The investigators consistently include patients who have been prescribed hormonal tablets for contraception, namely 1) COCs with bioidentical estrogen; 2) COCs with ethinyl estradiol 30mkg according to the scheme 21 + 7; 3) COCs with ethinyl estradiol 20mkg according to the scheme 21 + 7.</description>
    <arm_group_label>Tableted hormonal drugs for contraception</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The investigators consistently include patients who have been prescribed hormonal&#xD;
             tablets for contraception, namely 1) COCs with bioidentical estrogen; 2) COCs with&#xD;
             ethinyl estradiol 30mkg according to the scheme 21 + 7; 3) COCs with ethinyl estradiol&#xD;
             20mkg according to the scheme 21 + 7.&#xD;
&#xD;
          2. Clinical class C0-1 according to CEAP;&#xD;
&#xD;
        2) Able to come for checkups every 3 months; 3) The presence of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age up to 45 years;&#xD;
&#xD;
          2. A history of surgical treatment of veins of the lower extremities;&#xD;
&#xD;
          3. Clinical class C2 and higher according to CEAP;&#xD;
&#xD;
          4. History of DVT or PE;&#xD;
&#xD;
          5. Aplasia or angio-dysplasia of deep veins;&#xD;
&#xD;
          6. Restriction of mobility;&#xD;
&#xD;
          7. Arterial insufficiency;&#xD;
&#xD;
          8. Oncological diseases.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexey Fokin</last_name>
    <role>Study Chair</role>
    <affiliation>South Ural State Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Denis Borsuk</last_name>
    <phone>+79630777333</phone>
    <email>borsuk-angio@mail.ru</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clinic of phlebology and laser surgery</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454090</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denis Borsuk</last_name>
      <phone>89630777333</phone>
      <email>borsuk-angio@mail.ru</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>August 12, 2023</last_update_submitted>
  <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia</investigator_affiliation>
    <investigator_full_name>Denis Borsuk</investigator_full_name>
    <investigator_title>Clinic of Phlebology and Laser Surgery</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Contraceptive Agents</mesh_term>
    <mesh_term>Contraceptives, Oral</mesh_term>
    <mesh_term>Contraceptives, Oral, Combined</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04451746
org study id: 000000114
nct id: NCT04451746
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Investigation of the influence of combined oral contraception on the development and
      progression of chronic venous diseases
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Development and progression of chronic venous diseases
time frame: 1 year
measure: Deep venous thrombosis
time frame: 1 year
arm group label: Tableted hormonal drugs for contraception
arm group type: Other
description: Tableted hormonal drugs for contraception, 1) COCs with bioidentical estrogen; 2) COCs with ethinyl estradiol 30mkg according to the scheme 21 + 7; 3) COCs with ethinyl estradiol 20mkg according to the scheme 21 + 7.
intervention type: Drug
intervention name: Combined Oral Contraceptive
description: The investigators consistently include patients who have been prescribed hormonal tablets for contraception, namely 1) COCs with bioidentical estrogen; 2) COCs with ethinyl estradiol 30mkg according to the scheme 21 + 7; 3) COCs with ethinyl estradiol 20mkg according to the scheme 21 + 7.
arm group label: Tableted hormonal drugs for contraception
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Alexey Fokin
role: Study Chair
affiliation: South Ural State Medical University
last name: Denis Borsuk
phone: +79630777333
email: borsuk-angio@mail.ru
facility: 
status: Recruiting
contact: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
investigator full name: Denis Borsuk
investigator title: Clinic of Phlebology and Laser Surgery
mesh term: Contraceptive Agents
mesh term: Contraceptives, Oral
mesh term: Contraceptives, Oral, Combined
sharing ipd: Undecided