The Influence of Combined Oral Contraception on the DEvelopment and progRession of Chronic venoUs diSeases (ICODERUS)

March 4, 2026 updated by: Denis Borsuk, Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
Investigation of the influence of combined oral contraception on the development and progression of chronic venous diseases

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
      • Chelyabinsk, Russia, 454090
        • Clinic of phlebology and laser surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Clinical class C0-1 according to CEAP;

2) Able to come for checkups every 3 months; 3) The presence of informed consent.

Exclusion Criteria:

  1. Age up to 45 years;
  2. A history of surgical treatment of veins of the lower extremities;
  3. Clinical class C2 and higher according to CEAP;
  4. History of DVT or PE;
  5. Aplasia or angio-dysplasia of deep veins;
  6. Restriction of mobility;
  7. Arterial insufficiency;
  8. Oncological diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tableted hormonal drugs for contraception
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.
Drug: Combined Oral Contraceptive
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development and progression of chronic venous diseases
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Deep venous thrombosis
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Investigators

  • Study Chair: Alexey Fokin, South Ural State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2020

Primary Completion (Actual)

February 23, 2026

Study Completion (Actual)

February 23, 2026

Study Registration Dates

First Submitted

June 24, 2020

First Submitted That Met QC Criteria

June 25, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000000114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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