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Completed

NCT Number: NCT04451746

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

Investigation of the influence of combined oral contraception on the development and progression of chronic venous diseases

Completed

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Key information

Conditions

Chronic Venous Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinic of phlebology and laser surgery

Chelyabinsk, 454090, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Clinical class C0-1 according to CEAP;
  • Able to come for checkups every 3 months; 3) The presence of informed consent.

Exclusion criteria

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

Treatment and study plan

Combined oral contraceptive

Drug

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.

Primary outcomes

  1. Development and progression of chronic venous diseases

    Time frame: 1 year

Secondary outcomes

  1. Deep venous thrombosis

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Other

Registry information

Acronym: ICODERUS

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2020
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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