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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04451746
Acronym
ICODERUS
Enrollment
116
Registered
2020-06-30
Start date
2020-06-24
Completion date
2026-02-23
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Venous Diseases

Brief summary

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

Interventions

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.

Sponsors

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Development and progression of chronic venous diseases1 year

Secondary

MeasureTime frame
Deep venous thrombosis1 year

Countries

Russia

Contacts

STUDY_CHAIRAlexey Fokin

South Ural State Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026