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

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Status: Enrolling

Conditions: Chronic Venous Diseases

Treatments: Drug: Combined Oral Contraceptive

Study type: Interventional

Funder types: Other

Identifiers

NCT04451746

000000114

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Tableted hormonal drugs for contraception

Other group

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.

Treatment:

Drug: Combined Oral Contraceptive