The Influence of Combined Oral Contraception on the DEvelopment and progRession of Chronic venoUs diSeases
Not Applicable
Recruiting
- Conditions
- Chronic Venous Diseases
- Interventions
- Drug: Combined Oral Contraceptive
- Registration Number
- NCT04451746
- Lead Sponsor
- Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
- Brief Summary
Investigation of the influence of combined oral contraception on the development and progression of chronic venous diseases
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tableted hormonal drugs for contraception Combined Oral Contraceptive 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.
- Primary Outcome Measures
Name Time Method Development and progression of chronic venous diseases 1 year
- Secondary Outcome Measures
Name Time Method Deep venous thrombosis 1 year
Trial Locations
- Locations (1)
Clinic of phlebology and laser surgery
🇷🇺Chelyabinsk, Russian Federation