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

Chronic Venous Diseases Clinical Trial

— ICODERUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451746
• Other study ID #: 000000114
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2020
• Est. completion date: June 24, 2025

Study information

• Verified date: August 2023
• Source: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
• Contact: Denis Borsuk
• Phone: +79630777333
• Email: borsuk-angio[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 24, 2025
• Est. primary completion date: July 24, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Venous Diseases

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Clinic of phlebology and laser surgery	Chelyabinsk

Sponsors (1)

Lead Sponsor	Collaborator
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development and progression of chronic venous diseases		1 year
Secondary	Deep venous thrombosis		1 year