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

NCT04451746 | Completed

• 1 other identifier: 000000114
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Venous Diseases

Outcome Measures

Primary Outcomes (1)

• Development and progression of chronic venous diseases

  1 year

Secondary Outcomes (1)

• Deep venous thrombosis

  1 year

Study Arms (1)

Tableted hormonal drugs for contraception

OTHER

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.

Drug: Combined Oral Contraceptive

Interventions

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.

Tableted hormonal drugs for contraception

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia: lead

Study Sites (1)

Clinic of phlebology and laser surgery

Chelyabinsk, 454090, Russia

Location

MeSH Terms

Interventions

Contraceptives, Oral, Combined

Intervention Hierarchy (Ancestors)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Alexey Fokin

  South Ural State Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic of Phlebology and Laser Surgery

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 30, 2020
• Study Start: June 24, 2020
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

RU (1)