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

NCT ID: NCT04451746

Last Updated: 2024-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-24

Study Completion Date

2025-08-24

Brief Summary

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

Detailed Description

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Conditions

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Chronic Venous Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Tableted hormonal drugs for contraception

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.

Group Type OTHER

Combined Oral Contraceptive

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

OTHER

Sponsor Role lead

Responsible Party

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Denis Borsuk

Clinic of Phlebology and Laser Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexey Fokin

Role: STUDY_CHAIR

South Ural State Medical University

Locations

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Clinic of phlebology and laser surgery

Chelyabinsk, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Denis Borsuk

Role: CONTACT

+79630777333

Facility Contacts

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Denis Borsuk

Role: primary

89630777333

Other Identifiers

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000000114

Identifier Type: -

Identifier Source: org_study_id

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