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

Sponsor
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04451746
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Combined Oral Contraceptive
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
The Influence of Combined Oral Contraception on the DEvelopment and progRession of Chronic venoUs diSeases
Actual Study Start Date :
Jun 24, 2020
Actual Primary Completion Date :
Jul 24, 2020
Anticipated Study Completion Date :
Jun 24, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Development and progression of chronic venous diseases [1 year]

Secondary Outcome Measures

  1. Deep venous thrombosis [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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;

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinic of phlebology and laser surgery Chelyabinsk Russian Federation 454090

Sponsors and Collaborators

  • Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Investigators

  • Study Chair: Alexey Fokin, South Ural State Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Denis Borsuk, Clinic of Phlebology and Laser Surgery, Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
ClinicalTrials.gov Identifier:
NCT04451746
Other Study ID Numbers:
  • 000000114
First Posted:
Jun 30, 2020
Last Update Posted:
Aug 3, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined

Study Results

No Results Posted as of Aug 3, 2021