Chronic Venous DiseasesICODERUSNCT04451746
The Influence of Combined Oral Contraception on the DEvelopment and progRession of Chronic venoUs diSeases
A study testing Combined Oral Contraceptive in people with Chronic Venous Diseases, run by Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia at 1 site in Russia.
Trial summary
Investigation of the influence of combined oral contraception on the development and progression of chronic venous diseases Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Chronic Venous Diseases
- What is being tested?
- Combined Oral Contraceptive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteRussia
- Study dates
- 24 Jun 2020to 23 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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;
- 2) Able to come for checkups every 3 months; 3) The presence of informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Investigation of the influence of combined oral contraception on the development and progression of chronic venous diseases
- Conditions
- Chronic Venous Diseases
- Being tested
- Combined Oral Contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Oral ContraceptiveDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Combined Oral Contraceptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development and progression of chronic venous diseases
Measured: 1 year
Secondary outcomes (1)
Deep venous thrombosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start24 Jun 2020
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis Borsuk, Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
- Investigators
- Alexey Fokin, Study chair, South Ural State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451746
- Sponsor's protocol ID
- 000000114
- Acronym
- ICODERUS
- Status last verified
- Mar 2026
- First submitted
- 24 Jun 2020
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Combined Oral Contraception on the DEvelopment and progRession of Chronic venoUs diSeases
- ClinicalTrials.gov ID
- NCT04451746
- Acronym / sponsor ID
- ICODERUS / 000000114
- Conditions
- Chronic Venous Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Clinic of Phlebology and Laser Surgery, Chelyabinsk, RussiaUniversity, hospital or other
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of the influence of combined oral contraception on the development and progression of chronic venous diseases
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tableted hormonal drugs for contraception | Other | Drug: Combined Oral ContraceptiveTableted 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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;
- 2) Able to come for checkups every 3 months; 3) The presence of informed consent.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Oral ContraceptiveThe 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. | Drug | Tableted hormonal drugs for contraception |
Primary outcome
Development and progression of chronic venous diseases
Time frame: 1 year
1 secondary outcome
Deep venous thrombosis
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexey Fokin study chair
South Ural State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Oral Contraceptive in people with Chronic Venous Diseases, run by Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development and progression of chronic venous diseases (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.