Examining how combined oral contraception affects chronic venous diseases
The Influence of Combined Oral Contraception on the DEvelopment and progRession of Chronic venoUs diSeases
This study is testing how combined oral contraceptives affect the development and worsening of chronic venous diseases in women with early-stage venous problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia Academic / other |
| Locations | 1 site (Chelyabinsk) |
| Trial ID | NCT04451746 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of combined oral contraceptives on the development and progression of chronic venous diseases. It focuses on patients who have been prescribed specific hormonal contraceptives and are classified as having early-stage venous issues. Participants will be monitored through regular check-ups every three months to assess changes in their condition. The study aims to provide insights into the relationship between hormonal contraception and venous health.
Who should consider this trial
Good fit: Ideal candidates are women over 45 years old who are prescribed specific combined oral contraceptives and have early-stage chronic venous diseases.
Not a fit: Patients under 45 years old or those with advanced venous conditions or a history of certain vascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify safer contraceptive options for women at risk of chronic venous diseases.
How similar studies have performed: There is limited information on similar studies, making this approach relatively novel in the context of chronic venous diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chelyabinsk
- Clinic of phlebology and laser surgery — Chelyabinsk, Russian Federation (Recruiting)
Study contacts
- Study coordinator: Denis Borsuk
- Email: borsuk-angio@mail.ru
- Phone: +79630777333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.