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This prospective cohort evaluates the longitudinal profile of hemostatic biomarkers during the first 3 months after having stopped a combined oral contraceptive.
Women using a combined oral contraceptive (COC) and who have decided to stop it or switch it to a non-estrogenic contraceptive are included. At baseline, before the COC is stopped, and at multiple time points during the 3 months of follow-up, blood will be drawn to evaluate the hemostatic profile. Findings are compared with a control group of women without an estrogenic contraceptive, who are also followed for 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estrogenic contraceptive users |
| ||
| Non-estrogenic contraceptive users |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tests of biological hemostatic profile associated with contraceptives | Other | Tests of biological hemostatic profile associated with contraceptives will be done before and after having stopped an estrogenic contraceptive (group 1) and during the non-use of an estrogenic contraceptive (group 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in normalized APC sensitivity ratio | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Endogenous Thrombin Potential (Thrombin Generation Assay) | Three months | |
| Change in concentrations of sex hormone-binding globulin | Three months | |
| Change in fibrinolysis assay |
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Inclusion Criteria:
Exclusion Criteria:
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Women aged 18-50 years who are current users of estrogenic contraceptives and have decided to stop it or replace it with a non-estrogenic contraceptive.
Women aged 18-50 years who are not current users of estrogenic contraceptives.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Geneva | 1205 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37939264 | Derived | Hugon-Rodin J, Fontana P, Poncet A, Streuli I, Casini A, Blondon M. Longitudinal profile of estrogen-related thrombotic biomarkers after cessation of combined hormonal contraceptives. Blood. 2024 Jan 4;143(1):70-78. doi: 10.1182/blood.2023021717. |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003270 | Contraceptive Agents |
| ID | Term |
|---|---|
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
| Three months |
| Change in individual coagulation factors | The following coagulation factors will be assessed: fibrinogen, protein C, protein S, antithrombin, factor VIII | Three months |
| Contraception-related satisfaction | Satisfaction will be estimated by the use of the Ortho Birth Control Satisfaction Assessment Tool questionnaire. | Three months |
| D045506 | Therapeutic Uses |