Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives: a Prospective Cohort Study

Conditions
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Venous Thromboembolism, Contraception

Intervention / Treatment
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* Other: Tests of biological hemostatic profile associated with contraceptives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women 18-50 years current use (for at least 3 months) of an estrogenic contraceptive with the decision to stop it or replace it with a non-estrogenic contraceptive (estrogen group) no current use of an estrogenic contraceptive (control group) Exclusion Criteria: personal history of VTE known thrombophilia recent medical event (hospitalization, surgery, cancer) pregnancy, post-partum period, current breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Estrogenic contraceptive users<br> | Other: Tests of biological hemostatic profile associated with contraceptives<br>* 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)<br>|
| Non-estrogenic contraceptive users<br> | Other: Tests of biological hemostatic profile associated with contraceptives<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in normalized APC sensitivity ratio |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |