Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives

Completed

• Conditions: Venous Thromboembolism; Contraception
• Interventions: Other: Tests of biological hemostatic profile associated with contraceptives

• Registration Number: NCT03949985
• Lead Sponsor: University Hospital, Geneva

Brief Summary

This prospective cohort evaluates the longitudinal profile of hemostatic biomarkers during the first 3 months after having stopped a combined oral contraceptive.

Detailed Description

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.

Study Timeline

• Study Start: 2018-10-08
• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-14
• Primary Completion: 2020-09-14
• Study Completion: 2020-09-14
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 103

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Estrogenic contraceptive users	Tests of biological hemostatic profile associated with contraceptives	-
Non-estrogenic contraceptive users	Tests of biological hemostatic profile associated with contraceptives	-

Primary Outcome Measures

Name	Time	Method
Change in normalized APC sensitivity ratio	Three months

Secondary Outcome Measures

Name	Time	Method
Change in individual coagulation factors	Three months	The following coagulation factors will be assessed: fibrinogen, protein C, protein S, antithrombin, factor VIII
Change in concentrations of sex hormone-binding globulin	Three months
Change in fibrinolysis assay	Three months
Contraception-related satisfaction	Three months	Satisfaction will be estimated by the use of the Ortho Birth Control Satisfaction Assessment Tool questionnaire.
Change in Endogenous Thrombin Potential (Thrombin Generation Assay)	Three months

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland