Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-08

Study Completion Date

2020-09-14

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.

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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.

Conditions

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Venous Thromboembolism Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Estrogenic contraceptive users

Tests of biological hemostatic profile associated with contraceptives

Intervention Type 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)

Non-estrogenic contraceptive users

Tests of biological hemostatic profile associated with contraceptives

Intervention Type 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)

Interventions

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Tests of biological hemostatic profile associated with contraceptives

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)

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No