Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives (PILL-OFF)

University Hospitals (UH)

Status: Completed

Conditions: Venous Thromboembolism; Contraception

Treatments: Other: Tests of biological hemostatic profile associated with contraceptives

Study type: Observational

Funder types: Other

Identifiers

NCT03949985

2018-00448

Details and patient eligibility

About

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

Full 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.

Enrollment: 103 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

103 participants in 2 patient groups

Estrogenic contraceptive users

Treatment:

Other: Tests of biological hemostatic profile associated with contraceptives

Non-estrogenic contraceptive users

Treatment:

Other: Tests of biological hemostatic profile associated with contraceptives