Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives

Contraception Clinical Trial

— PILL-OFF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949985
• Other study ID #: 2018-00448
• Status: Completed
• Start date: October 8, 2018
• Est. completion date: September 14, 2020

Study information

• Verified date: May 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: September 14, 2020
• Est. primary completion date: September 14, 2020
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Thromboembolism
• Venous Thromboembolism

Intervention

Other:
• 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)

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in normalized APC sensitivity ratio		Three months
Secondary	Change in Endogenous Thrombin Potential (Thrombin Generation Assay)		Three months
Secondary	Change in concentrations of sex hormone-binding globulin		Three months
Secondary	Change in fibrinolysis assay		Three months
Secondary	Change in individual coagulation factors	The following coagulation factors will be assessed: fibrinogen, protein C, protein S, antithrombin, factor VIII	Three months
Secondary	Contraception-related satisfaction	Satisfaction will be estimated by the use of the Ortho Birth Control Satisfaction Assessment Tool questionnaire.	Three months