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Completed

NCT Number: NCT03949985

Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives

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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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Contraception Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Geneva University Hospitals

Geneva, 1205, Switzerland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tests of biological hemostatic profile associated with contraceptives

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)

Primary outcomes

  1. Change in normalized APC sensitivity ratio

    Time frame: Three months

Secondary outcomes

  1. Change in Endogenous Thrombin Potential (Thrombin Generation Assay)

    Time frame: Three months

  2. Change in concentrations of sex hormone-binding globulin

    Time frame: Three months

  3. Change in fibrinolysis assay

    Time frame: Three months

  4. Change in individual coagulation factors

    Time frame: Three months

    The following coagulation factors will be assessed: fibrinogen, protein C, protein S, antithrombin, factor VIII

  5. Contraception-related satisfaction

    Time frame: Three months

    Satisfaction will be estimated by the use of the Ortho Birth Control Satisfaction Assessment Tool questionnaire.

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Acronym: PILL-OFF

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 14, 2019
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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