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出境医 / 临床实验 / Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives (PILL-OFF)
Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives (PILL-OFF)
Study Description
Brief Summary:
This prospective cohort evaluates the longitudinal profile of hemostatic biomarkers during the first 3 months after having stopped a combined oral contraceptive.
| Condition or disease | Intervention/treatment |
|---|---|
| Venous Thromboembolism Contraception | Other: Tests of biological hemostatic profile associated with contraceptives |
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 Design
| Study Type : | Observational |
| Actual Enrollment : | 103 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives: a Prospective Cohort Study |
| Actual Study Start Date : | October 8, 2018 |
| Actual Primary Completion Date : | September 14, 2020 |
| Actual Study Completion Date : | September 14, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
| Estrogenic contraceptive users |
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)
|
| Non-estrogenic contraceptive users |
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)
|
Outcome Measures
Primary Outcome Measures :
- Change in normalized APC sensitivity ratio [ Time Frame: Three months ]
Secondary Outcome Measures :
- Change in Endogenous Thrombin Potential (Thrombin Generation Assay) [ Time Frame: Three months ]
- Change in concentrations of sex hormone-binding globulin [ Time Frame: Three months ]
- Change in fibrinolysis assay [ Time Frame: Three months ]
- Change in individual coagulation factors [ Time Frame: Three months ]The following coagulation factors will be assessed: fibrinogen, protein C, protein S, antithrombin, factor VIII
- Contraception-related satisfaction [ Time Frame: Three months ]Satisfaction will be estimated by the use of the Ortho Birth Control Satisfaction Assessment Tool questionnaire.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Sampling Method: | Non-Probability Sample |
Study Population
Women aged 18-50 years who are current users of estrogenic contraceptives and have decided to stop it or replace it with a non-estrogenic contraceptive.
Women aged 18-50 years who are not current users of estrogenic contraceptives.
Criteria
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
Contacts and Locations
Locations
| Switzerland | |
| Geneva University Hospitals | |
| Geneva, Switzerland, 1205 | |
Sponsors and Collaborators
University Hospital, Geneva
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | May 8, 2019 | ||||||
| First Posted Date | May 14, 2019 | ||||||
| Last Update Posted Date | May 21, 2021 | ||||||
| Actual Study Start Date | October 8, 2018 | ||||||
| Actual Primary Completion Date | September 14, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
Change in normalized APC sensitivity ratio [ Time Frame: Three months ] | ||||||
| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives | ||||||
| Official Title | Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives: a Prospective Cohort Study | ||||||
| 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 Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population |
Women aged 18-50 years who are current users of estrogenic contraceptives and have decided to stop it or replace it with a non-estrogenic contraceptive. Women aged 18-50 years who are not current users of estrogenic contraceptives. |
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| Condition |
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| 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)
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Completed | ||||||
| Actual Enrollment |
103 | ||||||
| Original Estimated Enrollment |
85 | ||||||
| Actual Study Completion Date | September 14, 2020 | ||||||
| Actual Primary Completion Date | September 14, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 50 Years (Adult) | ||||||
| Accepts Healthy Volunteers | Not Provided | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | Switzerland | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03949985 | ||||||
| Other Study ID Numbers | 2018-00448 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Marc Blondon, University Hospital, Geneva | ||||||
| Study Sponsor | University Hospital, Geneva | ||||||
| Collaborators | Not Provided | ||||||
| Investigators | Not Provided | ||||||
| PRS Account | University Hospital, Geneva | ||||||
| Verification Date | May 2021 | ||||||
