Venous ThromboembolismPILL-OFFNCT03949985
Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives
An observational study of Venous Thromboembolism and Contraception, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
This prospective cohort evaluates the longitudinal profile of hemostatic biomarkers during the first 3 months after having stopped a combined oral contraceptive. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Venous Thromboembolism, Contraception
- What is being tested?
- Tests of biological hemostatic profile associated with contraceptives
- How many people
- 103 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Oct 2018to 14 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
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.
Who may be able to join
- 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)
Who cannot join
- personal history of VTE
- known thrombophilia
- recent medical event (hospitalization, surgery, cancer)
- pregnancy, post-partum period, current breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives: a Prospective Cohort Study
This prospective cohort evaluates the longitudinal profile of hemostatic biomarkers during the first 3 months after having stopped a combined oral contraceptive.
Read the 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.
- Conditions
- Venous Thromboembolism, Contraception
- Being tested
- Tests of biological hemostatic profile associated with contraceptives
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tests of biological hemostatic profile associated with contraceptivesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Estrogenic contraceptive users | Not described Receives: Other: Tests of biological hemostatic profile associated with contraceptives | |
| Non-estrogenic contraceptive users | Not described Receives: Other: Tests of biological hemostatic profile associated with contraceptives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in normalized APC sensitivity ratio
Measured: Three months
Secondary outcomes (5)
Change in Endogenous Thrombin Potential (Thrombin Generation Assay)
Measured: Three months
Change in concentrations of sex hormone-binding globulin
Measured: Three months
Change in fibrinolysis assay
Measured: Three months
Change in individual coagulation factors
The following coagulation factors will be assessed: fibrinogen, protein C, protein S, antithrombin, factor VIII
Measured: Three months
Contraception-related satisfaction
Satisfaction will be estimated by the use of the Ortho Birth Control Satisfaction Assessment Tool questionnaire.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start8 Oct 2018
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Blondon, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949985
- Sponsor's protocol ID
- 2018-00448
- Other IDs
- 2018
- Acronym
- PILL-OFF
- Status last verified
- May 2021
- First submitted
- 8 May 2019
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hugon-Rodin J, Fontana P, Poncet A, Streuli I, Casini A, Blondon M. Longitudinal profile of estrogen-related thrombotic biomarkers after cessation of combined hormonal contraceptives. Blood. 2024 Jan 4;143(1):70-78. doi: 10.1182/blood.2023021717.
PubMed 37939264
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03949985
- Acronym / sponsor ID
- PILL-OFF / 2018-00448
- Conditions
- Venous Thromboembolism, Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estrogenic contraceptive users | – | Other: Tests of biological hemostatic profile associated with contraceptives |
| Non-estrogenic contraceptive users | – | Other: Tests of biological hemostatic profile associated with contraceptives |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- personal history of VTE
- known thrombophilia
- recent medical event (hospitalization, surgery, cancer)
- pregnancy, post-partum period, current breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tests of biological hemostatic profile associated with contraceptivesTests 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) | Other | Estrogenic contraceptive users, Non-estrogenic contraceptive users |
Primary outcome
Change in normalized APC sensitivity ratio
Time frame: Three months
5 secondary outcomes
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
Contraception-related satisfaction
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Derived from this study: PubMed 37939264Hugon-Rodin J, Fontana P, Poncet A, Streuli I, Casini A, Blondon M. Longitudinal profile of estrogen-related thrombotic biomarkers after cessation of combined hormonal contraceptives. Blood. 2024 Jan 4;143(1):70-78. doi: 10.1182/blood.2023021717.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Contraception, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in normalized APC sensitivity ratio (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03949985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.