NCT06339567Active, not recruiting
Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of women of childbearing age. PCOS can be individualized into several phenotypes, taking into account in particular the presence of hyperandrogenism, insulin resistance and BMI. Hyperandrogenism and insulin resistance appear to be important factors in the development of cardiovascular cardiovascular disease. In addition, patients frequently use anti-androgenic and/or contraceptive treatments contraceptives, such as combined hormonal contraception (CHC), the use of which is associated with an increased cardiovascular and thrombo and venous thrombosis (VTE). A meta-analysis published in 2020 by Gariani et al. based on three large studies, estimated the risk of VTE in women with PCOS after adjustment for obesity and hormone therapy. This risk was significantly higher compared with women without PCOS (pooled OR 1.89, CI95% 1.60-2.24). No study has looked specifically investigated the risk of VTE according to different PCOS phenotypes. Such data would be very useful in clinical practice, as it would enable monitoring, contraceptive treatment and anti-androgenic anti-androgen treatment according to the PCOS phenotype, while limiting risks. Assessing the differences PCOS phenotypes is limited by the large sample size required. required. VTE is a rare event in women of childbearing age, and the number of PCOS phenotypes is high. PCOS phenotypes. Intermediate markers of VTE risk are used in these situations. These markers are thrombin generation tests (notably ETP) and their sensitivity to activated protein C (nAPCsr) and thrombomodulin (nTMsr), as well as sex-hormone binding globulin (SHBG).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 352 (actual)
- First submitted
- 25 Mar 2024
- Start date
- 8 Feb 2024
- Primary completion date
- 7 Jan 2026
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- NCT number
- NCT06339567
What you commit to
- Study type: Interventional
- Participants enrolled: 352
- From 8 Feb 2024 to the primary completion date, 7 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Using hormonal contraception or insulin-sensitizing therapy (a wash-out of at least 3 months before inclusion).
- Current anticoagulant or antiaggregant treatment or treatment stopped less than one month before inclusion.
- Have a severe personal medical history in the previous 6 weeks (fracture, infection, hospitalization, surgery, cardiovascular event, cancer).
Other illness
- Have a personal history of VTE or known thrombophilia.
Other
- Already included in a type 1 interventional research protocol (RIPH1).
- Be under guardianship or curatorship
- Deprived of liberty
- Under court protection
- Pregnant (positive urine or blood pregnancy test), or within 3 months of post-partum or post abortum, or breastfeeding (or within 3 months of weaning)
Who the study is looking for
- Be between 18 and 35 years of age at the time of inclusion;
- Able to give non-opposition
- Strong suspicion of PCOS according to 2023 recommendations
- Have stopped hormonal contraception for at least 3 months or insulin-sensitizing treatment for at least 3 months.
- Fasting for at least 12 hours.
- Be affiliated to a health insurance scheme.
- French-speaking
Age in the registry: 18 years to 35 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Paris Saint Joseph Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.