Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339567
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-25
Brief Title:
Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes French Cross-sectional Study
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
Official Title:
Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes French Cross-sectional Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hemo-PCOS
Brief Summary:
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 andor 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 189 CI95 160-224 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
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 189 CI95 160-224 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None