Sexual Hormones and Haemostasis: Observations for Women Health (SHOW)
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|ClinicalTrials.gov Identifier: NCT02055001|
Recruitment Status : Unknown
Verified May 2015 by Stefania Basili, University of Roma La Sapienza.
Recruitment status was: Recruiting
First Posted : February 4, 2014
Last Update Posted : May 28, 2015
Atherothrombotic disorders account for 25% of all deaths among women and for substantial morbidity and resource use in health care. Nonetheless, gender-related differences in the epidemiology of cardiovascular disease (CVD) remain largely unexplained. Among mechanisms that could account for such differences, the biology of platelets, which exert a pivotal pathogenetic role in atherothrombosis, and of coagulation system are on investigation.
Thus, differences in platelet reactivity between women and men have been described using several methods and in response to varying stimuli. Indeed, sex steroid hormones could be involved in a different response of platelet to physiological response to agonists. The finding that estrogen receptors are expressed in platelets makes these cells an excellent model for studying the non-genomic effects of steroid hormones. Also coagulation cascade has been reported to be influenced by sexual endogenous as well as exogeneous hormones (i.e contraceptives) In particular, the impact of endogenous estrogens (menstrual cycle) on platelet activity and on response to antiplatelets drugs in fertile women has never been evaluated.
Accordingly, the goal of this proposal is to investigate relationship between platelet function (assessed by aggregometry tests and markers of platelet activation in vivo such as thromboxane production, CD40L and P- selectin levels) and sex hormones during physiological regular menstrual cycles (28-30 days) in healthy pre-menopausal women aged from 18 to 40 years. Moreover, in a subgroup of healthy women free from antiplatelet drugs, will be planned a proof of concept study to investigate if there will be variations, during a short term (1 month) low dose aspirin, in platelet reactivity according to the different phases of menstrual cycle in 10 healthy premenopausal women aged from 18 to 40 years. Moreover, it will be investigate effect of steroid hormonal pattern on residual platelet activity response on treatment
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Haemostasis Evaluation Related to Sexual Hormones: Gender Perspective|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
- Change in platelet activation markers levels according to sex hormones levels at the beginnig, during and at the end of a physiological regular menstrual cycles (28-30 days) in healthy pre-menopausal women. [ Time Frame: baseline (beginning of menstruation); day 5 ± 2; day 14 ± 2; day 21 of menstrual cycle, according to the hormonal fluctuations ]To investigate relationship between platelet function (assessed by aggregometry tests and markers of platelet activation in vivo such as thromboxane production, CD40L and P- selectin levels) and sex hormones during physiological regular menstrual cycles (28-30 days) in healthy pre-menopausal women aged from 18 to 40 years
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055001
|Contact: Stefania Basili, MDfirstname.lastname@example.org|
|Sapienza University of Rome - Policlinico Umberto I Roma||Recruiting|
|Rome, I, Italy|
|Contact: Stefania Basili, MD +390649974678 email@example.com|
|Principal Investigator: Stefania Basili, MD|
|Principal Investigator:||Stefania Basili, MD||Sapienza University of Rome|