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Sexual Hormones and Haemostasis: Observations for Women Health

NCT02055001 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2015-05-28

No results posted yet for this study

Summary

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

Conditions

  • Gender
  • Sex

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Stefania Basili, MD · University of Roma La Sapienza

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02055001 on ClinicalTrials.gov