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Trial record 66 of 88 for:    ASPIRIN AND thromboxane

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
Sponsor:
Information provided by (Responsible Party):
Stefania Basili, University of Roma La Sapienza

Brief 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


Condition or disease
Gender Sex

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones




Primary Outcome Measures :
  1. 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
Whole blood, serum samples Urine


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
21 healthy women with 28-30 day regular menstrual cycle
Criteria

Inclusion Criteria:

  • Healthy pre-menopausal women wiith regular menstrual cycle
  • Age 18 - 40 years
  • Written Informed Consent

Exclusion Criteria:

  • History of recent (within the last 2 months) ingestion of anticoagulants, antifibrinolytics, non-steroidal antiinflammatory medications, combined oral contraceptives, and progestagens.
  • Pregnancy
  • Presence of kidney, liver, heart, endocrine diseases or infective diseases for at least 2 months prior to the study
  • No history of gastrointestinal disease at risk of bleeding and/or previous gastrointestinal bleeding
  • Use chronic pharmaceutical treatments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055001


Contacts
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Contact: Stefania Basili, MD +390649974678 stefania.basili@uniroma1.it

Locations
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Italy
Sapienza University of Rome - Policlinico Umberto I Roma Recruiting
Rome, I, Italy
Contact: Stefania Basili, MD    +390649974678    stefania.basili@uniroma1.it   
Principal Investigator: Stefania Basili, MD         
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Stefania Basili, MD Sapienza University of Rome

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Responsible Party: Stefania Basili, Prof., University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02055001     History of Changes
Other Study ID Numbers: SHOW
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by Stefania Basili, University of Roma La Sapienza:
gender medicine
platelet function
sex hormones
antiplatelet drugs
haemostasis
Additional relevant MeSH terms:
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Hemostatics
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Coagulants