Sexual Hormones and Haemostasis: Observations for Women Health

NCT02055001 | Unknown

• 1 other identifier: SHOW
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Gender; Sex

Keywords

gender medicine; platelet function; sex hormones; antiplatelet drugs; haemostasis

Outcome Measures

Primary Outcomes (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.

  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

  baseline (beginning of menstruation); day 5 ± 2; day 14 ± 2; day 21 of menstrual cycle, according to the hormonal fluctuations

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

21 healthy women with 28-30 day regular menstrual cycle

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome - Policlinico Umberto I Roma

Rome, I, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum samples Urine

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Stefania Basili, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefania Basili, MD

CONTACT

+390649974678; stefania.basili@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: February 4, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

IT (1)