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NCT01538602 Clinical Trial

Mean Platelet Volume and TXA2 Levels in Patients With Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01538602
Other study ID # MPV_PCOS
Secondary ID
Status Completed
Phase N/A
First received February 21, 2012
Last updated February 23, 2012

Study information
Verified date February 2012
Source AGUNCO Obstetrics and Gynecology Centre
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Observational

Clinical Trial Summary

Polycystic ovary syndrome (PCOS)is closely associated with insulin resistance and hyperinsulinemia as well as with increased incidence in diabetes, hypertension, dyslipidemia and atherosclerosis. Indeed, subjects with PCOS were reported to carry an increased long-term cardiovascular risk, among others. Aiming to correlate the mean platelet volume, the thromboxane A2 level and the PCOS, an observational study was planned. Clinical evaluation of metabolic outcomes in PCOS patients is compared to a placebo group.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria:

- Women fulfilled two out of three diagnostic criteria for PCOS

Exclusion Criteria:

- Pre-existing secondary endocrine disorders

- History of hypertension, diabetes mellitus or cardiovascular disorders

- Pharmacologic treatment in the last 6 months before entering the study.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Istituto di Patologia Ostetrica e Ginecologica Catania

Sponsors (1)
Lead Sponsor Collaborator
AGUNCO Obstetrics and Gynecology Centre

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean platelet volume
Primary Thromboxane A2
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