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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:
NCT01538602
First received: February 21, 2012
Last updated: February 23, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition
Polycystic Ovary Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AGUNCO Obstetrics and Gynecology Centre:

Primary Outcome Measures:
  • Mean platelet volume
  • Thromboxane A2

Groups/Cohorts
PCOS patients
Healthy volunteers

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population

Volunteers

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538602

Locations
Italy
Istituto di Patologia Ostetrica e Ginecologica
Catania, Italy
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre
  More Information

No publications provided

Responsible Party: AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier: NCT01538602     History of Changes
Other Study ID Numbers: MPV_PCOS
Study First Received: February 21, 2012
Last Updated: February 23, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by AGUNCO Obstetrics and Gynecology Centre:
PCOS
cardiovascular disorders

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
 Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013