NCT01538602

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
Last Updated

February 24, 2012

Status Verified

February 1, 2012

First QC Date

February 21, 2012

Last Update Submit

February 23, 2012

Conditions

Polycystic Ovary Syndrome

Keywords

PCOScardiovascular disorders

Outcome Measures

Primary Outcomes (2)

  • Mean platelet volume

  • Thromboxane A2

Study Arms (2)

PCOS patients

Healthy volunteers

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Volunteers

You may qualify if:

  • Women fulfilled two out of three diagnostic criteria for PCOS

You may not qualify if:

  • Pre-existing secondary endocrine disorders
  • History of hypertension, diabetes mellitus or cardiovascular disorders
  • Pharmacologic treatment in the last 6 months before entering the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto di Patologia Ostetrica e Ginecologica

Catania, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeCardiovascular Diseases

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2012

First Posted

February 24, 2012

Last Updated

February 24, 2012

Record last verified: 2012-02

Locations

IT(1)