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Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS) (CS)

T

The Adelaide and Meath Hospital

Status

Completed

Conditions

Polycystic Ovary Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT01195168
DDC-UCD-CS

Details and patient eligibility

About

Women with polycystic ovary syndrome (PCOS) are more often overweight or obese and are more insulin resistant than women without the condition and may be at greater risk of developing cardiovascular disease. It is not know whether it is the overweight and insulin resistant component of PCOS, or PCOS per se which leads to the greater cardiovascular disease risk. The aim of this study was to examine cardiovascular risk markers in women with PCOS versus a control population matched for body mass index (BMI), and or, insulin resistance

Enrollment

201 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.
  • Were between the ages of 18 and 40

Exclusion criteria

  • Were under 18 years or greater than 40 years old,
  • Were non-Caucasian
  • Were pregnant, lactating or trying to conceive
  • Had a body mass index (BMI) <18kg/m2 or >50kg/m2
  • Had a recent illness or any chronic illness likely to influence results
  • Were taking hormonal contraception

Trial design

201 participants in 2 patient groups

PCOS cohort
Description:
Women with PCOS as diagnosed by the NIH criteria
Control cohort
Description:
Women without PCOS

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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