Status:
COMPLETED
Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
The Adelaide and Meath Hospital
Collaborating Sponsors:
University College Dublin
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Brief Summary
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT01195168
Start Date
November 1 2006
End Date
July 1 2008
Last Update
September 6 2010
Active Locations (2)
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1
Diabetes Day Centre, The Adelaide and Meath Hosptial
Dublin, Leinster, Ireland, Dublin 24
2
Nutrigenomics Research Group, University College Dublin
Dublin, Leinster, Ireland, Dublin 4