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ISRCTN
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ISRCTN24474824
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ClinicalTrials.gov identifier
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Public title
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Atorvastatin in polycystic ovary syndrome (PCOS)
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Scientific title
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Effect of atorvastatin on the metabolic syndrome of polycystic ovary syndrome
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Acronym
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PAT
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Serial number at source
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R0061
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Study hypothesis
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Atorvastatin improves metabolic syndrome and hyperandrogenaemia in patients with polycystic ovary syndrome (PCOS) compared to placebo.
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Ethics approval
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Ethics approval received from South Humberside Local Research Ethics Committee on the 5th September 2004 (ref: 04/Q1105/60).
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Study design
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A double blind placebo controlled parallel study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Polycystic ovary syndrome (PCOS)
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Participants - inclusion criteria
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1. A diagnosis of PCOS was based on Rotterdam criteria
2. Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, and androgen secreting tumours excluded by appropriate tests
3. Subjects were advised not to alter their usual dietary and exercise habits
4. Females aged 18 - 40 years
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Participants - exclusion criteria
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1. No concurrent illness
2. Patients not wishing to allow disclosure to their GPs
3. Patients not on barrier or oral progesterone contraception
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Anticipated start date
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13/07/2006
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Anticipated end date
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01/05/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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40
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Interventions
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40 patients with polycystic ovary syndrome will be randomised to:
1. 20 patients treated with atorvastatin 20 mg
2. 20 patients treated placebo
The total duration of the study and follow up is three months.
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Primary outcome measure(s)
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Improvement in biochemical hyperandrogenaemia, measured at baseline and after three months.
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Secondary outcome measure(s)
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Improvement in insulin resistance, measured at baseline and after three months.
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Sources of funding
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University of Hull (UK) - Diabetes Endowment Fund
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Trial website
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Publications
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Contact name
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Prof
Stephen
Atkin
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Address
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Michael White Diabetes Centre
Hull Royal Infirmary
220 - 236 Analby Road
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City/town
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Hull
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Zip/Postcode
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HU3 2RZ
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Country
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United Kingdom
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Sponsor
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Hull and East Yorkshire Hospital NHS Trust (UK)
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Address
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c/o Mrs Nina Dunham
Research and Development Manager
Research and Development Admin Portacabin
Castle Hill Hospital, Castle Road
Cottingham
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City/town
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Hull
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Zip/Postcode
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HU16 5JQ
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Country
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United Kingdom
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Sponsor website:
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http://www.hey.nhs.uk/
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Date applied
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03/04/2008
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Last edited
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09/05/2008
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Date ISRCTN assigned
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09/05/2008
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