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ISRCTN
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ISRCTN51367236
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ClinicalTrials.gov identifier
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Public title
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The effects of medical therapy on insulin resistance and the cardiovascular system in PolyCystic Ovarian Syndrome
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Scientific title
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Acronym
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PCOS
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Serial number at source
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N/A
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Study hypothesis
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Women with polycystic ovarian syndrome (PCOS) and insulin resistance will have equivalent efficacy with metformin and both high- and low-dose oral contraceptives, yet the metabolic effects of the therapy will differ with metformin and the lower dose oral contraceptive pill (OCP) having relatively more favorable effects on insulin resistance and metabolic and cardiovascular parameters.
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Lay summary
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Ethics approval
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Ethics approval received from the Southern Health Human Ethics Committee in October 2002.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Polycystic ovarian syndrome
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Participants - inclusion criteria
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1. Overweight women (body mass index [BMI] greater than 27 kg/m^2)
2. Aged 18 - 40 years with PCOS diagnosed from a history of perimenarchal onset of irregular cycles (less than 21 days or greater than 35 days) plus clinical manifestations of hyperandrogenism (hirsutism, acne) or biochemical hyperandrogenism with elevation of at least one circulating ovarian androgen (1990 National Institute of Health [NIH] criteria)
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Participants - exclusion criteria
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1. BMI less than 27 kg/m^2
2. Other concurrent medical conditions
3. Ongoing use of the OCP
4. Pregnancy or desire for pregnancy
4. Secondary causes of amenorrhoea and hyperandrogenism
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Anticipated start date
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01/10/2002
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Anticipated end date
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01/06/2005
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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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110
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Interventions
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Patients are randomised to receive one of the following interventions:
1. Control group: higher dose OCP - 35 mcg ethinyl oestradiol (EE), 2 mg cyproterone acetate
2. Metformin - 1 g greater than twice daily (bd)
3. Low dose OCP - 20 mcg EE, 100 mcg levonorgestrel and 50 mg aldactone bd
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Primary outcome measure(s)
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Effects on insulin resistance
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Secondary outcome measure(s)
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1. Clinical symptom improvement
2. Arterial function
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Sources of funding
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Pfizer (Australia) - competitive cardiovascular lipid grant 2003 and internal departmental fund
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Trial website
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http://www.jeanhailes.org.au
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/17327307
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Contact name
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Prof
Helena
Teede
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Address
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Monash Institute of Health Services Research
Monash Medical Centre
246 Clayton Road
Clayton
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City/town
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Melbourne
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Zip/Postcode
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3168
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Country
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Australia
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Tel
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+61 (0)3 9594 7545
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Fax
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+61 (0)3 9594 7554
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Email
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helena.teede@med.monash.edu.au
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Sponsor
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Southern Health (Australia)
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Address
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246 Clayton Road
Clayton
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City/town
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Melbourne
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Zip/Postcode
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3168
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Country
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Australia
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Tel
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+61 (0)3 9594 6666
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Fax
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+61 (0)3 9594 7554
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Email
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malar.thiagarajan@southernhealth.org.au
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Sponsor website:
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http://www.southernhealth.org.au
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Date applied
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28/03/2006
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Last edited
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11/04/2008
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Date ISRCTN assigned
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03/04/2006
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