Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000202066
Ethics application status
Approved
Date submitted
2/03/2010
Date registered
10/03/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the risk of heart disease in women with polycystic ovary syndrome
Scientific title
Assessment of cardiovascular risk in polycystic ovary syndrome - effects of therapy
Secondary ID [1] 1470 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic ovary syndrome 256868 0
Cardiovascular risk 256869 0
Condition category
Condition code
Metabolic and Endocrine 257019 257019 0 0
Metabolic disorders
Cardiovascular 257020 257020 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Metformin - oral tablet.
To be taken at dose 750mg, twice a day for a total duration of 12 weeks with 4 week washout period before moving onto the placebo (or vice versa)
Intervention code [1] 256063 0
Treatment: Drugs
Comparator / control treatment
Sugar pill orally twice a day for a duration of 12 weeks with 4 week washout period before mevoing onto the metformin treatment (or vice versa)
Control group
Placebo

Outcomes
Primary outcome [1] 257912 0
Platelet nitric oxide reponsiveness
- 10 mls of venous blood will be obtained. Platelet aggregation in response to adenosine diphosphate (ADP 2.5uM) and its inhibition of aggregation by the exogenous nitric oxide donor, sodium nitroprusside (10uM) will be measured using platelet aggregometer
Timepoint [1] 257912 0
3months after randomisation
Secondary outcome [1] 263386 0
Homeostasis model assessment of insulin resistance (HOMAR-IR)
Timepoint [1] 263386 0
3 months from randomisation
Secondary outcome [2] 263387 0
Endothelial function
- using applanation tonometry at baseline and in response to nitrolingual sublingually(25mcg) and salbulatamol inhaled (400mcg)
Timepoint [2] 263387 0
3 months from randomisation

Eligibility
Key inclusion criteria
Women with previously diagnosed polycystic ovary syndrome
Minimum age
20 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Already on metformin or oral contraceptives
On clopidogrel

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Performed by pharmacy - Allocation was concealed using numbered containers
The person recruiting patients for trial are blinded to the group that patient will be allocated
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1. Randomisation and packaging performed by Pharmacy Department
2. Numbered boxes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256566 0
Hospital
Name [1] 256566 0
Cardiology Unit
Country [1] 256566 0
Australia
Primary sponsor type
Hospital
Name
Cardiology Unit
Address
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
SA 5011
Country
Australia
Secondary sponsor category [1] 255862 0
Hospital
Name [1] 255862 0
Cardiology Unit
Address [1] 255862 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
SA 5011
Country [1] 255862 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258603 0
Ethics Committee
Ethics committee address [1] 258603 0
Basil Hetzel Institute
Woodville Road
Woodville South
SA 5011
Ethics committee country [1] 258603 0
Australia
Date submitted for ethics approval [1] 258603 0
Approval date [1] 258603 0
11/01/2010
Ethics approval number [1] 258603 0
2008046

Summary
Brief summary
Metformin is a commonly used medication in the management of polycystic ovary syndrome (PCOS). It appears to play an improtant role in the regulation of menstural cycles, fertility and improvement in insulin sensitivity in PCOS. We have recently shown in a small group of young PCOS women the evidence of marked abnormalities in both platelet and endothelial function (surrogate markers of increased cardiovascular risk) when compared to nromal controls. The primary aim is to assess if metformin improves/reverses these anomalies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30872 0
Address 30872 0
Country 30872 0
Phone 30872 0
Fax 30872 0
Email 30872 0
Contact person for public queries
Name 14119 0
Dr Alicia Chan
Address 14119 0
Cardiology Unit
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
SA 5011
Country 14119 0
Australia
Phone 14119 0
+61882227539
Fax 14119 0
+61882226422
Email 14119 0
wai.chan@adelaide.edu.au
Contact person for scientific queries
Name 5047 0
Professor John Horowitz
Address 5047 0
Cardiology Unit
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
SA 5011
Country 5047 0
Australia
Phone 5047 0
+61882227539
Fax 5047 0
+61882226422
Email 5047 0
john.horowitz@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.