Assessing the risk of heart disease in women with polycystic ovary syndrome

Assessment of cardiovascular risk in polycystic ovary syndrome - effects of therapy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000202066

Enrollment

Registered

2010-03-10

Start date

2010-03-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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)

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Healthy volunteers

Inclusion criteria

Women with previously diagnosed polycystic ovary syndrome

Exclusion criteria

Already on metformin or oral contraceptives On clopidogrel

Outcome results