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The effects of medical therapy on insulin resistance and the cardiovascular system in PolyCystic Ovarian Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51367236
Enrollment
110
Registered
2006-04-03
Start date
2002-10-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Polycystic ovarian syndrome Nutritional, Metabolic, Endocrine Polycystic ovarian syndrome

Interventions

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 twic

Sponsors

Southern Health (Australia)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Effects on insulin resistance

Secondary

MeasureTime frame
1. Clinical symptom improvement 2. Arterial function

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026