PCOS, Therapy and Markers of Cardiovascular Risk

Medical University of Gdansk

Status and phase: Unknown; Phase 4

Conditions: PCOS

Treatments: Drug: oral metformin; Drug: oral contraceptive

Study type: Interventional

Funder types: Other

Identifiers

NCT01798875

POLovaRIS

Details and patient eligibility

About

In addition to chronic anovulation and hyperandrogenemia, polycystic ovary syndrome (PCOS) is also characterized by peripheral insulin resistance and hyperinsulinaemia, which in turn lead to the development of diabetes, hypertension, atherosclerosis and coronary heart disease. Serum markers of inflammation are being increasingly recognized as predictors of atherosclerosis and cardiovascular risk, and chronic low-grade inflammation has been recently proposed to play a role in the pathogenesis of metabolic syndrome and type 2 diabetes mellitus. Therefore, the aim of the present study is to evaluate the effects of commonly used non-pharmacologic (diet and lifestyle change) and pharmacologic (oral contraceptives, metformin, anti-androgens) treatment strategies on classical and surrogate cardiovascular risk markers in women with PCOS. The study hypothesis is that some of the commonly used therapies of women with PCOS may have more favorable effects on classical and surrogate markers of cardiovascular risk then others or some of them may even confer a higher risk of cardiovascular events

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• PCOS

Exclusion criteria

• diabetes
• pregnancy
• contraindications to oral contraceptives

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Metformin

Active Comparator group

Description:

oral metformin at a dose of 850mg twice daily

Treatment:

Drug: oral metformin

Oral contraceptive

Active Comparator group

Description:

oral contraceptive containing 35ug of ethynylestradiol and 2mg of cyproterone acetate (21 day regimen)

Treatment:

Drug: oral contraceptive