PCOS, Therapy and Markers of Cardiovascular Risk

Phase 4

• Conditions: PCOS
• Interventions: Drug: oral metformin; Drug: oral contraceptive

• Registration Number: NCT01798875
• Lead Sponsor: Medical University of Gdansk

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Status Verified: 2013-02
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-02-25
• Study First Posted: 2013-02-26
• Last Update Submitted: 2013-02-28
• Last Update Posted: 2013-03-01
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• PCOS

Exclusion Criteria

• diabetes
• pregnancy
• contraindications to oral contraceptives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Metformin	oral metformin	oral metformin at a dose of 850mg twice daily
Oral contraceptive	oral contraceptive	oral contraceptive containing 35ug of ethynylestradiol and 2mg of cyproterone acetate (21 day regimen)

Primary Outcome Measures

Name	Time	Method
serum C-reactive protein (CRP) levels	6 months

Trial Locations

Locations (1)

Department of Clinical and Experimental Endocrinology, Medical University of Gdansk; 🇵🇱 Gdansk, Poland