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PCOS, Therapy and Markers of Cardiovascular Risk

NCT ID: NCT01798875

Last Updated: 2013-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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PCOS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin

oral metformin at a dose of 850mg twice daily

Group Type ACTIVE_COMPARATOR

oral metformin

Intervention Type DRUG

Oral contraceptive

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

Group Type ACTIVE_COMPARATOR

oral contraceptive

Intervention Type DRUG

Interventions

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oral metformin

Intervention Type DRUG

oral contraceptive

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* PCOS

Exclusion Criteria

* diabetes
* pregnancy
* contraindications to oral contraceptives
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Dominik Rachon

M.D. PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Clinical and Experimental Endocrinology, Medical University of Gdansk

Gdansk, , Poland

Site Status RECRUITING

Countries

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Poland

Facility Contacts

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Dominik Rachon, MD, PhD

Role: primary

[email protected]
+48583491947

References

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Dardzinska JA, Rachon D, Kuligowska-Jakubowska M, Aleksandrowicz-Wrona E, Ploszynski A, Wyrzykowski B, Lysiak-Szydlowska W. Effects of metformin or an oral contraceptive containing cyproterone acetate on serum c-reactive protein, interleukin-6 and soluble vascular cell adhesion molecule-1 concentrations in women with polycystic ovary syndrome. Exp Clin Endocrinol Diabetes. 2014 Feb;122(2):118-25. doi: 10.1055/s-0033-1363261. Epub 2014 Feb 19.

Reference Type DERIVED
PMID: 24554512 (View on PubMed)

Other Identifiers

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POLovaRIS

Identifier Type: -

Identifier Source: org_study_id

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