PCOS, Therapy and Markers of Cardiovascular Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01798875
Recruitment Status : Unknown
Verified February 2013 by Dominik Rachon, Medical University of Gdansk.
Recruitment status was:  Recruiting
First Posted : February 26, 2013
Last Update Posted : March 1, 2013
Information provided by (Responsible Party):
Dominik Rachon, Medical University of Gdansk

February 22, 2013
February 26, 2013
March 1, 2013
April 2012
December 2015   (Final data collection date for primary outcome measure)
serum C-reactive protein (CRP) levels [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01798875 on Archive Site
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PCOS, Therapy and Markers of Cardiovascular Risk
Effects of Different Therapies on Surrogate Markers of Cardiovascular Risk in Women With Polycystic Ovary Syndrome (PCOS)
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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Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Drug: oral metformin
  • Drug: oral contraceptive
  • Active Comparator: Metformin
    oral metformin at a dose of 850mg twice daily
    Intervention: Drug: oral metformin
  • Active Comparator: Oral contraceptive
    oral contraceptive containing 35ug of ethynylestradiol and 2mg of cyproterone acetate (21 day regimen)
    Intervention: Drug: oral contraceptive
Dardzińska JA, Rachoń D, Kuligowska-Jakubowska M, Aleksandrowicz-Wrona E, Płoszyński A, Wyrzykowski B, Lysiak-Szydłowska 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2015
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • PCOS

Exclusion Criteria:

  • diabetes
  • pregnancy
  • contraindications to oral contraceptives
Sexes Eligible for Study: Female
18 Years to 35 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Dominik Rachon, Medical University of Gdansk
Medical University of Gdansk
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Not Provided
Medical University of Gdansk
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP