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PCOS, Therapy and Markers of Cardiovascular Risk

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Medical University of Gdansk.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dominik Rachon, Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT01798875
First received: February 22, 2013
Last updated: February 28, 2013
Last verified: February 2013

February 22, 2013
February 28, 2013
April 2012
December 2015   (final data collection date for primary outcome measure)
serum C-reactive protein (CRP) levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01798875 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
PCOS
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • PCOS

Exclusion Criteria:

  • diabetes
  • pregnancy
  • contraindications to oral contraceptives
Female
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01798875
POLovaRIS
No
Not Provided
Not Provided
Dominik Rachon, Medical University of Gdansk
Medical University of Gdansk
Not Provided
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