PCOS, Therapy and Markers of Cardiovascular Risk
Effects of Different Therapies on Surrogate Markers of Cardiovascular Risk in Women With Polycystic Ovary Syndrome (PCOS)
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2012
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 22, 2013
CompletedFirst Posted
Study publicly available on registry
February 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 1, 2013
February 1, 2013
3.7 years
February 22, 2013
February 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serum C-reactive protein (CRP) levels
6 months
Study Arms (2)
Metformin
ACTIVE COMPARATORoral metformin at a dose of 850mg twice daily
Oral contraceptive
ACTIVE COMPARATORoral contraceptive containing 35ug of ethynylestradiol and 2mg of cyproterone acetate (21 day regimen)
Interventions
Eligibility Criteria
You may qualify if:
- PCOS
You may not qualify if:
- diabetes
- pregnancy
- contraindications to oral contraceptives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Clinical and Experimental Endocrinology, Medical University of Gdansk
Gdansk, Poland
Related Publications (1)
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.
PMID: 24554512DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D. PhD
Study Record Dates
First Submitted
February 22, 2013
First Posted
February 26, 2013
Study Start
April 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 1, 2013
Record last verified: 2013-02