Metformin Plus EE30µg-drospirenone and Weight Loss- Impact on Endothelial Function and hsCRP Levels in PCOS
Women with polycystic ovary syndrome (PCOS) frequently cluster several cardiovascular risk
markers and early subclinical atherosclerosis. Because combined oral contraceptives (COCs),
the most common treatment of this disease, might adversely influence insulin resistance,
glucose tolerance, lipid profile or aggravate chronic inflammation the possibility of
worsening the already unfavorable cardiovascular risk profile of PCOS subjects is of
concern. On the contrary, the insulin sensitizer metformin has been shown to ameliorate
insulin resistance, reduce hyperandrogenism and triglyceride levels and also to improve
endothelial structure and function in PCOS. Drospirenone (DRP) is a progestin with
antiandrogenic and antimineralocorticoid activity. However, the studies assessing the effect
of the COC containing 30 µg EE+3mg DRP (DRP/EE30µg) on surrogate markers of atherosclerosis
are few and inconclusive. Therefore,the purpose of the present study is to assess the
effects of the oral contraceptive DRP/EE30µg combined with metformin and weight loss by
means of dietary intervention on the indices of endothelial dysfunction, i.e. flow-mediated
dilation and serum endothelin-1, serum hsCRP,lipids, and insulin resistance in young women
with PCOS.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
flow-mediated dilation
six months
Yes
Carmen Georgescu
Principal Investigator
University of Medicine and Pharmacy Iuliu Hatieganu
Romania: Ministry of Public Health
IuliuHatieganuU246
NCT01459445
February 2011
January 2012
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