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Metformin Plus EE30µg-drospirenone and Weight Loss- Impact on Endothelial Function and hsCRP Levels in PCOS

15 Years
35 Years
Open (Enrolling)
Polycystic Ovary Syndrome, Endothelial Dysfunction

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Trial Information

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.

Inclusion Criteria:

- women with diagnosis of polycystic ovary syndrome defined according to Androgen
Excess Society 2006 guidelines

Exclusion Criteria:

- secondary causes of hyperandrogenism such as hyperprolactinemia, thyroid disease,
androgen-secreting tumours, Cushing's syndrome and congenital adrenal hyperplasia

- current or previous use (within 6 months) of oral contraceptives, anti-androgens,
ovulation induction medications

- use of drugs known to affect carbohydrate-lipid metabolism or inflammation
(anti-inflammatory drugs) at the time of evaluation and during the last one month
preceding the evaluations

- concurrent minor infection reported during the last one month preceding the

- personal history of diabetes mellitus

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

flow-mediated dilation

Outcome Time Frame:

six months

Safety Issue:


Principal Investigator

Carmen Georgescu

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Medicine and Pharmacy Iuliu Hatieganu


Romania: Ministry of Public Health

Study ID:




Start Date:

February 2011

Completion Date:

January 2012

Related Keywords:

  • Polycystic Ovary Syndrome
  • Endothelial Dysfunction
  • ethinylestradiol 30µg-drospirenone
  • flow-mediated dilatation
  • endothelial dysfunction
  • hsCRP
  • metformin
  • polycystic ovary syndrome
  • Polycystic Ovary Syndrome