Status:
UNKNOWN
Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome
Lead Sponsor:
Iuliu Hatieganu University of Medicine and Pharmacy
Conditions:
Polycystic Ovary Syndrome
Endothelial Dysfunction
Eligibility:
FEMALE
15-35 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the effects of ethinylestradiol 30µg-drospirenone combined with metformin and weight loss by means of dietary intervention on the indices of endothelial dysfunct...
Detailed Description
Women with polycystic ovary syndrome (PCOS) frequently cluster several cardiovascular risk markers and early subclinical atherosclerosis. Because combined oral contraceptives (COCs), the most common t...
Eligibility Criteria
Inclusion
- women with diagnosis of polycystic ovary syndrome defined according to Androgen Excess Society 2006 guidelines
Exclusion
- 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 evaluations
- personal history of diabetes mellitus
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01459445
Start Date
February 1 2011
End Date
January 1 2012
Last Update
October 25 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinic of Endocrinology
Cluj-Napoca, Cluj, Romania, 400349