Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome

• Status: Unknown status
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Female

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 dysfunction (i.e. flow-mediated dilation and serum endothelin-1), serum hsCRP,lipids,insulin resistance and body composition in young women with PCOS.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
• Treatments: Drospirenone; Drospirenone and ethinyl estradiol combination; Ethinyl Estradiol; Metformin

Criteria

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 evaluations

• personal history of diabetes mellitus