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

Not Applicable

• Conditions: Polycystic Ovary Syndrome; Endothelial Dysfunction
• Interventions: Drug: Metformin, Ethinylestradiol 30µg-Drospirenone

• Registration Number: NCT01459445
• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

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

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 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.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-06
• Status Verified: 2011-10
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-23
• Last Update Submitted: 2011-10-23
• Study First Posted: 2011-10-25
• Last Update Posted: 2011-10-25
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin+Drospirenone / EE 30µg	Metformin, Ethinylestradiol 30µg-Drospirenone	-

Primary Outcome Measures

Name	Time	Method
flow-mediated dilation	six months

Secondary Outcome Measures

Name	Time	Method
endothelin-1	six months
hsCRP	six months
insulin resistance indices	six months
body composition	six months
lipid profile	six months
total testosterone	six months
sex hormone-binding globulin	six months
systolic blood pressure and diastolic blood pressure	six months

Trial Locations

Locations (1)

Clinic of Endocrinology; 🇷🇴 Cluj-Napoca, Cluj, Romania