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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Polycystic Ovary Syndrome, Endothelial Dysfunction

Intervention / Treatment
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* Drug: Metformin, Ethinylestradiol 30µg-Drospirenone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Metformin+Drospirenone / EE 30µg<br> | Drug: Metformin, Ethinylestradiol 30µg-Drospirenone<br>* Metformin: 1700 mg /day (twice per day)-6 months; EE30µg-drospirenone: 1 tb/day, 21 days/month, 6 months<br>* Other names: yasmin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow-mediated dilation |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ethinylestradiol 30µg-drospirenone, flow-mediated dilatation, endothelial dysfunction, hsCRP, metformin, polycystic ovary syndrome