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

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy (Other)

Overall Status

Unknown status

CT.gov ID

NCT01459445

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Endothelial Dysfunction	Drug: Metformin, Ethinylestradiol 30µg-Drospirenone	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Jun 1, 2011

Anticipated Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Metformin+Drospirenone / EE 30µg	Drug: Metformin, Ethinylestradiol 30µg-Drospirenone Metformin: 1700 mg /day (twice per day)-6 months; EE30µg-drospirenone: 1 tb/day, 21 days/month, 6 months Other Names: metformin yasmin

Arm

Intervention/Treatment

Other: Metformin+Drospirenone / EE 30µg

Drug: Metformin, Ethinylestradiol 30µg-Drospirenone

Metformin: 1700 mg /day (twice per day)-6 months; EE30µg-drospirenone: 1 tb/day, 21 days/month, 6 months

Other Names:

metformin

yasmin

Outcome Measures

Primary Outcome Measures

flow-mediated dilation [six months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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