Overview

This trial is active, not recruiting.

Conditions polycystic ovary syndrome, endothelial dysfunction
Treatment metformin, ethinylestradiol 30µg-drospirenone
Sponsor Iuliu Hatieganu University of Medicine and Pharmacy
Start date February 2011
End date June 2011
Trial size 26 participants
Trial identifier NCT01459445, IuliuHatieganuU246, PNCDI II 41_068/2007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
metformin, ethinylestradiol 30µg-drospirenone metformin
Metformin: 1700 mg /day (twice per day)-6 months; EE30µg-drospirenone: 1 tb/day, 21 days/month, 6 months

Primary Outcomes

Measure
flow-mediated dilation
time frame: six months

Secondary Outcomes

Measure
endothelin-1
time frame: six months
hsCRP
time frame: six months
insulin resistance indices
time frame: six months
body composition
time frame: six months
lipid profile
time frame: six months
total testosterone
time frame: six months
sex hormone-binding globulin
time frame: six months
systolic blood pressure and diastolic blood pressure
time frame: six months

Eligibility Criteria

Female participants from 15 years up to 35 years old.

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

Additional Information

Official title Metformin Plus EE30µg-drospirenone and Weight Loss- Impact on Endothelial Function and hsCRP Levels in PCOS
Principal investigator Carmen Georgescu
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Iuliu Hatieganu University of Medicine and Pharmacy.