Endothelial Dysfunction, Polycystic Ovary Syndrome
Conditions
Keywords
ethinylestradiol 30µg-drospirenone, flow-mediated dilatation, endothelial dysfunction, hsCRP, metformin, polycystic ovary syndrome
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.
Interventions
DRUGMetformin, Ethinylestradiol 30µg-Drospirenone
Metformin: 1700 mg /day (twice per day)-6 months; EE30µg-drospirenone: 1 tb/day, 21 days/month, 6 months
Sponsors
Iuliu Hatieganu University of Medicine and Pharmacy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| flow-mediated dilation | six months |
Secondary
| Measure | Time frame |
|---|---|
| sex hormone-binding globulin | six months |
| systolic blood pressure and diastolic blood pressure | six months |
| endothelin-1 | six months |
| total testosterone | six months |
| insulin resistance indices | six months |
| body composition | six months |
| lipid profile | six months |
| hsCRP | six months |
Countries
Romania
Outcome results
None listed