Clinical trial NCT01459445: Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome
Official title: Metformin Plus EE30µg-drospirenone and Weight Loss- Impact on Endothelial Function and hsCRP Levels in PCOS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Endothelial Dysfunction
Keywords: ethinylestradiol 30µg-drospirenone
flow-mediated dilatation
endothelial dysfunction
hsCRP
metformin
polycystic ovary syndrome
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 26
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: flow-mediated dilation
timeFrame: six months
Secondary outcomes:
measure: endothelin-1
timeFrame: six months
measure: hsCRP
timeFrame: six months
measure: insulin resistance indices
timeFrame: six months
measure: body composition
timeFrame: six months
measure: lipid profile
timeFrame: six months
measure: total testosterone
timeFrame: six months
measure: sex hormone-binding globulin
timeFrame: six months
measure: systolic blood pressure and diastolic blood pressure
timeFrame: six months
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Clinic of Endocrinology
state: Cluj
Study officials:
affiliation: University of Medicine and Pharmacy Iuliu Hatieganu
name: Carmen Georgescu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ilie IR, Marian I, Mocan T, Ilie R, Mocan L, Duncea I, Pepene CE. Ethinylestradiol30mug-drospirenone and metformin: could this combination improve endothelial dysfunction in polycystic ovary syndrome? BMC Endocr Disord. 2012 Jun 19;12:9. doi: 10.1186/1472-6823-12-9.