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

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

Overview[ - collapse ][ - ]

Purpose	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	Polycystic Ovary Syndrome Endothelial Dysfunction
Intervention	Drug: Metformin, Ethinylestradiol 30µg-Drospirenone
Phase	N/A
Sponsor	Iuliu Hatieganu University of Medicine and Pharmacy
Responsible Party	Iuliu Hatieganu University of Medicine and Pharmacy
ClinicalTrials.gov Identifier	NCT01459445
First Received	October 18, 2011
Last Updated	October 23, 2011
Last verified	October 2011

Tracking Information[ + expand ][ + ]

First Received Date	October 18, 2011
Last Updated Date	October 23, 2011
Start Date	February 2011
Estimated Primary Completion Date	January 2012
Current Primary Outcome Measures	flow-mediated dilation [Time Frame: six months] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	endothelin-1 [Time Frame: six months] [Designated as safety issue: Yes] hsCRP [Time Frame: six months] [Designated as safety issue: Yes] insulin resistance indices [Time Frame: six months] [Designated as safety issue: Yes] body composition [Time Frame: six months] [Designated as safety issue: Yes] lipid profile [Time Frame: six months] [Designated as safety issue: Yes] total testosterone [Time Frame: six months] [Designated as safety issue: Yes] sex hormone-binding globulin [Time Frame: six months] [Designated as safety issue: Yes] systolic blood pressure and diastolic blood pressure [Time Frame: six months] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	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
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.
Study Type	Interventional
Study Phase	N/A
Study Design	Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Polycystic Ovary Syndrome Endothelial Dysfunction
Intervention	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
Study Arm (s)	Other: Metformin+Drospirenone / EE 30µg

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	26
Estimated Completion Date	January 2012
Estimated Primary Completion Date	June 2011
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
Gender	Female
Ages	15 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Romania

Administrative Information[ + expand ][ + ]

NCT Number	NCT01459445
Other Study ID Numbers	IuliuHatieganuU246
Has Data Monitoring Committee	Yes
Information Provided By	Iuliu Hatieganu University of Medicine and Pharmacy
Study Sponsor	Iuliu Hatieganu University of Medicine and Pharmacy
Collaborators	Not Provided
Investigators	Principal Investigator: Carmen Georgescu University of Medicine and Pharmacy Iuliu Hatieganu
Verification Date	October 2011

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