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. |
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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 |
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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 |
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Descriptive Information[ + expand ][ + ]
Brief Title | Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome |
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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 |
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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:
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Study Arm (s) | Other: Metformin+Drospirenone / EE 30µg |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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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 |
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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 |
Locations[ + expand ][ + ]
Clinic of Endocrinology | Cluj-Napoca, Cluj, Romania, 400349 |
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