Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome
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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 | Intervention |
|---|---|
|
Polycystic Ovary Syndrome Endothelial Dysfunction |
Drug: Metformin, Ethinylestradiol 30µg-Drospirenone |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Metformin Plus EE30µg-drospirenone and Weight Loss- Impact on Endothelial Function and hsCRP Levels in PCOS |
- flow-mediated dilation [ Time Frame: six months ] [ Designated as safety issue: Yes ]
- 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 ]
| Estimated Enrollment: | 26 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | January 2012 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Metformin+Drospirenone / EE 30µg |
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:
|
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| Ages Eligible for Study: | 15 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts 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
Contacts and Locations| Romania | |
| Clinic of Endocrinology | |
| Cluj-Napoca, Cluj, Romania, 400349 | |
| Principal Investigator: | Carmen Georgescu | University of Medicine and Pharmacy Iuliu Hatieganu |
More Information
No publications provided
| Responsible Party: | Carmen Georgescu, Associated Professor, Iuliu Hatieganu University of Medicine and Pharmacy |
| ClinicalTrials.gov Identifier: | NCT01459445 History of Changes |
| Other Study ID Numbers: | IuliuHatieganuU246, PNCDI II 41_068/2007 |
| Study First Received: | October 18, 2011 |
| Last Updated: | October 23, 2011 |
| Health Authority: | Romania: Ministry of Public Health |
Keywords provided by Iuliu Hatieganu University of Medicine and Pharmacy:
|
ethinylestradiol 30µg-drospirenone flow-mediated dilatation endothelial dysfunction |
hsCRP metformin polycystic ovary syndrome |
Additional relevant MeSH terms:
|
Polycystic Ovary Syndrome Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Ethinyl Estradiol Drospirenone Metformin |
Drospirenone and ethinyl estradiol combination Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Hypoglycemic Agents Aldosterone Antagonists Hormone Antagonists Reproductive Control Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013