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

NCT ID: NCT01459445

Last Updated: 2011-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Polycystic Ovary Syndrome Endothelial Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin+Drospirenone / EE 30µg

Group Type OTHER

Metformin, Ethinylestradiol 30µg-Drospirenone

Intervention Type DRUG

Metformin: 1700 mg /day (twice per day)-6 months; EE30µg-drospirenone: 1 tb/day, 21 days/month, 6 months

Interventions

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Metformin, Ethinylestradiol 30µg-Drospirenone

Metformin: 1700 mg /day (twice per day)-6 months; EE30µg-drospirenone: 1 tb/day, 21 days/month, 6 months

Intervention Type DRUG

Other Intervention Names

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metformin yasmin

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Carmen Georgescu

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carmen Georgescu

Role: PRINCIPAL_INVESTIGATOR

University of Medicine and Pharmacy Iuliu Hatieganu

Locations

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Clinic of Endocrinology

Cluj-Napoca, Cluj, Romania

Site Status

Countries

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Romania

References

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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.

Reference Type DERIVED
PMID: 22713099 (View on PubMed)

Other Identifiers

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PNCDI II 41_068/2007

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IuliuHatieganuU246

Identifier Type: -

Identifier Source: org_study_id