Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome, Endothelial Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Metformin, Ethinylestradiol 30µg-Drospirenone
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring ethinylestradiol 30µg-drospirenone, flow-mediated dilatation, endothelial dysfunction, hsCRP, metformin, polycystic ovary syndrome
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
Sites / Locations
- Clinic of Endocrinology
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Metformin+Drospirenone / EE 30µg
Arm Description
Outcomes
Primary Outcome Measures
flow-mediated dilation
Secondary Outcome Measures
endothelin-1
hsCRP
insulin resistance indices
body composition
lipid profile
total testosterone
sex hormone-binding globulin
systolic blood pressure and diastolic blood pressure
Full Information
NCT ID
NCT01459445
First Posted
October 18, 2011
Last Updated
October 23, 2011
Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT01459445
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Endothelial Dysfunction
Keywords
ethinylestradiol 30µg-drospirenone, flow-mediated dilatation, endothelial dysfunction, hsCRP, metformin, polycystic ovary syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metformin+Drospirenone / EE 30µg
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Metformin, Ethinylestradiol 30µg-Drospirenone
Other Intervention Name(s)
metformin, yasmin
Intervention Description
Metformin: 1700 mg /day (twice per day)-6 months; EE30µg-drospirenone: 1 tb/day, 21 days/month, 6 months
Primary Outcome Measure Information:
Title
flow-mediated dilation
Time Frame
six months
Secondary Outcome Measure Information:
Title
endothelin-1
Time Frame
six months
Title
hsCRP
Time Frame
six months
Title
insulin resistance indices
Time Frame
six months
Title
body composition
Time Frame
six months
Title
lipid profile
Time Frame
six months
Title
total testosterone
Time Frame
six months
Title
sex hormone-binding globulin
Time Frame
six months
Title
systolic blood pressure and diastolic blood pressure
Time Frame
six months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Georgescu
Organizational Affiliation
University of Medicine and Pharmacy Iuliu Hatieganu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of Endocrinology
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400349
Country
Romania
12. IPD Sharing Statement
Citations:
PubMed Identifier
22713099
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.
Results Reference
derived
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Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome
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