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

Polycystic Ovary Syndrome Clinical Trial

Official title:

Metformin Plus EE30µg-drospirenone and Weight Loss- Impact on Endothelial Function and hsCRP Levels in PCOS

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01459445
• Other study ID #: IuliuHatieganuU246
• Secondary ID: PNCDI II 41_068/
• Status: Active, not recruiting
• Phase: N/A
• First received: October 18, 2011
• Last updated: October 23, 2011
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: October 2011
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: January 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 35 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Polycystic Ovary Syndrome

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

Locations

Country	Name	City	State
Romania	Clinic of Endocrinology	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	flow-mediated dilation		six months	Yes
Secondary	endothelin-1		six months	Yes
Secondary	hsCRP		six months	Yes
Secondary	insulin resistance indices		six months	Yes
Secondary	body composition		six months	Yes
Secondary	lipid profile		six months	Yes
Secondary	total testosterone		six months	Yes
Secondary	sex hormone-binding globulin		six months	Yes
Secondary	systolic blood pressure and diastolic blood pressure		six months	Yes