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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Iuliu Hatieganu University of Medicine and Pharmacy.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Carmen Georgescu, Iuliu Hatieganu University of Medicine and Pharmacy Identifier:
First received: October 18, 2011
Last updated: October 23, 2011
Last verified: October 2011
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

Resource links provided by NLM:

Further study details as provided by Iuliu Hatieganu University of Medicine and Pharmacy:

Primary Outcome Measures:
  • flow-mediated dilation [ Time Frame: six months ]

Secondary Outcome Measures:
  • endothelin-1 [ Time Frame: six months ]
  • hsCRP [ Time Frame: six months ]
  • insulin resistance indices [ Time Frame: six months ]
  • body composition [ Time Frame: six months ]
  • lipid profile [ Time Frame: six months ]
  • total testosterone [ Time Frame: six months ]
  • sex hormone-binding globulin [ Time Frame: six months ]
  • systolic blood pressure and diastolic blood pressure [ Time Frame: six months ]

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:
  • metformin
  • yasmin

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.

Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes 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
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Please refer to this study by its identifier: NCT01459445

Clinic of Endocrinology
Cluj-Napoca, Cluj, Romania, 400349
Sponsors and Collaborators
Iuliu Hatieganu University of Medicine and Pharmacy
Principal Investigator: Carmen Georgescu University of Medicine and Pharmacy Iuliu Hatieganu
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Carmen Georgescu, Associated Professor, Iuliu Hatieganu University of Medicine and Pharmacy Identifier: NCT01459445     History of Changes
Other Study ID Numbers: IuliuHatieganuU246
PNCDI II 41_068/2007 ( Other Grant/Funding Number: Romanian Ministry of Education and Research )
Study First Received: October 18, 2011
Last Updated: October 23, 2011

Keywords provided by Iuliu Hatieganu University of Medicine and Pharmacy:
ethinylestradiol 30µg-drospirenone
flow-mediated dilatation
endothelial dysfunction
polycystic ovary syndrome

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Ethinyl Estradiol
Drospirenone and ethinyl estradiol combination
Hypoglycemic Agents
Physiological Effects of Drugs
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Natriuretic Agents
Reproductive Control Agents processed this record on April 28, 2017