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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Iuliu Hatieganu University of Medicine and Pharmacy.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Carmen Georgescu, Iuliu Hatieganu University of Medicine and Pharmacy
ClinicalTrials.gov Identifier:
NCT01459445
First received: October 18, 2011
Last updated: October 23, 2011
Last verified: October 2011
  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

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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:
  • 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.

  Eligibility

Ages Eligible for Study:   15 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459445

Locations
Romania
Clinic of Endocrinology
Cluj-Napoca, Cluj, Romania, 400349
Sponsors and Collaborators
Iuliu Hatieganu University of Medicine and Pharmacy
Investigators
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
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 31, 2014