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Trial record 9 of 101 for:    ETHINYL ESTRADIOL AND DROSPIRENONE

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

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ClinicalTrials.gov Identifier: NCT01459445
Recruitment Status : Unknown
Verified October 2011 by Carmen Georgescu, Iuliu Hatieganu University of Medicine and Pharmacy.
Recruitment status was:  Active, not recruiting
First Posted : October 25, 2011
Last Update Posted : October 25, 2011
Sponsor:
Information provided by (Responsible Party):
Carmen Georgescu, Iuliu Hatieganu University of Medicine and Pharmacy

Tracking Information
First Submitted Date  ICMJE October 18, 2011
First Posted Date  ICMJE October 25, 2011
Last Update Posted Date October 25, 2011
Study Start Date  ICMJE February 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2011)
flow-mediated dilation [ Time Frame: six months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome
Official Title  ICMJE Metformin Plus EE30µg-drospirenone and Weight Loss- Impact on Endothelial Function and hsCRP Levels in PCOS
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Polycystic Ovary Syndrome
  • Endothelial Dysfunction
Intervention  ICMJE 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
Study Arms  ICMJE Metformin+Drospirenone / EE 30µg
Intervention: Drug: Metformin, Ethinylestradiol 30µg-Drospirenone
Publications * Ilie IR, Marian I, Mocan T, Ilie R, Mocan L, Duncea I, Pepene CE. Ethinylestradiol30μg-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 23, 2011)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2012
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Romania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01459445
Other Study ID Numbers  ICMJE IuliuHatieganuU246
PNCDI II 41_068/2007 ( Other Grant/Funding Number: Romanian Ministry of Education and Research )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carmen Georgescu, Iuliu Hatieganu University of Medicine and Pharmacy
Study Sponsor  ICMJE Iuliu Hatieganu University of Medicine and Pharmacy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carmen Georgescu University of Medicine and Pharmacy Iuliu Hatieganu
PRS Account Iuliu Hatieganu University of Medicine and Pharmacy
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP