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Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT00428311
First received: January 29, 2007
Last updated: January 30, 2007
Last verified: January 2007

January 29, 2007
January 30, 2007
April 2004
Not Provided
  • Serum androgen levels
  • Lipid profiles
  • Blood pressure
  • Cardiovascular performance
  • Non-classic cardiovascular risk markers
  • Indexes of insulin secretion and sensitivity
Same as current
Complete list of historical versions of study NCT00428311 on ClinicalTrials.gov Archive Site
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Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS
The Cardiovascular Risk Profile Associated With The Polycystic Ovary Syndrome And With Ovulatory Hyperandrogenism, And Its Changes During Treatment With Metformin Or Oral Contraceptives

Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting with the polycystic ovary syndrome - in association with insulin resistance, obesity, and other metabolic disorders.

The present clinical trial intends to compare the effects of oral contraceptives and metformin on PCOS patients, focusing on classic and non-classic cardiovascular risk markers and indexes of cardiovascular performance, in order to whether or not, as suspected by previous data obtained in non-hyperandrogenic women, oral contraceptives worsen the cardiovascular risk profile of PCOS women, favoring the use of metformin if the latter actually ameliorates such a risk.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • Drug: Metformin
  • Drug: Ethynyl-estradiol plus cyproterone acetate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2006
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Inclusion Criteria:

  • Women of fertile age presenting with PCOS
  • Non-hyperandrogenic women of fertile age (these women will not receive the interventions and will serve only to obtain normative data for some variables)

Exclusion Criteria:

  • Severe disease not related to the condition under study
  • Pregnancy
  • Medical or surgical treatment of PCOS during the previous 3 months
  • Contraindication for the use of oral contraceptives or metformin
  • Inability to understand the proposal of the study precluding effective informed consent
  • Minors who are not accompanied by their legal representative
Female
12 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00428311
ENDOPCOS 01/2003
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Hospital Universitario Ramon y Cajal
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Principal Investigator: Héctor F Escobar-Morreale, MD, PhD Hospital Universitario Ramón y Cajal
Hospital Universitario Ramon y Cajal
January 2007

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