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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00428311
Recruitment Status : Completed
First Posted : January 30, 2007
Last Update Posted : January 31, 2007
Information provided by:
Hospital Universitario Ramon y Cajal

January 29, 2007
January 30, 2007
January 31, 2007
April 2004
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  • 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 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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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: Female
12 Years to 45 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
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