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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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Drug: Ethynyl-estradiol plus cyproterone acetate Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Cardiovascular Risk Profile Associated With The Polycystic Ovary Syndrome And With Ovulatory Hyperandrogenism, And Its Changes During Treatment With Metformin Or Oral Contraceptives
Study Start Date : April 2004
Study Completion Date : October 2006

Primary Outcome Measures :
  1. Serum androgen levels
  2. Lipid profiles
  3. Blood pressure
  4. Cardiovascular performance
  5. Non-classic cardiovascular risk markers
  6. Indexes of insulin secretion and sensitivity

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00428311

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Department of Endocrinology, Hospital Ramón y Cajal
Madrid, Spain, E-28034
Sponsors and Collaborators
Hospital Universitario Ramon y Cajal
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Principal Investigator: Héctor F Escobar-Morreale, MD, PhD Hospital Universitario Ramón y Cajal
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00428311    
Other Study ID Numbers: ENDOPCOS 01/2003
First Posted: January 30, 2007    Key Record Dates
Last Update Posted: January 31, 2007
Last Verified: January 2007
Keywords provided by Hospital Universitario Ramon y Cajal:
Polycystic ovary syndrome
Cardiovascular risk
Chronic inflammation
Cyproterone acetate
Oral contraceptives
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Cyproterone Acetate
Ethinyl Estradiol
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents
Reproductive Control Agents