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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Hospital Universitario Ramon y Cajal

Current Primary Outcome:

  • Serum androgen levels
  • Lipid profiles
  • Blood pressure
  • Cardiovascular performance
  • Non-classic cardiovascular risk markers
  • Indexes of insulin secretion and sensitivity


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hospital Universitario Ramon y Cajal

Dates:
Date Received: January 29, 2007
Date Started: April 2004
Date Completion: October 2006
Last Updated: January 30, 2007
Last Verified: January 2007