NCT00428311

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: Female
• Age: 12 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Metformin
DRUG	Ethynyl-estradiol plus cyproterone acetate

Timeline

• Start date: 2004-04-01
• Completion: 2006-10-01
• First posted: 2007-01-30
• Last updated: 2007-01-31

Locations

1 site across 1 country: Spain