drugset / Trial / NCT00428311

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

NCT00428311

Phase 4 Completed 50 enrolled Hospital Universitario Ramon y Cajal
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2004-04
Primary completion
Completion
2006-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 850 mg Oral
Subject cyproterone acetate Small molecule 2 mg Oral
Subject ethynylestradiol Unknown 35 ug Oral