drugset / Trial / NCT00593294

Oral Contraceptive and Cardiovascular Risk in PCOS

NCT00593294

Phase 4 Completed 150 enrolled Federico II University
RandomizedParallel-groupDouble-blindTreatment

Summary

Oral contraceptive therapy is routinely used for the treatment of menstrual disturbances of patients with polycystic ovary syndrome (PCOS). To date, the cardiovascular risk (CVR) of the oral contraceptives (OC) are known but no data are available on the CVR in PCOS patients treated with OC or physical exercise. The purpose of this study is to compare the effects of OC to physical exercise on the CVR of PCOS women and show the hormonal and metabolic effects of these two different treatment. We hypothesize that physical exercise has the same beneficial effects of OC therapy on hormonal and metabolic features of PCOS women with less cardiovascular consequences.

Timeline

Start
2006-01
Primary completion
2007-09
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator drospirenone Unknown 3 mg Oral
Comparator ethynylestradiol Unknown 30 ug Oral