drugset / Trial / NCT01581814

Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome

NCT01581814

Phase 3 Completed 99 enrolled Catholic University of the Sacred Heart
RandomizedParallel-groupTriple-blindTreatment

Summary

To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic PCOS patients

Timeline

Start
2008-10
Primary completion
2011-07
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 500 mg
Comparator drospirenone Unknown 3 mg Oral
Comparator ethinyl estradiol Small molecule 0.03 mg Oral