drugset / Trial / NCT00953355

Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients

NCT00953355

Phase 4 Completed 50 enrolled University Magna Graecia
Non-randomizedParallel-groupDouble-blindPrevention

Summary

Context: Metformin administration in women with polycystic ovary syndrome (PCOS) improves hormonal and metabolic patterns with beneficial effects in terms of reproductive outcomes and intermediate cardiovascular disease risk factors. Furthermore, reduced folate and vitamin B12, and increased homocysteine (Hcy) levels have been found in type-2 diabetes mellitus patients treated with metformin. Objective: To evaluate if metformin administration exerts any effects on Hcy levels, and if folate supplementation may improve endothelial structure and function in PCOS patients.

Timeline

Start
2004-01
Primary completion
Completion
2007-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 1700 mg
Subject folic acid Other / unclassified 400 ug