drugset / Trial / NCT00953355
Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 1700 mg | — |
| Subject | folic acid | Other / unclassified | 400 ug | — |