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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Magna Graecia
• Treatments: Folic Acid; Metformin; Vitamin B Complex

Criteria

Inclusion Criteria:

• PCOS

Exclusion Criteria:

• age <18 or >35 years

• BMI >35 kg/m2

• neoplastic, metabolic, hepatic, renal, and cardiovascular disorders

• Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.