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

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome; Anovulation
• Interventions: Drug: Folate plus metformin; Drug: Placebo plus metformin

• Registration Number: NCT00953355
• Lead Sponsor: University Magna Graecia

Brief 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.

Detailed Description

Fifty patients affected by PCOS without additional metabolic or cardiovascular diseases grouped in two age- and body mass index-matched treatment arms.

Interventions: A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily) (experimental group, n=25) or placebo (control group, n=25) supplementation.

In each patient were evaluated: Complete hormonal and metabolic patterns, serum Hcy, folate, vitamin B12, and endothelin-1 (ET-1) concentrations, brachial artery diameter at baseline (BAD-B) and after reactive hyperemia (BAD-RH), flow-mediated dilation (FMD), and intima-media thickness (IMT) on both common carotid arteries.

Study Timeline

• Study Start: 2004-01
• Study Completion: 2007-05
• Status Verified: 2009-08
• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Last Update Submitted: 2010-11-02
• Last Update Posted: 2010-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Folate	Folate plus metformin	Folate plus metformin
Placebo	Placebo plus metformin	Placebo plus metformin

Primary Outcome Measures

Name	Time	Method
Endothelial structure and function	six months

Secondary Outcome Measures

Name	Time	Method
Clinical outcome Metabolic outcome Endocrine outcome	six months

Trial Locations

Locations (1)

"Pugliese" Hospital; 🇮🇹 Catanzaro, Italy