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

• Sponsor: University Magna Graecia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00953355
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 40
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome; Anovulation	Drug: Folate plus metformin; Drug: Placebo plus metformin	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Effects of Metformin With or Without Folate Supplementation on Homocysteine Levels and Endothelium in Women With Polycystic Ovary Syndrome
• Study Start Date: Jan 1, 2004
• Actual Study Completion Date: May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Folate Folate plus metformin	Drug: Folate plus metformin; A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily).
Placebo Comparator: Placebo Placebo plus metformin	Drug: Placebo plus metformin; A six-month course of metformin (1700 mg daily) plus placebo

Outcome Measures

Primary Outcome Measures

1. Endothelial structure and function [six months]

Secondary Outcome Measures

1. Clinical outcome Metabolic outcome Endocrine outcome [six months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	"Pugliese" Hospital	Catanzaro		Italy

Sponsors and Collaborators

• University Magna Graecia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00953355
• Other Study ID Numbers: 07/009
• First Posted: Aug 6, 2009
• Last Update Posted: Nov 3, 2010
• Last Verified: Aug 1, 2009

• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Anovulation; Syndrome; Metformin

Study Results

No Results Posted as of Nov 3, 2010