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

This study has been completed.
Information provided by:
University Magna Graecia Identifier:
First received: August 5, 2009
Last updated: November 2, 2010
Last verified: August 2009

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 Intervention Phase
Polycystic Ovary Syndrome Anovulation Drug: Folate plus metformin Drug: Placebo plus metformin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Endothelial structure and function [ Time Frame: six months ]

Secondary Outcome Measures:
  • Clinical outcome Metabolic outcome Endocrine outcome [ Time Frame: six months ]

Enrollment: 50
Study Start Date: January 2004
Study Completion Date: May 2007
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
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.
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Please refer to this study by its identifier: NCT00953355

"Pugliese" Hospital
Catanzaro, Italy
Sponsors and Collaborators
University Magna Graecia
  More Information

Publications: Identifier: NCT00953355     History of Changes
Other Study ID Numbers: 07/009
Study First Received: August 5, 2009
Last Updated: November 2, 2010

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Folic Acid
Vitamin B Complex
Hypoglycemic Agents
Physiological Effects of Drugs
Growth Substances processed this record on August 21, 2017