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

This study has been completed.
Sponsor:
Information provided by:
University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00953355
First received: August 5, 2009
Last updated: November 2, 2010
Last verified: August 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical outcome Metabolic outcome Endocrine outcome [ Time Frame: six months ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00953355

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

Publications:
ClinicalTrials.gov Identifier: NCT00953355     History of Changes
Other Study ID Numbers: 07/009
Study First Received: August 5, 2009
Last Updated: November 2, 2010
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Anovulation
Polycystic Ovary Syndrome
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Folic Acid
Metformin
Vitamin B Complex
Growth Substances
Hematinics
Hematologic Agents
Hypoglycemic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014