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

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ClinicalTrials.gov Identifier: NCT00953355
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : November 3, 2010
Sponsor:
Information provided by:
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.


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 Type : Interventional  (Clinical Trial)
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 : January 2004
Actual Study Completion Date : May 2007


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



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

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


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953355


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

Publications of Results:
ClinicalTrials.gov Identifier: NCT00953355     History of Changes
Other Study ID Numbers: 07/009
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: November 3, 2010
Last Verified: August 2009

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