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
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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
U.S. FDA Resources
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
- Endothelial structure and function [ Time Frame: six months ]
- Clinical outcome Metabolic outcome Endocrine outcome [ Time Frame: six months ]
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