Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients
Overview[ - collapse ][ - ]
| 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 | Polycystic Ovary Syndrome Anovulation |
| Intervention | Drug: Folate plus metformin Drug: Placebo plus metformin |
| Phase | Phase 4 |
| Sponsor | University Magna Graecia |
| Responsible Party | University Magna Graecia |
| ClinicalTrials.gov Identifier | NCT00953355 |
| First Received | August 5, 2009 |
| Last Updated | November 2, 2010 |
| Last verified | August 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 5, 2009 |
|---|---|
| Last Updated Date | November 2, 2010 |
| Start Date | January 2004 |
| Estimated Primary Completion Date | May 2007 |
| Current Primary Outcome Measures | Endothelial structure and function [Time Frame: six months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Clinical outcome Metabolic outcome Endocrine outcome [Time Frame: six months] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients |
|---|---|
| Official Title | Effects of Metformin With or Without Folate Supplementation on Homocysteine Levels and Endothelium in Women With Polycystic Ovary Syndrome |
| 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. |
| 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 |
| Study Phase | Phase 4 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention |
| Condition |
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| Intervention | Drug: Folate plus metformin A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily). Drug: Placebo plus metformin A six-month course of metformin (1700 mg daily) plus placebo |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 50 |
| Estimated Completion Date | May 2007 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility 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. |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Italy |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00953355 |
|---|---|
| Other Study ID Numbers | 07/009 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | University Magna Graecia |
| Study Sponsor | University Magna Graecia |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | August 2009 |
Locations[ + expand ][ + ]
| "Pugliese" Hospital | Catanzaro, Italy |
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