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

NCT00953355 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-11-03

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome
  • Anovulation

Interventions

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

Sponsors & Collaborators

  • University Magna Graecia

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Completion
2007-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00953355 on ClinicalTrials.gov