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Metformin and Folate in Pregnant Polycystic Ovary Syndrome(PCOS) Women

NCT01115140 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-05-24

No results posted yet for this study

Summary

A more recent prospective nonrandomized placebo-controlled double-blind clinical study demonstrated that metformin exerts a slight but significant deleterious effect on serum homocysteine (Hcy) levels in patients with PCOS, and supplementation with folate is useful to increase the beneficial effect of metformin on the vascular endothelium.

Conditions

  • Pregnancy
  • Polycystic Ovary Syndrome

Interventions

DRUG

metformin plus placebo

metformin 850 mg cp, 2 cps daily

DRUG

Metformin plus folic acid

metformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily

DRUG

placebo plus folic acid

Placebo 1 cp daily plus folic acid 0.4 mg daily

DRUG

placebo alone

placebo cp, 2 cps daily

Sponsors & Collaborators

  • University Magna Graecia

    lead OTHER

Principal Investigators

  • Fulvio Zullo, MD · Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

  • Stefano Palomba, MD · Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-05-31
Completion
2011-05-31

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 NCT01115140 on ClinicalTrials.gov