Effects of Metformin With or Without Folate Supplementation on Homocysteine Levels and Endothelium in Women With Polycystic Ovary Syndrome
18 Years
35 Years
Female
Polycystic Ovary Syndrome, Anovulation
Trial Information
Effects of Metformin With or Without Folate Supplementation on Homocysteine Levels and Endothelium in Women With Polycystic Ovary Syndrome
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Endothelial structure and function
Outcome Time Frame:
six months
Safety Issue:
No
Authority:
Italy: The Italian Medicines Agency
Study ID:
07/009
NCT ID:
NCT00953355
Start Date:
January 2004
Completion Date:
May 2007
Related Keywords:
- Polycystic Ovary Syndrome
- Anovulation
- Anovulation
- Polycystic Ovary Syndrome
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