Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome. A Randomized, Double-Blind, Placebo-Controlled Trial
Inclusion Criteria:
- premenopausal women ≥ 18 years
- diagnosis of PCOS based on the recent 2006 Androgen Excess Society criteria (modified
from Rotterdam 2003)
- waist circumference >88 cm
- fasting TG 2.0 - 5.0 mmol/L
- stable on any type of oral contraceptive for a minimum of 3-months
Exclusion Criteria:
- known contraindications for MRI
- pregnancy, lactation, desire to become pregnant
- participation in another clinical trial
- fasting TF level ≥ 5.0 mmol/L
- AST or ALT > 2.5 times upper limit of normal (ULN)
- creatinine kinase (CK) > 6x ULN
- creatinine > 115 μmol/L
- fasting glucose ≥ 7.0 mmol/L and/or 2h glucose post oral glucose tolerance test
(OGTT) ≥ 11.1 mmol/L or personal history of DM2
- personal history of renal disease, liver disease (except NAFLD), or heart disease
- body mass index (BMI) < 18 or > 40 kg/m²
- increased alcohol use (>9 standard drinks per week [standard drink = 12oz beer, 5oz
wine, or 1.5oz spirits]) or drug use
- use of other hormonal contraception, growth hormone, glucocorticoids,
anti-diabetic/anti-dyslipidemia medications, or anabolic steroids.