Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome

Official Title: “Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome. A Randomized, Double-Blind, Placebo-Controlled Trial”

This is a prospective randomized, double-blind placebo-controlled trial of 6 months' duration evaluating the effect of fenofibrate (200 mg/day) in females with polycystic ovary syndrome and mild hypertriglyceridemia. The investigators primary objective will be to determine whether fenofibrate will reduce hepatic adiposity as measured using MRI, and our secondary outcomes will be to delineate the impact of fenofibrate on biochemical or clinical parameters for insulin resistance, cardiovascular disease, and reproductive status.

Intervention(s) in this Clinical Trial

• Drug: Fenofibrate
  • fenofibrate 200 mg daily for 6-months
• Other: Placebo
  • Placebo match for 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • fenofibrate 200mg/daily for 6 months
• Placebo Comparator: 2
  • Placebo match for 6 months

Primary Measures

• Hepatic adiposity as assessed using MRI
  • Time Frame: 6-months
    Safety Issue?: No

Secondary Measures

• Body composition using bioelectrical impedance analysis (BIA), anthropometry (skin-fold thickness measurement), and MRI
  • Time Frame: 6-months
    Safety Issue?: No
• Insulin resistance using HOMA-IR
  • Time Frame: 6 months
    Safety Issue?: No
• Biochemical parameters related to insulin resistance (adipocytokines, free fatty acids, 25-hydroxyvitamin D)
  • Time Frame: 6 months
    Safety Issue?: No
• Traditional and non-traditional cardiovascular risk factors (lipids, apolipoproteins, fibrinogen, PAI-1, CRP)
  • Time Frame: 6 months
    Safety Issue?: No
• Reproductive parameters (androgens, hirsutism)
  • Time Frame: 6 months
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Lawson Health Research Institute Other

Overall Clinical Trial Officials and Contacts

Tisha Joy, MD FRCPC Principal Investigator St. Joseph's Health Care, Department of Medicine  

Overall Contact: Tisha Joy, MD FRCPC 519-646-6296 tisha.joy@sjhc.london.on.ca

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00884819

Study ID Number: R-08-573

ClinicalTrials.gov Identifier: NCT00884819

Health Authority: Canada: Ethics Review Committee