Status:
TERMINATED
Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
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 hyper...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00884819
Start Date
December 1 2008
End Date
February 1 2015
Last Update
April 3 2015
Active Locations (1)
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1
St. Joseph's Health Care
London, Ontario, Canada, N6A 4L6