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

Lawson Health Research Institute

Status: Terminated

Conditions: Polycystic Ovary Syndrome

Treatments: Other: Placebo; Drug: Fenofibrate

Study type: Interventional

Funder types: Other

Identifiers

NCT00884819

15581 (Other Identifier)

R-08-573

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

fenofibrate 200mg/daily for 6 months

Treatment:

Drug: Fenofibrate

2

Placebo Comparator group

Description:

Placebo match for 6 months

Treatment:

Other: Placebo