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

Not Applicable

Terminated

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: Placebo; Drug: Fenofibrate

• Registration Number: NCT00884819
• Lead Sponsor: Lawson Health Research Institute

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-21
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-01
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo match for 6 months
1	Fenofibrate	fenofibrate 200mg/daily for 6 months

Primary Outcome Measures

Name	Time	Method
Hepatic adiposity as assessed using MRI	6-months

Secondary Outcome Measures

Name	Time	Method
Body composition using bioelectrical impedance analysis (BIA), anthropometry (skin-fold thickness measurement), and MRI	6-months
Biochemical parameters related to insulin resistance (adipocytokines, free fatty acids, 25-hydroxyvitamin D)	6 months
Insulin resistance using HOMA-IR	6 months
Traditional and non-traditional cardiovascular risk factors (lipids, apolipoproteins, fibrinogen, PAI-1, CRP)	6 months
Reproductive parameters (androgens, hirsutism)	6 months

Trial Locations

Locations (1)

St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada