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

Study Overview
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Brief Summary
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Fenofibrate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>fenofibrate 200mg/daily for 6 months | Drug: Fenofibrate<br>* fenofibrate 200 mg daily for 6-months<br>|
| Placebo Comparator: 2<br>Placebo match for 6 months | Other: Placebo<br>* Placebo match for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic adiposity as assessed using MRI |  | 6-months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polycystic ovary syndrome, hepatic adiposity, diabetes, hormones, cardiovascular disease