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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2015-02-28

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.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

fenofibrate 200mg/daily for 6 months

Group Type EXPERIMENTAL

Fenofibrate

Intervention Type DRUG

fenofibrate 200 mg daily for 6-months

2

Placebo match for 6 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo match for 6 months

Interventions

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Fenofibrate

fenofibrate 200 mg daily for 6-months

Intervention Type DRUG

Placebo

Placebo match for 6 months

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No